MedTrace Logo

Addressing Involuntary Movements in Tardive Dyskinesia

NCT02291861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2021-11-09

Study results available
· View outcomes & findings →

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

  • Tardive Dyskinesia

Interventions

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.

Sponsors & Collaborators

  • Auspex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-08-19
Completion
2016-08-19

Countries

  • United States
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02291861 on ClinicalTrials.gov