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

Completed · Phase 3

Conditions studied: Binge Eating Disorder

In brief

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

Key facts

Study ID

NCT01657019

Run by

Shire

People needed

604

Starts

2012-08-21

Expected to finish

2014-10-21

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of an antecedent SPD489 BED Double-blind Study
• Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED
• Subject has a body mass index (BMI) of > or =18 and < or =45

You may not qualify if…

• Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
• Subject is considered a suicide risk or risk to harm others

Where it is running

• 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
• Birmingham Research Group — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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