Trial Outcomes & Findings for A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS) (NCT NCT03571256)

NCT ID: NCT03571256

Last Updated: 2021-11-09

Results Overview

YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (3 levels: Weeks 2, 4, and 8), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 158 participants
• Primary outcome timeframe: Baseline, Week 8
• Results posted on: 2021-11-09

Participant Flow

A total of 158 participants were randomized in a 1:1:1 ratio to TEV-50717 high-dose, TEV-50717 low-dose or placebo group.

Participant milestones

Measure	TEV-50717 High-Dose TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks	TEV-50717 Low-Dose TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Overall Study STARTED	52	54	52
Overall Study Safety Analysis Set	52	54	51
Overall Study Modified ITT (mITT) Analysis Set	49	53	51
Overall Study COMPLETED	46	51	48
Overall Study NOT COMPLETED	6	3	4

Reasons for withdrawal

Measure	TEV-50717 High-Dose TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks	TEV-50717 Low-Dose TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Overall Study Adverse Event	3	0	1
Overall Study Withdrawal by Subject	3	1	1
Overall Study Other than specified	0	1	1
Overall Study Protocol Violation	0	1	1

Baseline Characteristics

A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

Baseline characteristics by cohort

Measure	TEV-50717 High-Dose n=52 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	TEV-50717 Low-Dose n=54 Participants TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks	Placebo n=52 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Total n=158 Participants Total of all reporting groups
Age, Continuous	11.7 years STANDARD_DEVIATION 2.63 • n=5 Participants	11.7 years STANDARD_DEVIATION 2.70 • n=7 Participants	11.8 years STANDARD_DEVIATION 2.62 • n=5 Participants	11.7 years STANDARD_DEVIATION 2.64 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	42 Participants n=7 Participants	40 Participants n=5 Participants	119 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	45 Participants n=7 Participants	37 Participants n=5 Participants	125 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	48 Participants n=5 Participants	48 Participants n=7 Participants	39 Participants n=5 Participants	135 Participants n=4 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	33.9 units on a scale STANDARD_DEVIATION 6.17 • n=5 Participants	32.9 units on a scale STANDARD_DEVIATION 7.20 • n=7 Participants	34.7 units on a scale STANDARD_DEVIATION 6.29 • n=5 Participants	33.8 units on a scale STANDARD_DEVIATION 6.58 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (3 levels: Weeks 2, 4, and 8), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.

Outcome measures

Measure	TEV-50717 High-Dose n=49 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-7.8 units on a scale Standard Error 1.24	-7.0 units on a scale Standard Error 1.16	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (3 levels: Weeks 2, 4, and 8), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.

Outcome measures

Measure	TEV-50717 High-Dose n=49 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.8 units on a scale Standard Error 0.14	-0.6 units on a scale Standard Error 0.13	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. LS mean and SE was calculated using MMRM with treatment group, week (3 levels: Weeks 2, 4, and 8), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.

Outcome measures

Measure	TEV-50717 High-Dose n=53 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-5.9 units on a scale Standard Error 1.18	-7.0 units on a scale Standard Error 1.16	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

The TS-CGI scale is a 7-point Likert scale that allows the clinician to use all available information to assess the impact of tics on the participant's quality of life. The TS-CGI is rated as follows: 1 (normal or no tics at all), 2 (borderline), 3 (mild), 4 (moderate), 5 (marked), 6 (severe), and 7 (extreme, incapacitating tics). Lower scores indicate better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (3 levels: Weeks 2, 4, and 8), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.

Outcome measures

Measure	TEV-50717 High-Dose n=53 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.6 units on a scale Standard Error 0.13	-0.6 units on a scale Standard Error 0.13	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy.

Outcome measures

Measure	TEV-50717 High-Dose n=49 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.8 units on a scale Standard Error 0.17	-0.7 units on a scale Standard Error 0.16	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

The TS-PGII is a single-item questionnaire that asks the participant to assess the degree of impact due to current tics (How much do your current tics disrupt things in your life?). The TS-PGII uses a 5-point scale, ranging from not at all (1) to very much (5), to assess overall response to therapy.

Outcome measures

Measure	TEV-50717 High-Dose n=53 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-0.7 units on a scale Standard Error 0.15	-0.7 units on a scale Standard Error 0.16	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

C&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (3 levels: Weeks 2, 4, and 8), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates.

Outcome measures

Measure	TEV-50717 High-Dose n=49 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-10.3 units on a scale Standard Error 2.85	-9.0 units on a scale Standard Error 2.66	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: mITT analysis set included all randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline YGTSS assessment.

C&A-GTS-QOL is a 27-item questionnaire that asks participant to assess the extent to which their quality of life is impacted by their symptoms. C&A-GTS-QOL contains 6 subscales (cognitive, coprophenomena, psychological, physical, obsessive-compulsive, and ADL) and uses a 5-point Likert scale ranging from no problem to extreme problem. Following 3 questions from 27-item questionnaire were assessed in ADL C&A-GTS-QOL subscale: Question 2 (Had difficulty with school or sport activities?), 24 (Felt you needed more help or support from other people?), and 26 (Had difficulty going out with other people?). Total score of ADL subscale ranged from 0 (no problem) to 12 (extreme problem). Lower score indicated better quality of life. LS mean and SE was calculated using MMRM with treatment group, week (3 levels: Weeks 2, 4, and 8), and treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6-11 years, 12-16 years) as covariates.

Outcome measures

Measure	TEV-50717 High-Dose n=53 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the C&A-GTS-QOL ADL Subscale Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants	-10.0 units on a scale Standard Error 2.68	-9.0 units on a scale Standard Error 2.66	—

SECONDARY outcome

Timeframe: Baseline, Week 9

Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable for specified categories.

CDI-2 self-report: 28-item questionnaire assessing depressive symptoms in children 7 to 17 years of age with basic reading and comprehension skills. Children were asked to choose 1 of 3 statements that most closely aligns with their feelings in past 2 weeks. It contains 6 subscales (emotional problem, negative mood/physical symptoms, negative self-esteem, functional problems, ineffectiveness, interpersonal problems). Total score: sum of all subscales scores, ranging from 0 to 56, with higher score indicating greater depression severity.CDI-2 parent: 17-item questionnaire administered to parents to assess depression-related behaviors observed in their children. Parents were asked to rate their child's behaviors in past 2 weeks on a 4-point Likert scale from "not at all" to "much or most of the time." It contains 2 subscales (emotional problems and functional problem). Total score: sum of 2 subscales, ranging from 0 to 51, with higher score indicating more depression-related behaviors.

Outcome measures

Measure	TEV-50717 High-Dose n=52 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=54 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version and Self-reported Version) Total Score at Week 9 CDI-2 Parent Version	-1.2 units on a scale Standard Deviation 6.53	-3.8 units on a scale Standard Deviation 6.34	-0.8 units on a scale Standard Deviation 5.36
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version and Self-reported Version) Total Score at Week 9 CDI-2 Self-Reported Version	-2.0 units on a scale Standard Deviation 4.13	-2.6 units on a scale Standard Deviation 4.90	-0.4 units on a scale Standard Deviation 4.99

SECONDARY outcome

Timeframe: Baseline, Week 9

Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable at specified timepoints.

C-SSRS included responses for Suicidal Ideation or Suicidal Behavior in following 10 categories: 1 = Wish to be dead; 2 = Non-specific active suicidal thoughts; 3 = Active suicidal ideation with any methods (not plan) without intent to act; 4 = Active suicidal ideation with some intent to act, without specific plan; 5 = Active suicidal ideation with specific plan and intent; 6 = Preparatory acts or behavior; 7 = Aborted attempt; 8 = Interrupted attempt; 9 = Non-fatal suicide attempt; and 10 = Completed suicide. Number of participants with any suicidal ideation or suicidal behavior are reported. Any Suicidal ideation or Suicidal Behavior events reported as TEAEs along with all other reported TEAEs are included in the AE module.

Outcome measures

Measure	TEV-50717 High-Dose n=52 Participants TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	Placebo n=54 Participants Placebo matched to TEV-50717 for a total of 8 weeks	Placebo n=51 Participants Placebo matched to TEV-50717 for a total of 8 weeks
Number of Participants at Baseline and Week 9 With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) Baseline	0 Participants	0 Participants	2 Participants
Number of Participants at Baseline and Week 9 With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) Week 9	0 Participants	0 Participants	0 Participants

Adverse Events

TEV-50717 High-Dose

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

TEV-50717 Low-Dose

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	TEV-50717 High-Dose n=52 participants at risk TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	TEV-50717 Low-Dose n=54 participants at risk TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks	Placebo n=51 participants at risk Placebo matched to TEV-50717 for a total of 8 weeks
Psychiatric disorders Attention deficit/hyperactivity disorder	1.9% 1/52 • Number of events 1 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/54 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/51 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Tic	1.9% 1/52 • Number of events 1 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/54 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/51 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.

Other adverse events

Measure	TEV-50717 High-Dose n=52 participants at risk TEV-50717 tablets BID up to 48 mg/day orally for a total of 8 weeks	TEV-50717 Low-Dose n=54 participants at risk TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks	Placebo n=51 participants at risk Placebo matched to TEV-50717 for a total of 8 weeks
Gastrointestinal disorders Nausea	3.8% 2/52 • Number of events 2 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	5.6% 3/54 • Number of events 3 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/51 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	5.8% 3/52 • Number of events 3 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	1.9% 1/54 • Number of events 1 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	7.8% 4/51 • Number of events 5 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
General disorders Fatigue	9.6% 5/52 • Number of events 6 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	1.9% 1/54 • Number of events 2 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/51 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	11.5% 6/52 • Number of events 6 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	3.7% 2/54 • Number of events 2 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	5.9% 3/51 • Number of events 4 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Increased appetite	7.7% 4/52 • Number of events 4 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	1.9% 1/54 • Number of events 1 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/51 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 2/52 • Number of events 2 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/54 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	5.9% 3/51 • Number of events 4 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	11.5% 6/52 • Number of events 8 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	14.8% 8/54 • Number of events 13 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	7.8% 4/51 • Number of events 4 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	15.4% 8/52 • Number of events 11 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	3.7% 2/54 • Number of events 2 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.	2.0% 1/51 • Number of events 1 • Baseline (Day 1) to follow-up (Week 10) Safety analysis set included all participants who received at least 1 dose of study drug.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products R&D, Inc.

Phone: 1-888-483-8279

Email: USMedInfo@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor has the right 60 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 90 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