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Alternatives for Reducing Chorea in Huntington Disease

NCT01897896 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-11-09

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in "Switch" participants as well as "Rollover" participants completing a randomized, double blind, placebo-controlled study of SD-809 ER.

Conditions

  • Chorea Associated With Huntington Disease

Interventions

DRUG

SD-809

SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.

Sponsors & Collaborators

  • Auspex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-12
Primary Completion
2017-08-21
Completion
2017-08-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

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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 NCT01897896 on ClinicalTrials.gov