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

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RDC-0313 (ALKS 33)
Placebo
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge eating disorder, RDC-0313

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes' Investigational Study Site
  • Alkermes' Investigational Study Site
  • Alkermes' Investigational Study Site
  • Alkermes' Investigational Study Site
  • Alkermes' Investigational Study Site
  • Alkermes' Investigational Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RDC-0313 (ALKS 33)

Placebo

Arm Description

2-capsules taken orally

2-capsules taken orally

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2010
Last Updated
August 18, 2011
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01098435
Brief Title
ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder
Keywords
Binge eating disorder, RDC-0313

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RDC-0313 (ALKS 33)
Arm Type
Experimental
Arm Description
2-capsules taken orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2-capsules taken orally
Intervention Type
Drug
Intervention Name(s)
RDC-0313 (ALKS 33)
Intervention Description
Capsules for daily oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules containing lactose and no active drug for daily oral administration
Primary Outcome Measure Information:
Title
Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc deSomer, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes' Investigational Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alkermes' Investigational Study Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Alkermes' Investigational Study Site
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Alkermes' Investigational Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Alkermes' Investigational Study Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Alkermes' Investigational Study Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23381803
Citation
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.
Results Reference
derived

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

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