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NCT02291861 · ClinicalTrials.gov registry record · Phase 3
Addressing Involuntary Movements in Tardive Dyskinesia
A Phase 3 study of Tardive Dyskinesia, sponsored by Auspex Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 298
- Enrollment target
- 20
- Study locations
NCT02291861: Completed Phase 3 study of Tardive Dyskinesia, sponsored by Auspex Pharmaceuticals.
NCT02291861 is a Phase 3 study of Tardive Dyskinesia that has completed, run by Auspex Pharmaceuticals. The registered enrollment target is 298 participants, above the 89-participant average among 5 other Tardive Dyskinesia trials with a reported enrollment target (235% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02291861, a Phase 3 study of Tardive Dyskinesia, has completed, sponsored by Auspex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 298 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-poin
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SD-809
Study Locations (20)
California
- Teva Investigational Site 107 - Anaheim
- Teva Investigational Site 108 - Anaheim
- Teva Investigational Site 123 - Glendale
- Teva Investigational Site 177 - Imperial
- Teva Investigational Site 160 - Irvine
- Teva Investigational Site 106 - Irvine
- Teva Investigational Site 176 - Loma Linda
- Teva Investigational Site 121 - Los Angeles
- Teva Investigational Site 147 - Los Angeles
- Teva Investigational Site 174 - Norwalk
- Teva Investigational Site 170 - Oceanside
- Teva Investigational Site 102 - Orange
- Teva Investigational Site 104 - San Bernardino
- Teva Investigational Site 110 - San Diego
- Teva Investigational Site 169 - San Rafael
Alabama
- Teva Investigational Site 145 - Tuscaloosa
Colorado
- Teva Investigational Site 129 - Englewood
Connecticut
- Teva Investigational Site 139 - New Haven
District of Columbia
- Teva Investigational Site 156 - Washington D.C.
Florida
- Teva Investigational Site 157 - Boca Raton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2016-08-19 |
| Phase | Phase 3 |
What the finished NCT02291861 record still lists
NCT02291861 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, above the 89-participant average among 5 other Tardive Dyskinesia trials with a reported enrollment target (235% higher).
The record links to 1 condition, with Tardive Dyskinesia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02291861 names 20 study sites across 6 states, led by California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT02291861 about?
NCT02291861 is a clinical study titled "Addressing Involuntary Movements in Tardive Dyskinesia". 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.
What is the current status of trial NCT02291861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2014-10-31. Estimated completion is 2016-08-19.
What conditions does trial NCT02291861 study?
This clinical trial studies the following conditions: Tardive Dyskinesia.
What interventions are being tested in trial NCT02291861?
The interventions under investigation include: Placebo (DRUG), SD-809 (DRUG).
Who is sponsoring clinical trial NCT02291861?
This trial is sponsored by Auspex Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02291861 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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