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Reducing Involuntary Movements in Participants With Tardive Dyskinesia — RIM-TD  

Tardive Dyskinesia Clinical Trial

Official title:
An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.

Clinical Trial Description

Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02198794
Study type Interventional
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 20, 2014
Completion date December 14, 2020
View Details
See also
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