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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 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.

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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.

Conditions Studied

Binge-Eating Disorder

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

FieldValue
Enrollment Target 69 participants
Start Date 2010-05
Est. Completion 2011-06
Phase Phase 2

Sponsor

Alkermes

66 total trials

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What the Registry Record Tells You About NCT01098435

The ClinicalTrials.gov registry entry for NCT01098435 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,142-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (94% lower). The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.