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45 Long-term Treatment with Deutetrabenazine Is Associated with Continued Improvement in Tardive Dyskinesia: Results from an Open-label Extension Study

Published online by Cambridge University Press:  12 March 2019

Robert A. Hauser ,
Hubert H. Fernandez ,
David Stamler ,
Mat D. Davis ,
Stewart A. Factor ,
Joohi Jimenez-Shahed ,
William G. Ondo ,
L. Fredrik Jarskog ,
Scott W. Woods  and
Mark S. LeDoux
...Show all authors
Robert A. Hauser
Affiliation:
University of South Florida Parkinson’s Disease and Movement Disorders Center, Tampa, Florida, USA
Hubert H. Fernandez
Affiliation:
Cleveland Clinic, Center for Neurological Restoration, Cleveland, Ohio, USA
David Stamler
Affiliation:
Teva Pharmaceuticals, La Jolla, California, USA
Mat D. Davis
Affiliation:
Teva Pharmaceuticals, Frazer, Pennsylvania, USA
Stewart A. Factor
Affiliation:
Emory University, Atlanta, Georgia, USA
Joohi Jimenez-Shahed
Affiliation:
Baylor College of Medicine, Houston, Texas, USA
William G. Ondo
Affiliation:
Methodist Neurological Institute, Houston, Texas, USA; Weill Cornell Medical College, New York, New York, USA
L. Fredrik Jarskog
Affiliation:
University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Scott W. Woods
Affiliation:
Yale School of Medicine, New Haven, Connecticut, USA
Mark S. LeDoux
Affiliation:
University of Tennessee Health Science Center, Memphis, Tennessee, USA
David R. Shprecher
Affiliation:
University of Utah, Salt Lake City, Utah, USA; Banner Sun Health Research Institute, Sun City, Arizona, USA
Karen E. Anderson
Affiliation:
Georgetown University, Washington, District of Columbia, USA
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Abstract

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Study Objective

To evaluate long-term efficacy of deutetrabenazine in patients with tardive dyskinesia (TD) by examining response rates from baseline in Abnormal Involuntary Movement Scale (AIMS) scores. Preliminary results of the responder analysis are reported in this analysis.

Background

In the 12-week ARM-TD and AIM-TD studies, the odds of response to deutetrabenazine treatment were higher than the odds of response to placebo at all response levels, and there were low rates of overall adverse events and discontinuations associated with deutetrabenazine.

Method

Patients with TD who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12mg/day, titrating up to a maximum total daily dose of 48mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration and a long-term maintenance phase. The cumulative proportion of AIMS responders from baseline was assessed. Response was defined as a percent improvement from baseline for each patient from 10% to 90% in 10% increments. AlMS score was assessed by local site ratings for this analysis.

Results

343 patients enrolled in the extension study (111 patients received placebo in the parent study and 232 patients received deutetrabenazine). At Week 54 (n=145; total daily dose [mean±standard error]: 38.1±0.9mg), 63% of patients receiving deutetrabenazine achieved ≥30% response, 48% of patients achieved ≥50% response, and 26% achieved ≥70% response. At Week 80 (n=66; total daily dose: 38.6±1.1mg), 76% of patients achieved ≥30% response, 59% of patients achieved ≥50% response, and 36% achieved ≥70% response. Treatment was generally well tolerated.

Conclusions

Patients who received long-term treatment with deutetrabenazine achieved response rates higher than those observed in positive short-term studies, indicating clinically meaningful long-term treatment benefit.

Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018, Los Angeles, California, USA.

Funding Acknowledgements: This study was supported by Teva Pharmaceuticals, Petach Tikva, Israel.

Type
Abstracts
Information
CNS Spectrums , Volume 24 , Issue 1 , February 2019 , pp. 200 - 201
Copyright
© Cambridge University Press 2019