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

A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder

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

Study Overview

• Status: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Drug: Lisdexamfetamine dimesylate

• Study Type: Interventional
• Enrollment (Actual): 604
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 10629
    • Ernovis GmbH
  • Dresden, Germany, 1069
    • Klinische Forschung Dresden GmbH
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte
• Spain
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Birmingham Research Group
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Radiant Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Clinical Study Centers, LLC
  • California
    • Beverly Hills, California, United States, 90210
      • Southwestern Research, Inc.
    • Corona, California, United States, 92880
      • TRIMED Clinical Trials
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • La Jolla, California, United States, 92037
      • Scripps Clinical Research Services
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Oakland, California, United States, 94612
      • Pacific Research Partners, LLC
    • Oceanside, California, United States, 92056
      • Excell Research, Inc
    • San Diego, California, United States, 92108
      • PCSD - Feighner Research
  • Colorado
    • Denver, Colorado, United States, 80239
      • Radiant Research, Inc
    • Denver, Colorado, United States, 80209
      • Western Affiliated Research Institute, Inc
  • Florida
    • Bradenton, Florida, United States, 34201
      • Florida Clinical Research
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc
    • Lauderhill, Florida, United States, 33319
      • Fidelity Clinical Research, Inc
    • Leesburg, Florida, United States, 34748
      • Compass Research, LLC
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • North Miami, Florida, United States, 33161
      • Scientific Clinical Research, Inc
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials Research, Inc
    • Atlanta, Georgia, United States, 30328
      • Atlanta Institute of Medicine and Research
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
    • Naperville, Illinois, United States, 60563
      • Baber Research Group
    • Oak Brook, Illinois, United States, 60523
      • American Medical Research, Inc
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Goldpoint Clinical Research, LLC
    • Newburgh, Indiana, United States, 47630
      • Deaconess Health Center
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisana Research Associates, Inc
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Trials, LLC
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates-Midwest Research Group
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Robert Lynne Horne, MD
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry & Behavioral Medicine, Inc
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institues, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Pacific Institute for Research & Evaluation
  • New York
    • Brooklyn, New York, United States, 11214
      • Brooklyn Medical Institute
    • Jamaica, New York, United States, 11432
      • Comprehensive Clinical Development
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research LLC
    • New York, New York, United States, 10023
      • CNS Clinica
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Lindner Center of Hope
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oregon Psychiatric Partners, Llp
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research, LLC
    • Portland, Oregon, United States, 97210
      • Oregon Center for Clinical Research, Inc
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations, Inc
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC.
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Pittsburgh, Pennsylvania, United States, 15206
      • Clinical Trials Research Services, LLC
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc
    • Greer, South Carolina, United States, 29650
      • Radiant Research, Inc
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc (CNS Healthcare)
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Clinical Trials
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc
    • Plano, Texas, United States, 75093
      • Psychiatric Medical Associates
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research, Inc
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Dean Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lisdexamfetamine dimesylate	Drug: Lisdexamfetamine dimesylate; 50 or 70 mg administered orally, once a day for 52 weeks; Other Names: Vyvanse; LDX; SPD489

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2012
• Primary Completion (Actual): October 21, 2014
• Study Completion (Actual): October 21, 2014

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-345; 2012-003313-34 (EudraCT Number)