Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

Phase 2/3 Completed 119 enrolled Teva Branded Pharmaceutical Products R&D, Inc. Nuvelution TS Pharma, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.

Timeline

Start: 2018-02-05
Primary completion: 2019-11-12
Completion: 2019-11-12

Outcome

Missed primary endpoint

registry analysis (other test); TEV-50717 vs Placebo; p = 0.692; LS mean difference -0.7 (95% CI -4.1 to 2.8) NCT03452943 ↗

paper the primary efficacy end point was not met. PMID 34609495 ↗

Publications

Jankovic J, Coffey B, Claassen DO, Jimenez-Shahed J, Gertz BJ, Garofalo EA, Stamler DA, Wieman M, Savola JM, Gordon MF, Alexander J, Barkay H, Harary E. Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128204. doi: 10.1001/jamanetworkopen.2021.28204.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TEV-50717	Unknown	6 mg	Oral
Subject	TEV-50717	Unknown	9 mg	Oral
Subject	TEV-50717	Unknown	12 mg	Oral
Subject	TEV-50717	Unknown	15 mg	Oral
Subject	TEV-50717	Unknown	18 mg	Oral