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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Alkermes, Inc.

Current Primary Outcome: Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE) [ Time Frame: 6 Weeks ]

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.


Original Primary Outcome:

  • Weekly frequency of binge episodes [ Time Frame: 6 Weeks ]
  • Routine safety assessments including adverse events, labs, vital signs, electrocardiogram results, and physical exam findings [ Time Frame: 6 Weeks ]


Current Secondary Outcome:

Original Secondary Outcome:

  • Weekly frequency of binge days [ Time Frame: 6 Weeks ]
  • Scores to study-related questionnaires [ Time Frame: 6 Weeks ]
    Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE); the Clinical Global Impression Severity (CGI-S) and Improvement (CGI-I) Scales; the Beck Depression Inventory (BDI); the Eating Inventory (EI); and the Food Craving Inventory (FCI)
  • Response and remission [ Time Frame: 6 Weeks ]
    Response categories based on percentage decrease in frequency of binges from baseline to the last evaluation
  • Change from baseline in weight, body mass index (BMI) and waist circumference [ Time Frame: 6 Weeks ]


Information By: Alkermes, Inc.

Dates:
Date Received: April 1, 2010
Date Started: May 2010
Date Completion:
Last Updated: August 18, 2011
Last Verified: August 2011