NCT01291173

Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	lisdexamfetamine dimesylate (SPD489)	SPD489-30mg capsules taken once daily for up to 11 weeks
DRUG	lisdexamfetamine dimesylate (SPD489)	SPD489 50mg capsules taken once-daily for up to 11 weeks
DRUG	lisdexamfetamine dimesylate (SPD489)	SPD489 70mg capsule taken once-daily for up to 11 weeks
DRUG	Placebo	Placebo capsule taken once daily for up to 11 weeks

Timeline

• Start date: 2011-05-10
• Primary completion: 2012-01-30
• Completion: 2012-01-30
• First posted: 2011-02-08
• Last updated: 2021-06-10
• Results posted: 2012-12-31

Locations

31 sites across 1 country: United States