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The SPD489-344, 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

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Trial Profile

The SPD489-344, 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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2021

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At a glance

  • Drugs Lisdexamfetamine (Primary)
  • Indications Binge-eating disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire

Most Recent Events

  • 26 Feb 2019 Results of the post-hoc analysis assessing characteristics and lisdexamfetamine dimesylate treatment effects, based on gender and age, in adults diagnosed with moderate to severe binge eating disorder pooling data from NCT01718483 and NCT01718509, published in the Journal of Clinical Psychiatry
  • 09 May 2018 Results (n=724) of post hoc analysis of 2 identically designed phase 3 studies (NCT01718509 and NCT01718483) presented at the 171st Annual Meeting of the American Psychiatric Association
  • 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.

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