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A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease

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Trial Profile

A Randomized Double-Blind, Placebo-Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Nov 2021

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At a glance

  • Drugs Deutetrabenazine (Primary)
  • Indications Chorea; Huntington's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms First-HD
  • Sponsors Auspex Pharmaceuticals; Teva Branded Pharmaceutical Products R&D; Teva Pharmaceutical Industries

    • Most Recent Events

    • 22 Apr 2021 Results of pooled analysis of two pivotal studies First-HD and ARC-HD assessing the safety of deutetrabenazine in treating tardive dyskinesia and chorea associated with Huntingtons disease, presented at the 73rd Annual Meeting of the American Academy of Neurology.
    • 15 Apr 2021 According to a Teva Pharmaceutical Industries media release, data from First-HD pivotal trial and long-term open label extension trial (ARC-HD) will be presented at the upcoming 2021 American Academy of Neurology (AAN) Virtual Annual Meeting.
    • 03 Apr 2017 The U.S. Food and Drug Administration (FDA) has approved AUSTEDO (deutetrabenazine) tablets for the treatment of chorea associated with Huntingtons disease, based on the data from this trial, according to Teva Pharmaceuticals media release.

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