NCT03567291

Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents

An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.

Detailed description

This is an otherwise open-label, single-arm study (Part A) that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period (Part B) followed by a 3 week blinded maintenance or re-titration (Part A resumed), and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies (SD-809-C-17 \[Phase 1b\], TV50717-CNS 30046 \[Phase 2/3\], or TV50717-CNS 30060 \[Phase 3\]).

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	TEV-50717	6, 9, and 12 mg oral tablets
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2018-05-25
• Primary completion: 2020-05-15
• Completion: 2020-05-15
• First posted: 2018-06-25
• Last updated: 2021-11-09
• Results posted: 2021-03-23

Locations

76 sites across 15 countries: United States, Argentina, Australia, Canada, Colombia, Denmark, Hungary, Italy, Mexico, Poland, Russia, Serbia, South Korea, Spain, Ukraine

Regulatory

• FDA-regulated drug study