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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01098435
First received: April 1, 2010
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Binge Eating Disorder
Drug: RDC-0313 (ALKS 33)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098435

Locations
United States, Arizona
Alkermes' Investigational Study Site
Tucson, Arizona, United States, 85712
United States, Minnesota
Alkermes' Investigational Study Site
Minneapolis, Minnesota, United States, 55454
United States, New York
Alkermes' Investigational Study Site
Manlius, New York, United States, 13104
United States, North Carolina
Alkermes' Investigational Study Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Alkermes' Investigational Study Site
Mason, Ohio, United States, 45040
Alkermes' Investigational Study Site
Toledo, Ohio, United States, 43623
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Marc deSomer, MD Alkermes, Inc.
  More Information

No publications provided by Alkermes, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01098435     History of Changes
Other Study ID Numbers: ALK33-101
Study First Received: April 1, 2010
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
Binge eating disorder
RDC-0313

Additional relevant MeSH terms:
Disease
Eating Disorders
Binge-Eating Disorder
Bulimia
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014