NCT02009163

Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	Lisdexamfetamine dimesylate	SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)
OTHER	Placebo	Placebo capsule once per day (double-blind period)

Timeline

• Start date: 2014-01-27
• Primary completion: 2015-04-08
• Completion: 2015-04-08
• First posted: 2013-12-11
• Last updated: 2021-06-14
• Results posted: 2016-04-01

Locations

53 sites across 5 countries: United States, Canada, Germany, Spain, Sweden