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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 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.

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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.

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

FieldValue
Enrollment Target 298 participants
Start Date 2014-10-31
Est. Completion 2016-08-19
Phase Phase 3

Sponsor

Auspex Pharmaceuticals

5 total trials

What the Registry Record Tells You About NCT02291861

The ClinicalTrials.gov registry entry for NCT02291861 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 298 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 89-participant average among 5 other Tardive Dyskinesia trials with a reported enrollment target (235% higher). The listed sponsor is Auspex Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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