NCT02198794

Reducing Involuntary Movements in Participants With Tardive Dyskinesia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Auspex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	SD-809	SD-809 will be administered per dose and schedule specified in the arm.
DRUG	Placebo	Placebo matching to SD-809 will be administered per schedule specified in the arm.

Timeline

• Start date: 2014-10-20
• Primary completion: 2019-12-06
• Completion: 2020-12-14
• First posted: 2014-07-24
• Last updated: 2022-04-01
• Results posted: 2021-03-01

Locations

82 sites across 6 countries: United States, Czechia, Germany, Hungary, Poland, Slovakia

Regulatory

• FDA-regulated drug study