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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Binge Eating Disorder

Intervention / Treatment
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* Drug: RDC-0313 (ALKS 33)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDC-0313 (ALKS 33)<br>2-capsules taken orally | Drug: RDC-0313 (ALKS 33)<br>* Capsules for daily oral administration<br>|
| Placebo Comparator: Placebo<br>2-capsules taken orally | Drug: Placebo<br>* Capsules containing lactose and no active drug for daily oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge eating disorder, RDC-0313