Trial Outcomes & Findings for A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (NCT NCT03922711)

NCT ID: NCT03922711

Last Updated: 2022-07-01

Results Overview

Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical \[Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)\] and Objective \[Part 3 (Impairment) and Part 4 (Disability)\] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit.
• Results posted on: 2022-07-01

Participant Flow

A total of 23 patients were randomized to pridopidine 100 mg BID (n=7), pridopidine 150 mg BID (n=8), or placebo (n=8). Of these, 5 patients randomized to 150 mg BID discontinued study drug during the titration period prematurely (i.e. did not reach the maintenance dose) and were therefore analyzed in the 100 mg BID group. The study was terminated early due to the COVID-19 pandemic.

Participant milestones

Measure	Pridopidine 100 mg BID Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Pridopidine 150 mg BID Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Placebo Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo.
Overall Study STARTED	7	8	8
Overall Study Treatment Group Based on Maximal Possible Highest Dose Received (Used for Analysis)	12	3	8
Overall Study COMPLETED	3	3	4
Overall Study NOT COMPLETED	4	5	4

Reasons for withdrawal

Measure	Pridopidine 100 mg BID Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Pridopidine 150 mg BID Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Placebo Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo.
Overall Study Adverse Event	3	2	2
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	0	3	1
Overall Study Not further specified	0	0	1

Baseline Characteristics

A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease

Baseline characteristics by cohort

Measure	Pridopidine 100 mg BID n=12 Participants Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Pridopidine 150 mg BID n=3 Participants Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Placebo n=8 Participants Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo.	Total n=23 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 7.5 • n=5 Participants	61.3 years STANDARD_DEVIATION 12.7 • n=7 Participants	64.0 years STANDARD_DEVIATION 9.7 • n=5 Participants	66.3 years STANDARD_DEVIATION 9.0 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants	23 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit.

Population: The primary endpoint was analyzed for the population of patients randomized and on study drug at Visit 5 (Week 8/10). Of the 3 pridopidine patients included, 1 and 2 patients, respectively, received pridopidine 100 and 150 mg. Analysis of these data, separately for each pridopidine dose, is not meaningful or conclusive.

Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state.

The UDysRS comprises 2 primary sections i.e. Historical [Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)] and Objective [Part 3 (Impairment) and Part 4 (Disability)] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia.

The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4.

Outcome measures

Measure	Pridopidine Total n=3 Participants All patients on treatment with pridopidine at the time of Visit 5 (Week 8/10) regardless of the pridopidine dose.	Placebo n=7 Participants All patients on treatment with pridopidine-matching placebo at the time of Visit 5 (Week 8/10).
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score Baseline	32.0 score on a scale Standard Deviation 10.44	35.9 score on a scale Standard Deviation 6.44
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score Visit 5	14.7 score on a scale Standard Deviation 5.13	26.1 score on a scale Standard Deviation 11.02
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score Change from baseline at Visit 5	-17.3 score on a scale Standard Deviation 6.03	-9.7 score on a scale Standard Deviation 9.43

Adverse Events

Pridopidine 100 mg BID

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Pridopidine 150 mg BID

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pridopidine 100 mg BID n=12 participants at risk Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Pridopidine 150 mg BID n=3 participants at risk Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Placebo n=8 participants at risk Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo.
Infections and infestations Diverticulitis	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.

Other adverse events

Measure	Pridopidine 100 mg BID n=12 participants at risk Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 100 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Pridopidine 150 mg BID n=3 participants at risk Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment at a dose of 150 mg BID. 2-week titration: 3 days pridopidine 75 mg QD, then 4 days pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID 4-week titration: 1 week pridopidine 75 mg every 48 h, then 1 week pridopidine 75 mg QD, then 1 week pridopidine 75 mg BID, then 1 week pridopidine 100 mg BID.	Placebo n=8 participants at risk Titration period of 2-week (original protocol) or 4-week (Amendment 1) duration, followed by 12-week maintenance treatment, using pridopidine-matching placebo.
Ear and labyrinth disorders Tinnitus	16.7% 2/12 • Number of events 2 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Ear and labyrinth disorders Vertigo	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Eye disorders Dry eye	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Dry mouth	25.0% 3/12 • Number of events 3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Nausea	25.0% 3/12 • Number of events 4 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Abnormal faeces	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Faeces discoloured	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Colitis	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Gastrointestinal disorders Vomiting	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Fatigue	25.0% 3/12 • Number of events 3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Chest pain	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Drug ineffective	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Feeling abnormal	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Feeling jittery	8.3% 1/12 • Number of events 16 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Gait disturbance	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Oedema peripheral	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Temperature intolerance	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 2 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
General disorders Drug effect decreased	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Infections and infestations Bronchitis	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Infections and infestations Urinary tract infection	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Infections and infestations Localised infection	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Injury, poisoning and procedural complications Fall	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Injury, poisoning and procedural complications Head injury	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Investigations Bacterial test positive	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Investigations Blood potassium increased	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Investigations Platelet count decreased	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Investigations Protein urine present	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Investigations Weight decreased	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Investigations White blood cell count increased	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Metabolism and nutrition disorders Decreased appetite	25.0% 3/12 • Number of events 3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 2 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Dizziness	25.0% 3/12 • Number of events 6 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Headache	16.7% 2/12 • Number of events 8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Parkinson's disease	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Amnesia	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Anosmia	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Dysgeusia	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Dyskinesia	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Freezing phenomenon	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Parkinsonism	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	25.0% 2/8 • Number of events 2 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Syncope	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Tremor	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Nervous system disorders Somnolence	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Psychiatric disorders Anxiety	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Psychiatric disorders Insomnia	16.7% 2/12 • Number of events 2 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Psychiatric disorders Confusional state	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Psychiatric disorders Hallucination	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Psychiatric disorders Initial insomnia	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Renal and urinary disorders Pollakiuria	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Renal and urinary disorders Renal impairment	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	33.3% 1/3 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Renal and urinary disorders Urinary incontinence	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Renal and urinary disorders Urinary retention	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Reproductive system and breast disorders Vaginal odour	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Skin and subcutaneous tissue disorders Cold sweat	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	12.5% 1/8 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Vascular disorders Hot flush	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Vascular disorders Hypotension	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.
Vascular disorders Orthostatic hypotension	8.3% 1/12 • Number of events 1 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/3 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.	0.00% 0/8 • From screening onwards, through to Week 18 (planned); this included 2 weeks' safety follow-up after treatment completion. The study was discontinued early due to the COVID-19 pandemic. Actual exposure (mean treatment duration) was 38 days in all patients receiving pridopidine and 93 days in all patients receiving placebo. A total of 8 patients were randomized to pridopidine 150 mg BID. Of these, 5 patients discontinued study drug during titration, i.e. did not reach the full maintenance dose. Therefore, they were analyzed under the 100 mg BID group. The 100 mg BID group included patients who received any dose between 75 mg QD and 100 mg BID.

Additional Information

Prilenia

Prilenia

Phone: +972 775558

Email: info@prilenia.com

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