Overview

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