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A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS) (ARTISTS2)

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TEV-50717
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant weighs at least 44 pounds (20 kg) at baseline.
  • Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participant's active tics are causing distress or impairment.
  • Participant has a TTS of 20 or higher on the YGTSS at screening and baseline.
  • Participant is able to swallow study medication whole.
  • -Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
  • The participant 's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder.
  • Participant has clinically significant depression at screening or baseline.
  • Participant has a history of suicidal intent or related behaviors within 2 years of screening
  • Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
  • Participant has a first-degree relative who has completed suicide.
  • Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
  • Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
  • Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics.
  • Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure.
  • Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer.
  • Participant is a pregnant or lactating female, or plans to be pregnant during the study.
  • -Additional criteria apply, please contact the investigator for more information

Sites / Locations

  • Teva Investigational Site 060-0160
  • Teva Investigational Site 060-0166
  • Teva Investigational Site 060-0161
  • Teva Investigational Site 060-0151
  • Teva Investigational Site 060-0153
  • Teva Investigational Site 060-0168
  • Teva Investigational Site 060-0155
  • Teva Investigational Site 060-0164
  • Teva Investigational Site 060-0152
  • Teva Investigational Site 060-0158
  • Teva Investigational Site 060-0167
  • Teva Investigational Site 060-0165
  • Teva Investigational Site 060-0170
  • Teva Investigational Site 060-0154
  • Teva Investigational Site 060-0169
  • Teva Investigational Site 060-0157
  • Teva Investigational Site 060-0156
  • Teva Investigational Site 060-0163
  • Teva Investigational Site 060-0162
  • Teva Investigational Site 060-1407
  • Teva Investigational Site 060-1401
  • Teva Investigational Site 060-1402
  • Teva Investigational Site 060-1403
  • Teva Investigational Site 060-1404
  • Teva Investigational Site 060-1802
  • Teva Investigational Site 060-1801
  • Teva Investigational Site 060-1503
  • Teva Investigational Site 060-1501
  • Teva Investigational Site 060-1506
  • Teva Investigational Site 060-1504
  • Teva Investigational Site 060-0901
  • Teva Investigational Site 060-0902
  • Teva Investigational Site 060-1005
  • Teva Investigational Site 060-1001
  • Teva Investigational Site 060-1003
  • Teva Investigational Site 060-1004
  • Teva Investigational Site 060-1901
  • Teva Investigational Site 060-1903
  • Teva Investigational Site 060-1904
  • Teva Investigational Site 060-1902
  • Teva Investigational Site 060-1601
  • Teva Investigational Site 060-1603
  • Teva Investigational Site 060-1602
  • Teva Investigational Site 060-1604
  • Teva Investigational Site 060-1104
  • Teva Investigational Site 060-1101
  • Teva Investigational Site 060-1105
  • Teva Investigational Site 060-1102
  • Teva Investigational Site 060-1106
  • Teva Investigational Site 060-1103
  • Teva Investigational Site 060-2003
  • Teva Investigational Site 060-2001
  • Teva Investigational Site 060-2002
  • Teva Investigational Site 060-2007
  • Teva Investigational Site 060-2005
  • Teva Investigational Site 060-2006

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TEV-50717 High-Dose

TEV-50717 Low-Dose

Placebo

Arm Description

TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks

TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks

Placebo matched to TEV-50717 for a total of 8 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
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.

Secondary Outcome Measures

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
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.
Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
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.
Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
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.
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
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.
Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
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.
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
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.
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
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.
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-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.
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)
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.

Full Information

First Posted
June 18, 2018
Last Updated
November 5, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
Nuvelution TS Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03571256
Brief Title
A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)
Acronym
ARTISTS2
Official Title
A Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
Nuvelution TS Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Standard placebo-controlled, double-blind study design (TEV-50717 [low dose and high dose] vs. placebo in a 1:1:1 ratio) was chosen to determine whether study drug treatment results in a statistically significant effect on the tics in participants with TS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEV-50717 High-Dose
Arm Type
Experimental
Arm Description
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 8 weeks
Arm Title
TEV-50717 Low-Dose
Arm Type
Experimental
Arm Description
TEV-50717 tablets BID up to 36 mg/day orally for a total of 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to TEV-50717 for a total of 8 weeks
Intervention Type
Drug
Intervention Name(s)
TEV-50717
Other Intervention Name(s)
AUSTEDO, Deutetrabenazine
Intervention Description
6-, 9-, 12-, 15-, and 18 mg oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to TEV-50717 tablets will be taken BID.
Primary Outcome Measure Information:
Title
Change From Baseline in the TTS of the YGTSS at Week 8 Between High-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in the TTS of the YGTSS at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in the TS-CGI Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Description
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.
Time Frame
Baseline, Week 8
Title
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
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in the TS-PGII Score at Week 8 Between Low-Dose TEV-50717-Treated Participants and Placebo-Treated Participants
Description
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.
Time Frame
Baseline, Week 8
Title
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
Description
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.
Time Frame
Baseline, Week 8
Title
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
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version and Self-reported Version) Total Score at Week 9
Description
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.
Time Frame
Baseline, Week 9
Title
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)
Description
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.
Time Frame
Baseline, Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant weighs at least 44 pounds (20 kg) at baseline. Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5™) diagnostic criteria for TS and, in the opinion of the investigator, participant, and parent/legal guardian, the participant's active tics are causing distress or impairment. Participant has a TTS of 20 or higher on the YGTSS at screening and baseline. Participant is able to swallow study medication whole. -Additional criteria apply, please contact the investigator for more information Exclusion Criteria: Participant has a neurologic disorder other than TS that could obscure the evaluation of tics. The participant 's predominant movement disorder is stereotypy (coordinated movements that repeat continually and identically) associated with autism spectrum disorder. Participant has clinically significant depression at screening or baseline. Participant has a history of suicidal intent or related behaviors within 2 years of screening Participant has a history of a previous actual, interrupted, or aborted suicide attempt. Participant has a first-degree relative who has completed suicide. Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder. Participant has received Comprehensive Behavioral Intervention for Tics for TS or Cognitive Behavioral Therapy for obsessive-compulsive disorder (OCD) within 4 weeks of screening. Participant has received treatment with deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation within 4 weeks of the screening visit for reduction of tics. Participant has a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias, or uncompensated heart failure. Participant has participated in an investigational drug or device study and received investigational medicinal product (IMP)/intervention within 30 days or 5 drug half-lives of baseline, whichever is longer. Participant is a pregnant or lactating female, or plans to be pregnant during the study. -Additional criteria apply, please contact the investigator for more information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 060-0160
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Teva Investigational Site 060-0166
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561-4458
Country
United States
Facility Name
Teva Investigational Site 060-0161
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-2107
Country
United States
Facility Name
Teva Investigational Site 060-0151
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Teva Investigational Site 060-0153
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Teva Investigational Site 060-0168
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Teva Investigational Site 060-0155
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Teva Investigational Site 060-0164
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Teva Investigational Site 060-0152
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Teva Investigational Site 060-0158
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Teva Investigational Site 060-0167
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852-4219
Country
United States
Facility Name
Teva Investigational Site 060-0165
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Teva Investigational Site 060-0170
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Teva Investigational Site 060-0154
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Teva Investigational Site 060-0169
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414-5834
Country
United States
Facility Name
Teva Investigational Site 060-0157
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
Facility Name
Teva Investigational Site 060-0156
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2551
Country
United States
Facility Name
Teva Investigational Site 060-0163
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Teva Investigational Site 060-0162
City
Everett
State/Province
Washington
ZIP/Postal Code
98201-4077
Country
United States
Facility Name
Teva Investigational Site 060-1407
City
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Teva Investigational Site 060-1401
City
Buenos Aires
ZIP/Postal Code
C1058AAJ
Country
Argentina
Facility Name
Teva Investigational Site 060-1402
City
Buenos Aires
ZIP/Postal Code
C1425AHQ
Country
Argentina
Facility Name
Teva Investigational Site 060-1403
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Teva Investigational Site 060-1404
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Teva Investigational Site 060-1802
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Teva Investigational Site 060-1801
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Teva Investigational Site 060-1503
City
Bello
ZIP/Postal Code
051050
Country
Colombia
Facility Name
Teva Investigational Site 060-1501
City
Medellin
ZIP/Postal Code
5500515
Country
Colombia
Facility Name
Teva Investigational Site 060-1506
City
Medellin
ZIP/Postal Code
78 B 50
Country
Colombia
Facility Name
Teva Investigational Site 060-1504
City
Pereira
ZIP/Postal Code
660003
Country
Colombia
Facility Name
Teva Investigational Site 060-0901
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Facility Name
Teva Investigational Site 060-0902
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Teva Investigational Site 060-1005
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Teva Investigational Site 060-1001
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Teva Investigational Site 060-1003
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Teva Investigational Site 060-1004
City
Rome
ZIP/Postal Code
00165
Country
Italy
Facility Name
Teva Investigational Site 060-1901
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Teva Investigational Site 060-1903
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Teva Investigational Site 060-1904
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Teva Investigational Site 060-1902
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Teva Investigational Site 060-1601
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Teva Investigational Site 060-1603
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Teva Investigational Site 060-1602
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Teva Investigational Site 060-1604
City
Monterrey
ZIP/Postal Code
64610
Country
Mexico
Facility Name
Teva Investigational Site 060-1104
City
Gdansk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
Teva Investigational Site 060-1101
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Teva Investigational Site 060-1105
City
Krakow
ZIP/Postal Code
31503
Country
Poland
Facility Name
Teva Investigational Site 060-1102
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Teva Investigational Site 060-1106
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Teva Investigational Site 060-1103
City
Warsaw
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Teva Investigational Site 060-2003
City
Dnipropetrovsk
ZIP/Postal Code
49101
Country
Ukraine
Facility Name
Teva Investigational Site 060-2001
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Teva Investigational Site 060-2002
City
Kharkiv
ZIP/Postal Code
61153
Country
Ukraine
Facility Name
Teva Investigational Site 060-2007
City
Kiev
ZIP/Postal Code
4080
Country
Ukraine
Facility Name
Teva Investigational Site 060-2005
City
Kyiv
ZIP/Postal Code
4209
Country
Ukraine
Facility Name
Teva Investigational Site 060-2006
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Citations:
PubMed Identifier
34661664
Citation
Coffey B, Jankovic J, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander JK, Barkay H, Harary E. Efficacy and Safety of Fixed-Dose Deutetrabenazine in Children and Adolescents for Tics Associated With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2129397. doi: 10.1001/jamanetworkopen.2021.29397.
Results Reference
derived

Learn more about this trial

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

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