Phase 3
Completed N=119
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Source: ClinicalTrials.gov NCT03452943 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Change From Baseline in the TTS of the YGTSS at Week 12 — -9.1; -8.4 units on a scale — p=0.692
◆ Published Evidence
Established
39citations · ~8 / year
Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial.
Summary
This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.
Linked Publications
-
Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the TTS of the YGTSS at Week 12 |
-9.1; -8.4 | 0.692 |
| SECONDARY Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12 |
-0.7; -0.7 | — |
| SECONDARY Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12 |
-0.7; -0.4 | — |
| 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 |
-9.9; -8.8 | — |
| SECONDARY Percentage of Participants With Adverse Events |
65.5; 55.9; 50.0; 20.3; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is 6 to 16 years of age, inclusive.
- Participant weighs at least 44 pounds (20 kilograms [kg]).
- The participant's active tics are causing distress or impairment.
- Participant is able to swallow study medication whole.
- Participant is in good general health.
- Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study.
- 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.
- Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic 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 received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
- Participant has an unstable or serious medical illness at screening or baseline.
- Participant is pregnant or breastfeeding.
- Additional criteria apply, please contact the investigator for more information.
Data sourced from ClinicalTrials.gov (NCT03452943) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.