Aim to Reduce Movements in Tardive Dyskinesia

NCT02195700 ↗

Phase 2/3 Completed 117 enrolled Auspex Pharmaceuticals, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Timeline

Start: 2014-06
Primary completion: 2015-05
Completion: 2015-05

Outcome

Met primary endpoint

registry analysis (superiority test); SD-809 vs Placebo; p = 0.0188; LSM difference -1.4 (95% CI -2.6 to -0.2); NCT02195700 ↗

release “ARM-TD study meets primary endpoint; results show SD-809 reduces abnormal involuntary movement in patients with tardive dyskinesia” tevapharm.com ↗

Publications

Frank S, Anderson KE, Fernandez HH, Hauser RA, Claassen DO, Stamler D, Factor SA, Jimenez-Shahed J, Barkay H, Wilhelm A, Alexander JK, Chaijale N, Barash S, Savola JM, Gordon MF, Chen M. Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease. Neurol Ther. 2024 Jun;13(3):655-675. doi: 10.1007/s40120-024-00600-1. Epub 2024 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deutetrabenazine	Unknown	—	—