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

Binge Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098435
• Other study ID #: ALK33-101
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2010
• Last updated: August 18, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

Drug:
• RDC-0313 (ALKS 33)
Capsules for daily oral administration
• Placebo
Capsules containing lactose and no active drug for daily oral administration

Locations

Country	Name	City	State
United States	Alkermes' Investigational Study Site	Manlius	New York
United States	Alkermes' Investigational Study Site	Mason	Ohio
United States	Alkermes' Investigational Study Site	Minneapolis	Minnesota
United States	Alkermes' Investigational Study Site	Raleigh	North Carolina
United States	Alkermes' Investigational Study Site	Toledo	Ohio
United States	Alkermes' Investigational Study Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No