NCT01718509

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

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: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) 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

Detailed description

Not Required

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	SPD489 (Lisdexamfetamine dimesylate)	50 or 70 mg administered orally, once-daily for up to 12 weeks
DRUG	Placebo	Administered once-daily, orally, for up to 12 weeks

Timeline

• Start date: 2012-11-26
• Primary completion: 2013-09-20
• Completion: 2013-09-20
• First posted: 2012-10-31
• Last updated: 2021-07-16
• Results posted: 2014-08-21

Locations

48 sites across 2 countries: United States, Germany