Clinical trial NCT01657019: Open Label Extension in Adults With Binge Eating Disorder (BED)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Binge Eating Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
timeFrame: 52 weeks
measure: Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 53 weeks
Secondary outcomes:
measure: Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
timeFrame: Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
measure: Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)
measure: Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
timeFrame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
measure: Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
timeFrame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
measure: Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
timeFrame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
measure: Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
timeFrame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
measure: Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
timeFrame: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Beverly Hills
country: United States
facility: Southwestern Research, Inc.
state: California
city: Corona
country: United States
facility: TRIMED Clinical Trials
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: La Jolla
country: United States
facility: Scripps Clinical Research Services
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute, Inc
state: Colorado
city: Denver
country: United States
facility: Radiant Research, Inc
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research, Inc
state: Florida
city: Leesburg
country: United States
facility: Compass Research, LLC
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Atlanta
country: United States
facility: Neurotrials Research, Inc
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Health Center
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Center, LLC
state: Kansas
city: New Orleans
country: United States
facility: Louisana Research Associates, Inc
state: Louisiana
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: Activmed Practices & Research
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates-Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Robert Lynne Horne, MD
state: Nevada
city: Las Vegas
country: United States
facility: Center for Psychiatry & Behavioral Medicine, Inc
state: Nevada
city: Princeton
country: United States
facility: Global Medical Institues, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Pacific Institute for Research & Evaluation
state: New Mexico
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: Jamaica
country: United States
facility: Comprehensive Clinical Development
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research LLC
state: New York
city: New York
country: United States
facility: CNS Clinica
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Akron
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Lindner Center of Hope
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Psychiatric Partners, Llp
state: Oregon
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Research, Inc
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC.
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc (CNS Healthcare)
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc
state: Tennessee
city: Austin
country: United States
facility: Futuresearch Clinical Trials
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc
state: Texas
city: Plano
country: United States
facility: Psychiatric Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Herndon
country: United States
facility: Neuroscience, Inc
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Middleton
country: United States
facility: Dean Foundation
state: Wisconsin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Ernovis GmbH
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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. 2017 Jun;37(3):315-322. doi: 10.1097/JCP.0000000000000702.