At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 119 enrolled
Drug / intervention
TEV-50717 +1 moredrug
Likely dose
TEV-50717 18 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 2, 2018·Updated Nov 9, 2021
In Brief
A Phase 3 clinical trial evaluating TEV-50717 and Placebo for Tourette Syndrome. Completed, enrolled 119 participants across 42 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome
CountriesCanada, Denmark, Russia, Serbia, Spain, United States
CollaboratorsNuvelution TS Pharma, Inc.
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedMar 2018
Primary CompletionNov 2019
TodayJul 2026
First PostedMar 2, 2018
Enrollment StartFeb 5, 2018
Primary CompletionNov 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.3 years ago
Interventions
TEV-50717drug
6, 9, 12, 15, and 18 mg oral tablets
Placebodrug
Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.