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

Binge Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657019
• Other study ID #: SPD489-345
• Secondary ID: 2012-003313-34
• Status: Completed
• Phase: Phase 3
• Start date: August 21, 2012
• Est. completion date: October 21, 2014

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: October 21, 2014
• Est. primary completion date: October 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• Lisdexamfetamine dimesylate
50 or 70 mg administered orally, once a day for 52 weeks

Locations

Country	Name	City	State
Germany	Ernovis GmbH	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Klinische Forschung Hannover-Mitte	Hannover
Spain	Hospital Infanta Leonor	Madrid
United States	Radiant Research, Inc	Akron	Ohio
United States	Pacific Institute for Research & Evaluation	Albuquerque	New Mexico
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Radiant Research, Inc	Anderson	South Carolina
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	Neurotrials Research, Inc	Atlanta	Georgia
United States	Futuresearch Clinical Trials	Austin	Texas
United States	Northwest Clinical Research	Bellevue	Washington
United States	McLean Hospital	Belmont	Massachusetts
United States	Southwestern Research, Inc.	Beverly Hills	California
United States	Birmingham Research Group	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Florida Clinical Research	Bradenton	Florida
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Community Research	Cincinnati	Ohio
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
United States	TRIMED Clinical Trials	Corona	California
United States	Futuresearch Trials of Dallas, LP	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research, Inc	Denver	Colorado
United States	Western Affiliated Research Institute, Inc	Denver	Colorado
United States	Pharmacology Research Institute	Encino	California
United States	Oregon Psychiatric Partners, Llp	Eugene	Oregon
United States	Gulfcoast Clinical Research	Fort Myers	Florida
United States	Radiant Research, Inc	Greer	South Carolina
United States	Neuroscience, Inc	Herndon	Virginia
United States	Texas Center for Drug Development, Inc	Houston	Texas
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Comprehensive Clinical Development	Jamaica	New York
United States	The Clinical Trial Center, LLC.	Jenkintown	Pennsylvania
United States	Scripps Clinical Research Services	La Jolla	California
United States	Center for Psychiatry & Behavioral Medicine, Inc	Las Vegas	Nevada
United States	Robert Lynne Horne, MD	Las Vegas	Nevada
United States	Fidelity Clinical Research, Inc	Lauderhill	Florida
United States	Compass Research, LLC	Leesburg	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Lindner Center of Hope	Mason	Ohio
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions, Inc (CNS Healthcare)	Memphis	Tennessee
United States	Activmed Practices & Research	Methuen	Massachusetts
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Dean Foundation	Middleton	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Bioscience Research LLC	Mount Kisco	New York
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Radiant Research, Inc	Murray	Utah
United States	Baber Research Group	Naperville	Illinois
United States	Clinical Research Associates, Inc	Nashville	Tennessee
United States	Louisana Research Associates, Inc	New Orleans	Louisiana
United States	CNS Clinica	New York	New York
United States	Deaconess Health Center	Newburgh	Indiana
United States	Pharmacology Research Institute	Newport Beach	California
United States	Scientific Clinical Research, Inc	North Miami	Florida
United States	American Medical Research, Inc	Oak Brook	Illinois
United States	Pacific Research Partners, LLC	Oakland	California
United States	Excell Research, Inc	Oceanside	California
United States	Advanced Research Institute	Ogden	Utah
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	Psychiatric Medical Associates	Plano	Texas
United States	Oregon Center for Clinical Research, Inc	Portland	Oregon
United States	Clinical Trials Technology, Inc	Prairie Village	Kansas
United States	Global Medical Institues, LLC	Princeton	New Jersey
United States	Wake Research Associates	Raleigh	North Carolina
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	St. Charles Psychiatric Associates-Midwest Research Group	Saint Charles	Missouri
United States	Oregon Center for Clinical Investigations, Inc	Salem	Oregon
United States	Radiant Research, Inc	San Antonio	Texas
United States	PCSD - Feighner Research	San Diego	California
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Miami Research Associates	South Miami	Florida
United States	Radiant Research	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts
United States	Cypress Medical Research Center, LLC	Wichita	Kansas
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

References & Publications (1)

Gasior M, Hudson J, Quintero J, Ferreira-Cornwell MC, Radewonuk J, McElroy SL. A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder. J Clin Psychopharmacol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety		52 weeks
Primary	Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)	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.	53 weeks
Secondary	Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale	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.	Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
Secondary	Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)	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.	Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
Secondary	Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility	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.	End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Secondary	Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care	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.	End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Secondary	Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities	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.	End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Secondary	Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort	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.	End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Secondary	Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression	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.	End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)