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.
GLOSSARY
- AE=
- adverse event;
- AIMS=
- Abnormal Involuntary Movement Scale;
- ARM-TD=
- Aim to Reduce Movements in Tardive Dyskinesia;
- CGIC=
- Clinical Global Impression of Change;
- CI=
- confidence interval;
- DRA=
- dopamine receptor antagonist;
- First-HD=
- First Time Use of SD-809 in Huntington Disease;
- HADS=
- Hospital Anxiety and Depression Scale;
- HD=
- Huntington disease;
- LS=
- least-squares;
- mCDQ-24=
- modified Craniocervical Dystonia Questionnaire;
- mITT=
- modified intent-to-treat;
- PGIC=
- Patient Global Impression of Change;
- QTcF=
- QT interval corrected with the Fridericia formula;
- SE=
- standard error;
- TD=
- tardive dyskinesia;
- VMAT2=
- vesicular monoamine transporter 2
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. The Article Processing Charge was funded by Teva Pharmaceutical Industries.
- Received November 3, 2016.
- Accepted in final form March 3, 2017.
- Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
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