Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01098435 | ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder | PHASE2 | COMPLETED | 69 | — | — | May 1, 2010 | Jun 1, 2011 | Aug 23, 2011 | 6 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| RDC-0313 (ALKS 33) | EXPERIMENTAL | 2-capsules taken orally |
| Placebo | PLACEBO_COMPARATOR | 2-capsules taken orally |
| Name | Type | Description |
|---|---|---|
| RDC-0313 (ALKS 33) | DRUG | Capsules for daily oral administration |
| Placebo | DRUG | Capsules containing lactose and no active drug for daily oral administration |
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/...