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

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.

Timeline

Start

2018-05-25

Primary completion

2020-05-15

Completion

2020-05-15

Outcome

Outcome not reported

Stopped: “The parent trials did not meet the primary endpoints of reduction in motor and phonic tics.”

Drugs

Indications