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CPMS-7001_Parkinson’s disease Confidential 1
CPMS-7001 Treatment of Parkinson’s Disease Using NEXALIN, a Transcranial Electrical Stimulator
STATISTICAL REPORT
February 05, 2009
Nexalin Technology, Inc.
Nexalin Technology, Inc.1382 Valencia Ave., Unit F Tustin, CA 92780 Phone: (714) 258-8004Email: [email protected]
CPMS-7001_Parkinson’s disease Confidential 2
Table of Contents
Topic Page
Table of Contents ................................................................................................................ 2
Introduction ......................................................................................................................... 3
Overview of Study .............................................................................................................. 3
Statistical Methods .............................................................................................................. 4
Results ................................................................................................................................. 5
Arm 1 .............................................................................................................................. 5
Arm 2 .............................................................................................................................. 5
Conclusions ......................................................................................................................... 5
Reference Tables ................................................................................................................. 6
UPDRS Total Score: Improvement from Baseline_Arm1 .............................................. 6
UPDRS Total Score: Means over Time_Arm 1 ............................................................. 7
UPDRS Mentation Section: Improvement from Baseline_Arm 1 .................................. 8
UPDRS Mentation Section: Means over Time_Arm 1 ................................................... 9
UPDRS Activities Section: Improvement from Baseline_Arm 1 ................................. 10
UPDRS Activities Section: Means over Time_Arm 1 ................................................. 11
UPDRS Motor Exam Section: Improvement from Baseline_Arm 1 ............................ 12
UPDRS Motor Exam Section: Means over Time_Arm 1 ............................................. 13
TUG Time Test: Improvement from Baseline_Arm 1 ................................................. 14
TUG Time Test: Means over Time_Arm 1 .................................................................. 15
UPDRS Total Score: Improvement from Baseline_Arm 2 ........................................... 16
UPDRS Total Score: Means over Time_Arm 2 ........................................................... 17
UPDRS Mentation Section: Improvement from Baseline_Arm 2 ................................ 18
UPDRS Mentation Section: Means over Time_Arm 2 ................................................. 19
UPDRS Activities Section: Improvement from Baseline_Arm 2 ................................. 20
UPDRS Activities Section: Means over Time_Arm 2 ................................................. 21
UPDRS Motor Exam Section: Improvement from Baseline_Arm 2 ............................ 22
UPDRS Motor Exam Section: Means over Time_Arm 2 ............................................. 23
TUG Test Time: Improvement from Baseline_Arm 2 ................................................. 24
TUG Test Time: Means over Time_Arm 2 .................................................................. 25
CPMS-7001_Parkinson’s disease Confidential 3
Introduction
This open label, uncontrolled study of Nexalin in Parkinson’s disease was done in Russia.
The study had two arms. The primary efficacy outcomes were changes from Baseline of
the United Parkinson’s Disease Rating Scale (UPDRS) and the Timed Up and Go Test
(TUG). This report presents a brief summary of the statistical analysis done on the
primary efficacy variables:
Overview of Study
There were two Arms in this study. Arm 1 had 20 subjects and lasted 5 weeks. Arm 2 had
30 subjects and lasted 22 weeks.
Arm 1 consisted of: two initial weeks, a one week (seven days) treatment period, and two
weeks of follow-up. The Baseline values were the single measures before the first
treatment. The changes from Baseline were analyzed at the following time periods:
Arm 1: Treatment Day 7
Post study Week 4
Post study Week5
Arm 2 consisted of: two initial weeks, a two-week treatment period, a two week interim
period, a second two week treatment period, and four follow-up visits (Weeks 9, 10, 16,
and 22). During the two week treatment periods, Nexalin was administered at Days 1 to 5
and days 8 to 12. The Baseline values were the single measures before the first treatment.
The changes from Baseline were analyzed at the following time periods:
Arm 2: Treatment session 1, day 5
Treatment session 1, day 6
Treatment session 1, day 10
Interim visit – Week 5
Treatment session 2, day 1
Treatment session 2, day 5
Treatment session 2, day 6
Treatment session 2, day 10
Post study visit – Week 9
Post study visit – Week 10
Follow-up – Week 16
Follow-up – Week 22
CPMS-7001_Parkinson’s disease Confidential 4
Statistical Methods
The 5 efficacy variables were:
UPDRS Total Score. 44 = 4 + 26 + 14 questions.
UPDRS Mentation Subsection Score. 4 questions
UPDRS Activities Subsection Score. 26 questions
UPDRS Motor Exam Subsection Score. 14 questions
TUG Time, in seconds
The UPDRS question responses usually range between 0 and 4, with higher values being
worse for the subject.
There was no missing data.
This was an uncontrolled study and covariates were not considered an issue.
These variables were tested for change from Baseline with two sided paired t-tests. The
results are presented on the attached tables. Results were considered statistically
significant at p ≤ 0.05.
The graphs on the attached tables show means of the variables and percentage change of
mean from Baseline, computed using the formula:
100 * (mean baseline score – mean follow-up score) / mean baseline score.
Note that paired tests are not directly done on these plotted values.
Normality assumptions were examined by looking at q-q plots. The deviations from
normality seen were not considered enough to cause any concern with the analysis.
Paired Wilcox tests were also examined, to check for normality problems. As expected
the p-values were somewhat greater, but consistent with normally distributed data.
Two other measures were taken in the initial two weeks before Baseline. They were very
consistent with the Baseline values. If these were used in a 2 way ANOVA, smaller p-
values would be expected in most cases.
For these reasons we feel comfortable with the p values presented.
CPMS-7001_Parkinson’s disease Confidential 5
Results
Arm 1
Statistically significant improvements (p≤0.05) were found with the assessment tools
noted below, at the listed measurement intervals:
UPDRS Total Score: Treatment Day 7, Post Study Week 4, Post Study Week 5
UPDRS Mentation Section: Treatment Day 7, Post Study Week 4
UPDRS Activities Section: Treatment Day 7, Post Study Week 4
UPDRS Motor Exam Section: Post Study Week 4
TUG Time: Treatment Day 7, Post Study Week 4, Post Study Week 5
Arm 2
Statistically significant improvements (p≤0.05) were found with the assessment tools
noted below, at the listed measurement intervals:
UPDRS Total Score: All times except Follow-up Week 22
UPDRS Mentation Section: All times except
Treatment 2 Day 1, Follow-up Week 16, and Follow-up Week 22
UPDRS Activities Section: All times except Follow-up Week 22
UPDRS Motor Exam Section: All times except Follow-up Week 22
TUG Time: All times except Treatment 1 day 5 and Follow-up Week 22
Actual p-values are shown in the reference tables included in the following pages.
Conclusions
Although significant results were noted in both treatment groups, the most effective
treatment regimen for patients suffering from the symptoms associated with Parkinson’s
disease remains unclear. A positive aspect that supports further research is that the
results demonstrate statistically significant improvements in many areas for up to 16
weeks in patients with a disease that is a continuously progressive disease.
Some of the flaws associated with the clinical investigation include the small sample size,
the lack of an objective test for the symptoms associated with Parkinson’s disease, the
potential for a high placebo response, and the lack of a strong response from a placebo
controlled feasibility study.
Further studies will need to be done in order to determine the maximum effectiveness of
Nexalin Therapy on the symptoms associated with Parkinson’s disease.
CPMS-7001_Parkinson’s disease Confidential 6
Reference Tables
Parkinson’s Disease Study – Arm 1
UPDRS Total Score: Improvement from Baseline_Arm1
UPDRS Total Score: Improvement from Baseline
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
18.00
20.00
Baseline S7W3 P1W4 P2W5
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Total Score: Percent Improvement from Baseline
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 % change 0.00 14.1 18.5 11.7 p-value 0.009152* 0.001574* 0.02656*
* Statistically significant (p≤0.05)
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Parkinson’s Disease Study – Arm 1
UPDRS Total Score: Means over Time_Arm 1
UPDRS Total Score
0.0
10.0
20.0
30.0
40.0
50.0
60.0
B S7W3 P1W4 P2W5
Study Visit
Mea
n
UPDRS Total Score: Means over Time
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 Mean 49.6 42.6 40.5 43.9
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Parkinson’s Disease Study – Arm 1
UPDRS Mentation Section: Improvement from Baseline_Arm 1
UPDRS Mentation Section: Improvement from Baseline
0.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
B S7W3 P1W4 P2W5
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Mentation Section: Percent Improvement from Baseline
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 % change 0.00 31.5 29.6 27.8 p-value 0.04329* 0.03852* 0.06507
* Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 9
Parkinson’s Disease Study – Arm 1
UPDRS Mentation Section: Means over Time_Arm 1
UPDRS Mentation Section
0.0
0.5
1.0
1.5
2.0
2.5
3.0
B S7W3 P1W4 P2W5
Study Visit
Mea
n
UPDRS Mentation Section: Means over Time
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 Mean 2.7 1.9 1.9 1.9
CPMS-7001_Parkinson’s disease Confidential 10
Parkinson’s Disease Study – Arm 1
UPDRS Activities Section: Improvement from Baseline_Arm 1
UPDRS Activities Section: Improvement from Baseline
0.00
5.00
10.00
15.00
20.00
25.00
B S7W3 P1W4 P2W5
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Activities Section: Percent Improvement from Baseline
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 % change 0.00 19.8 22.1 12.1 p-value 0.003873* 0.001620* 0.05728
* Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 11
Parkinson’s Disease Study – Arm 1
UPDRS Activities Section: Means over Time_Arm 1
UPDRS Activities Section
0.0
5.0
10.0
15.0
20.0
25.0
30.0
B S7W3 P1W4 P2W5
Study Visit
Mea
n
UPDRS Activities Section: Means over Time
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 Mean 26.1 20.9 20.3 22.9
CPMS-7001_Parkinson’s disease Confidential 12
Parkinson’s Disease Study – Arm 1
UPDRS Motor Exam Section: Improvement from Baseline_Arm 1
UPDRS Motor Exam Section: Improvement from Baseline
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
B S7W3 P1W4 P2W5
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Motor Exam Section: Percent Improvement from Baseline
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 % change 0.00 4.8 12.7 9.1 p-value 0.1756 0.01044* 0.06644
* Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 13
Parkinson’s Disease Study – Arm 1
UPDRS Motor Exam Section: Means over Time_Arm 1
UPDRS Motor Exam Section
16.5
17.0
17.5
18.0
18.5
19.0
19.5
20.0
20.5
21.0
21.5
B S7W3 P1W4 P2W5
Study Visit
Mea
n
UPDRS Motor Exam Section: Means over Time
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 Mean 20.9 19.9 18.2 19.0
CPMS-7001_Parkinson’s disease Confidential 14
Parkinson’s Disease Study – Arm 1
TUG Time Test: Improvement from Baseline_Arm 1
Timed Up and Go (TUG) Time Test: Improvement from Baseline
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
B S7W3 P1W4 P2W5
Study Visit
Per
cen
t Im
pro
vem
ent
Timed Up and Go (TUG) Test Time: Percent Improvement from Baseline
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 % change 0.00 13.6 14.0 14.4 p-value 0.004332* 0.008148* 0.01096*
* Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 15
Parkinson’s Disease Study – Arm 1
TUG Time Test: Means over Time_Arm 1
Timed Up and Go (TUG) Time Test
9.0
9.5
10.0
10.5
11.0
11.5
12.0
B S7W3 P1W4 P2W5
Study Visit
Mea
n
Timed Up and Go (TUG) Test Time: Means over Time
Visit Baseline Treatment
Day 7 Post Study
Week 4 Post Study
Week 5
Visit Code B S7W3 P1W4 P2W5 Mean 11.8 10.2 10.2 10.1
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Parkinson’s Disease Study – Arm 2
UPDRS Total Score: Improvement from Baseline_Arm 2
UPDRS Total Score: Improvement from Baseline
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Total Score: Percent Improvement from Baseline
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
% change 0.0 6.8 9.6 15.2 11.3 7.5 10.2 12.0 14.6 14.0 12.7 8.1 2.7
p-value 0.005488* 0.000287* 3.85E-05* 0.000363* 0.003714* 0.002605* 0.00102* 0.000137* 0.00014* 0.000322* 0.003608* 0.2227 * Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 17
Parkinson’s Disease Study – Arm 2
UPDRS Total Score: Means over Time_Arm 2
UPDRS Total Score
34.0
36.0
38.0
40.0
42.0
44.0
46.0
B
S5W3
S6W3
S10W
4IW
5
S1W7
S5W7
S6W7
S10W
8
P1W9
P2W10
F1W16
F2W22
Study Visit
Mea
n
UPDRS Total Score: Means over Time
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Mean 44.6 41.6 40.4 37.9 39.6 41.3 40.1 39.3 38.1 38.4 39.0 41.0 43.4
CPMS-7001_Parkinson’s disease Confidential 18
Parkinson’s Disease Study – Arm 2
UPDRS Mentation Section: Improvement from Baseline_Arm 2
UPDRS Mentation Section: Improvement from Baseline
0.0
5.0
10.0
15.0
20.0
25.0
30.0
B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Mentation Section: Percent Improvement from Baseline
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
% change 0.0 14.1 23.1 28.2 25.6 14.1 20.5 25.6 25.6 25.6 21.8 12.8 10.3
p-value 0.04621* 0.002737* 0.000858* 0.005358* 0.1176 0.03991* 0.01119* 0.009853* 0.01119* 0.03247* 0.08632 0.1033 *Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 19
Parkinson’s Disease Study – Arm 2
UPDRS Mentation Section: Means over Time_Arm 2
UPDRS Mentation Section
0.0
0.5
1.0
1.5
2.0
2.5
3.0
B
S5W3
S6W3
S10W
4IW
5
S1W7
S5W7
S6W7
S10W
8
P1W9
P2W10
F1W16
F2W22
Study Visit
Mea
n
UPDRS Mentation Section: Means over Time
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Mean 2.6 2.2 2.0 1.9 1.9 2.2 2.1 1.9 1.9 1.9 2.0 2.3 2.3
CPMS-7001_Parkinson’s disease Confidential 20
Parkinson’s Disease Study – Arm 2
UPDRS Activities Section: Improvement from Baseline_Arm 2
UPDRS Activities Section: Improvement from Baseline
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
18.0
B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Activities Section: Percent Improvement from Baseline
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
% change 0.0 6.4 9.2 15.9 8.9 6.6 9.2 11.1 13.6 11.8 10.7 7.0 1.4
p-value 0.03042* 0.002793* 0.000212* 0.006994* 0.0157* 0.007681* 0.003952* 0.000879* 0.000691* 0.001636* 0.01584* 0.6236 * Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 21
Parkinson’s Disease Study – Arm 2
UPDRS Activities Section: Means over Time_Arm 2
UPDRS Activities Section
16.0
17.0
18.0
19.0
20.0
21.0
22.0
23.0
B
S5W3
S6W3
S10W
4IW
5
S1W7
S5W7
S6W7
S10W
8
P1W9
P2W10
F1W16
F2W22
Study Visit
Mea
n
UPDRS Activities Section: Means over Time
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Mean 21.8 20.4 19.8 18.4 19.9 20.4 19.8 19.4 18.9 19.3 19.5 20.3 21.5
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Parkinson’s Disease Study – Arm 2
UPDRS Motor Exam Section: Improvement from Baseline_Arm 2
UPDRS Motor Exam Section: Improvement from Baseline
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Study Visit
Per
cen
t Im
pro
vem
ent
UPDRS Motor Exam Section: Percent Improvement from Baseline
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
% change 0.0 6.3 8.3 12.7 12.0 7.6 9.9 11.2 14.4 15.0 13.7 8.7 3.1
p-value 0.02039* 0.002316* 0.00021* 0.001087* 0.007072* 0.005254* 0.002551* 0.000258* 0.000273* 0.00104* 0.008223* 0.2086 * Statistically significant (p≤0.05)
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Parkinson’s Disease Study – Arm 2
UPDRS Motor Exam Section: Means over Time_Arm 2
UPDRS Motor Exam Section
0.0
5.0
10.0
15.0
20.0
25.0
B
S5W3
S6W3
S10W
4IW
5
S1W7
S5W7
S6W7
S10W
8
P1W9
P2W10
F1W16
F2W22
Study Visit
Mea
n
UPDRS Motor Exam Section: Means over Time
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Mean 18.9 18.5 17.6 17.8 18.7 18.2 17.9 17.3 17.2 17.4 18.4 19.6 21.5
CPMS-7001_Parkinson’s disease Confidential 24
Parkinson’s Disease Study – Arm 2
TUG Test Time: Improvement from Baseline_Arm 2
Timed Up and Go (TUG) Test Time: Improvement from Baseline
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Study Visit
Per
cen
t Im
pro
vem
ent
Timed Up and Go (TUG) Test Time: Percent Improvement from Baseline
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10
Interim Visit Week
5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10 Post Study
Week 9 Post Study Week 10
Follow-up Week 16
Follow-up Week
22 Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
% change 0.0 3.2 7.8 7.4 10.3 7.4 11.3 12.4 13.1 11.0 9.2 5.0 2.5
p-value 0.1527 0.004696* 0.000144* 0.000867* 0.002337* 5.08E-05* 7.69E-06* 1.15E-05* 8.96E-05* 0.000703* 0.01687* 0.1287 * Statistically significant (p≤0.05)
CPMS-7001_Parkinson’s disease Confidential 25
Parkinson’s Disease Study – Arm 2
TUG Test Time: Means over Time_Arm 2
Timed Up and Go (TUG) Time Test
7.6
7.8
8.0
8.2
8.4
8.6
8.8
9.0
9.2
9.4
9.6
B
S5W3
S6W3
S10W
4IW
5
S1W7
S5W7
S6W7
S10W
8
P1W9
P2W10
F1W16
F2W22
Study Visit
Mea
n
Timed Up and Go (TUG) Time Test: Means over Time
Visit Baseline
Treatment Session1 Treatment
Day 5
Treatment Session1 Treatment
Day 6
Treatment Session1 Treatment
Day 10 Interim Visit
Week 5
Treatment Session2 Treatment
Day 1
Treatment Session2 Treatment
Day 5
Treatment Session2 Treatment
Day 6
Treatment Session2 Treatment
Day 10
Post Study
Week 9
Post Study
Week 10 Follow-up Week 16
Follow-up Week 22
Visit Code B S5W3 S6W3 S10W4 IW5 S1W7 S5W7 S6W7 S10W8 P1W9 P2W10 F1W16 F2W22
Mean 9.4 9.1 8.7 8.7 8.4 8.7 8.3 8.2 8.2 8.4 8.5 8.9 9.2