Addressing Involuntary Movements in Tardive Dyskinesia

Summary

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

Timeline

Start

2014-10-31

Primary completion

2016-08-19

Completion

2016-08-19

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs SD-809 36 mg/Day; p = 0.001; LSM difference -1.9 (95% CI -3.09 to -0.79) NCT02291861 ↗

registry analysis (superiority test); Placebo vs SD-809 24 mg/Day; p = 0.003; LSM difference -1.8 (95% CI -3.00 to -0.63) NCT02291861 ↗

release “SD-809 demonstrates a statistically significant improvement in Abnormal Involuntary Movement Scale score in AIM-TD study” tevapharm.com ↗

Publications

• Results Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojarvi J, Jarskog LF, Jimenez-Shahed J, Kumar R, McEvoy JP, Ochudlo S, Ondo WG, Fernandez HH. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017 Aug;4(8):595-604. doi: 10.1016/S2215-0366(17)30236-5. Epub 2017 Jun 28.
• 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	6 mg	Oral
Subject	Deutetrabenazine	Unknown	12 mg	Oral
Subject	Deutetrabenazine	Unknown	18 mg	Oral

Indications