Overview

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

Status:
Terminated

Trial end date:
2020-05-15

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products, R&D Inc.

Collaborator:

Nuvelution TS Pharma, Inc.

Treatments:

Tetrabenazine