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

Completed · Phase 2 · Has a placebo group

Conditions studied: Binge Eating Disorder

In brief

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.

Key facts

Study ID

NCT01098435

Run by

Alkermes, Inc.

People needed

69

Starts

2010-05-01

Expected to finish

2011-06-01

Last updated by the study team

2011-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alkermes' Investigational Study Site — Tucson, Arizona, United States
• Alkermes' Investigational Study Site — Minneapolis, Minnesota, United States
• Alkermes' Investigational Study Site — Manlius, New York, United States
• Alkermes' Investigational Study Site — Raleigh, North Carolina, United States
• Alkermes' Investigational Study Site — Mason, Ohio, United States
• Alkermes' Investigational Study Site — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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