Trials / Completed
CompletedNCT02291861
Addressing Involuntary Movements in Tardive Dyskinesia
A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 298 (actual)
- Sponsor
- Auspex Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SD-809 | SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food. |
| DRUG | Placebo | Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food. |
Timeline
- Start date
- 2014-10-31
- Primary completion
- 2016-08-19
- Completion
- 2016-08-19
- First posted
- 2014-11-17
- Last updated
- 2021-11-09
- Results posted
- 2018-04-11
Locations
106 sites across 6 countries: United States, Czechia, Germany, Hungary, Poland, Slovakia
Source: ClinicalTrials.gov record NCT02291861. Inclusion in this directory is not an endorsement.