Trial · NCT03567291
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents
NCT03567291, Phase 3, Terminated, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2021-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents. Trials, record NCT03567291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03567291
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents
- NCT number
- NCT03567291
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 228 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Tourette Syndrome
- Interventions
- TEV-50717, Placebo
- First posted
- 2018-06-25
- Last updated
- 2021-11-09
- Other registries' IDs
- eudract:2016-000630-22
- Results first posted
- 2021-03-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | Day 1 to Week 55 | Adverse events were analyzed for all participants in Parts A \& B combined as one group for this outcome measure. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Incudes clinically significant changes such as changes in vital signs or lab values. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Primary | Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Weeks 28 to 30 | Adverse events were analyzed for Part B for this outcome measure. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Incudes clinically significant changes such as changes in vital signs or lab values. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Primary | Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | 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. |
| Primary | Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | 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. |
| Primary | Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30 | Week 28, Week 30 | 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. |
| Primary | Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30 | Week 28, Week 30 | 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. |
| Primary | Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | 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. |
| Primary | Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30 | Week 28, Week 30 | 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. |
| Secondary | Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | 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. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication. |
| Secondary | Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | 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. Baseline is defined as the last measurement on or prior to the first dose of the open-label study medication. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | Day 1 to Week 55 | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Weeks 28 to 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). | Participants | NUMBER |
| PRIMARY | Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30 | Week 28, Week 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30 | Week 28, Week 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30 | Week 28, Week 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). Here, 'number analyzed' signifies participants evaluable at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | ITT analysis set includes all participants enrolled in part I. Here, 'number analyzed' signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | Data were not collected during Part B (Period II). ITT analysis set includes all participants enrolled in part I. Here, 'number analyzed' signifies participants evaluable at specified time points. | Units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | TEV-50717 | At least one adverse event | 161 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | TEV-50717 | At least one serious adverse event | 2 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | TEV-50717 | At least one severe adverse event | 6 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | TEV-50717 | At least one AE related to investigational product | 95 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | TEV-50717 | At least one adverse event leading to withdrawal | 14 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Randomized TEV-50717 | At least one adverse event | 16 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Randomized Placebo | At least one adverse event | 6 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Randomized TEV-50717 | At least one serious adverse event | 0 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Randomized Placebo | At least one serious adverse event | 0 | Participants | |
| Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Randomized TEV-50717 | At least one severe adverse event | 0 | Participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I | STARTED | TEV-50717 | 228 | |
| Period I | STARTED | Randomized TEV-50717 | 0 | |
| Period I | STARTED | Randomized Placebo | 0 | |
| Period I | STARTED | TEV-50717 Re-titration and Maintenance | 0 | |
| Period I | Safety Set | TEV-50717 | 227 | |
| Period I | Safety Set | Randomized TEV-50717 | 0 | |
| Period I | Safety Set | Randomized Placebo | 0 | |
| Period I | Safety Set | TEV-50717 Re-titration and Maintenance | 0 | |
| Period I | Intent to Treat Set | TEV-50717 | 228 | |
| Period I | Intent to Treat Set | Randomized TEV-50717 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Total | 15 | 227 | 30 |
| other | Pyrexia | General disorders | Total | 13 | 227 | 13 |
| other | Nasopharyngitis | Infections and infestations | Total | 23 | 227 | 33 |
| other | Weight increased | Investigations | Total | 22 | 227 | 22 |
| other | Headache | Nervous system disorders | Total | 30 | 227 | 55 |
| other | Somnolence | Nervous system disorders | Total | 28 | 227 | 33 |
| other | Anxiety | Psychiatric disorders | Total | 17 | 227 | 18 |
| other | Tic | Psychiatric disorders | Total | 15 | 227 | 29 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Total | 1 | 227 | 1 |
| serious | Self-injurious ideation | Psychiatric disorders | Total | 1 | 227 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total | 0 | 227 |
| Total, other adverse events | Total | 108 | 227 |
| Total, serious adverse events | Total | 2 | 227 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03567291
GET https://conductscience.org/api/trials/v1/NCT03567291/results?page=2