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NCT01657019 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension in Adults With Binge Eating Disorder (BED)
A Phase 3 study of Binge-Eating Disorder, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 604
- Enrollment target
- 20
- Study locations
NCT01657019 is a Phase 3 study of Binge-Eating Disorder that has completed, run by Shire. The registered enrollment target is 604 participants, below the 1,127-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT01657019, a Phase 3 study of Binge-Eating Disorder, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 604 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
Conditions Studied
Interventions
- DRUG Lisdexamfetamine dimesylate
Study Locations (20)
California
- Southwestern Research, Inc. - Beverly Hills
- TRIMED Clinical Trials - Corona
- Pharmacology Research Institute - Encino
- Scripps Clinical Research Services - La Jolla
- Pharmacology Research Institute - Los Alamitos
- Pharmacology Research Institute - Newport Beach
- Pacific Research Partners, LLC - Oakland
- Excell Research, Inc - Oceanside
- PCSD - Feighner Research - San Diego
Florida
- Florida Clinical Research - Bradenton
- Gulfcoast Clinical Research - Fort Myers
- Clinical Neuroscience Solutions, Inc - Jacksonville
- Fidelity Clinical Research, Inc - Lauderhill
- Compass Research, LLC - Leesburg
- Florida Clinical Research Center, LLC - Maitland
Colorado
- Western Affiliated Research Institute, Inc - Denver
- Radiant Research, Inc - Denver
Alabama
- Birmingham Research Group - Birmingham
Arizona
- Radiant Research - Tucson
Arkansas
- Clinical Study Centers, LLC - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 604 participants |
| Start Date | 2012-08-21 |
| Est. Completion | 2014-10-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01657019
The ClinicalTrials.gov registry entry for NCT01657019 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 604 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,127-participant average among 37 other Binge-Eating Disorder trials with a reported enrollment target (46% lower). The listed sponsor is Shire, which has 245 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 1 intervention - of which Lisdexamfetamine dimesylate is the first listed.
NCT01657019 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01657019 about?
NCT01657019 is a clinical study titled "Open Label Extension in Adults With Binge Eating Disorder (BED)". To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
What is the current status of trial NCT01657019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 604 participants. The study started on 2012-08-21. Estimated completion is 2014-10-21.
What conditions does trial NCT01657019 study?
This clinical trial studies the following conditions: Binge-Eating Disorder.
What interventions are being tested in trial NCT01657019?
The interventions under investigation include: Lisdexamfetamine dimesylate (DRUG).
Who is sponsoring clinical trial NCT01657019?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01657019 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.