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

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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.


We found this trial at
5
sites
Raleigh, North Carolina 27612
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Manlius, New York 13104
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Manlius, NY
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Mason, OH
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Minneapolis, Minnesota 55454
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Minneapolis, MN
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Tucson, Arizona 85712
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Tucson, AZ
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