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

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: August 1, 2012
Last updated: January 8, 2015
Last verified: December 2014
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

Condition Intervention Phase
Binge Eating Disorder
Drug: Lisdexamfetamine dimesylate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Occurrence of treatment-emergent adverse events (TEAEs) as a measure of safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Global Impressions of Improvement (CGI-I) scale [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: August 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisdexamfetamine dimesylate Drug: Lisdexamfetamine dimesylate
50 or 70 mg administered orally, once a day for 52 weeks
Other Name: Vyvanse, SPD489, LDX


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01657019

  Show 89 Study Locations
Sponsors and Collaborators
Principal Investigator: Susan McElroy University of Cincinnati
  More Information

No publications provided

Responsible Party: Shire Identifier: NCT01657019     History of Changes
Other Study ID Numbers: SPD489-345, 2012-003313-34
Study First Received: August 1, 2012
Last Updated: January 8, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Binge-Eating Disorder
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 24, 2015