At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 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 Well-Controlled, Fixed-Dose Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tics Associated With Tourette Syndrome
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jun 27, 2018·Updated Nov 9, 2021
In Brief
A Phase 3 clinical trial evaluating TEV-50717 and Placebo for Tourette Syndrome. Completed, enrolled 158 participants across 56 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome
CountriesArgentina, Australia, Colombia, Hungary, Italy, Mexico, Poland, South Korea, Ukraine, United States
CollaboratorsNuvelution TS Pharma, Inc.
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedJun 2018
Primary CompletionDec 2019
TodayJul 2026
First PostedJun 27, 2018
Enrollment StartMay 31, 2018
Primary CompletionDec 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.0 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.