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NCT01098435 · ClinicalTrials.gov registry record · Phase 2
ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder
A Phase 2 study of Binge-Eating Disorder, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 6
- Study locations
NCT01098435: Completed Phase 2 study of Binge-Eating Disorder, sponsored by Alkermes.
NCT01098435 is a Phase 2 study of Binge-Eating Disorder that has completed, run by Alkermes. The registered enrollment target is 69 participants, below the 1,142-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01098435, a Phase 2 study of Binge-Eating Disorder, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RDC-0313 (ALKS 33)
Study Locations (6)
Ohio
- Alkermes' Investigational Study Site - Mason
- Alkermes' Investigational Study Site - Toledo
Arizona
- Alkermes' Investigational Study Site - Tucson
Minnesota
- Alkermes' Investigational Study Site - Minneapolis
New York
- Alkermes' Investigational Study Site - Manlius
North Carolina
- Alkermes' Investigational Study Site - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01098435 record still lists
NCT01098435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,142-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Binge-Eating Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01098435 lists 6 locations in 5 states (Ohio, Arizona, Minnesota).
Frequently Asked Questions
What is clinical trial NCT01098435 about?
NCT01098435 is a clinical study titled "ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder". 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.
What is the current status of trial NCT01098435?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2010-05. Estimated completion is 2011-06.
What conditions does trial NCT01098435 study?
This clinical trial studies the following conditions: Binge-Eating Disorder.
What interventions are being tested in trial NCT01098435?
The interventions under investigation include: Placebo (DRUG), RDC-0313 (ALKS 33) (DRUG).
Who is sponsoring clinical trial NCT01098435?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01098435 being conducted?
This trial has 6 study locations across Arizona, Minnesota, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01098435's enrollment target sits among peer trials
69 21st of 37 higher than 17 of 37 other Binge-Eating Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Binge-Eating Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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