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
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
- 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 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.
- 15 Sep 2014 The US FDA has accepted a regulatory filing that was supported by results from this trial.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History