A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Trial Profile

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2016

At a glance

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

    • 22 Jul 2015 Based on the results of this trial, as well as findings from other study (see profile 224561), the Company plans to submit a sNDA to the U.S. FDA by year end 2015. The FDA will evaluate adding these data to the current labeling for Vyvanse, according to a Shire media release.
    • 22 Jul 2015 Top-line results were published in the Shire Media Release.
    • 27 Apr 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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