Open Label Extension in Adults With Binge Eating Disorder (BED)
Sponsored by Shire
About this trial
Last updated 4 years ago
Study ID
SPD489-345
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 55 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 11 years ago
What is this trial about?
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 are the participation requirements?
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