Trial · NCT03452943

Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

NCT03452943, Phase 2, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2020-06-04

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. Trials, record NCT03452943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03452943

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
NCT number: NCT03452943
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 119 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Tourette Syndrome
Interventions: TEV-50717, Placebo
First posted: 2018-03-02
Last updated: 2021-11-09
Other registries' IDs: eudract:2016-000622-19
Results first posted: 2020-06-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the TTS of the YGTSS at Week 12	Baseline, Week 12	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 (5 levels: weeks 2, 4, 6, 9, and 12), 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	Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12	Baseline, Week 12	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 (5 levels: weeks 2, 4, 6, 9, and 12), 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	Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12	Baseline, Week 12	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.
Secondary	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 12	Baseline, Week 12	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 (5 levels: weeks 2, 4, 6, 9, and 12), 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.
Secondary	Percentage of Participants With Adverse Events	Baseline (Day 1) to follow-up (Week 14)	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. 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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the TTS of the YGTSS at Week 12	Baseline, Week 12	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.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12	Baseline, Week 12	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.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12	Baseline, Week 12	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.	units on a scale	MEAN
SECONDARY	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 12	Baseline, Week 12	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.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Adverse Events	Baseline (Day 1) to follow-up (Week 14)	Safety analysis set included all participants who received at least 1 dose of study drug.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the TTS of the YGTSS at Week 12	TEV-50717		-9.1	Standard Error 1.28	units on a scale
Change From Baseline in the TTS of the YGTSS at Week 12	Placebo		-8.4	Standard Error 1.25	units on a scale
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12	TEV-50717		-0.7	Standard Error 0.13	units on a scale
Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12	Placebo		-0.7	Standard Error 0.12	units on a scale
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12	TEV-50717		-0.7	Standard Error 0.18	units on a scale
Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12	Placebo		-0.4	Standard Error 0.14	units on a scale
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 12	TEV-50717		-9.9	Standard Error 2.37	units on a scale
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 12	Placebo		-8.8	Standard Error 2.27	units on a scale
Percentage of Participants With Adverse Events	TEV-50717	Any AEs	65.5		percentage of participants
Percentage of Participants With Adverse Events	Placebo	Any AEs	55.9		percentage of participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Titration Period (7 Weeks)	STARTED	TEV-50717	59
Titration Period (7 Weeks)	STARTED	Placebo	60
Titration Period (7 Weeks)	Safety Analysis Set	TEV-50717	58
Titration Period (7 Weeks)	Safety Analysis Set	Placebo	59
Titration Period (7 Weeks)	Modified ITT (mITT) Analysis Set	TEV-50717	58
Titration Period (7 Weeks)	Modified ITT (mITT) Analysis Set	Placebo	59
Titration Period (7 Weeks)	COMPLETED	TEV-50717	54
Titration Period (7 Weeks)	COMPLETED	Placebo	56
Titration Period (7 Weeks)	NOT COMPLETED	TEV-50717	5
Titration Period (7 Weeks)	NOT COMPLETED	Placebo	4

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events30

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	Abdominal pain	Gastrointestinal disorders	TEV-50717	1	58	2
other	Abdominal pain	Gastrointestinal disorders	Placebo	3	59	3
other	Diarrhoea	Gastrointestinal disorders	TEV-50717	4	58	4
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	59	1
other	Nausea	Gastrointestinal disorders	TEV-50717	4	58	5
other	Nausea	Gastrointestinal disorders	Placebo	5	59	11
other	Vomiting	Gastrointestinal disorders	TEV-50717	3	58	3
other	Vomiting	Gastrointestinal disorders	Placebo	3	59	3
other	Fatigue	General disorders	TEV-50717	7	58	8
other	Fatigue	General disorders	Placebo	3	59	4

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TEV-50717	0	58
Total, all-cause mortality	Placebo	0	59
Total, other adverse events	TEV-50717	22	58
Total, other adverse events	Placebo	23	59
Total, serious adverse events	TEV-50717	0	58
Total, serious adverse events	Placebo	0	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34609495	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TEV-50717 vs Placebo: deaths from any cause	Trial comparisons
TEV-50717 vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT03452943/events?page=2

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