Clinical trial NCT01098435: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Binge Eating Disorder
Keywords: Binge eating disorder
RDC-0313
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE)
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alkermes' Investigational Study Site
state: Arizona
city: Minneapolis
country: United States
facility: Alkermes' Investigational Study Site
state: Minnesota
city: Manlius
country: United States
facility: Alkermes' Investigational Study Site
state: New York
city: Raleigh
country: United States
facility: Alkermes' Investigational Study Site
state: North Carolina
city: Mason
country: United States
facility: Alkermes' Investigational Study Site
state: Ohio
city: Toledo
country: United States
facility: Alkermes' Investigational Study Site
state: Ohio
Study officials:
affiliation: Alkermes, Inc.
name: Marc deSomer, MD
role: STUDY_DIRECTOR
References:
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.