Randomized controlled trial of deutetrabenazine for tardive dyskinesia: The ARM-TD study.

Abstract

OBJECTIVE:

To determine the efficacy and safety of deutetrabenazine as a treatment for tardive dyskinesia (TD).

METHODS:

One hundred seventeen patients with moderate to severe TD received deutetrabenazine or placebo in this randomized, double-blind, multicenter trial. Eligibility criteria included an Abnormal Involuntary Movement Scale (AIMS) score of ≥6 assessed by blinded central video rating, stable psychiatric illness, and stable psychoactive medication treatment. Primary endpoint was the change in AIMS score from baseline to week 12. Secondary endpoints included treatment success at week 12 on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change.

RESULTS:

For the primary endpoint, deutetrabenazine significantly reduced AIMS scores from baseline to week 12 vs placebo (least-squares mean [standard error] -3.0 [0.45] vs -1.6 [0.46], p = 0.019). Treatment success on CGIC (48.2% vs 40.4%) favored deutetrabenazine but was not significant. Deutetrabenazine and placebo groups showed low rates of psychiatric adverse events: anxiety (3.4% vs 6.8%), depressed mood/depression (1.7% vs 1.7%), and suicidal ideation (0% vs 1.7%, respectively). In addition, no worsening in parkinsonism, as measured by the Unified Parkinson's Disease Rating Scale motor subscale, was noted from baseline to week 12 in either group.

CONCLUSIONS:

In patients with TD, deutetrabenazine was well tolerated and significantly reduced abnormal movements.

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that in patients with TD, deutetrabenazine reduces AIMS scores.

• Authors: Hubert H Fernandez, Stewart A Factor, Robert A Hauser, Joohi Jimenez-Shahed, William G Ondo, L Fredrik Jarskog, Herbert Y Meltzer, Scott W Woods, Danny Bega, Mark S LeDoux, David R Shprecher, Charles Davis, Mat D Davis, David Stamler, Karen E Anderson
• Journal: Neurology (Neurology) Vol. 88 Issue 21 Pg. 2003-2010 (May 23 2017) ISSN: 1526-632X [Electronic] United States
• PMID: 28446646 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Chemical References

• Neuromuscular Agents
• deutetrabenazine
• Tetrabenazine

Topics

• Comorbidity
• Double-Blind Method
• Europe
• Female
• Humans
• Least-Squares Analysis
• Male
• Mental Disorders (complications, drug therapy)
• Middle Aged
• Neuromuscular Agents (adverse effects, therapeutic use)
• Severity of Illness Index
• Tardive Dyskinesia (complications, drug therapy, psychology)
• Tetrabenazine (adverse effects, analogs & derivatives, therapeutic use)
• Treatment Outcome
• United States