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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01657019
First received: August 1, 2012
Last updated: November 10, 2015
Last verified: December 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:
  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 53 weeks ] [ Designated as safety issue: No ]
    Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "no," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.


Secondary Outcome Measures:
  • Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale [ Time Frame: Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.

  • Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.

  • Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.

  • Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.

  • Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.

  • Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.

  • Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression [ Time Frame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) ] [ Designated as safety issue: No ]
    The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.


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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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 89 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Susan McElroy University of Cincinnati
  More Information

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
Results First Received: October 5, 2015
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Bulimia
Binge-Eating Disorder
Feeding and Eating Disorders
Pathologic Processes
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on December 02, 2016