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Open Label Extension in Adults With Binge Eating Disorder (BED)

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Binge Eating Disorder

Intervention: Lisdexamfetamine dimesylate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Susan McElroy, Principal Investigator, Affiliation: University of Cincinnati

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

Clinical Details

Official title: A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Occurrence of treatment-emergent adverse events (TEAEs) as a measure of safety

Columbia Suicide Severity Rating Scale (C-SSRS)

Secondary outcome:

Clinical Global Impressions of Improvement (CGI-I) scale

Eating Disorder Examination Questionnaire (EDE-Q)

EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Completion of an antecedent SPD489 BED Double-blind Study 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: 1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. 2. Subject is considered a suicide risk or risk to harm others

Locations and Contacts

Ernovis GmbH, Berlin 10629, Germany

Klinische Forschung Berlin-Mitte GmbH, Berlin 10117, Germany

Klinische Forschung Dresden GmbH, Dresden 1069, Germany

Klinische Forschung Hannover-Mitte, Hannover 30159, Germany

Hospital Infanta Leonor, Madrid 28031, Spain

Birmingham Research Group, Birmingham, Alabama 35216, United States

Radiant Research, Tucson, Arizona 85710, United States

Clinical Study Centers, LLC, Little Rock, Arkansas 72211, United States

Southwestern Research, Inc., Beverly Hills, California 90210, United States

TRIMED Clinical Trials, Corona, California 92880, United States

Pharmacology Research Institute, Encino, California 91316, United States

Scripps Clinical Research Services, La Jolla, California 92037, United States

Pharmacology Research Institute, Los Alamitos, California 90720, United States

Pharmacology Research Institute, Newport Beach, California 92660, United States

Pacific Research Partners, LLC, Oakland, California 94612, United States

Excell Research, Inc, Oceanside, California 92056, United States

PCSD - Feighner Research, San Diego, California 92108, United States

Radiant Research, Inc, Denver, Colorado 80239, United States

Western Affiliated Research Institute, Inc, Denver, Colorado 80209, United States

Florida Clinical Research, Brandenton, Florida 34201, United States

Gulfcoast Clinical Research, Fort Myers, Florida 33912, United States

Clinical Neuroscience Solutions, Inc, Jacksonville, Florida 32216, United States

Fidelity Clinical Research, Inc, Lauderhill, Florida 33319, United States

Compass Research, LLC, Leesburg, Florida 34748, United States

Florida Clinical Research Center, LLC, Maitland, Florida 32751, United States

Scientific Clinical Research, Inc, North Miami, Florida 33161, United States

Clinical Neuroscience Solutions, Inc, Orlando, Florida 32806, United States

Miami Research Associates, South Miami, Florida 33143, United States

Atlanta Institute of Medicine and Research, Atlanta, Georgia 30328, United States

Neurotrials Research, Inc, Atlanta, Georgia 30342, United States

Capstone Clinical Research, Libertyville, Illinois 60048, United States

Baber Research Group, Naperville, Illinois 60563, United States

American Medical Research, Inc, Oak Brook, Illinois 60523, United States

Goldpoint Clinical Research, LLC, Indianapolis, Indiana 46260, United States

Deaconess Health Center, Newburgh, Indiana 47630, United States

Clinical Trials Technology, Inc, Prairie Village, Kansas 66206, United States

Cypress Medical Research Center, LLC, Wichita, Kansas 67226, United States

Louisana Research Associates, Inc, New Orleans, Louisiana 70114, United States

McLean Hospital, Belmont, Massachusetts 02478, United States

Boston Clinical Trials, Boston, Massachusetts 02131, United States

Activmed Practices & Research, Methuen, Massachusetts 01844, United States

Adams Clinical Trials, LLC, Watertown, Massachusetts 02472, United States

Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States

University of Minnesota, Minneapolis, Minnesota 55454, United States

St. Charles Psychiatric Associates-Midwest Research Group, St. Charles, Missouri 63304, United States

Center for Psychiatry & Behavioral Medicine, Inc, Las Vegas, Nevada 89128, United States

Robert Lynne Horne, MD, Las Vegas, Nevada 89102, United States

Global Medical Institues, LLC, Princeton, New Jersey 08540, United States

Pacific Institute for Research & Evaluation, Albuquerque, New Mexico 87102, United States

Brooklyn Medical Institute, Brooklyn, New York 11214, United States

Comprehensive Clinical Development, Jamaica, New York 11432, United States

Bioscience Research LLC, Mt. Kisco, New York 10549, United States

CNS Clinica, New York, New York 10023, United States

Wake Research Associates, Raleigh, North Carolina 27612, United States

Radiant Research, Inc, Akron, Ohio 44311, United States

Community Research, Cincinnati, Ohio 45227, United States

Patient Priority Clinical Sites, Cincinnati, Ohio 45215, United States

Midwest Clinical Research Center, Dayton, Ohio 45417, United States

Lindner Center of Hope, Mason, Ohio 45040, United States

North Star Medical Research, LLC, Middleburg Heights, Ohio 44130, United States

IPS Research Company, Oklahoma City, Oklahoma 73103, United States

Oregon Psychiatric Partners, Llp, Eugene, Oregon 97401, United States

Sunstone Medical Research, LLC, Medford, Oregon 97504, United States

Oregon Center for Clinical Research, Inc, Portland, Oregon 97210, United States

Oregon Center for Clinical Investigations, Inc, Salem, Oregon 97301, United States

Lehigh Center for Clinical Research, Allentown, Pennsylvania 18104, United States

The Clinical Trial Center, LLC., Jenkintown, Pennsylvania 19046, United States

Suburban Research Associates, Media, Pennsylvania 19063, United States

Clinical Trials Research Services, LLC, Pittsburgh, Pennsylvania 15206, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Radiant Research, Inc, Anderson, South Carolina 29621, United States

Radiant Research, Inc, Greer, South Carolina 29650, United States

Coastal Carolina Research Center, Mt Pleasant, South Carolina 29464, United States

Clinical Neuroscience Solutions, Inc (CNS Healthcare), Memphis, Tennessee 38119, United States

Clinical Research Associates, Inc, Nashville, Tennessee 37203, United States

Futuresearch Clinical Trials, Austin, Texas 78731, United States

Futuresearch Trials of Dallas, LP, Dallas, Texas 75231, United States

Texas Center for Drug Development, Inc, Houston, Texas 77081, United States

Psychiatric Medical Associates, Plano, Texas 75093, United States

Radiant Research, Inc, San Antonio, Texas 78229, United States

Grayline Clinical Drug Trials, Wichita Falls, Texas 76309, United States

Radiant Research, Inc, Murray, Utah 84123, United States

Advanced Research Institute, Ogden, Utah 84405, United States

Neuropsychiatric Associates, Woodstock, Vermont 05091, United States

Charlottesville Medical Research, Charlottesville, Virginia 22911, United States

Neuroscience, Inc, Herndon, Virginia 20170, United States

Northwest Clinical Research, Bellevue, Washington 98007, United States

Summit Research Network (Seattle) LLC, Seattle, Washington 98104, United States

Dean Foundation, Middleton, Wisconsin 53562, United States

Additional Information

Starting date: August 2012
Last updated: January 8, 2015

Page last updated: August 23, 2015

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