Trial Outcomes & Findings for A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease (NCT NCT02006472)
NCT ID: NCT02006472
Last Updated: 2021-07-19
Results Overview
TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
408 participants
Primary outcome timeframe
26 weeks
Results posted on
2021-07-19
Participant Flow
A total of 492 patients were screened; of these, 408 were randomized. The main reason for not randomizing patients was noncompliance with the eligibility criteria.
Participant milestones
| Measure |
Pridopidine 112.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Placebo
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to the randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Period 1 (Through Week 26)
STARTED
|
82
|
82
|
81
|
82
|
81
|
|
Period 1 (Through Week 26)
ITT
|
82
|
82
|
81
|
82
|
81
|
|
Period 1 (Through Week 26)
FAS
|
81
|
81
|
75
|
79
|
81
|
|
Period 1 (Through Week 26)
Safety Set
|
82
|
82
|
81
|
82
|
81
|
|
Period 1 (Through Week 26)
COMPLETED
|
62
|
70
|
59
|
65
|
67
|
|
Period 1 (Through Week 26)
NOT COMPLETED
|
20
|
12
|
22
|
17
|
14
|
|
Period 2 (Through Week 52)
STARTED
|
46
|
57
|
49
|
54
|
56
|
|
Period 2 (Through Week 52)
Started Treatment in Period 2
|
46
|
57
|
49
|
52
|
56
|
|
Period 2 (Through Week 52)
COMPLETED
|
44
|
52
|
43
|
44
|
53
|
|
Period 2 (Through Week 52)
NOT COMPLETED
|
2
|
5
|
6
|
10
|
3
|
Reasons for withdrawal
| Measure |
Pridopidine 112.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Placebo
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to the randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Period 1 (Through Week 26)
Protocol Violation
|
0
|
1
|
1
|
1
|
1
|
|
Period 1 (Through Week 26)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
|
Period 1 (Through Week 26)
Noncompliance
|
0
|
2
|
1
|
1
|
0
|
|
Period 1 (Through Week 26)
Other
|
3
|
1
|
5
|
0
|
2
|
|
Period 1 (Through Week 26)
Adverse Event
|
14
|
5
|
6
|
11
|
11
|
|
Period 1 (Through Week 26)
Withdrawal by Subject
|
3
|
3
|
9
|
3
|
0
|
|
Period 2 (Through Week 52)
Lack of Efficacy
|
1
|
1
|
0
|
0
|
1
|
|
Period 2 (Through Week 52)
Noncompliance
|
0
|
1
|
0
|
0
|
0
|
|
Period 2 (Through Week 52)
Adverse Event
|
1
|
1
|
4
|
5
|
1
|
|
Period 2 (Through Week 52)
Other
|
0
|
0
|
1
|
0
|
1
|
|
Period 2 (Through Week 52)
Not treated
|
0
|
0
|
0
|
2
|
0
|
|
Period 2 (Through Week 52)
Withdrawal by Subject
|
0
|
2
|
1
|
2
|
0
|
|
Period 2 (Through Week 52)
Sponsor decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
n=82 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
n=82 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 12.69 • n=4 Participants
|
47.5 years
STANDARD_DEVIATION 11.40 • n=21 Participants
|
50.4 years
STANDARD_DEVIATION 11.85 • n=8 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
203 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
205 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
378 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Missing
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Use of neuroleptics
Yes
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
157 Participants
n=8 Participants
|
|
Use of neuroleptics
No
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
251 Participants
n=8 Participants
|
|
CYP2D6 genotype
Poor metaboliser
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
CYP2D6 genotype
Extensive metaboliser
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
355 Participants
n=8 Participants
|
|
CYP2D6 genotype
Intermediate metaboliser
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
CYP2D6 genotype
Ultra-rapid metaboliser
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Number of Cytosine-Adenosine-Guanine (CAG) Repeats
|
44.4 Number of CAG repeats
STANDARD_DEVIATION 3.23 • n=5 Participants
|
44.1 Number of CAG repeats
STANDARD_DEVIATION 4.12 • n=7 Participants
|
45.0 Number of CAG repeats
STANDARD_DEVIATION 4.73 • n=5 Participants
|
44.5 Number of CAG repeats
STANDARD_DEVIATION 4.90 • n=4 Participants
|
45.3 Number of CAG repeats
STANDARD_DEVIATION 3.66 • n=21 Participants
|
44.7 Number of CAG repeats
STANDARD_DEVIATION 4.18 • n=8 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Full analysis set (FAS) i.e. patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement.
Outcome measures
| Measure |
Placebo
n=81 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=75 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
n=79 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26
|
-4.79 score on a scale
Standard Error 0.99
|
-3.37 score on a scale
Standard Error 1.05
|
-3.09 score on a scale
Standard Error 1.02
|
-4.13 score on a scale
Standard Error 1.00
|
-2.74 score on a scale
Standard Error 1.01
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety Analysis set, i.e. patients who received at least one dose of study drug
Outcome measures
| Measure |
Placebo
n=82 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
n=82 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
n=82 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Number of Patients With Adverse Events
|
62 Participants
|
63 Participants
|
69 Participants
|
71 Participants
|
67 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 52 weeksPopulation: Full analysis set (FAS) i.e. patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment
The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening.
Outcome measures
| Measure |
Placebo
n=81 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=75 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
n=78 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
n=81 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Functional Capacity (TFC) at Week 52
|
-0.83 score on a scale
Standard Error 0.20
|
0.04 score on a scale
Standard Error 0.22
|
-0.72 score on a scale
Standard Error 0.21
|
-0.65 score on a scale
Standard Error 0.20
|
-0.59 score on a scale
Standard Error 0.22
|
POST_HOC outcome
Timeframe: 52 weeksPopulation: FAS i.e. pts receiving ≥1 dose of study drug and with ≥1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7. The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3.
The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening.
Outcome measures
| Measure |
Placebo
n=62 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=59 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Change in Total Functional Capacity (TFC) From Baseline in Patients With Early HD (Defined as Patients With TFC>=7)
|
-1.17 score on a scale
Standard Error 0.22
|
-0.01 score on a scale
Standard Error 0.23
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: 52 weeksPopulation: FAS i.e. pts receiving ≥1 dose of study drug and with ≥1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7 who completed 52 weeks. The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3.
The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Responder was defined as a TFC change to Week 52 of TFC\>=0.
Outcome measures
| Measure |
Placebo
n=41 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=37 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Total Functional Capacity Responder Rate in Early HD
|
20 Participants
|
30 Participants
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: 26 and 52 weeksPopulation: FAS i.e. pts receiving \>=1 dose of study drug and with \>=1 post-BL efficacy assessment; pts with early HD defined by BL TFC score ≥7. The study tested 4 pridopidine doses on TMS for 26 w. Due to a new understanding on pridopidine's mechanism of action (S1R agonist), the study was extended to 52w to assess TFC in all HD. A post-hoc analysis for the 45 mg bid dose was performed for TFC in early HD, and the dose was chosen for Phase 3.
Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Tap-interval-MN-Hand, measured in seconds. Positive change from baseline indicates worsening.
Outcome measures
| Measure |
Placebo
n=62 Participants
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of placebo matching pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 45 mg BID
n=59 Participants
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 67.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 90 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
Pridopidine 112.5 mg BID
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg and were during the first 4 weeks of treatment titrated to their randomized dose level. The randomized dose level was then to be maintained for the remainder of the treatment period through Week 52.
|
|---|---|---|---|---|---|
|
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Tap-interval-MN-Hand, Early HD
Change from baseline to Week 26
|
0.0247 seconds
Standard Error 0.0118
|
-0.0096 seconds
Standard Error 0.0110
|
—
|
—
|
—
|
|
Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Tap-interval-MN-Hand, Early HD
Change from baseline to Week 52
|
0.0447 seconds
Standard Error 0.0142
|
0.0003 seconds
Standard Error 0.0150
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Pridopidine 45 mg BID
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Pridopidine 67.5 mg BID
Serious events: 9 serious events
Other events: 63 other events
Deaths: 0 deaths
Pridopidine 90 mg BID
Serious events: 9 serious events
Other events: 57 other events
Deaths: 1 deaths
Pridopidine 112.5 mg BID
Serious events: 9 serious events
Other events: 53 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=82 participants at risk
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 45 mg BID
n=81 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 67.5 mg BID
n=82 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 90 mg BID
n=81 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 112.5 mg BID
n=82 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/82 • 52 weeks
|
4.9%
4/81 • Number of events 5 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/82 • 52 weeks
|
2.5%
2/81 • Number of events 2 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the colon
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Nervous system disorders
Akathisia
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Reproductive system and breast disorders
Urinary tetention
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Infections and infestations
Peritonitis
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
Placebo
n=82 participants at risk
Pridopidine matching placebo (hard capsules)
Patients received a starting dose of pridopidine 22.5 mg or matching placebo and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 45 mg BID
n=81 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 67.5 mg BID
n=82 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 90 mg BID
n=81 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
Pridopidine 112.5 mg BID
n=82 participants at risk
Pridopidine given as hard capsules, twice daily
Patients received a starting dose of pridopidine 22.5 mg (or matching placebo) and were during the first 4 weeks of treatment titrated to their randomised dose level. The randomised dose level was then to be maintained for the remainder of the treatment period through Week 26.
|
|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
6.2%
5/81 • Number of events 6 • 52 weeks
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
20.7%
17/82 • Number of events 31 • 52 weeks
|
19.8%
16/81 • Number of events 44 • 52 weeks
|
25.6%
21/82 • Number of events 31 • 52 weeks
|
16.0%
13/81 • Number of events 19 • 52 weeks
|
19.5%
16/82 • Number of events 42 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
7.4%
6/81 • Number of events 7 • 52 weeks
|
7.3%
6/82 • Number of events 8 • 52 weeks
|
0.00%
0/81 • 52 weeks
|
3.7%
3/82 • Number of events 4 • 52 weeks
|
|
Investigations
Weight decreased
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
4.9%
4/81 • Number of events 4 • 52 weeks
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
3.7%
3/81 • Number of events 3 • 52 weeks
|
8.5%
7/82 • Number of events 7 • 52 weeks
|
|
Investigations
Creatinine renal clearance decreased
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
6.2%
5/81 • Number of events 6 • 52 weeks
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
3.7%
3/81 • Number of events 4 • 52 weeks
|
6.1%
5/82 • Number of events 8 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
6.2%
5/81 • Number of events 5 • 52 weeks
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
6.1%
5/82 • Number of events 5 • 52 weeks
|
|
Nervous system disorders
Headache
|
9.8%
8/82 • Number of events 8 • 52 weeks
|
8.6%
7/81 • Number of events 18 • 52 weeks
|
8.5%
7/82 • Number of events 11 • 52 weeks
|
13.6%
11/81 • Number of events 19 • 52 weeks
|
9.8%
8/82 • Number of events 10 • 52 weeks
|
|
Nervous system disorders
Chorea
|
1.2%
1/82 • Number of events 1 • 52 weeks
|
4.9%
4/81 • Number of events 4 • 52 weeks
|
15.9%
13/82 • Number of events 15 • 52 weeks
|
3.7%
3/81 • Number of events 3 • 52 weeks
|
8.5%
7/82 • Number of events 8 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
2.5%
2/81 • Number of events 2 • 52 weeks
|
7.3%
6/82 • Number of events 12 • 52 weeks
|
6.2%
5/81 • Number of events 5 • 52 weeks
|
7.3%
6/82 • Number of events 8 • 52 weeks
|
|
Nervous system disorders
Balance disorder
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
2.5%
2/81 • Number of events 3 • 52 weeks
|
6.1%
5/82 • Number of events 6 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
|
General disorders
Fatigue
|
8.5%
7/82 • Number of events 10 • 52 weeks
|
3.7%
3/81 • Number of events 3 • 52 weeks
|
7.3%
6/82 • Number of events 6 • 52 weeks
|
8.6%
7/81 • Number of events 8 • 52 weeks
|
6.1%
5/82 • Number of events 5 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
7.4%
6/81 • Number of events 6 • 52 weeks
|
7.3%
6/82 • Number of events 6 • 52 weeks
|
8.6%
7/81 • Number of events 8 • 52 weeks
|
6.1%
5/82 • Number of events 5 • 52 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/82 • 52 weeks
|
2.5%
2/81 • Number of events 2 • 52 weeks
|
8.5%
7/82 • Number of events 8 • 52 weeks
|
1.2%
1/81 • Number of events 1 • 52 weeks
|
0.00%
0/82 • 52 weeks
|
|
Psychiatric disorders
Insomnia
|
3.7%
3/82 • Number of events 5 • 52 weeks
|
6.2%
5/81 • Number of events 6 • 52 weeks
|
13.4%
11/82 • Number of events 11 • 52 weeks
|
11.1%
9/81 • Number of events 10 • 52 weeks
|
11.0%
9/82 • Number of events 11 • 52 weeks
|
|
Psychiatric disorders
Irritability
|
8.5%
7/82 • Number of events 8 • 52 weeks
|
4.9%
4/81 • Number of events 4 • 52 weeks
|
7.3%
6/82 • Number of events 7 • 52 weeks
|
6.2%
5/81 • Number of events 5 • 52 weeks
|
2.4%
2/82 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
11.0%
9/82 • Number of events 14 • 52 weeks
|
11.1%
9/81 • Number of events 11 • 52 weeks
|
13.4%
11/82 • Number of events 14 • 52 weeks
|
13.6%
11/81 • Number of events 17 • 52 weeks
|
12.2%
10/82 • Number of events 15 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
4/82 • Number of events 6 • 52 weeks
|
6.2%
5/81 • Number of events 7 • 52 weeks
|
7.3%
6/82 • Number of events 7 • 52 weeks
|
6.2%
5/81 • Number of events 5 • 52 weeks
|
4.9%
4/82 • Number of events 4 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.9%
4/82 • Number of events 4 • 52 weeks
|
4.9%
4/81 • Number of events 6 • 52 weeks
|
8.5%
7/82 • Number of events 10 • 52 weeks
|
4.9%
4/81 • Number of events 6 • 52 weeks
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
4.9%
4/81 • Number of events 4 • 52 weeks
|
3.7%
3/82 • Number of events 3 • 52 weeks
|
7.4%
6/81 • Number of events 9 • 52 weeks
|
6.1%
5/82 • Number of events 6 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
7/82 • Number of events 8 • 52 weeks
|
17.3%
14/81 • Number of events 21 • 52 weeks
|
14.6%
12/82 • Number of events 16 • 52 weeks
|
16.0%
13/81 • Number of events 15 • 52 weeks
|
18.3%
15/82 • Number of events 23 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.9%
4/82 • Number of events 4 • 52 weeks
|
3.7%
3/81 • Number of events 3 • 52 weeks
|
7.3%
6/82 • Number of events 6 • 52 weeks
|
4.9%
4/81 • Number of events 5 • 52 weeks
|
6.1%
5/82 • Number of events 6 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data and results are owned by the sponsor. Results can be used by the institution for (a) internal noncommercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER