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

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.

Inclusion Criteria:

• Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED)
• Display greater than or equal to 3 binge eating days per week
• Body mass index (BMI) greater than or equal to 30 kg/m2
• Age of 18 years or older
• Women of childbearing potential must agree to use an approved method of birth control for the duration of the study

Exclusion Criteria:

• Concurrent symptoms of bulimia nervosa or anorexia nervosa
• Suicidal ideation
• DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine or caffeine) within 6 months prior to randomization
• Positive urine toxicological screen for benzodiazepines, opioids, amphetamine/methamphetamine, or cocaine at screening or randomization
• Women who are pregnant or breastfeeding
• Participation in a psychological or weight loss intervention for BED that was initiated within the 3 months prior to screening
• Clinically unstable medical disease
• History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• History of seizures, including clinically significant febrile seizures in childhood
• Current or anticipated need for prescribed opioid medication during the study period
• Use of any psychotropic medications (other than hypnotics)
• Participation in a clinical trial of a pharmacological agent within 30 days prior to screening