Open Label Extension in Adults With Binge Eating Disorder (BED)
- Registration Number
- NCT01657019
- Lead Sponsor
- Shire
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 604
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lisdexamfetamine dimesylate Lisdexamfetamine dimesylate -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety 52 weeks Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) 53 weeks 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
Name Time Method Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) 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.
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) 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 Mobility End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) 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 End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) 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 End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) 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 Anxiety or Depression End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) 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.
Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) 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.
Trial Locations
- Locations (81)
Southwestern Research, Inc.
🇺🇸Beverly Hills, California, United States
Birmingham Research Group
🇺🇸Birmingham, Alabama, United States
TRIMED Clinical Trials
🇺🇸Corona, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
Scripps Clinical Research Services
🇺🇸La Jolla, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
Western Affiliated Research Institute, Inc
🇺🇸Denver, Colorado, United States
Florida Clinical Research
🇺🇸Bradenton, Florida, United States
Gulfcoast Clinical Research
🇺🇸Fort Myers, Florida, United States
Radiant Research, Inc
🇺🇸Murray, Utah, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Orlando, Florida, United States
Fidelity Clinical Research, Inc
🇺🇸Lauderhill, Florida, United States
Florida Clinical Research Center, LLC
🇺🇸Maitland, Florida, United States
Compass Research, LLC
🇺🇸Leesburg, Florida, United States
Scientific Clinical Research, Inc
🇺🇸North Miami, Florida, United States
Atlanta Institute of Medicine and Research
🇺🇸Atlanta, Georgia, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Neurotrials Research, Inc
🇺🇸Atlanta, Georgia, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
American Medical Research, Inc
🇺🇸Oak Brook, Illinois, United States
Deaconess Health Center
🇺🇸Newburgh, Indiana, United States
Louisana Research Associates, Inc
🇺🇸New Orleans, Louisiana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Activmed Practices & Research
🇺🇸Methuen, Massachusetts, United States
Adams Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States
Rochester Center for Behavioral Medicine
🇺🇸Rochester Hills, Michigan, United States
Robert Lynne Horne, MD
🇺🇸Las Vegas, Nevada, United States
St. Charles Psychiatric Associates-Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Pacific Institute for Research & Evaluation
🇺🇸Albuquerque, New Mexico, United States
Brooklyn Medical Institute
🇺🇸Brooklyn, New York, United States
Bioscience Research LLC
🇺🇸Mount Kisco, New York, United States
CNS Clinica
🇺🇸New York, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Patient Priority Clinical Sites
🇺🇸Cincinnati, Ohio, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Lindner Center of Hope
🇺🇸Mason, Ohio, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
Oregon Psychiatric Partners, Llp
🇺🇸Eugene, Oregon, United States
Oregon Center for Clinical Research, Inc
🇺🇸Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc
🇺🇸Salem, Oregon, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
The Clinical Trial Center, LLC.
🇺🇸Jenkintown, Pennsylvania, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Futuresearch Clinical Trials
🇺🇸Austin, Texas, United States
Clinical Neuroscience Solutions, Inc (CNS Healthcare)
🇺🇸Memphis, Tennessee, United States
Clinical Research Associates, Inc
🇺🇸Nashville, Tennessee, United States
Futuresearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Texas Center for Drug Development, Inc
🇺🇸Houston, Texas, United States
Psychiatric Medical Associates
🇺🇸Plano, Texas, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
Neuroscience, Inc
🇺🇸Herndon, Virginia, United States
Northwest Clinical Research
🇺🇸Bellevue, Washington, United States
Dean Foundation
🇺🇸Middleton, Wisconsin, United States
Ernovis GmbH
🇩🇪Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Klinische Forschung Hannover-Mitte
🇩🇪Hannover, Germany
Hospital Infanta Leonor
🇪🇸Madrid, Spain
Cypress Medical Research Center, LLC
🇺🇸Wichita, Kansas, United States
Clinical Trials Technology, Inc
🇺🇸Prairie Village, Kansas, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Global Medical Institues, LLC
🇺🇸Princeton, New Jersey, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
Comprehensive Clinical Development
🇺🇸Jamaica, New York, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States
Goldpoint Clinical Research, LLC
🇺🇸Indianapolis, Indiana, United States
Center for Psychiatry & Behavioral Medicine, Inc
🇺🇸Las Vegas, Nevada, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Radiant Research
🇺🇸Tucson, Arizona, United States