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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

April 1, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed

29 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed

Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

April 1, 2010

Last Update Submit

August 18, 2011

Conditions

Binge Eating Disorder

Keywords

Binge eating disorderRDC-0313

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

RDC-0313 (ALKS 33)

EXPERIMENTAL

2-capsules taken orally

Drug: RDC-0313 (ALKS 33)

Placebo

PLACEBO COMPARATOR

2-capsules taken orally

Drug: Placebo

Interventions

RDC-0313 (ALKS 33)DRUG

Capsules for daily oral administration

RDC-0313 (ALKS 33)

PlaceboDRUG

Capsules containing lactose and no active drug for daily oral administration

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.