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

May 25, 2021 updated by: Shire

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
604

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
Time Frame: 52 weeks
52 weeks
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
53 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD489-345
  • 2012-003313-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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