Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01657019
First received: August 1, 2012
Last updated: June 6, 2014
Last verified: February 2014
  Purpose

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 ]

Estimated Enrollment: 530
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657019

  Show 87 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Susan McElroy University of Cincinnati
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01657019     History of Changes
Other Study ID Numbers: SPD489-345, 2012-003313-34
Study First Received: August 1, 2012
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Hyperphagia
Mental Disorders
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Dextroamphetamine
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

ClinicalTrials.gov processed this record on November 19, 2014