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

Shire

Status and phase: Completed; Phase 3

Conditions: Binge Eating Disorder

Treatments: Drug: Lisdexamfetamine dimesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657019

SPD489-345

2012-003313-34 (EudraCT Number)

Details and patient eligibility

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

Enrollment: 604 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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604 participants in 1 patient group

Lisdexamfetamine dimesylate

Experimental group

Treatment:

Drug: Lisdexamfetamine dimesylate