NCT01098435

ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of daily doses of RDC-0313 (ALKS 33) compared with placebo in adults with binge-eating disorder (BED). An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder.

Detailed description

Following screening, eligible subjects will be randomized in a 1:1 ratio to RDC-0313 (ALKS 33) or matching placebo. Once-daily at-home dosing will begin at randomization and will continue for 6 weeks. There will be 8 study visits over a 12-week study period. On an ongoing basis, subjects will complete a take-home binge diary designed to record the number of binge-eating episodes (binge episodes) and binge-eating days (binge days, days during which at least 1 binge occurred), as well as snacks and meals consumed daily over each 7-day period.

Conditions

• Binge Eating Disorder

Interventions

Type	Name	Description
DRUG	RDC-0313 (ALKS 33)	Capsules for daily oral administration
DRUG	Placebo	Capsules containing lactose and no active drug for daily oral administration

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2010-04-02
• Last updated: 2011-08-23

Locations

6 sites across 1 country: United States