Trial Outcomes & Findings for A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease (NCT NCT00724048)

Last Updated: 2023-08-31

Results Overview

The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS included dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items were rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranged from 0 to 52, with higher scores indicating more severe motor impairment. The last observation carried forward (LOCF) method was used to generate an mMS score for each participant for Week 12 assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

227 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2023-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Overall Study STARTED	58	56	55	58
Overall Study Received at Least 1 Dose of Study Drug	58	56	55	58
Overall Study Full Analysis Set	58	55	55	58
Overall Study COMPLETED	55	51	52	55
Overall Study NOT COMPLETED	3	5	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Overall Study Adverse Event	1	1	1	0
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Withdrawal by Subject	1	2	1	2
Overall Study Investigator decision	0	0	1	0
Overall Study Did not tolerate study drug	0	0	0	1
Overall Study Other than specified	1	1	0	0

Baseline Characteristics

A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=58 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=55 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).	Total n=226 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	54.0 years STANDARD_DEVIATION 10.8 • n=7 Participants	50.0 years STANDARD_DEVIATION 10.5 • n=5 Participants	50.3 years STANDARD_DEVIATION 9.7 • n=4 Participants	51.0 years STANDARD_DEVIATION 10.5 • n=21 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	32 Participants n=7 Participants	27 Participants n=5 Participants	28 Participants n=4 Participants	120 Participants n=21 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	106 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants	52 Participants n=7 Participants	52 Participants n=5 Participants	54 Participants n=4 Participants	214 Participants n=21 Participants
Race/Ethnicity, Customized More than 1 Race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Unified Huntington's Disease Rating Scale (UHDRS) Modified Motor Score (mMS)	17.19 units on a scale STANDARD_DEVIATION 6.49 • n=5 Participants	16.96 units on a scale STANDARD_DEVIATION 6.18 • n=7 Participants	14.18 units on a scale STANDARD_DEVIATION 5.03 • n=5 Participants	16.22 units on a scale STANDARD_DEVIATION 6.39 • n=4 Participants	16.15 units on a scale STANDARD_DEVIATION 6.13 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=53 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=53 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=56 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Change From Baseline in Modified Motor Score (mMS) (Sum of Score of Items 4-10 and 13-15 of the UHDRS Motor Assessments) at Week 12	-1.40 units on a scale Standard Deviation 3.72	-1.30 units on a scale Standard Deviation 3.33	-2.49 units on a scale Standard Deviation 3.37	-2.32 units on a scale Standard Deviation 3.72

SECONDARY outcome

Timeframe: Basline, Week 12

Population: The FAS was defined as all randomized participants who received at least 1 dose of study drug and had undergone at least 1 clinical assessment post randomization. Here, 'Overall number of participants analyzed signifies participants evaluable for this outcome measure.

The UHDRS Motor Assessment comprises 31 responses from the 15 items, where each response is rated on a 5-point scale from 0 (normal) to 4 (maximally abnormal). The Total Motor Score (TMS) is the sum of all the 31 responses with higher scores indicating more severe motor impairment than lower scores.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=53 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=53 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=56 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Change From Baseline in Total Motor Score (TMS)	-2.09 Units on a scale Standard Deviation 8.31	-1.92 Units on a scale Standard Deviation 6.07	-3.30 Units on a scale Standard Deviation 6.91	-4.61 Units on a scale Standard Deviation 7.21

SECONDARY outcome

Timeframe: Week 12

The CGI-C was rated by the investigator on a 7-point scale as: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=55 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Minimally worse	4 Participants	4 Participants	5 Participants	1 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Very much worse	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Not assessed	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Very much improved	0 Participants	1 Participants	2 Participants	4 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Much improved	8 Participants	3 Participants	8 Participants	4 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Minimally improved	20 Participants	14 Participants	17 Participants	21 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale No change	24 Participants	31 Participants	22 Participants	25 Participants
Number of Participants in Each of the Ratings of the Clinical Global Impression of Change (CGI-C) Scale Much worse	1 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

The Stroop test measures the ability to concentrate and ward off distractions. The test consists of three items: (i) colour naming; (ii) word reading; (iii) interference. The word reading test requires participants to read colour words written in black and each response is scored as the number of correct answers made in 45 seconds. Higher scores indicate less severe disease, and an increase in score represents an improvement.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=55 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Change From Baseline in Stroop Word Reading Test	2.5 correct responses Standard Deviation 13.0	3.7 correct responses Standard Deviation 10.6	-0.0 correct responses Standard Deviation 12.7	2.8 correct responses Standard Deviation 10.5

SECONDARY outcome

Timeframe: Baseline, Week 12

The total behavioral assessment score is the sum of the 11 products (depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations) of frequency and severity symptom scores and excluded the 3 yes/no questions relating to confusion, dementia, and depression. Frequency is rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity is rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment), with higher scores indicating greater behavioral impairments.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=55 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Change From Baseline in Total UHDRS Behavioral Assessment Score	-3.56 Units on a scale Standard Deviation 8.51	-3.24 Units on a scale Standard Deviation 11.24	-3.45 Units on a scale Standard Deviation 10.10	-6.19 Units on a scale Standard Deviation 10.17

SECONDARY outcome

Timeframe: Baseline, Week 12

HADS is a self-administered instrument reliable for detecting states of depression and anxiety. It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale is comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale where higher scores indicate greater severity of anxiety and depression symptoms. The total HADS score was a composite score summed of all 14 items for a total range of 0-42. Lower change from baseline scores indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=55 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) Score	-1.04 Units on a scale Standard Deviation 3.67	-1.24 Units on a scale Standard Deviation 4.57	-0.95 Units on a scale Standard Deviation 4.68	-2.10 Units on a scale Standard Deviation 5.68

SECONDARY outcome

Timeframe: Baseline up to Week 14

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug.

An adverse event (AE) was defined as any change from the participant's baseline (pre-treatment) condition, other than improvement, that did not necessarily have causal relationship with the study drug. TEAEs were defined as adverse events that began after ACR16/placebo administration. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10 mg BID n=56 Participants Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 Participants Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 Participants Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	33 Participants	30 Participants	25 Participants	40 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

ACR16 10mg BID

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

ACR16 22.5 mg BID

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

ACR16 45 mg BID

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=58 participants at risk Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10mg BID n=56 participants at risk Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 participants at risk Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 participants at risk Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/55 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Nervous system disorders Convulsion	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/55 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Psychiatric disorders Adjustment disorder	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/55 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Psychiatric disorders Bipolar disorder	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/55 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Psychiatric disorders Depression	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/55 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Psychiatric disorders Suicidal ideation	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/55 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Reproductive system and breast disorders Testicular torsion	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/55 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.

Other adverse events

Other adverse events
Measure	Placebo n=58 participants at risk Participants received a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule was taken twice daily (BID) as 2 separate doses.	ACR16 10mg BID n=56 participants at risk Participants received ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 20 mg).	ACR16 22.5 mg BID n=55 participants at risk Participants received ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 45 mg).	ACR16 45 mg BID n=58 participants at risk Participants received ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule was taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Gastrointestinal disorders Diarrhoea	5.2% 3/58 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.4% 3/56 • Number of events 4 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	7.3% 4/55 • Number of events 6 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.4% 2/58 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Gastrointestinal disorders Dry mouth	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/56 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/55 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.2% 3/58 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Gastrointestinal disorders Nausea	6.9% 4/58 • Number of events 5 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/56 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/55 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	8.6% 5/58 • Number of events 5 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
General disorders Fatigue	8.6% 5/58 • Number of events 6 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/56 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/55 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.4% 2/58 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Infections and infestations Nasopharyngitis	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/56 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/55 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.2% 3/58 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Infections and infestations Urinary tract infection	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/56 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/55 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	6.9% 4/58 • Number of events 4 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Injury, poisoning and procedural complications Excoriation	6.9% 4/58 • Number of events 4 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/56 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/55 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.7% 1/58 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Injury, poisoning and procedural complications Fall	12.1% 7/58 • Number of events 10 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	16.1% 9/56 • Number of events 10 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	14.5% 8/55 • Number of events 12 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	13.8% 8/58 • Number of events 9 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Nervous system disorders Dizziness	0.00% 0/58 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/55 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	6.9% 4/58 • Number of events 4 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Nervous system disorders Headache	5.2% 3/58 • Number of events 4 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.4% 3/56 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.5% 3/55 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.2% 3/58 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Nervous system disorders Huntington's chorea	3.4% 2/58 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.4% 3/56 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/55 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.2% 3/58 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Psychiatric disorders Depression	6.9% 4/58 • Number of events 4 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/56 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.6% 2/55 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	3.4% 2/58 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	3.4% 2/58 • Number of events 2 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	0.00% 0/56 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	1.8% 1/55 • Number of events 1 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.	5.2% 3/58 • Number of events 3 • Baseline up to Week 14 Safety analysis set included all randomized participants who received at least 1 dose of study drug. Adverse events were analyzed for the once a day (first 4 weeks) and twice a day (weeks 5-12) dosing periods and the 2-week follow-up period (up to week 14), as one time period combined per planned analysis for each treatment group.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products R&D, Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 30 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 60 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER