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

Phase 2

Completed

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 Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
RDC-0313 (ALKS 33)	RDC-0313 (ALKS 33)	2-capsules taken orally
Placebo	Placebo	2-capsules taken orally

Primary Outcome Measures

Name	Time	Method
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)	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.

Secondary Outcome Measures