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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Capsules for daily oral administration
Capsules containing lactose and no active drug for daily oral administration
Alkermes' Investigational Study Site
Tucson, Arizona, United States
Alkermes' Investigational Study Site
Minneapolis, Minnesota, United States
Alkermes' Investigational Study Site
Manlius, New York, United States
Alkermes' Investigational Study Site
Raleigh, North Carolina, United States
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
A TEAE is any adverse event (AE), regardless of causality, that either: begins after a participant's first dose of study drug, up to and including the final follow-up visit; or started before a participant's first dose of study drug but worsens in severity after the first dose of study drug, up to and including the final follow-up visit.
Time frame: 6 Weeks
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Alkermes' Investigational Study Site
Mason, Ohio, United States
Alkermes' Investigational Study Site
Toledo, Ohio, United States