clinicaltrials.gov search results...
TRANSCRIPT
- Page 1 of 56 -
ClinicalTrials.gov Search Results 08/15/2018
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
1 NCT03613038 A Systematic Investigation ofPhonetic Complexity Effects onArticulatory Motor Performancein Progressive Dysarthria
Study Documents:
Title Acronym:
Other Ids:
•1209643
•1R15DC016383-01
Recruiting •AmyotrophicLateral Sclerosis
•Parkinson Disease
•Behavioral:Phoneticcomplexity effectson speech motorperformance
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: BasicScience
Outcome Measures:
•Peak movement speed
•Range of movement
•Duration
•Spatiotemporal movementvariability (STI)
•Inter-articulatorcoordination
Enrollment:
150
Age:
19 Years to 90Years (Adult,Older Adult)
Sex:
All
•Universityof Missouri-Columbia
•National Instituteon Deafnessand OtherCommunicationDisorders(NIDCD)
•Other
•NIH
Study Start:
July 15, 2017
Primary Completion:
January 31, 2020
Study Completion:
July 14, 2020
First Posted:
August 2, 2018
Results First Posted:
No Results Posted
Last Update Posted:
August 3, 2018
•University of Kansas MedicalCenter, Fairway, Kansas,United States
•University of Missouri-Columbia, Columbia, Missouri,United States
2 NCT03519880 A Pilot Study of the Utility of 3DPrinted Masks for ALS Subjects
Study Documents:
Title Acronym:
Other Ids:
HUM00112433
Enrolling byinvitation
•AmyotrophicLateral Sclerosis
•Device: CustomMask Interface
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: DeviceFeasibility
Outcome Measures:
•Average number of hoursthe custom NIV maskinterface is used per night
•Leak parameters fromdevice
•Tidal volumemeasurements
•Interviews with subjectsregarding their experiencewith the custom maskQualitative assessment ofcustom NIV mask efficacy
Enrollment:
40
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofMichigan
•ALS Association
•Other Study Start:
March 14, 2017
Primary Completion:
April 2020
Study Completion:
April 2021
First Posted:
May 9, 2018
Results First Posted:
No Results Posted
Last Update Posted:
May 9, 2018
•Michigan Medicine, Ann Arbor,Michigan, United States
- Page 2 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
3 NCT03520517 Open-label Study to EvaluateSafety, Tolerability and PK ofBHV-0223 in ALS
Study Documents:
Title Acronym:
Other Ids:
BHV0223-103
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•ALS
•Lou Gehrig Disease
•Lou Gehrig'sDisease
•Lou-GehrigsDisease
•Motor NeuronDisease,AmyotrophicLateral Sclerosis
•Drug: BHV-0223 Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Incidence of TreatmentEmergent Adverse Events(Safety and Tolerability)
•BHV-0223 Concentrationsin Blood at Days 1, 29 and57
Enrollment:
22
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•BiohavenPharmaceuticals,Inc.
•CognitiveResearchCorporation
•Industry Study Start:
February 2, 2018
Primary Completion:
October 31, 2018
Study Completion:
October 31, 2018
First Posted:
May 9, 2018
Results First Posted:
No Results Posted
Last Update Posted:
August 6, 2018
•Holy Cross NeuroscienceResearch Institute, FortLauderdale, Florida, UnitedStates
•Somnos/Neurology AssociatesClinical Research, Lincoln,Nebraska, United States
•Neurosciences Institute,Neurology - Charlotte,Charlotte, North Carolina,United States
•Wesley Neurology Clinic,Cordova, Tennessee, UnitedStates
•Texas Neurology, Dallas,Texas, United States
4 NCT03516994 Reducing Disparities in theQuality of Advance CarePlanning for Older Adults
Study Documents:
Title Acronym:
EQUALACP
Other Ids:
•Pro00091633
•OLC-1609-36381
Not yetrecruiting
•Metastatic Cancer
•Congestive HeartFailure
•Chronic ObstructivePulmonary Disease
•Parkinson Disease
•Interstitial LungDisease
•AmyotrophicLateral Sclerosis
•End Stage LiverDisease
•End Stage RenalDisease
•DiabetesComplications
•Behavioral:RespectingChoices First Steps
•Behavioral: FiveWishes Form
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: None (OpenLabel)
•Primary Purpose: Other
Outcome Measures:
•Proportion of AfricanAmericans who completeadvance care planning
•Proportion of Whites whocomplete advance careplanning
•Difference in Proportionof Whites versus AfricanAmericans who completeadvance care planning
•Patient Readiness toEngage in Advance CarePlanning
•Patient Quality of Life
Enrollment:
800
Age:
65 Years and older (Older Adult)
Sex:
All
•Duke University •Other Study Start:
August 1, 2018
Primary Completion:
September 1, 2022
Study Completion:
September 1, 2022
First Posted:
May 7, 2018
Results First Posted:
No Results Posted
Last Update Posted:
May 8, 2018
•University of Alabama atBirmingham, Birmingham,Alabama, United States
•Emory University, Atlanta,Georgia, United States
•University of South Carolina,Columbia, South Carolina,United States
•University of TexasSouthwestern, Dallas, Texas,United States
- Page 3 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
5 NCT03506425 A Pilot Trial of Triheptanoin forPeople With Amyotrophic LateralSclerosis (PALS)
Study Documents:
Title Acronym:
Other Ids:
Pro00092250
Recruiting •ALS •Drug: Triheptanoin Study Type:
Interventional
Phase:
•Phase 1
•Phase 2
Study Design:
•Allocation: Non-Randomized
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•ALSFRS-R slope ontreatment compared to pre-treatment
•Magnetic ResonanceSpectroscopy
•Oxidative Stress Markers
Enrollment:
10
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Richard Bedlack,M.D., Ph.D.
•UltragenyxPharmaceuticalInc
•Duke University
•Other
•Industry
Study Start:
June 21, 2018
Primary Completion:
February 2019
Study Completion:
February 2019
First Posted:
April 24, 2018
Results First Posted:
No Results Posted
Last Update Posted:
August 13, 2018
•Duke University, Durham, NorthCarolina, United States
- Page 4 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
6 NCT03505021 Effects of Oral Levosimendan(ODM-109) on RespiratoryFunction in Patients With ALS
Study Documents:
Title Acronym:
REFALS
Other Ids:
3119002
Recruiting •AmyotrophicLateral Sclerosis
•Drug:Levosimendan
•Drug: Placebo forlevosimendan
Study Type:
Interventional
Phase:
Phase 3
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Supine slow vital capacitySVC
•Combined assessment ofRevised ALS FunctionalRating Scale ALSFRS-R function and survivalthrough 48 weeks
•Time to respiratory eventthrough 48 weeks
•Clinical Global ImpressionCGI at 48 weeks
•Change from baselinein respiratory function ofALSFRS-R at 48 weeks
Enrollment:
450
Age:
18 Years to 120Years (Adult,Older Adult)
Sex:
All
•OrionCorporation,Orion Pharma
•Industry Study Start:
June 21, 2018
Primary Completion:
August 30, 2020
Study Completion:
October 30, 2020
First Posted:
April 20, 2018
Results First Posted:
No Results Posted
Last Update Posted:
July 17, 2018
•Neuromuscular ResearchCenter and NeuromuscularClinic of Arizona, Phoenix,Arizona, United States
•Colorado Springs NeurologicalAssociates, Colorado Springs,Colorado, United States
•Hospital of Special Care, NewBritain, Connecticut, UnitedStates
•The George WashingtonMedical Faculty Associates -Foggy Bottom North Pavilion,Washington, District ofColumbia, United States
•Providence Holy Cross MedicalCenter, Fort Lauderdale,Florida, United States
•University of Florida Health- Jacksonville, Jacksonville,Florida, United States
•University of South Florida,Tampa, Florida, United States
•Emory University School ofMedicine, Atlanta, Georgia,United States
•University of KentuckyChandler Medical Center,Lexington, Kentucky, UnitedStates
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•and 36 more
- Page 5 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
7 NCT03488524 Open Label Extension Study ofAMX0035 in Patients With ALS
Study Documents:
Title Acronym:
CENTAUR-OLE
Other Ids:
AMX-3500-OLE
Recruiting •AmyotrophicLateral Sclerosis
•ALS
•Drug: AMX0035 Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Quantity of adverse eventsand serious adverseevents observed in thestudy
•Hospitalizations
•Rate of Progression onthe Amyotrophic LateralSclerosis Rating ScaleRevised (ALSFRS-R)
•Rate of Progressionon ATLIS StrengthMeasurement
•Rate of Progression onSlow Vital Capacity
•Gastric Tube Frequency
•Permanent InvasiveVentilation
Enrollment:
132
Age:
Child, Adult, OlderAdult
Sex:
All
•AmylyxPharmaceuticalsInc.
•MassachusettsGeneral HospitalNeurologyClinicalResearchInstitute
•Industry
•Other
Study Start:
March 29, 2018
Primary Completion:
January 1, 2020
Study Completion:
January 1, 2020
First Posted:
April 5, 2018
Results First Posted:
No Results Posted
Last Update Posted:
April 13, 2018
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•University of MassachusettsMemorial Medical Center,Worcester, Massachusetts,United States
8 NCT03489278 Clinical Procedures to SupportResearch
Study Documents:
Title Acronym:
CAPTURE
Other Ids:
•20170785
•U54NS092091
Recruiting •AmyotrophicLateral Sclerosis
•ALS-FrontotemporalDementia
•Primary LateralSclerosis
•ProgressiveMuscular Atrophy
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
Using the ALS Toolkitfor collecting and usingelectronic health recorddata for research purposes
Enrollment:
1200
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofMiami
•MuscularDystrophyAssociation
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•National Centerfor AdvancingTranslationalScience(NCATS)
•NationalInstitutes ofHealth (NIH)
•Other
•NIH
Study Start:
February 15, 2018
Primary Completion:
January 2021
Study Completion:
January 2021
First Posted:
April 5, 2018
Results First Posted:
No Results Posted
Last Update Posted:
April 5, 2018
•California Pacific MedicalCenter, San Francisco,California, United States
•University of Miami, Miami,Florida, United States
- Page 6 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
9 NCT03474263 IC14 for Rapidly ProgressiveAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
Other Ids:
ALS02
Not yetrecruiting
•AmyotrophicLateral Sclerosis
•Biological: Biologic:IC14 (monoclonalantibody againsthuman CD14)
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Glial Activation
•Serum neurofilament
•Urinary p75 neurotrophinreceptor
•Safety
•Immunogenicity
•Pharmacokinetics
•Pharmacodynamics
Enrollment:
20
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
• ImplicitBioscience
•MassachusettsGeneral Hospital
• Industry
•Other
Study Start:
September 1, 2018
Primary Completion:
April 12, 2020
Study Completion:
July 12, 2020
First Posted:
March 22, 2018
Results First Posted:
No Results Posted
Last Update Posted:
April 18, 2018
•Neurological Clinical ResearchInstitute (NCRI), Boston,Massachusetts, United States
10 NCT03472950 Safety and Efficacy ofRanolazine for the Treatment ofAmyotrophic Lateral Sclerosis
Study Documents:
Title Acronym:
Other Ids:
STUDY00141491
Recruiting •ALS •Drug: Ranolazine500 MG
•Drug: Ranolazine1000 MG
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Non-Randomized
•Intervention Model:Sequential Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Dose limiting toxicities(DLT)
•Cramp Questionnaire
•Fasciculation frequency onmuscle ultrasound
•Cramp potential duration
Enrollment:
20
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofKansas MedicalCenter
•Gilead Sciences
•Other
•Industry
Study Start:
June 11, 2018
Primary Completion:
June 11, 2019
Study Completion:
June 11, 2019
First Posted:
March 21, 2018
Results First Posted:
No Results Posted
Last Update Posted:
June 19, 2018
•University of Kansas MedicalCenter, Kansas City, Kansas,United States
- Page 7 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
11 NCT03464903 Study of ALS Reversals 2:Genetic Analyses
Study Documents:
Title Acronym:
StAR2
Other Ids:
•Pro00091570
•8007
Enrolling byinvitation
•AmyotrophicLateral Sclerosis
•ProgressiveMuscular Atrophy
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective: Other
Outcome Measures:
•genetic comparison
•factors associated withgenes
Enrollment:
30
Age:
Child, Adult, OlderAdult
Sex:
All
•Duke University
•ClinicalResearch in ALSand RelatedDisorders forTherapeuticDevelopment(CReATe)Consortium(funded by NIH/NCATS/NINDS)
•Other Study Start:
June 25, 2018
Primary Completion:
December 2018
Study Completion:
December 2018
First Posted:
March 14, 2018
Results First Posted:
No Results Posted
Last Update Posted:
July 30, 2018
•Duke ALS Clinic / DUSOMDept of Neurology / DUHS,Durham, North Carolina, UnitedStates
12 NCT03457753 Riluzole Oral Soluble FilmSafety and Tolerability inAmyotrophic Lateral Sclerosis
Study Documents:
Title Acronym:
Other Ids:
17MO1R-0016
Not yetrecruiting
•ALS •Drug: Riluzole OralSoluble Film
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: Other
Outcome Measures:
Change from baseline inNCI-CTC score at week 12
Enrollment:
25
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•AquestiveTherapeutics
•Inventiv Health
•Covance
•Industry
•Other
Study Start:
March 2018
Primary Completion:
September 2018
Study Completion:
October 2018
First Posted:
March 8, 2018
Results First Posted:
No Results Posted
Last Update Posted:
March 21, 2018
•University of Florida MedicalCenter, Gainesville, Florida,United States
•Neurology Associates, P.C.,Lincoln, Nebraska, UnitedStates
•Texas Neurology, P.A., Dallas,Texas, United States
- Page 8 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
13 NCT03456882 The Effect of RNS60 on ALSBiomarkers
Study Documents:
Title Acronym:
RNS60
Other Ids:
RNS60
Recruiting •AmyotrophicLateral Sclerosis
•Drug: RNS60 Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Primary Purpose: Other
Outcome Measures:
•Pharmacodynamicbiomarkers
•ALSFRS-R scale
•Survival
•Forced Vital Capacity(FVC)
•Incidence of adverse event(Tolerability) related toRNS60
•Quality of life
Enrollment:
142
Age:
18 Years to 70Years (Adult,Older Adult)
Sex:
All
•Mario NegriInstitute forPharmacologicalResearch
•ALS Association
•Get out ONLUS
•Other Study Start:
November 18, 2016
Primary Completion:
April 30, 2019
Study Completion:
April 30, 2019
First Posted:
March 7, 2018
Results First Posted:
No Results Posted
Last Update Posted:
June 8, 2018
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Azienda OpsedalieraUniversitaria ConsorzialePoliclinico- Università deglistudi di Bari, Bari, Italy
•Spedali civili di Brescia,Brescia, Italy
•ASST Valle Olona Presidioospedaliero Gallarate,Gallarate, Italy
•IRCCS Azienda OspedalieraUniversitaria San Martino IST,Genova, Italy
•Ospedale San Raffaele, Miano,Italy
•Centro Clinico NEMO -Fondazione Serena Onlus,Milano, Italy
•Presidio OspedalieroProvinciale - Nuovo OspedaleCivile "S. Agostino Estense",Modena, Italy
•Azienda OspedalieraUniversitaria della SecondaUniv. Degli Studi di Napoli(AOU-SUN), Napoli, Italy
•Azienda OspedalieroUniversitaria Maggiore dellaCarità, Novara, Italy
•and 10 more
14 NCT03449212 SOD1 Kinetics Measurements inALS Patients
Study Documents:
Title Acronym:
Other Ids:
SOD1-001
Recruiting •AmyotrophicLateral Sclerosis,Familial
•AmyotrophicLateral Sclerosis,Sporadic
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
•The primary outcomemeasurement will be thedetermination of the SOD1half-life in the CSF of eachsubject.
•ALS Functional RatingScale-Revised (ALSFRS-R)
•Slow Vital Capacity (SVC)
Enrollment:
86
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•WashingtonUniversitySchool ofMedicine
•MassachusettsGeneral Hospital
•Other Study Start:
December 2012
Primary Completion:
October 2019
Study Completion:
October 2019
First Posted:
February 28, 2018
Results First Posted:
No Results Posted
Last Update Posted:
February 28, 2018
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Washington University in St.Louis, Saint Louis, Missouri,United States
- Page 9 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
15 NCT03411863 Cervical Electrical Stimulationfor ALS
Study Documents:
Title Acronym:
Other Ids:
B2527-P
Recruiting •AmyotrophicLateral Sclerosis
•Device: CES at rest
•Device: CES plusactive hand or wristmovements
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: BasicScience
Outcome Measures:
•Electromyographicresponses (rest)
•Electromyographicresponses (active)
Enrollment:
50
Age:
21 Years to 65Years (Adult,Older Adult)
Sex:
All
•VA Office ofResearch andDevelopment
•U.S.Fed
Study Start:
January 4, 2018
Primary Completion:
December 31, 2019
Study Completion:
May 29, 2020
First Posted:
January 26, 2018
Results First Posted:
No Results Posted
Last Update Posted:
July 20, 2018
•James J. Peters VA MedicalCenter, Bronx, NY, Bronx, NewYork, United States
16 NCT03362658 Novel MRI Biomarkers forMonitoring Disease Progressionin ALS
Study Documents:
Title Acronym:
Other Ids:
RES0027887
Recruiting •AmyotrophicLateral Sclerosis
•Motor NeuronDisease
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
•Change in corticalthickness in millimetres.
•Change in DTI indices(unitless).
Enrollment:
700
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofAlberta
•University ofCalgary
•WesternUniversity,Canada
•McGill University
•University ofToronto
•University ofBritish Columbia
•Laval University
•Other Study Start:
October 2016
Primary Completion:
December 2020
Study Completion:
December 2020
First Posted:
December 5, 2017
Results First Posted:
No Results Posted
Last Update Posted:
May 14, 2018
•University of Miami, Miami,Florida, United States
•University of Calgary / HeritageMedical Research Clinic,Calgary, Alberta, Canada
•University of Alberta,Edmonton, Alberta, Canada
•University of British Columbia /GF Strong Rehab Centre,Vancouver, British Columbia,Canada
•Western University / LondonHealth Sciences Centre,London, Ontario, Canada
•University of Toronto /Sunnybrook Health SciencesCentre, Toronto, Ontario,Canada
•McGill University / MontrealNeurological Institute andHospital, Montreal, Quebec,Canada
•Laval University, Quebec City,Quebec, Canada
- Page 10 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
17 NCT03334786 Study to Evaluate Safety &Efficacy of FLX-787-ODT toTreat Fasciculations in Tongueand Appendicular Muscle inAdult Subjects With ALS
Study Documents:
Title Acronym:
Other Ids:
FLX-787-107
Recruiting •AmyotrophicLateral Sclerosis
•Fasciculation
•Drug: FLX-787-ODT
Study Type:
Interventional
Phase:
•Phase 1
•Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Change from Baseline ofDiastolic Blood Pressure inmmHg
•Change from Baseline ofSystolic Blood Pressure inmmHg
•Change from Baseline inHeart Rate in beats perminute
•Change from Baseline inRespiration Rate in breathsper minute
•Change from Baselinein Body Temperaturein degrees Celsius orFahrenheit
•Change from Baseline ofOral Cavity Examination
•Incidence of Treatment-Emergent Adverse Events
•Change from Baseline ofFasciculation Frequency
•Change from Baseline inPeak Tongue Strengthin kPa by Iowa OralPerformance Instrument
•Change from Baseline inSpeech Assessments
•Change from Baseline inSwallowing Assessments
Enrollment:
15
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Flex Pharma,Inc.
•Industry Study Start:
April 5, 2018
Primary Completion:
August 2018
Study Completion:
August 2018
First Posted:
November 7, 2017
Results First Posted:
No Results Posted
Last Update Posted:
April 11, 2018
•Beth Israel DeaconessMedical Center, Boston,Massachusetts, United States
- Page 11 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
18 NCT03330353 Chromatic Pupillometry toAssess the Melanopsin-Light Pathway in ProgressiveSupranuclear Palsy
Study Documents:
•Study Protocol and StatisticalAnalysis Plan
•Informed Consent Form
Title Acronym:
PMPSP
Other Ids:
2017p001603
Recruiting •PSP - ProgressiveSupranuclear Palsy
•PD - Parkinson'sDisease
•AD - Alzheimer'sDisease
•ALS (AmyotrophicLateral Sclerosis)
•Diagnostic Test:Pupillometry
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Maximal Pupil Constriction
•Post-illumination pupilresponse (PIPR)
Enrollment:
56
Age:
55 Years and older (Adult, OlderAdult)
Sex:
All
•MassachusettsGeneral Hospital
•NeurOptics Inc.
•University ofToronto
•Other
•Industry
Study Start:
November 1, 2017
Primary Completion:
October 1, 2019
Study Completion:
October 1, 2019
First Posted:
November 6, 2017
Results First Posted:
No Results Posted
Last Update Posted:
November 7, 2017
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
19 NCT03324399 A Study of Protein Metabolism,Microbiome and InvestigationalProbiotic Use in Patients WithALS
Study Documents:
Title Acronym:
Other Ids:
AIHG-2017.004-ALS
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•ALS
•DietarySupplement:probiotic
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Allocation: Non-Randomized
•Intervention Model: ParallelAssignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Evaluate amino acid levelsbefore and after probioticuse.
•Measure changes inquestionnaires relatingto subjective functionalassessments.
•Measure changes inQuality of Life.
•Evaluate pain levels withthe Numbered Pain Scale.
Enrollment:
15
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•AveraMcKennanHospital &University HealthCenter
•Other Study Start:
June 1, 2017
Primary Completion:
July 2019
Study Completion:
July 2019
First Posted:
October 27, 2017
Results First Posted:
No Results Posted
Last Update Posted:
June 26, 2018
•Avera Medical GroupNeurology Sioux Falls, SiouxFalls, South Dakota, UnitedStates
- Page 12 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
20 NCT03280056 Safety and Efficacy of RepeatedAdministrations of NurOwn® inALS Patients
Study Documents:
Title Acronym:
Other Ids:
BCT-002-US
Recruiting •AmyotrophicLateral Sclerosis(ALS)
•Biological:NurOwn® (MSC-NTF cells)
•Other: Placebo
Study Type:
Interventional
Phase:
Phase 3
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•To evaluate the efficacyand safety of NurOwn®(autologous MSC-NTFcells) as compared toplacebo as measured bythe amyotrophic lateralsclerosis functional ratingscale (ALSFRS-R)
•Biomarkers
Enrollment:
200
Age:
18 Years to 60Years (Adult)
Sex:
All
•Brainstorm-CellTherapeutics
•CaliforniaInstitute forRegenerativeMedicine
•Industry
•Other
Study Start:
August 28, 2017
Primary Completion:
April 30, 2019
Study Completion:
July 30, 2019
First Posted:
September 12, 2017
Results First Posted:
No Results Posted
Last Update Posted:
May 25, 2018
•University of California IrvineAlpha Stem Cell Clinic, Irvine,California, United States
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
•California Pacific MedicalCenter, San Francisco,California, United States
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•University of MassachusettsMedical School, Worcester,Massachusetts, United States
•Mayo Clinic, Rochester,Minnesota, United States
21 NCT03268603 Intrathecal Autologous Adipose-derived Mesenchymal StromalCells for Amyotrophic LateralSclerosis (ALS)
Study Documents:
Title Acronym:
Other Ids:
•15-008008
•UL1TR000135
Recruiting •ALS
•AmyotrophicLateral Sclerosis
•Drug: AutologousAdipose-derivedMesenchymalStromal Cells
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Number of Adverse Events
•Change in slope of ALSFunctional Rating Scale -Revised (ALSFRS-R)
Enrollment:
60
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Mayo Clinic
•State ofMinnesotaRegenerativeMedicineMinnesota
•Other Study Start:
October 10, 2017
Primary Completion:
December 2019
Study Completion:
December 2019
First Posted:
August 31, 2017
Results First Posted:
No Results Posted
Last Update Posted:
January 30, 2018
•Mayo Clinic in Rochester,Rochester, Minnesota, UnitedStates
- Page 13 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
22 NCT03241784 T-Regulatory Cells inAmyotrophic Lateral Sclerosis
Study Documents:
Title Acronym:
Other Ids:
Pro00013616
Active, notrecruiting
•ALS (AmyotrophicLateral Sclerosis)
•Biological:AutologousT-regulatorylymphocytes
•Biological:Interleukin-2
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Number of participants withtreatment-related adverseevents as assessed byCTCAE v4.0
•AALS (Appel ALS) Scale
•ALSFRS-R (ALSFunctional Rating Scale-Revised)
•T-Regulatory Cells
•Treg Suppression
•TH17 and Th1lymphocytes
Enrollment:
4
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Stanley H.Appel, MD
•The MethodistHospital System
•Other Study Start:
May 16, 2016
Primary Completion:
February 2018
Study Completion:
March 2018
First Posted:
August 7, 2017
Results First Posted:
No Results Posted
Last Update Posted:
March 26, 2018
•Methodist NeurologicalInstitute, Houston, Texas,United States
23 NCT03225144 Investigating ComplexNeurodegenerative DisordersRelated to Amyotrophic LateralSclerosis and FrontotemporalDementia
Study Documents:
Title Acronym:
Other Ids:
•170131
•17-N-0131
Recruiting •FrontotemporalLobar Degeneration
•Amytrophic LateralSclerosis
•ProgressiveSupranuclear Palsy
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective: Cross-Sectional
Outcome Measures:
eligibility for researchprotocols
Enrollment:
200
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•NationalInstitutes ofHealth ClinicalCenter (CC)
•NIH Study Start:
October 11, 2017
Primary Completion:
June 30, 2022
Study Completion:
June 30, 2022
First Posted:
July 21, 2017
Results First Posted:
No Results Posted
Last Update Posted:
July 11, 2018
•National Institutes of HealthClinical Center, Bethesda,Maryland, United States
- Page 14 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
24 NCT03201991 ALS Study Determining VariousBiomarkers and StrengthComparison After Exercise
Study Documents:
Title Acronym:
ADVANCE
Other Ids:
STUDY00003843
Recruiting •AmyotrophicLateral Sclerosis
•Other: ResistanceExercise Program
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Prevention
Outcome Measures:
Change in functional musclestrength
Enrollment:
7
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofKansas MedicalCenter
•Other Study Start:
May 1, 2017
Primary Completion:
May 1, 2018
Study Completion:
May 1, 2018
First Posted:
June 28, 2017
Results First Posted:
No Results Posted
Last Update Posted:
June 28, 2017
•University of Kansas MedicalCenter, Kansas City, Kansas,United States
25 NCT03202017 Lung Volume RecruitmentCombined With ExpiratoryMuscle Strength Training in ALS
Study Documents:
Title Acronym:
Other Ids:
NEUR-2017-25778
Recruiting •AmyotrophicLateral Sclerosis
•Procedure:Expiratory MuscleStrength Training(EMST)
•Procedure: EMST+ Lung VolumeRecruitment (LVR)
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Single(Outcomes Assessor)
•Primary Purpose:Supportive Care
Outcome Measures:
•Peak Cough Flow
•Maximal ExpiratoryPressure
•Forced Vital Capacity
•Eating Assessment Tool -10 (EAT-10)
•Swallowing Related Qualityof Life (SWAL-QOL)
•Speech Intelligibility Test(SIT)
Enrollment:
24
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofMinnesota -Clinical andTranslationalScience Institute
•Other Study Start:
March 1, 2018
Primary Completion:
December 2020
Study Completion:
December 2021
First Posted:
June 28, 2017
Results First Posted:
No Results Posted
Last Update Posted:
May 7, 2018
•University of Florida,Gainesville, Florida, UnitedStates
•University of Minnesota,Minneapolis, Minnesota, UnitedStates
- Page 15 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
26 NCT03196375 A Study to Assess FLX-787 inSubjects With Motor NeuronDisease Experiencing MuscleCramps.
Study Documents:
Title Acronym:
Other Ids:
FLX-787-203
Active, notrecruiting
•Motor NeuronDisease
•Drug: FLX-787-ODT (orallydisintegratingtablet)
•Drug: Placebo ODT
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
Cramp frequency
Enrollment:
120
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Flex Pharma,Inc.
•Industry Study Start:
July 28, 2017
Primary Completion:
June 2018
Study Completion:
June 2018
First Posted:
June 22, 2017
Results First Posted:
No Results Posted
Last Update Posted:
June 14, 2018
•Honor Health ResearchInstitute, Scottsdale, Arizona,United States
•Mayo Clinic, Scottsdale,Arizona, United States
•California Pacific MedicalCenter, Sacramento, California,United States
•University of California - Davis,Sacramento, California, UnitedStates
•University of California SanFrancisco, San Francisco,California, United States
•University of Colorado, Aurora,Colorado, United States
•Hospital for Special Care, NewBritain, Connecticut, UnitedStates
•GW Medical Faculty AssociatesInc., Washington, District ofColumbia, United States
•Mayo Clinic, Jacksonville,Florida, United States
•University of South FloridaHealth, Tampa, Florida, UnitedStates
•and 25 more
- Page 16 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
27 NCT03192358 Physiological Flow of LiquidsUsed in Dysphagia Management
Study Documents:
Title Acronym:
Other Ids:
•DC011020
•5R01DC011020-05
Recruiting •AmyotrophicLateral Sclerosis
•Parkinson Disease
•Dysphagia
•Diagnostic Test:VideofluoroscopicSwallowingExamination
•Other: TongueStrengthMeasurement
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective: Cross-Sectional
Outcome Measures:
•Penetration-AspirationScale (Swallow Safety)
•Normalized Residue RatioScale (Swallow Efficiency)
•Number of Swallows perBolus (Swallow Efficiency)
•Pharyngeal TransitDuration (Bolus Flow)
•Time to LaryngealVestibule Closure (SwallowKinematics)
•Hyoid Bone Range ofMovement (SwallowKinematics)
•Hyoid Speed/Velocity(Swallow Kinematics)
•Change in AnteriorMaximum TonguePressure (IOPI)
•Change in PosteriorMaximum TonguePressure (IOPI)
•Change in Saliva SwallowTongue Pressure (IOPI)
Enrollment:
40
Age:
18 Years to 90Years (Adult,Older Adult)
Sex:
All
•UniversityHealth Network,Toronto
•University ofFlorida
•National Instituteon Deafnessand OtherCommunicationDisorders(NIDCD)
•Other
•NIH
Study Start:
November 1, 2017
Primary Completion:
August 2019
Study Completion:
February 28, 2021
First Posted:
June 20, 2017
Results First Posted:
No Results Posted
Last Update Posted:
November 9, 2017
•University of Florida,Gainesville, Florida, UnitedStates
- Page 17 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
28 NCT03168711 Safety of Urate Elevation inAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
SURE-ALS2
Other Ids:
SURE-ALS2
Recruiting •AmyotrophicLateral Sclerosis
•Drug: Inosine
•Drug: Placebo
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Safety Will be Assessed bythe Occurrence of AdverseEvents
•Tolerability to Completethe Entire 20 Week Studyon Study Drug
Enrollment:
30
Age:
18 Years to 85Years (Adult,Older Adult)
Sex:
All
•MassachusettsGeneral Hospital
•The SalahFoundation
•MGH cure ALSFund
•Other Study Start:
October 1, 2017
Primary Completion:
October 2019
Study Completion:
January 2020
First Posted:
May 30, 2017
Results First Posted:
No Results Posted
Last Update Posted:
February 1, 2018
•Holy Cross Hospital, FortLauderdale, Florida, UnitedStates
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•University of Minnesota,Minneapolis, Minnesota, UnitedStates
- Page 18 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
29 NCT03160898 A Study to Evaluate Efficacy,Safety and Tolerability ofCK-2127107 in Patients WithAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
FORTITUDE-ALS
Other Ids:
CY 5022
Recruiting •AmyotrophicLateral Sclerosis
•Drug: CK-2127107
•Drug: Placebo
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Change from baseline toWeek 12 in the percentpredicted slow vitalcapacity (SVC)
•Slope of change frombaseline in the mega-score of muscle strengthmeasured by handheld dynamometry andhandgrip dynamometryfrom baseline to Week 12
•Change from baselineto Week 12 in the ALSFunctional Rating Scale -Revised (ALSFRS-R)
•Mean plasmaconcentrations over time ofCK-2127107 at Week 12
Enrollment:
445
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•Cytokinetics
•Astellas PharmaInc
•Industry Study Start:
July 24, 2017
Primary Completion:
March 2019
Study Completion:
March 2019
First Posted:
May 19, 2017
Results First Posted:
No Results Posted
Last Update Posted:
August 1, 2018
•St. Joseph's Hospital andMedical Center - BarrowNeurological Clinics, Phoenix,Arizona, United States
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
•University of California Irvine,Orange, California, UnitedStates
•Forbes Norris MDA/ALSResearch Center, SanFrancisco, California, UnitedStates
•Stanford Hospital and Clinics,Stanford, California, UnitedStates
•University of Colorado HospitalAnschutz Outpatient Pavilion,Aurora, Colorado, UnitedStates
•Hospital for Special Care, NewBritain, Connecticut, UnitedStates
•George Washington UniversityMedical Faculty Associates,Washington, District ofColumbia, United States
•University of Florida,Gainesville, Florida, UnitedStates
•Mayo Clinic, Jacksonville,Florida, United States
•and 50 more
- Page 19 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
30 NCT03127514 AMX0035 in Patients WithAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
CENTAUR
Other Ids:
AMX-3500
Recruiting •AmyotrophicLateral Sclerosis
•Motor NeuronDisease
•NeuromuscularDiseases
•NeurodegenerativeDiseases
•Spinal CordDiseases
•TDP-43Proteinopathies
•Nervous SystemDiseases
•Central NervousSystem Diseases
•Drug: AMX0035
•Other: Placebo
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•ALSFRS-R Slope
•Incidence of AdverseEvents
•Proportion of subjects ineach group able to remainon study drug until planneddiscontinuation
•Accurate Testing of LimbIsometric Strength (ATLIS)
•Blood-based Biomarkers
•Slow Vital Capacity
•Survival, tracheostomy andhospitalizations
•Imaging Biomarkers
Enrollment:
132
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•AmylyxPharmaceuticalsInc.
•ALS Finding aCure Foundation
•ALS Association
•Northeast ALSConsortium
•MassachusettsGeneral HospitalNeurologyClinicalResearchInstitute
•LeandroP. RizzutoFoundation
•Industry
•Other
Study Start:
June 22, 2017
Primary Completion:
December 2018
Study Completion:
May 2019
First Posted:
April 25, 2017
Results First Posted:
No Results Posted
Last Update Posted:
May 22, 2018
•Barrow Neurological Institute,Phoenix, Arizona, United States
•UC Irvine Medical Center,Orange, California, UnitedStates
•Forbes Norris MDA/ALSResearch Center - CaliforniaPacific Medical Center, SanFrancisco, California, UnitedStates
•University of Florida MedicalCenter, Gainesville, Florida,United States
•Carol and Frank Morsini Centerfor Advanced Health Care -University of South Florida,Tampa, Florida, United States
•Emory University Hospital,Atlanta, Georgia, United States
•University of Iowa Hospitalsand Clinics, Iowa City, Iowa,United States
•University of Kentucky MedicalCenter, Lexington, Kentucky,United States
•Ochsner NeuroscienceInstitute, New Orleans,Louisiana, United States
•Johns Hopkins Hospital,Baltimore, Maryland, UnitedStates
•and 15 more
- Page 20 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
31 NCT03095989 An Online MindfulnessIntervention for People With ALSand Their Caregivers
Study Documents:
Title Acronym:
Other Ids:
IRB14-3695
Recruiting •AmyotrophicLateral Sclerosis
•Behavioral:Mindfulness
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Single(Outcomes Assessor)
•Primary Purpose:Supportive Care
Outcome Measures:
•Quality of Life
•Depression and anxiety
•The patient's perception ofphysical impairment
•Physician-assessedphysical impairment
•Vital capacity (VC)
•Cognitive and behavioralfunction
•Caregiver burden(caregivers only)
Enrollment:
100
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•HarvardUniversity
•ALS Association
•Milton S.Hershey MedicalCenter
•CatholicUniversity of theSacred Heart
•Other Study Start:
January 2015
Primary Completion:
December 2018
Study Completion:
December 2018
First Posted:
March 30, 2017
Results First Posted:
No Results Posted
Last Update Posted:
March 29, 2018
•Penn State Hershey MedicalCenter, Hershey, Pennsylvania,United States
32 NCT03090932 Longitudinal Study of InnateLymphoid Cells in PeripheralBlood in ALS
Study Documents:
Title Acronym:
Other Ids:
HUM00107546
Recruiting •AmyotrophicLateral Sclerosis
•Other: Blood draw Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
•Total number of classicalNK (natural killer) cells;total number of CD3+CD4+ CD8+ cells
•Cytokine expression
Enrollment:
40
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•University ofMichigan
•University ofSouth Florida
•Other Study Start:
January 18, 2016
Primary Completion:
December 31, 2018
Study Completion:
July 1, 2019
First Posted:
March 27, 2017
Results First Posted:
No Results Posted
Last Update Posted:
January 23, 2018
•University of Michigan, AnnArbor, Michigan, United States
- Page 21 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
33 NCT03068754 A Study to Assess the Efficacyand Safety of H.P. Acthar® Gelin the Treatment of SubjectsWith Amyotrophic LateralSclerosis
Study Documents:
Title Acronym:
Other Ids:
MNK14042068
Recruiting •AmyotrophicLateral Sclerosis
•Drug: Acthar
•Drug: Placebo
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Telephone administeredAmyotrophic LateralSclerosis Functional RatingScale Revised (ALSFRS-R)
•Telephone administeredALSFRS-R total scoredecline
•Investigator administeredALSFRS-R total scoredecline
•Telephone administeredALSFRS-R total score andinvestigator administeredALSFRS-R total score
•Pulmonary function testA: Mean slope of percentpredicted forced vitalcapacity test
•Pulmonary function testB: Mean slope of volumeexpired in 1 second test
•Columbia-Suicide SeverityRating Scale (C-SSRS)
•Telephone administeredALSFRS-R total score
•Pulmonary function test A
•Pulmonary function text B
•Survival
Enrollment:
213
Age:
18 Years to 75Years (Adult,Older Adult)
Sex:
All
•Mallinckrodt •Industry Study Start:
June 22, 2017
Primary Completion:
December 2019
Study Completion:
December 2019
First Posted:
March 3, 2017
Results First Posted:
No Results Posted
Last Update Posted:
August 13, 2018
•Neuromuscular ResearchCenter, Phoenix, Arizona,United States
•Mayo Clinic - Arizona,Scottsdale, Arizona, UnitedStates
•University of California SanDiego, La Jolla, California,United States
•Loma Linda University HealthSystem, Department ofNeurology, Loma Linda,California, United States
•Keck School of Medicine,University of SouthernCalifornia, Los Angeles,California, United States
•University of CaliforniaLos Angeles, Los Angeles,California, United States
•University of California IrvineMedical Center, Orange,California, United States
•California Pacific MedicalCenter, San Francisco,California, United States
•University of California SanFrancisco, San Francisco,California, United States
•Colorado Springs NeurologicalAssociates, Colorado Springs,Colorado, United States
•and 33 more
- Page 22 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
34 NCT03070119 Long-Term Evaluation ofBIIB067
Study Documents:
Title Acronym:
Other Ids:
•233AS102
•2016-003225-41
Enrolling byinvitation
•ALS Causedby SuperoxideDismutase 1(SOD1) Mutation
•Drug: BIIB067 Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Allocation: Non-Randomized
•Intervention Model:Sequential Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Number of participantsexperiencing AEs andserious adverse events(SAEs)
•PK parameter of BIIB067in plasma: Maximumobserved concentration(Cmax)
•PK parameter of BIIB067in cerebrospinal fluid(CSF): Cmax
•PK parameter of BIIB067in plasma: Time to reachthe maximum observedconcentration (Tmax)
•PK parameter of BIIB067in CSF: Tmax
•PK parameter of BIIB067in plasma: Area underthe concentration-timecurve from time 0 to infinity(AUCinf)
•PK parameter of BIIB067in CSF: AUCinf
•PK parameter of BIIB067in plasma: Area under theconcentration-time curvefrom time 0 to time of thelast measurable (AUClast)
•PK parameter of BIIB067in CSF: AUClast
•PK parameter of BIIB067in plasma: Apparentterminal elimination half-life(t½)
•PK parameter of BIIB067in CSF: t½
Enrollment:
48
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Biogen
•IonisPharmaceuticals,Inc.
•Industry Study Start:
March 8, 2017
Primary Completion:
January 31, 2020
Study Completion:
January 31, 2020
First Posted:
March 3, 2017
Results First Posted:
No Results Posted
Last Update Posted:
August 15, 2018
•Research Site, Phoenix,Arizona, United States
•Research Site, La Jolla,California, United States
•Research Site, San Francisco,California, United States
•Research Site, Orlando,Florida, United States
•Research Site, Atlanta,Georgia, United States
•Research Site, Baltimore,Maryland, United States
•Research Site, Boston,Massachusetts, United States
•Research Site, Saint Louis,Missouri, United States
•Research Site, Knoxville,Tennessee, United States
•Research Site, Leuven,Belgium
•and 4 more
- Page 23 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
35 NCT03049046 CC100: Phase 1 Multiple-Dose Safety and Tolerability inSubjects With ALS
Study Documents:
Title Acronym:
CC100B
Other Ids:
•CC100B
•1R01FD004790-01A2
Recruiting •AmyotrophicLateral Sclerosis
•Drug: CC100
•Drug: Placebos
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Double(Participant, Investigator)
•Primary Purpose:Treatment
Outcome Measures:
•Safety and Tolerability:Adverse events, safetylabs, vital signs, and ECGs
•Pharmacokinetics (PK)--Peak plasma concentration(Cmax)
•Pharmacokinetics (PK)--Area under the plasmaconcentration versus timecurve (AUC)
•Pharmacokinetics (PK)--Half life (T 1/2)
•Pharmacodynamics (PD)--Monocyte chemotacticprotein 1 (MCP-1)
•Pharmacodynamics (PD)--Excitotoxicity/oxidativestress biomarkers
Enrollment:
21
Age:
18 Years to 64Years (Adult)
Sex:
All
•Chemigen, LLC •Industry Study Start:
April 7, 2017
Primary Completion:
January 30, 2018
Study Completion:
March 30, 2018
First Posted:
February 9, 2017
Results First Posted:
No Results Posted
Last Update Posted:
August 3, 2017
•Indiana University, IU HealthPhysicians Neurology,Indianapolis, Indiana, UnitedStates
- Page 24 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
36 NCT03020797 A Clinical Trial to Evaluate theSafety and Efficacy of Fycompain Subjects With AmyotrophicLateral Sclerosis (ALS)
Study Documents:
Title Acronym:
Other Ids:
Eisai-01
Recruiting •AmyotrophicLateral Sclerosis
•Drug: Perampanel
•Drug: Placebo OralTablet
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Incidence of treatment-emergent adverse events
•Efficacy as measuredby change in ALSFRS-R score (ALS functionalrating scale-revised);
Enrollment:
60
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•Stony BrookUniversity
•Eisai Inc.
•Other
•Industry
Study Start:
December 2016
Primary Completion:
December 2018
Study Completion:
First Posted:
January 13, 2017
Results First Posted:
No Results Posted
Last Update Posted:
January 13, 2017
•Stony Brook University MedicalCenter, Stony Brook, NewYork, United States
37 NCT03016897 ALS Testing Through Home-based Outcome Measures
Study Documents:
Title Acronym:
ALS AT HOME
Other Ids:
BNI_ALS_001
Enrolling byinvitation
•AmyotrophicLateral Sclerosis
•Other:Respirometer,Handgrip Meter,Skulpt Chisel,ActigraphyMeter
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
•Change in PulmonaryFunction
•Change in QuantitativeHand Grip
•Change in ElectricalImpedance Myography(EIM) Measurements
•Change in Actigraphy
•ALSFRS-R
•Change in Patient-reportedExperience measures(PREMs)
•Adverse Events
•Change in Voice/SpeechTracking
Enrollment:
250
Age:
18 Years to 85Years (Adult,Older Adult)
Sex:
All
•Jeremy Shefner
•Beth IsraelDeaconessMedical Center
•BarrowNeurologicalInstitute
•Other Study Start:
February 22, 2017
Primary Completion:
December 2018
Study Completion:
June 2019
First Posted:
January 11, 2017
Results First Posted:
No Results Posted
Last Update Posted:
August 7, 2018
•Barrow Neurological Institute,Phoenix, Arizona, United States
- Page 25 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
38 NCT02962050 Delineating SwallowingImpairment and Decline in ALS
Study Documents:
Title Acronym:
Other Ids:
•IRB201602098-N
•NS100859
Recruiting •AmyotrophicLateral Sclerosis
•Procedure:VideofluoroscopicSwallowing Study(VFSS)
•Procedure:High ResolutionManometry
•Other: DIGEST
•Other: PenetrationAspiration Scale
•Other: NormalizedResidue RatioScale
•Device: VoluntaryPeak Cough FlowTesting
•Device: IowaOral PerformanceInstrument
•Device: LingualElectricalImpedanceMyography
•Drug: CapsaicinChallenge
•Device: PulmonaryFunction Testing
•Other: EatingAssessment Tool10
•Other: The Centerfor NeurologicStudy BulbarFunction Scale
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Change in MaximumSwallowing Pressurewith High ResolutionManometry (HRM)
•Change in Rate ofPressure with HighResolution Manometry(HRM)
•Change in Mean Pressurewith High ResolutionManometry (HRM)
•Swallowing Safety (withDIGEST)
•Swallowing Efficiency (withDIGEST)
•Swallowing Efficiency (withNRRS)
•Swallowing Safety (withPAS)
•Change in ForcedVital Capacity withPulmonary FunctionTesting (with hand-helddigital manometer)
•Voluntary Peak CoughFlow Testing (withElectronic Peak CoughFlow Meter Device)
•Change in Lingual Strengthwith Lingual FunctionTesting (with IOPI)
•and 11 more
Enrollment:
110
Age:
18 Years to 90Years (Adult,Older Adult)
Sex:
All
•University ofFlorida
•NationalInstitutes ofHealth (NIH)
•Other
•NIH
Study Start:
May 31, 2017
Primary Completion:
June 30, 2022
Study Completion:
June 30, 2024
First Posted:
November 11, 2016
Results First Posted:
No Results Posted
Last Update Posted:
July 6, 2018
•University of Florida,Gainesville, Florida, UnitedStates
•University of Florida College ofMedicine, Jacksonville, Florida,United States
•University of South Florida,Tampa, Florida, United States
- Page 26 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
39 NCT02943850 CNS10-NPC-GDNF for theTreatment of ALS
Study Documents:
Title Acronym:
Other Ids:
Pro00042350
Recruiting •AmyotrophicLateral Sclerosis
•Biological:Stem cell (HPC)implantation
•Device:Stereotacticsurgical device
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Safety evaluated byAdverse Events andSerious Adverse Events,post-operative MRI,and clinical laboratoryassessments
•Compound Motor ActionPotential (CMAP)
•Force Generation viaATLIS testing
•Quantitative Muscle MRI
•Electrical ImpedanceMyography (EIM)
•Assessment of glial cellline derived neurotrophicfactor (GDNF) in thecerebral spianl fluid (CSF)
Enrollment:
18
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Cedars-SinaiMedical Center
•CaliforniaInstitute forRegenerativeMedicine
•Other Study Start:
April 1, 2017
Primary Completion:
April 2019
Study Completion:
April 2019
First Posted:
October 25, 2016
Results First Posted:
No Results Posted
Last Update Posted:
August 3, 2017
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
- Page 27 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
40 NCT02936635 A Study for Patients WhoCompleted VITALITY-ALS (CY4031)
Study Documents:
Title Acronym:
VIGOR-ALS
Other Ids:
•CY 4033
•2016-002629-13
Active, notrecruiting
•AmyotrophicLateral Sclerosis(ALS)
•Drug: tirasemtiv Study Type:
Interventional
Phase:
Phase 3
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Incidence of adverseevents (AEs) in patientpopulation
•Time to first use ofassisted ventilation ordeath
•Time to the first occurrenceof respiratory insufficiency(defined as tracheostomyor the use of non-invasiveventilation (NIV) for #22hours per day for #10consecutive days) or death
•Time to death
•Decline in percentpredicted Slow VitalCapacity (SVC) frombaseline
•Decline in ALS FunctionalRating Scale - Revised(ALSFRS-R) score frombaseline
•Slope of the changefrom baseline in percentpredicted SVC
•Slope of the change frombaseline in ALSFRS-R
Enrollment:
280
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Cytokinetics •Industry Study Start:
October 2016
Primary Completion:
October 2019
Study Completion:
October 2019
First Posted:
October 18, 2016
Results First Posted:
No Results Posted
Last Update Posted:
December 8, 2017
•St. Joseph's Hospital andMedical Center - BarrowNeurology Clinics, Phoenix,Arizona, United States
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
•University of California, Irvine,Orange, California, UnitedStates
•UC Davis Medical Center,Sacramento, California, UnitedStates
•Forbes Norris MDA/ALSResearch Center, SanFrancisco, California, UnitedStates
•Stanford Hospital and Clinics,Stanford, California, UnitedStates
•University of Colorado HospitalAnschutz Outpatient Pavilion,Aurora, Colorado, UnitedStates
•Hospital for Special Care, NewBritain, Connecticut, UnitedStates
•George Washington UniversityMedical Center, Washington,District of Columbia, UnitedStates
•Mayo Clinic, Jacksonville,Florida, United States
•and 57 more
- Page 28 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
41 NCT02916966 Population-Based Ohio ALSRepository and ALS RiskFactors
Study Documents:
Title Acronym:
Other Ids:
D06019
Recruiting •AmyotrophicLateral Sclerosis
•Other: PatientRegistry
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
Questionnaire forEnvironmental Exposures,Toxins, and NeurologicalDisease
Enrollment:
1000
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•Dartmouth-HitchcockMedical Center
•The ClevelandClinic
•Other Study Start:
October 2016
Primary Completion:
September 2018
Study Completion:
October 2018
First Posted:
September 28, 2016
Results First Posted:
No Results Posted
Last Update Posted:
April 13, 2018
•Cleveland Clinic Foundation,Cleveland, Ohio, United States
- Page 29 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
42 NCT02872142 Efficacy and Safety of PlasmaExchange With Albutein® 5%in Patients With AmyotrophicLateral Sclerosis
Study Documents:
Title Acronym:
Other Ids:
GBI1501
Recruiting •AmyotrophicLateral Sclerosis
•Biological: Albutein5%
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Changes from baseline inthe ALS Functional RatingScale - Revised
•Changes from baseline inforced vital capacity
•Changes from baselinein cognitive functiondetermined by the ALS- Cognitive BehavioralScreen test
•Changes from baseline inthe motor evoked potentialin thenar and hypothenareminence and anteriortibialis muscle determinedby electromyography
•Evaluation of quality of lifeusing the ALS AssessmentQuestionnaire 40
•Changes from baselinein plasma humanapolipoproteins
•Changes from baseline incerebrospinal fluid humanapolipoproteins
•Changes from baseline inplasma beta-methylamino-L-alanine levels
•Changes from baseline incerebrospinal fluid beta-methylamino-L-alaninelevels
•Changes from baseline inabsolute leukocyte count
•Changes from baselinein plasma neurofilamentanalysis
•Changes from baselinein cerebrospinal fluidneurofilament analysis
Enrollment:
10
Age:
19 Years to 69Years (Adult,Older Adult)
Sex:
All
•GrifolsTherapeuticsLLC
•GrifolsBiologicals Inc.
•Industry Study Start:
July 2016
Primary Completion:
January 2019
Study Completion:
January 2019
First Posted:
August 19, 2016
Results First Posted:
No Results Posted
Last Update Posted:
May 11, 2018
•Dartmouth-Hitchcock MedicalCenter, Lebanon, NewHampshire, United States
- Page 30 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
43 NCT02851914 SSRIs vs. TCAs for Depressionin ALS Patients
Study Documents:
Title Acronym:
Other Ids:
22974
Recruiting •Depression
•AmyotrophicLateral Sclerosis
•Drug: TricyclicAntidepressants("TCA")
•Drug: SelectiveSerotonin UptakeInhibitors ("SSRI")
Study Type:
Interventional
Phase:
Early Phase 1
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•BDI-II
•ANCOVA
Enrollment:
40
Age:
25 Years to 80Years (Adult,Older Adult)
Sex:
All
•St. LouisUniversity
•Other Study Start:
July 21, 2015
Primary Completion:
December 2018
Study Completion:
December 2018
First Posted:
August 2, 2016
Results First Posted:
No Results Posted
Last Update Posted:
February 12, 2018
•Monteleone Hall, Saint LouisUniversity, 1438 South GrandBlvd., Saint Louis, Missouri,United States
44 NCT02795897 Genomic Translation for ALSCare
Study Documents:
Title Acronym:
GTAC
Other Ids:
AAAQ7026
Recruiting •ALS Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Correlation of DNAgenotype with ALSphenotypes
•Correlation of geneexpression in blood withALS phenotypes
Enrollment:
1500
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•ColumbiaUniversity
•ALS Association
•Biogen
•Other
•Industry
Study Start:
November 2016
Primary Completion:
June 2019
Study Completion:
November 2020
First Posted:
June 10, 2016
Results First Posted:
No Results Posted
Last Update Posted:
June 8, 2018
•Cedar Sinai Medical Center,Los Angeles, California, UnitedStates
•Univeristy of Michigan, AnnArbor, Michigan, United States
•University of Minnesota,Minneapolis, Minnesota, UnitedStates
•Washington University, SaintLouis, Missouri, United States
•Columbia University, New York,New York, United States
•Duke University, Durham, NorthCarolina, United States
•Oregon Health & SciencesUniversity, Portland, Oregon,United States
•Penn State Collegeof Medicine, Hershey,Pennsylvania, United States
•University of PittsburghMedical Center, Pittsburgh,Pennsylvania, United States
•Houston MethodistNeurological Institute, Houston,Texas, United States
•and 3 more
- Page 31 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
45 NCT02781454 Mexiletine in SporadicAmyotrophic Lateral Sclerosis
Study Documents:
Title Acronym:
Mexiletine-2
Other Ids:
MX-ALS-002
Active, notrecruiting
•SporadicAmyotrophicLateral Sclerosis
•Drug: Mexiletine
•Drug: Placebo
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Change in resting motorthreshold
•Effects on motor evokedpotential (MEP)
•Effects on strengthduration time constant
•Effect on frequency andseverity of muscle cramps
•Effects on cortical silentperiod
•Effects on short-intervalintracortical inhibition(SICI)
•Effects on thresholdelectrotonus
•Effect on frequency andseverity of fasciculations(muscle twitching)
Enrollment:
60
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofWashington
•MassachusettsGeneral Hospital
•Other Study Start:
October 2016
Primary Completion:
September 30, 2018
Study Completion:
December 31, 2018
First Posted:
May 24, 2016
Results First Posted:
No Results Posted
Last Update Posted:
August 1, 2018
•Barrow Neurological Institute,Phoenix, Arizona, United States
•University of California, Irvine,Orange, California, UnitedStates
•Augusta University, Augusta,Georgia, United States
•Beth Israel DeaconessMedical Center, Boston,Massachusetts, United States
•University of Michigan, AnnArbor, Michigan, United States
•Columbia Universtiy MedicalCenter, New York, New York,United States
•Pennsylvania State HersheyMedical Center, Hershey,Pennsylvania, United States
•University of Pittsburgh,Pittsburgh, Pennsylvania,United States
•Medical University of SouthCarolina, Charleston, SouthCarolina, United States
•University of Washington,Seattle, Washington, UnitedStates
- Page 32 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
46 NCT02750982 Laughter Therapy Effects onMood, Stress and Self-efficacyin People With NeurologicalDiseases.
Study Documents:
Title Acronym:
Other Ids:
TRBROWN201601
Recruiting •Alzheimer'sDisease
•AmyotrophicLateral Sclerosis
•Brain Injury
•Huntington'sDisease
•Multiple Sclerosis
•Parkinson'sDisease
•Stroke
•Spinal Cord Injury
•Other: LaughterTherapy
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: HealthServices Research
Outcome Measures:
•Patient HealthQuestionnaire (PHQ-9, fordepression)
•Generalized AnxietyDisorder 7-item scale(GAD-7, for anxiety)
•The General Self-EfficacyScale (GSE)
Enrollment:
24
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Brown,Theodore R.,M.D., MPH
•Other Study Start:
July 2016
Primary Completion:
August 2018
Study Completion:
December 2018
First Posted:
April 26, 2016
Results First Posted:
No Results Posted
Last Update Posted:
January 23, 2018
•Evergreen Healthcare,Kirkland, Washington, UnitedStates
- Page 33 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
47 NCT02714036 A Biomarker Study to EvaluateMN-166 (Ibudilast) in SubjectsWith Amyotrophic LiteralSclerosis (ALS)
Study Documents:
Title Acronym:
Other Ids:
MN-166-ALS-1202
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•Drug: ibudilast Study Type:
Interventional
Phase:
•Phase 1
•Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•To measure the impactof MN-166 (ibudilast) on[11C]-PBR28 uptake in themotor cortices and brainstem measured by positronemission tomography(PET) imaging at 24 weeks
•To measure the impactof MN-166 (ibudilast) onseveral markers of neuro-inflammation measured byblood biomarkers
•To evaluate the safety andtolerability of MN-166 byassessing the number oftreatment-related adverseevents.
•To evaluate the effect ofibudilast on ALS functionalrating scale-revised(ALSFRS-R)
•To evaluate the effectof ibudilast on slow vitalcapacity (SVC)
•To evaluate the effect ofibudilast on strength asmeasured by Hand-helddynamometry (HHD)
Enrollment:
35
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•MediciNova
•MassachusettsGeneral Hospital
•South ShoreNeurologicAssociates
•Industry
•Other
Study Start:
March 2016
Primary Completion:
June 28, 2018
Study Completion:
April 2019
First Posted:
March 21, 2016
Results First Posted:
No Results Posted
Last Update Posted:
July 20, 2018
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•South Shore NeurologicAssociates, P.C., Patchogue,New York, United States
- Page 34 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
48 NCT02710110 Respiratory Strength Trainingin Persons With AmyotrophicLateral Sclerosis (ALS)
Study Documents:
Title Acronym:
Other Ids:
IRB201501172
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•Device: PowerLungtrainer
•Device: MicroMouth PressureMeter
•Procedure:PulmonaryFunction Testing
•Procedure:Videofluoroscopicswallowing study
•Other: SwallowingQuality of LifeQuestionnaire
•Device: IowaOral PressureInstrument
•Drug: Capsaicin
Study Type:
Interventional
Phase:
Early Phase 1
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Single(Participant)
•Primary Purpose:Treatment
Outcome Measures:
•Maximum ExpiratoryPressure will be measuredbetween the groups for achange from baseline tomonth 3
•Maximum InspiratoryPressure will be measuredbetween the groups for achange from baseline tomonth 3
•Pulmonary function tomeasure the forced vitalcapacity (FVC) betweenthe groups for a changefrom baseline to month 3
•Sniff Nasal InspiratoryPressure will be measuredbetween the groups for achange from baseline tomonth 3
•Pulmonary functionto measure the peakexpiratory flow (PEF) willbe measured between thegroups for a change frombaseline to month 3
•Pulmonary function tomeasure the forcedexpiratory volume (FEV1)will be measured betweenthe groups for a changefrom baseline to month 3
•The Penetration-aspirationscale will be used tomeasure swallowingfunction
•Lingual strength will bemeasured between thegroups for a change frombaseline to month 3
•Lingual endurance will bemeasured between thegroups for a change frombaseline to month 3
•Voluntary cough functionwill be measured betweenthe groups for a changefrom baseline to month 3
•Reflexive cough will bemeasured between thegroups for a change frombaseline to month 3
Enrollment:
46
Age:
21 Years to 85Years (Adult,Older Adult)
Sex:
All
•University ofFlorida
•ALS Association
•Other Study Start:
April 2016
Primary Completion:
November 30, 2017
Study Completion:
March 2020
First Posted:
March 16, 2016
Results First Posted:
No Results Posted
Last Update Posted:
April 5, 2018
•UF Health Shands, Gainesville,Florida, United States
- Page 35 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
49 NCT02686268 Understanding ClinicalPhenotype and CollectingBiomarker Samples in C9ORF72ALS
Study Documents:
Title Acronym:
Other Ids:
14LGCA123
Active, notrecruiting
•C9ORF72AmyotrophicLateral Sclerosis(ALS)
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Only
•Time Perspective:Prospective
Outcome Measures:
•Collection of clinical dataand biomarker samples
•Correlation of repeatexpansion size with clinicaloutcome measures anddetermination of C9ORF72patients eligibility forclinical trials
Enrollment:
128
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•WashingtonUniversitySchool ofMedicine
•Cedars-SinaiMedical Center
•UMC Utrecht
•Johns HopkinsUniversity
•Sentara HealthCare/SentaraNeurologySpecialists
•MassachusettsGeneral Hospital
•University ofMassachusetts,Amherst
•Biogen
•ALS Association
•ColumbiaUniversity
•Other
•Industry
Study Start:
February 2015
Primary Completion:
December 31, 2017
Study Completion:
June 2018
First Posted:
February 19, 2016
Results First Posted:
No Results Posted
Last Update Posted:
February 8, 2018
•Cedars Sinai Medical Center,Los Angeles, California, UnitedStates
•Johns Hopkins, Baltimore,Maryland, United States
•University of Massachusetts,Amherst, Massachusetts,United States
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Washington University in St.Louis, Saint Louis, Missouri,United States
•Columbia University MedicalCenter, New York, New York,United States
•Sentara Health Care / SentaraNeurology Specialists, VirginiaBeach, Virginia, United States
•UMC Utrecht, Utrecht,Netherlands
- Page 36 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
50 NCT02682030 The Use of Airway ClearanceDevices in ALS
Study Documents:
Title Acronym:
Other Ids:
Pro00039699
Recruiting •AmyotrophicLateral Sclerosis
•Device: HighFrequency ChestCompressionDevice (HFCC)
•Device: CoughAssist
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Change in Chest X-Raybetween baseline and endof study
•Change in Lung VentilationScan between baselineand end of study
•Change in McGill Singleitem quality of life questionbetween baseline and endof study
•Change in Forced VitalCapacity (FVC) betweenbaseline and end of study
•Change in MaximalInspiratory Pressure (MIP)between baseline and endof study
•Change in DiffusionCapacity between baselineand end of study
Enrollment:
20
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Cedars-SinaiMedical Center
•Other Study Start:
March 2016
Primary Completion:
December 2018
Study Completion:
December 2018
First Posted:
February 15, 2016
Results First Posted:
No Results Posted
Last Update Posted:
April 5, 2018
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
- Page 37 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
51 NCT02655614 A Study of GDC-0134to Determine InitialSafety, Tolerability, andPharmacokinetic Parameters inParticipants With AmyotrophicLateral Sclerosis
Study Documents:
Title Acronym:
Other Ids:
•GN29823
•2017-002931-41
Recruiting •AmyotrophicLateral Sclerosis
•Drug: GDC-0134
•Drug: Placebo
•Drug: Rabeprazole
•Drug: Midazolam
•Drug: Caffeine
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Allocation: Randomized
•Intervention Model:Sequential Assignment
•Masking: Double(Participant, Investigator)
•Primary Purpose:Treatment
Outcome Measures:
•Percentage of ParticipantsWith Adverse Events (AEs)
•Percentage of ParticipantsWith Clinically SignificantLaboratory Abnormalities
•Percentage of ParticipantsWith Clinically SignificantVital Signs Abnormalities
•Percentage of ParticipantsWith Clinically SignificantElectrocardiogram (ECG)Abnormalities
•Percentage of ParticipantsWith Clinically SignificantAbnormalities in PhysicalExamination Findings
•Maximum PlasmaConcentration (Cmax) ofGDC-0134
•Time to Maximum PlasmaConcentration (tmax) ofGDC-0134
•Area Under the PlasmaConcentration Versus TimeCurve (AUC) of GDC-0134
•Apparent Clearance (CL/F)of GDC-0134
•Apparent Terminal Volumeof Distribution (Vz/F) ofGDC-0134
•and 9 more
Enrollment:
82
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Genentech, Inc. •Industry Study Start:
May 31, 2016
Primary Completion:
October 29, 2019
Study Completion:
October 29, 2019
First Posted:
January 14, 2016
Results First Posted:
No Results Posted
Last Update Posted:
August 14, 2018
•Forbes Norris Mda/als Ctr;Research Center, SanFrancisco, California, UnitedStates
•Mayo Clinic Hospital - Florida,Jacksonville, Florida, UnitedStates
•University of Miami MillerSchool of Medicine, Miami,Florida, United States
•Bioclinica Research, Orlando,Florida, United States
•The Emory ALS Clinic, Atlanta,Georgia, United States
•Johns Hopkins UniversitySchool of Medicine, Baltimore,Maryland, United States
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Wake Research Associates,Raleigh, North Carolina, UnitedStates
•New Orleans Center forClinical Research, Knoxville,Tennessee, United States
•Methodist NeurologicalInstitute, Houston, Texas,United States
•MUCH - Montreal NeurologicalInstitute & Hospital, Montreal,Quebec, Canada
•UMC Utrecht, Utrecht,Netherlands
- Page 38 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
52 NCT02623699 Single and Multiple Dose Studyof BIIB067 in Adults WithAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
Other Ids:
•233AS101
•2015-004098-33
Recruiting •AmyotrophicLateral Sclerosis
•Drug: BIIB067
•Other: Placebo
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Number of participantsexperiencing AdverseEvents (AEs) and SeriousAdverse Events (SAEs)
•Number of participantswith clinically significantlaboratory assessmentabnormalities
•Number of participants withclinically significant vitalsign abnormalities
•Number of participantswith clinically significantphysical examinationabnormalities
•Number of participantswith clinically significantneurological examinationabnormalities
•Number of participants withclinically significant 12-leadelectrocardiograms (ECGs)abnormalities
•PK parameter of BIIB067in plasma: Maximumobserved concentration(Cmax)
•PK parameter of BIIB067in plasma: Time to reachmaximum observedconcentration (Tmax)
•PK parameter of BIIB067in plasma: Area under theconcentration-time curvefrom time zero to infinity(AUCinf)
•PK parameter of BIIB067in plasma: Area under theconcentration-time curvefrom time zero to the timeof the last measurableconcentration (AUClast)
•and 3 more
Enrollment:
84
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Biogen
•IonisPharmaceuticals,Inc.
•Industry Study Start:
January 31, 2016
Primary Completion:
February 2, 2019
Study Completion:
February 2, 2019
First Posted:
December 8, 2015
Results First Posted:
No Results Posted
Last Update Posted:
June 1, 2018
•Barrow Neurological Institute,Phoenix, Arizona, United States
•University of California SanDiego Medical Center, La Jolla,California, United States
•California Pacific MedicalCenter, San Francisco,California, United States
•Compass Research, LLC,Orlando, Florida, United States
•The Emory Clinic, Atlanta,Georgia, United States
•Johns Hopkins Hospital,Baltimore, Maryland, UnitedStates
•Massachusetts GeneralHospital, MA, Boston,Massachusetts, United States
•Washington University Schoolof Medicine, Saint Louis,Missouri, United States
•Volunteer Research Group,LLC, Knoxville, Tennessee,United States
•UZ Leuven, Leuven, Belgium
•and 7 more
- Page 39 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
53 NCT02611674 Methodology Study of NovelOutcome Measures to AssessProgression of ALS
Study Documents:
Title Acronym:
Other Ids:
999AS003
Active, notrecruiting
•AmyotrophicLateral Sclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessedby electrical impedancemyography (EIM)
•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessed bycompound muscle actionpotential (CMAP)
•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessedby motor unit numberestimation (MUNE)
•Longitudinal standardizedmean change inelectrophysiologicalmeasures as assessed bymotor unit number index(MUNIX)
•Longitudinal standardizedmean change in musclestrength measures asassessed by hand-helddynamometry (HHD)
•Longitudinal standardizedmean change in respiratorymeasures as assessed byslow vital capacity (SVC)
•Longitudinal standardizedmean change in functionalmeasures as assessedby Amyotrophic LateralSclerosis Functional RatingScale-Revised (ALSFRS-R)
•Within-participanttest-retest reliabilitybetween the 2 repeatedmeasurements occurringon Day 1 and Day 7 forEIM
•Within-participanttest-retest reliabilitybetween the 2 repeatedmeasurements for CMAP
•Within-participanttest-retest reliabilitybetween the 2 repeatedmeasurements for MUNE
•and 9 more
Enrollment:
100
Age:
16 Years to 85Years (Child,Adult, Older Adult)
Sex:
All
•Biogen •Industry Study Start:
January 6, 2016
Primary Completion:
August 2, 2019
Study Completion:
August 2, 2019
First Posted:
November 23, 2015
Results First Posted:
No Results Posted
Last Update Posted:
August 8, 2018
•University of California SanDiego Medical Center, SanDiego, California, United States
•California Pacific MedicalCenter, San Francisco,California, United States
•University of South Florida,Tampa, Florida, United States
•The Emory Clinic, Atlanta,Georgia, United States
•Johns Hopkins Hospital,Baltimore, Maryland, UnitedStates
•Massachusetts GeneralHospital, MA, Charlestown,Massachusetts, United States
•Washington University Schoolof Medicine, Saint Louis,Missouri, United States
•Penn State Milton S. HersheyMedical Center, Hershey,Pennsylvania, United States
•UZ Leuven, Leuven, Belgium
•Sunnybrook Health SciencesCentre, Toronto, Ontario,Canada
•and 11 more
- Page 40 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
54 NCT02574390 Answer ALS: IndividualizedInitiative for ALS Discovery
Study Documents:
Title Acronym:
AnswerALS
Other Ids:
IRB00082277
Recruiting •AmyotrophicLateral Sclerosis
•Primary LateralSclerosis
•Flail Arm ALS
•ProgressiveMuscular Atrophy
•MonomelicAmyotrophy
•Motor NeuronDisease
•Asymptomatic ALSGene Carriers
•Healthy Controls
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Only
•Time Perspective:Prospective
Outcome Measures:
•ALS Functional RatingScale-Revised (ALSFRS-R)
•ALS Cognitive BehavioralScale (ALS-CBS)
•Slow Vital Capacity (SVC)
•Strength Testing with HandHeld Dynamometer (HHD)
Enrollment:
1000
Age:
18 Years to 100Years (Adult,Older Adult)
Sex:
All
•Johns HopkinsUniversity
•MassachusettsGeneral Hospital
•Emory University
•Ohio StateUniversity
•WashingtonUniversitySchool ofMedicine
•Cedars-SinaiMedical Center
•University ofCalifornia, Irvine
•MassachusettsInstitute ofTechnology
•New YorkGenome Center
•LeandroP. RizzutoFoundation
•Texas Neurology
•NorthwesternUniversity LesTurner ALSCenter
•Other Study Start:
December 2015
Primary Completion:
January 2019
Study Completion:
July 2019
First Posted:
October 12, 2015
Results First Posted:
No Results Posted
Last Update Posted:
May 15, 2018
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
•Emory University, Atlanta,Georgia, United States
•Northwestern UniversityFeinberg School of Medicine,Chicago, Illinois, United States
•Johns Hopkins University,Baltimore, Maryland, UnitedStates
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Washington University Schoolof Medicine, Saint Louis,Missouri, United States
•Ohio State University WexnerMedical Center, Columbus,Ohio, United States
•Texas Neurology, Dallas,Texas, United States
55 NCT02567136 Imaging Biomarkers in ALS
Study Documents:
Title Acronym:
Other Ids:
130126
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•Primary LateralSclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
Imaging biomarkers
Enrollment:
30
Age:
21 Years to 75Years (Adult,Older Adult)
Sex:
All
•University ofMinnesota -Clinical andTranslationalScience Institute
•Other Study Start:
September 2015
Primary Completion:
September 2025
Study Completion:
September 2025
First Posted:
October 2, 2015
Results First Posted:
No Results Posted
Last Update Posted:
May 7, 2018
•University of Minnesota,Minneapolis, Minnesota, UnitedStates
- Page 41 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
56 NCT02559869 Imaging and BioFluidBiomarkers in AmyotrophicLateral Sclerosis
Study Documents:
Title Acronym:
TRACK-ALS
Other Ids:
2015P000140
Recruiting •AmyotrophicLateral Sclerosis(ALS)
•Drug: [18F] GE-180 Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
•Measure & localize braininflammation in people withALS via [18F] GE-180 PETimaging.
•Define anatomical,structural, and functionalchanges in the brain viaMRI of ALS Subjectsvs. Healthy Controls atBaseline
•Determine systemicinflammatory factorsthat may modify theprogression or otherclinical or imagingcorrelates of ALS.
•Determine the longitudinalchanges in braininflammation in peoplewith ALS in correlation withALS severity and rate ofprogression.
•Determine the longitudinalchanges in the anatomical,structural, and functionalmeasures in peoplewith ALS, and build ALSprediction models usingthe clinical and MRI data.
Enrollment:
200
Age:
18 Years to 80Years (Adult,Older Adult)
Sex:
All
•MassachusettsGeneral Hospital
•The MethodistHospital System
•Cedars-SinaiMedical Center
•ALS Association
•Other Study Start:
November 2015
Primary Completion:
January 2020
Study Completion:
May 2021
First Posted:
September 24, 2015
Results First Posted:
No Results Posted
Last Update Posted:
March 23, 2018
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Houston Methodist Hospital,Houston, Texas, United States
- Page 42 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
57 NCT02532244 Genetics of Pediatric-Onset Motor Neuron andNeuromuscular Diseases
Study Documents:
Title Acronym:
Other Ids:
764456
Recruiting •Spinal MuscularAtrophy
•Charcot-Marie-Tooth Disease
•Muscular Dystrophy
•Spinal MuscularAtrophy WithRespiratoryDistress 1
•AmyotrophicLateral Sclerosis
•Motor NeuronDisease
•NeuromuscularDisease
•Peroneal MuscularAtrophy
•Fragile X Syndrome
•Other: samplecollection
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Only
•Time Perspective:Prospective
Outcome Measures:
•genetic diagnosis
•SMN1 copy number
•SMN2 copy number
•target gene mRNA levels
•target gene protein levels
Enrollment:
300
Age:
6 Months and older (Child, Adult,Older Adult)
Sex:
All
•NemoursChildren's Clinic
•Other Study Start:
June 2015
Primary Completion:
December 2022
Study Completion:
December 2022
First Posted:
August 25, 2015
Results First Posted:
No Results Posted
Last Update Posted:
August 25, 2015
•Alfred I. duPont Hospitalfor Children, Wilmington,Delaware, United States
•Nemours Children'sSpecialty Care, Jacksonville,Jacksonville, Florida, UnitedStates
•Nemours Children's Hospital,Orlando, Florida, United States
58 NCT02469675 Brain and Nerve Stimulation forHand Muscles in Spinal CordInjury and ALS
Study Documents:
Title Acronym:
Other Ids:
HAR-15-001
Recruiting •Spinal Cord Injury(SCI)
•AmyotrophicLateral Sclerosis(ALS)
•Device:Transcranialmagneticstimulation
•Device: Mediannerve stimulation
•Device: Cervicaltranscutaneousstimulation
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: BasicScience
Outcome Measures:
•Change in motor evokedpotential (MEP) amplitudeof the abductor pollicisbrevis (APB) muscleresponse to single pulsesof TMS
•Hand dexterity
•Safety and tolerability
•Grip strength
•Change in the duration ofthe 'cortical silent period'after TMS stimulationduring APB contraction
•F-wave responses of theAPB muscle
Enrollment:
30
Age:
21 Years to 65Years (Adult,Older Adult)
Sex:
All
•Bronx VAMedical Center
•U.S.Fed
Study Start:
June 2015
Primary Completion:
March 31, 2018
Study Completion:
March 31, 2018
First Posted:
June 11, 2015
Results First Posted:
No Results Posted
Last Update Posted:
January 30, 2018
•James J. Peters VA MedicalCenter, Bronx, NY, Bronx, NewYork, United States
- Page 43 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
59 NCT02437110 HERV-K Suppression UsingAntiretroviral Therapy inVolunteers With AmyotrophicLateral Sclerosis (ALS)
Study Documents:
Title Acronym:
Other Ids:
•150126
•15-N-0126
Enrolling byinvitation
•AmyotrophicLateral Sclerosis
•Drug: Darunavir
•Drug: Ritonavir
•Drug: Raltegravir
•Drug: Zidovudine
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•The proportion ofparticipants with anundetectable HERV-K gagRNA level by quantitativePCR within 24 weeks ofstarting an antiretroviralregimen of darunavir,ritonavir, raltegravir, andzidovudine
•Safety and feasibility of upto 24 weeks of darunavir,ritonavir, raltegravir, andzidovudine for patients withALS
•The proportion ofparticipants with anundetectable HERV-Kenv or pol RNA level byquantitative PCR within24 weeks of starting anantiretroviral regimenof darunavir, ritonavir,raltegravir, and zidovudine
Enrollment:
20
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•NationalInstitutes ofHealth ClinicalCenter (CC)
•NIH Study Start:
April 23, 2015
Primary Completion:
December 31, 2018
Study Completion:
December 31, 2018
First Posted:
May 7, 2015
Results First Posted:
No Results Posted
Last Update Posted:
August 9, 2018
•National Institutes of HealthClinical Center, 9000 RockvillePike, Bethesda, Maryland,United States
- Page 44 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
60 NCT02414230 F 18 T807 Tau PET Imagingin Familial Amyotrophic LateralSclerosis
Study Documents:
Title Acronym:
T807ALS
Other Ids:
IND 123119Protocol B
Active, notrecruiting
•AmyotrophicLateral Sclerosis(ALS)
•Drug: Drug: F 18T807
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Diagnostic
Outcome Measures:
F 18 T807 Standard UptakeValue Ratios (SUVR) willbe correlated with otherimaging modalities (MRI,PET amyloid imaging) andcognitive performance.
Enrollment:
9
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•WashingtonUniversitySchool ofMedicine
•Other Study Start:
February 2015
Primary Completion:
March 2020
Study Completion:
September 2020
First Posted:
April 10, 2015
Results First Posted:
No Results Posted
Last Update Posted:
July 2, 2018
•Washington University Schoolof Medicine, Saint Louis,Missouri, United States
61 NCT02374606 Accurate Test of Limb IsometricStrength (ATLIS) in ALS
Study Documents:
Title Acronym:
Other Ids:
Pro00038868
Recruiting •AmyotrophicLateral Sclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Change in Accurate Testof Limb Isometric Strength(ATLIS) between each visit
•Change in ALS FunctionalRating Scale - Revised(ALSFRS-R) between eachvisit
Enrollment:
100
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Cedars-SinaiMedical Center
•Other Study Start:
March 2015
Primary Completion:
February 2020
Study Completion:
February 2020
First Posted:
March 2, 2015
Results First Posted:
No Results Posted
Last Update Posted:
April 3, 2018
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
- Page 45 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
62 NCT02365922 Advancing Research andTreatment for FrontotemporalLobar Degeneration (ARTFL)
Study Documents:
Title Acronym:
ARTFL
Other Ids:
•ARTFL8101
•1U54NS092089-01
Recruiting •FTLD
•ProgressiveSupranuclear Palsy(PSP)
•FrontotemporalDementia (FTD)
•CorticobasalDegeneration(CBD)
•PPA Syndrome
•Behavioral VariantFrontotemporalDementia (bvFTD)
•SemanticVariant PrimaryProgressiveAphasia (svPPA)
•NonfluentVariant PrimaryProgressiveAphasia (nfvPPA)
•FTD WithAmyotrophicLateral Sclerosis(FTD/ALS)
•AmyotrophicLateral Sclerosis(ALS)
•OligosymptomaticPSP (oPSP)
•CorticobasalSyndrome (CBS)
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Scores of UDS FTLDModule Tests
•Progressive SupranuclearPalsy Rating Scale(PSPRS)
•Neuroimaging
Enrollment:
1560
Age:
18 Years to 85Years (Adult,Older Adult)
Sex:
All
•University ofCalifornia, SanFrancisco
•National Centerfor AdvancingTranslationalScience(NCATS)
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•The BluefieldProject
•Tau Consortium
•Other
•NIH
Study Start:
September 2014
Primary Completion:
September 2020
Study Completion:
February 2021
First Posted:
February 19, 2015
Results First Posted:
No Results Posted
Last Update Posted:
May 4, 2018
•University of Alabama,Birmingham, Alabama, UnitedStates
•University of California,Los Angeles, Los Angeles,California, United States
•University of California, SanDiego, San Diego, California,United States
•University of California, SanFrancisco, San Francisco,California, United States
•Mayo Clinic - Jacksonville,Jacksonville, Florida, UnitedStates
•Northwestern University,Chicago, Illinois, United States
•Johns Hopkins University,Baltimore, Maryland, UnitedStates
•Harvard UniversityMassachusetts GeneralHospital, Charlestown,Massachusetts, United States
•Mayo Clinic - Rochester,Rochester, Minnesota, UnitedStates
•Washington University, SaintLouis, Missouri, United States
•and 8 more
- Page 46 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
63 NCT02327845 Phenotype, Genotype &Biomarkers in ALS and RelatedDisorders
Study Documents:
Title Acronym:
Other Ids:
U54NS092091
Recruiting •AmyotrophicLateral Sclerosis
•FrontotemporalDementia
•Primary LateralSclerosis
•Hereditary SpasticParaplegia
•ProgressiveMuscular Atrophy
•MultisystemProteinopathy
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
•Phenotypic correlates ofgenotype
•Genetic determinants ofphenotype
Enrollment:
700
Age:
Child, Adult, OlderAdult
Sex:
All
•University ofMiami
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•National Centerfor AdvancingTranslationalScience(NCATS)
•St. JudeChildren'sResearchHospital
•ALS Association
•Other
•NIH
Study Start:
April 2015
Primary Completion:
August 2019
Study Completion:
August 2019
First Posted:
December 30, 2014
Results First Posted:
No Results Posted
Last Update Posted:
January 23, 2018
•Stanford University, Palo Alto,California, United States
•University of California SanDiego (UCSD), San Diego,California, United States
•California Pacific MedicalCenter (CPMC), San Francisco,California, United States
•University of Miami, Miami,Florida, United States
•University of Iowa, Iowa City,Iowa, United States
•Kansas University MedicalCenter (KUMC), Kansas City,Kansas, United States
•Twin Cities ALS ResearchConsortium, Minneapolis,Minnesota, United States
•Wake Forest University,Winston-Salem, North Carolina,United States
•Cleveland Clinic, Cleveland,Ohio, United States
•University of Pennsylvania,Philadelphia, Pennsylvania,United States
•and 6 more
64 NCT02228915 Analysis of Post-TranslationalModifications of a Critical ProteinImplicated in AmyotrophicLateral Sclerosis
Study Documents:
Title Acronym:
SOD1
Other Ids:
14-1780
Recruiting •ALS Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
Post-translationalmodifications (PTMs) of Cu/Zn superoxide dismutase 1
Enrollment:
30
Age:
18 Years to 99Years (Adult,Older Adult)
Sex:
All
•University ofNorth Carolina,Chapel Hill
•Other Study Start:
August 2014
Primary Completion:
August 2018
Study Completion:
August 2018
First Posted:
August 29, 2014
Results First Posted:
No Results Posted
Last Update Posted:
November 14, 2017
•UNC Neurology ALS clinic,Chapel Hill, North Carolina,United States
- Page 47 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
65 NCT02118727 Therapy in Amyotrophic LateralSclerosis With Memantine at 20mg BID (TAME)
Study Documents:
Title Acronym:
TAME
Other Ids:
•TAME-ALSFD003937-01
•FDA
Not yetrecruiting
•AmyotrophicLateral Sclerosis
•Frontal TemporalDementia
•Drug: Memantine
•Drug: Placebo (forMemantine)
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)
•Primary Purpose:Treatment
Outcome Measures:
•Disease progression asmeasured by the numberof points lost on the ALSFunctional Rating-Scale-Revised (ALSFRS-R)
•Measuring the levels ofTau, pNFH and the pNFH/C3 ratio in CSF and blood
Enrollment:
90
Age:
18 Years to 85Years (Adult,Older Adult)
Sex:
All
•University ofKansas MedicalCenter
•Other Study Start:
March 2018
Primary Completion:
October 2021
Study Completion:
October 2021
First Posted:
April 21, 2014
Results First Posted:
No Results Posted
Last Update Posted:
February 21, 2018
•Phoenix NeurologicalAssociates, Phoenix, Arizona,United States
•UC Irvine, Irvine, California,United States
•University of Kansas MedicalCenter, Kansas City, Kansas,United States
•University of Washington,Seattle, Washington, UnitedStates
- Page 48 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
66 NCT02118805 Innovative Measures of Speechand Swallowing Dysfunction inNeurological Disorders
Study Documents:
Title Acronym:
QUESST
Other Ids:
2013P000204
Recruiting •AmyotrophicLateral Sclerosis(ALS)
•Myasthenia Gravis
•Myopathies
•Stroke
•Parkinson'sDisease
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Other
•Time Perspective: Cross-Sectional
Outcome Measures:
•Change in Muscle Healthover 18 months byStandard Ultrasound
•Change in Score onthe Sydney SwallowQuestionnaire (over 18months)
•Change in Number ofSeconds It takes to RepeatIndividual Words TenTimes (over 18 months)
•Change in Number ofSeconds It Takes toSwallow of 3 ounces ofWater (over 18 months)
•Change in Score on theAmyotrophic LateralSclerosis Rating Scale -Revised (ALSFRS-R) (over18 months)
•Change in Score on theQuantitative MyastheniaGravis Scale (over 18months)
•Change in Score onthe United Parkinson'sDisease Rating Scale(UPDRS) (over 18 months)
•Change in Muscle Healthby Standard ConcentricNeedle Electromyography(EMG) (over 18 months)
•Change in Muscle Healthby Specialized ElectricalImpedance Arrays
Enrollment:
200
Age:
20 Years to 90Years (Adult,Older Adult)
Sex:
All
•Beth IsraelDeaconessMedical Center
•Other Study Start:
October 2013
Primary Completion:
June 2018
Study Completion:
June 2019
First Posted:
April 21, 2014
Results First Posted:
No Results Posted
Last Update Posted:
March 5, 2018
•Beth Israel DeaconessMedical Center, Boston,Massachusetts, United States
- Page 49 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
67 NCT02104921 Innovative UltrasoundTechnology in NeuromuscularDisease
Study Documents:
Title Acronym:
AQUIRe
Other Ids:
•2012P000364
•2K24NS060951
Recruiting •AmyotrophicLateral Sclerosis
•Muscular Dystrophy
•Radiculopathy
•Myopathy
•PolyneuropathyandMononeuropathies
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective:Prospective
Outcome Measures:
Quantitative ultrasounddata, including quantifiedgrayscale data andbackscattered acoustic data
Enrollment:
240
Age:
21 Years to 80Years (Adult,Older Adult)
Sex:
All
•Beth IsraelDeaconessMedical Center
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•Other
•NIH
Study Start:
December 2013
Primary Completion:
July 2018
Study Completion:
July 2019
First Posted:
April 7, 2014
Results First Posted:
No Results Posted
Last Update Posted:
March 5, 2018
•Beth Israel DeaconessMedical Center, Boston,Massachusetts, United States
68 NCT02014246 Genetic Characterization ofMovement Disorders andDementias
Study Documents:
Title Acronym:
Other Ids:
•999903329
•03-AG-N329
Recruiting •Ataxia
•Dystonia
•Parkinson'sDisease
•AmyotrophicLateral Sclerosis
•CorticobasalDegeneration
•Multiple SystemAtrophy
•Alzheimer'sDisease
•Lewy BodyDementia
•Parkinson Disease-Dementia
•Dentatorubral-pallidoluysianAtrophy
•and 5 more
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Case-Control
•Time Perspective: Other
Outcome Measures:
Identify and characterizegenetic contributions toetiology for movementdisorders, such as dystonia,Parkinson's disease,and dementias, suchas Alzheimer's disease,Lewy Body Dementia,frontotemporal dementia.
Enrollment:
12000
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•National Instituteon Aging (NIA)
•NationalInstitutes ofHealth ClinicalCenter (CC)
•NIH Study Start:
February 12, 2003
Primary Completion:
December 31, 2018
Study Completion:
December 31, 2018
First Posted:
December 18, 2013
Results First Posted:
No Results Posted
Last Update Posted:
August 9, 2018
•National Institute of Aging,Clinical Research Unit,Baltimore, Maryland, UnitedStates
- Page 50 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
69 NCT01938495 Diaphragm Pacing System(DPS) In Participants WithAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
DPS in ALS
Other Ids:
2013P001504
Active, notrecruiting
•AmyotrophicLateral Sclerosis(ALS)
•Device: NeuRx®Diaphragm PacingSystem™ (DPS)
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model: ParallelAssignment
•Masking: None (OpenLabel)
•Primary Purpose:Supportive Care
Outcome Measures:
•Survival
•quality of life
Enrollment:
52
Age:
21 Years and older (Adult, OlderAdult)
Sex:
All
•BarrowNeurologicalInstitute
•ALS Association
•MuscularDystrophyAssociation
•SynapseBiomedical
•Other
•Industry
Study Start:
August 2013
Primary Completion:
January 2017
Study Completion:
April 2017
First Posted:
September 10, 2013
Results First Posted:
No Results Posted
Last Update Posted:
December 23, 2016
•Barrow Neurological Institute,Phoenix, Arizona, United States
•Cedars-Sinai Medical Center,Los Angeles, California, UnitedStates
•California Pacific MedicalCenter, San Diego, California,United States
•Stanford University, Stanford,California, United States
•Hospital for Special Care, NewBritain, Connecticut, UnitedStates
•Mayo Clinic Florida,Jacksonville, Florida, UnitedStates
•University of Florida,Jacksonville, Jacksonville,Florida, United States
•University of Iowa, Iowa City,Iowa, United States
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Henry Ford Health Systems,Detroit, Michigan, United States
•and 15 more
70 NCT01931644 Be the Bridge BetweenResearchers and a Cure(GVHD, ALS, Hepatitis B,Alzheimer's Disease, Leukemia,and More)
Study Documents:
Title Acronym:
Other Ids:
SAN-BB-01
Recruiting •All DiagnosedHealth Conditions
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective: Cross-Sectional
Outcome Measures:
Biospecimen & Clinical DataCollection
Enrollment:
20000
Age:
18 Years to 100Years (Adult,Older Adult)
Sex:
All
•SanguineBiosciences
•Industry Study Start:
July 2013
Primary Completion:
August 2020
Study Completion:
December 2040
First Posted:
August 29, 2013
Results First Posted:
No Results Posted
Last Update Posted:
April 18, 2018
•Sanguine Biosciences, LosAngeles, California, UnitedStates
- Page 51 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
71 NCT01925196 Natural History and Biomarkersof Amyotrophic Lateral Sclerosisand Frontotemporal DementiaCaused by the C9ORF72 GeneMutation
Study Documents:
Title Acronym:
Other Ids:
•130188
•13-N-0188
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•FrontotemporalLobar Degeneration
Study Type:
Observational
Phase:
Study Design:
Time Perspective:Prospective
Outcome Measures:
•ALS Functional RatingScale-revised
•Frontobehavioral Index
•Verbal Fluency Score
Enrollment:
48
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•National Instituteon Aging (NIA)
•NationalInstitutes ofHealth ClinicalCenter (CC)
•NIH Study Start:
August 15, 2013
Primary Completion:
September 10, 2018
Study Completion:
September 10, 2018
First Posted:
August 19, 2013
Results First Posted:
No Results Posted
Last Update Posted:
August 9, 2018
•National Institutes of HealthClinical Center, 9000 RockvillePike, Bethesda, Maryland,United States
72 NCT01786603 Rasagiline in Subjects WithAmyotrophic Lateral Sclerosis(ALS)
Study Documents:
Title Acronym:
Other Ids:
•12312
•R01FD003739
Active, notrecruiting
•AmyotrophicLateral Sclerosis(ALS)
•Drug: Rasagiline
•Drug: Placebo
Study Type:
Interventional
Phase:
Phase 2
Study Design:
•Allocation: Randomized
•Intervention Model:Crossover Assignment
•Masking: Triple(Participant, Care Provider,Investigator)
•Primary Purpose:Treatment
Outcome Measures:
•Change in the ALSFunctional Rating Scale-Revised (ALSFRS-R)
•Change in vital capacity(VC)
•Change in quality of life
•Number of participants withadverse events
•Difference in survivalstatus between studygroups
•Bcl2Bax expression ratio inRNA samples
•Biomarker Assays ofMitochondrial Function
•Effect of study drug onapoptosis markers
•Effect of study drug onoxidative stress
Enrollment:
80
Age:
21 Years to 80Years (Adult,Older Adult)
Sex:
All
•Richard Barohn,MD
•University ofKansas MedicalCenter
•Other Study Start:
September 2012
Primary Completion:
August 2017
Study Completion:
August 2017
First Posted:
February 8, 2013
Results First Posted:
No Results Posted
Last Update Posted:
June 14, 2017
•Phoenix NeurologicalAssociates, Phoenix, Arizona,United States
•University of California - Irvine,Irvine, California, United States
•California Pacific MedicalCenter, San Francisco,California, United States
•University of Kansas MedicalCenter, Kansas City, Kansas,United States
•St. Louis University, SaintLouis, Missouri, United States
•University of Nebraska,Omaha, Nebraska, UnitedStates
•Columbia University, New York,New York, United States
•Oregon Health and ScienceUniversity, Portland, Oregon,United States
•University of Pennsylvania,Philadelphia, Pennsylvania,United States
•UT Southwestern MedicalCenter, Dallas, Texas, UnitedStates
- Page 52 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
73 NCT01772602 The National AmyotrophicLateral Sclerosis Registry
Study Documents:
Title Acronym:
Other Ids:
CDC-NCEH/ATSDR-5768
Recruiting •AmyotrophicLateral Sclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Other
•Time Perspective: Other
Outcome Measures:
•The National AmyotrophicLateral Sclerosis (ALS)Registry
•Risk factors of ALS
Enrollment:
16000
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Centers forDisease Controland Prevention
•VA Office ofResearch andDevelopment
•Centers forMedicareand MedicaidServices
•U.S.Fed
Study Start:
October 2010
Primary Completion:
December 2022
Study Completion:
December 2022
First Posted:
January 21, 2013
Results First Posted:
No Results Posted
Last Update Posted:
February 14, 2018
•CDC, Atlanta, Georgia, UnitedStates
74 NCT01699451 DNA, Blood and Skin CellRepository for Research on ALSand Related NeurodegenerativeDisorders at Mayo Clinic Florida
Study Documents:
Title Acronym:
Other Ids:
12-004718
Enrolling byinvitation
•AmyotrophicLateral Sclerosis(ALS)
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Other
•Time Perspective:Prospective
Outcome Measures:
Repository samplecollection
Enrollment:
160
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Mayo Clinic •Other Study Start:
September 2012
Primary Completion:
December 2019
Study Completion:
December 2019
First Posted:
October 3, 2012
Results First Posted:
No Results Posted
Last Update Posted:
March 22, 2018
•Mayo Clinic Florida,Jacksonville, Florida, UnitedStates
- Page 53 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
75 NCT01609283 A Dose-escalation Safety Trialfor Intrathecal AutologousMesenchymal Stem CellTherapy in Amyotrophic LateralSclerosis
Study Documents:
Title Acronym:
Other Ids:
11-008415
Active, notrecruiting
•AmyotrophicLateral Sclerosis
•Biological:autologousmesenchymal stemcells
Study Type:
Interventional
Phase:
Phase 1
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose:Treatment
Outcome Measures:
•Number of patients withdose-limiting toxicities
•Number of patients withadverse events
•Change in serumsedimentation rate
•Change in C-reactiveprotein levels
•Change in complete bloodcounts
•Change in total nucleatedcell count in cerebrospinalfluid (CSF)
•Change in protein level incerebrospinal fluid (CSF)
•Number of patients withpresence of cancer cellsin their cerebrospinal fluid(CSF)
Enrollment:
27
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Mayo Clinic •Other Study Start:
May 2012
Primary Completion:
April 2018
Study Completion:
April 2018
First Posted:
May 31, 2012
Results First Posted:
No Results Posted
Last Update Posted:
January 12, 2018
•Mayo Clinic, Rochester,Minnesota, United States
76 NCT01508962 PRE-Symptomatic Studies inAmyotrophic Lateral Sclerosis
Study Documents:
Title Acronym:
PRESS-ALS
Other Ids:
PRESS-ALS
Active, notrecruiting
•AmyotrophicLateral Sclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
Phenoconversion
Enrollment:
100
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofMiami
•Other Study Start:
November 2013
Primary Completion:
December 2027
Study Completion:
December 2027
First Posted:
January 12, 2012
Results First Posted:
No Results Posted
Last Update Posted:
June 19, 2018
•University of Miami, Miami,Florida, United States
- Page 54 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
77 NCT01459302 Genetic Study of Familial andSporadic ALS/Motor NeuronDisease, Miyoshi Myopathy andOther Neuromuscular Disorders
Study Documents:
Title Acronym:
Other Ids:
•H-13019
•5RC2NS070342-02
Recruiting •AmyotrophicLateral Sclerosis
•FrontotemporalDementia
•PLS
•Motor NeuronDisease
•Lou GehrigsDisease
•Familial Disease
•AmyotrophicLateral Sclerosis,Sporadic
•Muscular Dystrophy
•Miyoshi Myopathy
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Other
•Time Perspective:Prospective
Outcome Measures:
identification of new genesthat may contribute to ALS
Enrollment:
6000
Age:
Child, Adult, OlderAdult
Sex:
All
•University ofMassachusetts,Worcester
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•Other
•NIH
Study Start:
January 2009
Primary Completion:
October 2018
Study Completion:
October 2018
First Posted:
October 25, 2011
Results First Posted:
No Results Posted
Last Update Posted:
August 31, 2017
•University of MassachusettsMedical School, Worcester,Massachusetts, United States
78 NCT00912041 BrainGate2: Feasibility Study ofan Intracortical Neural InterfaceSystem for Persons WithTetraplegia
Study Documents:
Title Acronym:
BrainGate2
Other Ids:
•MGH-BG2-TP-001
•R01DC009899
•1UH2NS095548
Recruiting •Tetraplegia
•Spinal Cord Injuries
•AmyotrophicLateral Sclerosis
•Brain StemInfarctions
•Locked inSyndrome
•Muscular Dystrophy
•Device: Placementof the BrainGate2sensor(s) intothe motor-relatedcortex
Study Type:
Interventional
Phase:
Not Applicable
Study Design:
•Intervention Model: SingleGroup Assignment
•Masking: None (OpenLabel)
•Primary Purpose: Other
Outcome Measures:
•The primary endpointof this Study is todetermine the safety ofthe BrainGate2 NeuralInterface System.
•To investigate thefeasibility of BrainGate2and to establish theparameters for a largerclinical study, suchas appropriate neuraldecoding algorithms,sample size, indices ofmeasurement, successcriteria, and endpoints.
Enrollment:
15
Age:
18 Years to 75Years (Adult,Older Adult)
Sex:
All
•Leigh R.Hochberg, MD,PhD.
•National Instituteon Deafnessand OtherCommunicationDisorders(NIDCD)
•VA Office ofResearch andDevelopment
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•MassachusettsGeneral Hospital
•Other
•NIH
•U.S.Fed
Study Start:
May 2009
Primary Completion:
September 2021
Study Completion:
December 2021
First Posted:
June 3, 2009
Results First Posted:
No Results Posted
Last Update Posted:
March 29, 2018
•Stanford University School ofMedicine, Stanford, California,United States
•Massachusetts GeneralHospital, Boston,Massachusetts, United States
•Case Western ReserveUniversity, Cleveland, Ohio,United States
•Providence VA Medical Center,Providence, Rhode Island,United States
- Page 55 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
79 NCT00821132 Genetics of Familial andSporadic ALS
Study Documents:
Title Acronym:
ALS
Other Ids:
•Lab01
•RO1N505641-04
Recruiting •AmyotrophicLateral Sclerosis(ALS)
•FamilialAmyotrophicLateral Sclerosis
•AmyotrophicLateralSclerosis WithFrontotemporalDementia
•Lou Gehrig'sDisease
•Motor NeuronDisease
•Primary LateralSclerosis
•Other: Geneticstudy of ALSfamilies
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Family-Based
•Time Perspective: Other
Outcome Measures:
Identification of genes thatincrease risk for sporadicALS or cause inherited ALS.
Enrollment:
15000
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•NorthwesternUniversity
•Other Study Start:
January 1991
Primary Completion:
December 2019
Study Completion:
December 2022
First Posted:
January 13, 2009
Results First Posted:
No Results Posted
Last Update Posted:
March 29, 2018
•Northwestern UniversityFeinberg School of Medicine,Chicago, Illinois, United States
80 NCT00317616 The Pre-symptomatic FamilialAmyotrophic Lateral Sclerosis(Pre-fALS) Study
Study Documents:
Title Acronym:
Pre-fALS
Other Ids:
Pre-fALS
Recruiting •AmyotrophicLateral Sclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective:Prospective
Outcome Measures:
Risk Factors forProgression to familial ALS
Enrollment:
500
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•University ofMiami
•ALS Association
•Other Study Start:
April 2006
Primary Completion:
December 2027
Study Completion:
December 2027
First Posted:
April 25, 2006
Results First Posted:
No Results Posted
Last Update Posted:
June 19, 2018
•University of Miami, Miami,Florida, United States
81 NCT00136500 Clinical Research in ALS Study
Study Documents:
Title Acronym:
CRiALS
Other Ids:
FALS feasibility
Recruiting •AmyotrophicLateral Sclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Other
•Time Perspective:Prospective
Outcome Measures:
Recruitment
Enrollment:
10000
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•Michael Benatar
•ALS Association
•ALS RecoveryFund
•University ofMiami
•Other Study Start:
February 2005
Primary Completion:
December 2027
Study Completion:
December 2027
First Posted:
August 29, 2005
Results First Posted:
No Results Posted
Last Update Posted:
June 19, 2018
•University of Miami, Miami,Florida, United States
- Page 56 of 56 -
NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators
FunderType
Dates Locations
82 NCT00015444 Screening and Natural History:Primary Lateral Sclerosis andRelated Disorders
Study Documents:
Title Acronym:
Other Ids:
•010145
•01-N-0145
Active, notrecruiting
•Primary LateralSclerosis
Study Type:
Observational
Phase:
Study Design:
•Observational Model:Cohort
•Time Perspective: Other
Outcome Measures:
The primary outcome of thisprotocol is to document thenatural history of clinicalprogression in PLS, definedas the change in clinicalmeasures of movementspeed over time: fingertapping, timed gait, and timeto read a standard passage.
Enrollment:
189
Age:
18 Years and older (Adult, OlderAdult)
Sex:
All
•National Instituteof NeurologicalDisorders andStroke (NINDS)
•NationalInstitutes ofHealth ClinicalCenter (CC)
•NIH Study Start:
May 1, 2001
Primary Completion:
Study Completion:
First Posted:
April 19, 2001
Results First Posted:
No Results Posted
Last Update Posted:
August 9, 2018
•National Institutes of HealthClinical Center, 9000 RockvillePike, Bethesda, Maryland,United States
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services