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A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2022

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At a glance

  • Drugs Deutetrabenazine (Primary)
  • Indications Drug-induced dyskinesia
  • Focus Registrational; Therapeutic Use
  • Acronyms AIM-TD
  • Sponsors Auspex Pharmaceuticals

Most Recent Events

  • 27 Apr 2021 According to a Teva Pharmaceuticals media release, data from the study will be presented at the upcoming 2021 American Psychiatric Association (APA) Annual Meeting.
  • 15 Apr 2021 According to a Teva Pharmaceutical Industries media release, results of an analysis assessing safety by comparing the incidence of adverse events with AUSTEDO versus placebo in two pivotal studies (ARM-TD and AIM-TD) and through week 15 of an open-label extension study (RIM-TD), will be presented at the upcoming 2021 American Academy of Neurology (AAN) Virtual Annual Meeting.
  • 01 May 2020 Results (N=758), an analysis of data from two RCTs and one OLE assessing the short- and long-term effects of deutetrabenazine treatment on weight and metabolic parameters in individuals treated for tardive dyskinesia, presented at the 72nd Annual Meeting of the American Academy of Neurology

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