A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome (TS)

Phase 3 Completed 158 enrolled Teva Branded Pharmaceutical Products R&D, Inc. Nuvelution TS Pharma, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2018-05-31
Primary completion: 2019-12-09
Completion: 2019-12-09

Outcome

Missed primary endpoint

paper the primary efficacy end point was not met. PMID 34661664 ↗

Publications

Coffey B, Jankovic J, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander JK, Barkay H, Harary E. Efficacy and Safety of Fixed-Dose Deutetrabenazine in Children and Adolescents for Tics Associated With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2129397. doi: 10.1001/jamanetworkopen.2021.29397.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TEV-50717	Unknown	36 mg	Oral
Subject	TEV-50717	Unknown	48 mg	Oral