Overview

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

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alkermes, Inc.
Treatments:
ALKS-33
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