Open Label Extension in Adults With Binge Eating Disorder (BED)
NCT ID: NCT01657019
Last Updated: 2021-06-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
604 participants
INTERVENTIONAL
2012-08-21
2014-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lisdexamfetamine dimesylate
Lisdexamfetamine dimesylate
50 or 70 mg administered orally, once a day for 52 weeks
Interventions
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Lisdexamfetamine dimesylate
50 or 70 mg administered orally, once a day for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED
3. Subject has a body mass index (BMI) of \> or =18 and \< or =45
Exclusion Criteria
2. Subject is considered a suicide risk or risk to harm others
18 Years
55 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham Research Group
Birmingham, Alabama, United States
Radiant Research
Tucson, Arizona, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
TRIMED Clinical Trials
Corona, California, United States
Pharmacology Research Institute
Encino, California, United States
Scripps Clinical Research Services
La Jolla, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
Excell Research, Inc
Oceanside, California, United States
PCSD - Feighner Research
San Diego, California, United States
Western Affiliated Research Institute, Inc
Denver, Colorado, United States
Radiant Research, Inc
Denver, Colorado, United States
Florida Clinical Research
Bradenton, Florida, United States
Gulfcoast Clinical Research
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States
Fidelity Clinical Research, Inc
Lauderhill, Florida, United States
Compass Research, LLC
Leesburg, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Scientific Clinical Research, Inc
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
Neurotrials Research, Inc
Atlanta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Baber Research Group
Naperville, Illinois, United States
American Medical Research, Inc
Oak Brook, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Deaconess Health Center
Newburgh, Indiana, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, United States
Louisana Research Associates, Inc
New Orleans, Louisiana, United States
McLean Hospital
Belmont, Massachusetts, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Activmed Practices & Research
Methuen, Massachusetts, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Charles Psychiatric Associates-Midwest Research Group
Saint Charles, Missouri, United States
Robert Lynne Horne, MD
Las Vegas, Nevada, United States
Center for Psychiatry & Behavioral Medicine, Inc
Las Vegas, Nevada, United States
Global Medical Institues, LLC
Princeton, New Jersey, United States
Pacific Institute for Research & Evaluation
Albuquerque, New Mexico, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Comprehensive Clinical Development
Jamaica, New York, United States
Bioscience Research LLC
Mount Kisco, New York, United States
CNS Clinica
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Radiant Research, Inc
Akron, Ohio, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Lindner Center of Hope
Mason, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Psychiatric Partners, Llp
Eugene, Oregon, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Oregon Center for Clinical Research, Inc
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc
Salem, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
The Clinical Trial Center, LLC.
Jenkintown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Radiant Research, Inc
Anderson, South Carolina, United States
Radiant Research, Inc
Greer, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solutions, Inc (CNS Healthcare)
Memphis, Tennessee, United States
Clinical Research Associates, Inc
Nashville, Tennessee, United States
Futuresearch Clinical Trials
Austin, Texas, United States
Futuresearch Trials of Dallas, LP
Dallas, Texas, United States
Texas Center for Drug Development, Inc
Houston, Texas, United States
Psychiatric Medical Associates
Plano, Texas, United States
Radiant Research, Inc
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Radiant Research, Inc
Murray, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Neuroscience, Inc
Herndon, Virginia, United States
Northwest Clinical Research
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Dean Foundation
Middleton, Wisconsin, United States
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Ernovis GmbH
Berlin, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Klinische Forschung Hannover-Mitte
Hanover, , Germany
Hospital Infanta Leonor
Madrid, , Spain
Countries
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References
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Gasior M, Hudson J, Quintero J, Ferreira-Cornwell MC, Radewonuk J, McElroy SL. A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder. J Clin Psychopharmacol. 2017 Jun;37(3):315-322. doi: 10.1097/JCP.0000000000000702.
Other Identifiers
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2012-003313-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD489-345
Identifier Type: -
Identifier Source: org_study_id
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