ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder
| Status: | Archived |
|---|---|
| Conditions: | Psychiatric, Eating Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2010 |
| End Date: | May 2011 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder
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.
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.
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