Skip to main content Accessibility help
×
Home
Hostname: page-component-78dcdb465f-f64jw Total loading time: 0.253 Render date: 2021-04-19T01:17:26.815Z Has data issue: true Feature Flags: { "shouldUseShareProductTool": true, "shouldUseHypothesis": true, "isUnsiloEnabled": true, "metricsAbstractViews": false, "figures": false, "newCiteModal": false, "newCitedByModal": true }

Article contents

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
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
Rights & Permissions[Opens in a new window]

Abstract

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
Copyright
© Cambridge University Press 2019 

Full text views

Full text views reflects PDF downloads, PDFs sent to Google Drive, Dropbox and Kindle and HTML full text views.

Total number of HTML views: 0
Total number of PDF views: 154 *
View data table for this chart

* Views captured on Cambridge Core between 12th March 2019 - 19th April 2021. This data will be updated every 24 hours.

You have Access

Send article to Kindle

To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

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

Send article to Dropbox

To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

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

Send article to Google Drive

To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

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

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *