Trial Outcomes & Findings for PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD (NCT NCT04556656)
NCT ID: NCT04556656
Last Updated: 2025-03-12
Results Overview
The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.
COMPLETED
PHASE3
499 participants
From baseline to Week 65
2025-03-12
Participant Flow
Participant milestones
| Measure |
Pridopidine
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
249
|
|
Overall Study
COMPLETED
|
222
|
227
|
|
Overall Study
NOT COMPLETED
|
28
|
22
|
Reasons for withdrawal
| Measure |
Pridopidine
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
12
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
4
|
7
|
|
Overall Study
Death
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Not further specified
|
2
|
1
|
Baseline Characteristics
PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
Baseline characteristics by cohort
| Measure |
Pridopidine
n=250 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=249 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
207 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
242 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
17 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
93 participants
n=7 Participants
|
201 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
37 participants
n=5 Participants
|
41 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
HD stage at randomization
HD1
|
102 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
HD stage at randomization
HD2
|
148 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 65Population: The modified intent to treat (mITT) population included all participants in the ITT population who received at least one dose of study drug and had valid in clinic TFC scores both at baseline and at least one post-baseline timepoint. The mITT population was analyzed according to the treatment to which the participant was randomized. The mITT population was the main analysis population for the primary endpoint in non-EMA regions. Note that the analysis was based on observed data.
The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.
Outcome measures
| Measure |
Pridopidine
n=243 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=247 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in the Unified Huntington Disease Rating Scale-Total Functional Capacity (UHDRS-TFC) Score (mITT)
|
-1.18 score on a scale
Standard Error 0.119
|
-0.95 score on a scale
Standard Error 0.119
|
PRIMARY outcome
Timeframe: From baseline to Week 65.Population: The intent to treat (ITT) population included all randomized participants. The ITT population was analyzed according to the treatment to which the participant was randomized. The ITT population was the main analysis population for the primary endpoint in the EMA region.
The primary efficacy endpoint for this study was the change from baseline to Week 65 in the TFC (defined as the sum of all TFC 5-items ratings \[domestic chores, activities of daily living, finances, care level, and occupation\]). The TFC is the standard and well-accepted clinical scale for staging and tracking the progression of HD using functional capacity. Scores range from 0 to 13, with 13 as the least affected and 0 as complete incapacity.
Outcome measures
| Measure |
Pridopidine
n=250 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=249 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline to Week 65 in the UHDRS TFC Score (ITT)
|
-1.17 score on a scale
Standard Error 0.120
|
-0.94 score on a scale
Standard Error 0.120
|
SECONDARY outcome
Timeframe: From baseline to Week 65Population: The modified intent to treat (mITT) population included all participants in the ITT population who received at least one dose of study drug and had valid in-clinic TFC scores both at baseline and at least one post-baseline timepoint. The mITT population was analyzed according to the treatment to which the participant was randomized. Note that the analysis was based on as observed data only, patient numbers are therefore lower.
The composite Unified Huntington Disease Rating Scale (cUHDRS) uses 4 components: Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0. Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0. Total integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better.
Outcome measures
| Measure |
Pridopidine
n=243 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=247 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline to Week 65 in Composite UHDRS (cUHDRS) Total Score (mITT)
|
-0.99 score on a scale
Standard Error 0.109
|
-0.88 score on a scale
Standard Error 0.108
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
The composite Unified Huntington Disease Rating Scale (cUHDRS) assesses 4 components (see secondary outcome for details): Total Motor Score (TMS) for motor features. Higher score = worse outcome. Worst = 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Higher score = better outcome. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Higher score = better outcome. Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. The higher, the better. Total cUHDRS scale range: -7.6 to 24.8 (assuming 150 as the max score of SWR). The higher, the better. This sensitivity analysis was performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)
Week 26
|
0.15 score on a scale
Standard Error 0.114
|
-0.31 score on a scale
Standard Error 0.108
|
|
Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)
Week 39
|
0.10 score on a scale
Standard Error 0.130
|
-0.34 score on a scale
Standard Error 0.125
|
|
Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)
Week 52
|
-0.07 score on a scale
Standard Error 0.140
|
-0.48 score on a scale
Standard Error 0.135
|
|
Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)
Week 65
|
-0.26 score on a scale
Standard Error 0.143
|
-0.53 score on a scale
Standard Error 0.137
|
|
Change From Baseline in cUHDRS Total Score - Patients Off ADMs (mITT)
Week 78
|
-0.40 score on a scale
Standard Error 0.159
|
-0.54 score on a scale
Standard Error 0.158
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 52, Week 65, and Week 78.Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Quantitative (Q)-motor is a clinical assessment of fine motor skills. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. The index finger is positioned above a force transducer and is to tap as fast as possible. The start was defined as a rise of the force by 0.05 Newton above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. The IOI refers to the time between the onset of consecutive taps (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 26
|
-14.85 milliseconds (decrease = improvement)
Standard Error 6.846
|
6.30 milliseconds (decrease = improvement)
Standard Error 6.449
|
|
Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 52
|
-2.37 milliseconds (decrease = improvement)
Standard Error 7.135
|
11.95 milliseconds (decrease = improvement)
Standard Error 6.792
|
|
Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 65
|
-0.79 milliseconds (decrease = improvement)
Standard Error 7.365
|
23.93 milliseconds (decrease = improvement)
Standard Error 7.028
|
|
Change From Baseline in Q-Motor Finger Tapping Inter-Onset Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 78
|
1.46 milliseconds (decrease = improvement)
Standard Error 7.444
|
24.36 milliseconds (decrease = improvement)
Standard Error 7.230
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 52, Week 65, and Week 78.Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assesses the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is ITI (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)
Week 26
|
-17.63 milliseconds
Standard Error 8.029
|
20.43 milliseconds
Standard Error 7.448
|
|
Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)
Week 52
|
-0.15 milliseconds
Standard Error 9.124
|
20.07 milliseconds
Standard Error 8.555
|
|
Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)
Week 65
|
4.64 milliseconds
Standard Error 8.380
|
28.55 milliseconds
Standard Error 7.867
|
|
Change From Baseline in Q-Motor Pronation/Supination Inter-Tap-Interval (ITI) Mean - Patients Off ADMs (mITT)
Week 78
|
12.73 milliseconds
Standard Error 9.740
|
34.97 milliseconds
Standard Error 9.412
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 52, Week 65, and Week 78.Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Pronation/Supination assess the regularity of hand taps. The force and duration of the hand taps were recorded similarly to the speeded tapping task. One pronation/supination hand tapping measure is IOI (the faster, the better). In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 26
|
-16.70 milliseconds
Standard Error 9.399
|
13.68 milliseconds
Standard Error 8.829
|
|
Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 52
|
7.40 milliseconds
Standard Error 10.978
|
24.23 milliseconds
Standard Error 10.467
|
|
Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 65
|
7.34 milliseconds
Standard Error 10.730
|
30.13 milliseconds
Standard Error 10.232
|
|
Change in Q-Motor Pronation/Supination Inter-Onset-Interval (IOI) Mean - Patients Off ADMs (mITT)
Week 78
|
19.21 milliseconds
Standard Error 12.702
|
41.93 milliseconds
Standard Error 12.435
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)
Week 26
|
-0.01 score on a scale
Standard Error 0.131
|
-0.23 score on a scale
Standard Error 0.124
|
|
Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)
Week 39
|
-0.11 score on a scale
Standard Error 0.137
|
-0.31 score on a scale
Standard Error 0.131
|
|
Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)
Week 52
|
-0.19 score on a scale
Standard Error 0.149
|
-0.45 score on a scale
Standard Error 0.143
|
|
Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)
Week 65
|
-0.49 score on a scale
Standard Error 0.156
|
-0.54 score on a scale
Standard Error 0.150
|
|
Change From Baseline in the UHDRS TFC Score - Patients Off ADMs (mITT)
Week 78
|
-0.42 score on a scale
Standard Error 0.166
|
-0.54 score on a scale
Standard Error 0.163
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78Population: The mITT population was used for subgroup analyses. Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Stroop Word Reading (SWR) measures attention and mental flexibility. Pat. reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)
Week 26
|
2.34 score on a scale
Standard Error 0.964
|
-0.82 score on a scale
Standard Error 0.916
|
|
Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)
Week 39
|
2.85 score on a scale
Standard Error 1.100
|
-0.04 score on a scale
Standard Error 1.051
|
|
Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)
Week 52
|
2.73 score on a scale
Standard Error 1.078
|
-0.32 score on a scale
Standard Error 1.039
|
|
Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)
Week 65
|
1.39 score on a scale
Standard Error 1.243
|
-0.94 score on a scale
Standard Error 1.193
|
|
Change From Baseline in Stroop Word Reading (SWR) - Patients Off ADMs (mITT)
Week 78
|
0.91 score on a scale
Standard Error 1.261
|
-1.08 score on a scale
Standard Error 1.249
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.Population: Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to write match numbers with symbols. Scoring sums correct substitutions in 90 second interval (max = 110). Higher score = better outcome. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)
Week 26
|
0.54 score on a scale
Standard Error 0.521
|
-0.47 score on a scale
Standard Error 0.484
|
|
Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)
Week 39
|
0.82 score on a scale
Standard Error 0.512
|
-0.06 score on a scale
Standard Error 0.478
|
|
Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)
Week 52
|
-0.42 score on a scale
Standard Error 0.578
|
-0.33 score on a scale
Standard Error 0.543
|
|
Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)
Week 65
|
0.35 score on a scale
Standard Error 0.616
|
0.07 score on a scale
Standard Error 0.576
|
|
Change From Baseline in Symbol Digit Modalities Test (SDMT) - Patients Off ADMs (mITT)
Week 78
|
0.07 score on a scale
Standard Error 0.617
|
-0.36 score on a scale
Standard Error 0.598
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time course from baseline to Week 26, Week 39, Week 52, Week 65, and Week 78.Population: Note: Analyses/p-values were generated on observed data. Patient numbers at individual weeks varied.
Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Each rated 0 (normal) - 4 (abnormal). Higher score = worse outcome. Worst = 124. In addition to the main efficacy analyses, sensitivity analyses were performed in a sub-group of patients who were off neuroleptics AND off vesicular monoamine transporter-2 (VMAT2) inhibitors (together called antidopaminergics, or ADMs) at any time during the study.
Outcome measures
| Measure |
Pridopidine
n=97 Participants
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=112 Participants
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)
Week 26
|
-0.21 score on a scale
Standard Error 0.568
|
-0.03 score on a scale
Standard Error 0.530
|
|
Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)
Week 39
|
0.06 score on a scale
Standard Error 0.780
|
0.96 score on a scale
Standard Error 0.729
|
|
Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)
Week 52
|
0.47 score on a scale
Standard Error 0.766
|
0.80 score on a scale
Standard Error 0.720
|
|
Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)
Week 65
|
0.92 score on a scale
Standard Error 0.847
|
1.28 score on a scale
Standard Error 0.790
|
|
Change From Baseline in Total Motor Score (TMS) - Patients Off ADMs (mITT)
Week 78
|
2.19 score on a scale
Standard Error 0.954
|
1.63 score on a scale
Standard Error 0.916
|
Adverse Events
Pridopidine
Placebo
Serious adverse events
| Measure |
Pridopidine
n=250 participants at risk
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=249 participants at risk
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.80%
2/250 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.80%
2/249 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Anxiety
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.80%
2/249 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
3/250 • Number of events 3 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Delusion
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Paranoia
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Psychotic disorder
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Anxiety disorder
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Depression
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Irritability
|
0.40%
1/250 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.80%
2/249 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.40%
1/250 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
COVID-19
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.80%
2/250 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
Appendicitis perforated
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
Pneumonia
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
Sepsis
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.80%
2/250 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Gastrointestinal disorders
Dysphagia
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Gastrointestinal disorders
Gastrointestinal polyp hemorrhage
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Gastrointestinal disorders
Hematemesis
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Nervous system disorders
Syncope
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.80%
2/249 • Number of events 3 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Nervous system disorders
Ataxia
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Nervous system disorders
Chorea
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Nervous system disorders
Radiculopathy
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
1.2%
3/249 • Number of events 3 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
General disorders
Death
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
General disorders
Gait disturbance
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Blood and lymphatic system disorders
Microcytic anemia
|
0.00%
0/250 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.40%
1/249 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Investigations
Weight decreased
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/250 • Number of events 1 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Vascular disorders
Hematoma
|
0.40%
1/250 • Number of events 2 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
0.00%
0/249 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
Other adverse events
| Measure |
Pridopidine
n=250 participants at risk
45 mg pridopidine twice daily (BID)
Pridopidine: Pridopidine hard gelatin capsule
|
Placebo
n=249 participants at risk
Matching placebo
Placebo: Pridopidine-matching placebo hard gelatin capsule
|
|---|---|---|
|
Investigations
Weight decreased
|
5.2%
13/250 • Number of events 13 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
2.8%
7/249 • Number of events 7 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
22.0%
55/250 • Number of events 114 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
22.9%
57/249 • Number of events 111 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
12/250 • Number of events 20 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
5.6%
14/249 • Number of events 15 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Nervous system disorders
Headache
|
6.4%
16/250 • Number of events 18 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
10.0%
25/249 • Number of events 34 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
8.4%
21/250 • Number of events 27 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
8.8%
22/249 • Number of events 32 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Depression
|
10.4%
26/250 • Number of events 27 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
4.8%
12/249 • Number of events 16 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Psychiatric disorders
Anxiety
|
7.6%
19/250 • Number of events 22 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
6.4%
16/249 • Number of events 20 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
12/250 • Number of events 13 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
5.6%
14/249 • Number of events 16 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
COVID-19
|
23.6%
59/250 • Number of events 62 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
22.9%
57/249 • Number of events 66 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
19/250 • Number of events 22 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
7.2%
18/249 • Number of events 20 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
|
Infections and infestations
Urinary tract infection
|
4.4%
11/250 • Number of events 12 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
6.8%
17/249 • Number of events 20 • From Screening until 2 weeks after End of Study/End of Treatment visit (total treatment period of up to 78 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs are not employed by the organization sponsoring the study. There is an agreement between PIs and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. 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