ALK33-101: A Study of RDC-0313 (ALKS 33) 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.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alkermes' Investigational Study Site, Tucson, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RDC-0313 (ALKS 33)

Drug

Capsules for daily oral administration

Placebo

Drug

Capsules containing lactose and no active drug for daily oral administration

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 2, 2010
Registry last updated: Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed