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

• Status: Completed
• Trial end date: 2014-10-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Lisdexamfetamine Dimesylate

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