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Reducing Involuntary Movements in Participants With Tardive Dyskinesia

NCT02198794 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-04-01

Study results available
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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.

Conditions

  • Tardive Dyskinesia

Interventions

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.

Sponsors & Collaborators

  • Auspex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-20
Primary Completion
2019-12-06
Completion
2020-12-14
FDA Drug
Yes

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 NCT02198794 on ClinicalTrials.gov