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.

Study Overview

• Status: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Drug: RDC-0313 (ALKS 33); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Alkermes' Investigational Study Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Alkermes' Investigational Study Site
  • New York
    • Manlius, New York, United States, 13104
      • Alkermes' Investigational Study Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Alkermes' Investigational Study Site
  • Ohio
    • Mason, Ohio, United States, 45040
      • Alkermes' Investigational Study Site
    • Toledo, Ohio, United States, 43623
      • Alkermes' Investigational Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Marc deSomer, MD, Alkermes, Inc.

Publications and helpful links

General Publications

• McElroy SL, Guerdjikova AI, Blom TJ, Crow SJ, Memisoglu A, Silverman BL, Ehrich EW. A placebo-controlled pilot study of the novel opioid receptor antagonist ALKS-33 in binge eating disorder. Int J Eat Disord. 2013 Apr;46(3):239-45. doi: 10.1002/eat.22114. Epub 2013 Feb 5.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 18, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Binge eating disorder; RDC-0313
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; ALKS-33
• Other Study ID Numbers: ALK33-101