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May 23, 2017; 88 (21) ArticleOpen Access

Randomized controlled trial of deutetrabenazine for tardive dyskinesia

The ARM-TD study

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
First published April 26, 2017, DOI: https://doi.org/10.1212/WNL.0000000000003960
Hubert H. Fernandez
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Stewart A. Factor
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Robert A. Hauser
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Joohi Jimenez-Shahed
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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William G. Ondo
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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L. Fredrik Jarskog
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Herbert Y. Meltzer
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Scott W. Woods
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Danny Bega
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Mark S. LeDoux
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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David R. Shprecher
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Charles Davis
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Mat D. Davis
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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David Stamler
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Karen E. Anderson
From the Cleveland Clinic (H.H.F.), Center for Neurological Restoration, Cleveland, OH; Emory University (S.A.F.), Atlanta, GA; University of South Florida Parkinson's Disease and Movement Disorders Center (R.A.H.), Tampa, FL; Baylor College of Medicine (J.J.-S.), Houston, TX; Methodist Neurological Institute (W.G.O.), Houston, TX; University of North Carolina School of Medicine (L.F.J.), Chapel Hill, NC; Northwestern University Feinberg School of Medicine (H.Y.M., D.B.), Chicago, IL; Yale School of Medicine (S.W.W.), New Haven, CT; University of Tennessee Health Science Center (M.S.L.), Memphis, TN; University of Utah Health Care (D.R.S.), Salt Lake City, UT; Banner Sun Health Research Institute (D.R.S.), Sun City, AZ; CSD Biostatistics (C.D.), Tucson, AZ; Teva Pharmaceutical Industries (M.D.D.), Frazer, PA; Teva Pharmaceuticals (D.S.), La Jolla, CA; and Georgetown University (K.E.A.), Washington, DC.
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Full PDF
Citation
Randomized controlled trial of deutetrabenazine for tardive dyskinesia
The ARM-TD study
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
Neurology May 2017, 88 (21) 2003-2010; DOI: 10.1212/WNL.0000000000003960

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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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