The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder

Trial Profile

The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Dec 2015

At a glance

  • Drugs Lisdexamfetamine (Primary)
  • Indications Binge-Eating Disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire
  • Most Recent Events

    • 11 Nov 2015 Pooled, post-hoc analysis results of two placebo controlled trials, presented at the 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 30 Jan 2015 Results published in Shire media release.
    • 30 Jan 2015 The US FDA approved lisdexamfetamine [Vyvanse] for the treatment of moderate to severe binge eating disorder in adults, based on results from this and another identically designed trial, according to a Shire media release.
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