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Binge Eating DisorderPhase 3NCT01657019

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

A Phase 3 study testing Lisdexamfetamine dimesylate in people with Binge Eating Disorder, run by Shire at 89 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Binge Eating Disorder
What is being tested?
Lisdexamfetamine dimesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
604 participants
Where
89 sitesin 3 countries
Study dates
21 Aug 2012to 21 Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Completion of an antecedent SPD489 BED Double-blind Study
  • Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED
  • Subject has a body mass index (BMI) of > or =18 and < or =45

Who cannot join

  • Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
  • Subject is considered a suicide risk or risk to harm others

Trial locations and contacts

89 sites in 3 countries.

89 sites in 3 countries

United States84 sites

  • Radiant Research, Inc

    Akron, Ohio, 44311

  • Pacific Institute for Research & Evaluation

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Radiant Research, Inc

    Anderson, South Carolina, 29621

  • Atlanta Institute of Medicine and Research

    Atlanta, Georgia, 30328

  • Neurotrials Research, Inc

    Atlanta, Georgia, 30342

  • Futuresearch Clinical Trials

    Austin, Texas, 78731

  • Northwest Clinical Research

    Bellevue, Washington, 98007

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Southwestern Research, Inc.

    Beverly Hills, California, 90210

  • Birmingham Research Group

    Birmingham, Alabama, 35216

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Florida Clinical Research

    Bradenton, Florida, 34201

  • Brooklyn Medical Institute

    Brooklyn, New York, 11214

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Patient Priority Clinical Sites

    Cincinnati, Ohio, 45215

  • Community Research

    Cincinnati, Ohio, 45227

  • TRIMED Clinical Trials

    Corona, California, 92880

  • Futuresearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Western Affiliated Research Institute, Inc

    Denver, Colorado, 80209

  • Radiant Research, Inc

    Denver, Colorado, 80239

  • Pharmacology Research Institute

    Encino, California, 91316

  • Oregon Psychiatric Partners, Llp

    Eugene, Oregon, 97401

  • Gulfcoast Clinical Research

    Fort Myers, Florida, 33912

  • Radiant Research, Inc

    Greer, South Carolina, 29650

  • Neuroscience, Inc

    Herndon, Virginia, 20170

  • Texas Center for Drug Development, Inc

    Houston, Texas, 77081

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32216

  • Comprehensive Clinical Development

    Jamaica, New York, 11432

  • The Clinical Trial Center, LLC.

    Jenkintown, Pennsylvania, 19046

  • Scripps Clinical Research Services

    La Jolla, California, 92037

  • Robert Lynne Horne, MD

    Las Vegas, Nevada, 89102

  • Center for Psychiatry & Behavioral Medicine, Inc

    Las Vegas, Nevada, 89128

  • Fidelity Clinical Research, Inc

    Lauderhill, Florida, 33319

  • Compass Research, LLC

    Leesburg, Florida, 34748

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Clinical Study Centers, LLC

    Little Rock, Arkansas, 72211

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Lindner Center of Hope

    Mason, Ohio, 45040

  • Sunstone Medical Research, LLC

    Medford, Oregon, 97504

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions, Inc (CNS Healthcare)

    Memphis, Tennessee, 38119

  • Activmed Practices & Research

    Methuen, Massachusetts, 01844

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Dean Foundation

    Middleton, Wisconsin, 53562

  • University of Minnesota

    Minneapolis, Minnesota, 55454

  • Bioscience Research LLC

    Mount Kisco, New York, 10549

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Radiant Research, Inc

    Murray, Utah, 84123

  • Baber Research Group

    Naperville, Illinois, 60563

  • Clinical Research Associates, Inc

    Nashville, Tennessee, 37203

  • Louisana Research Associates, Inc

    New Orleans, Louisiana, 70114

  • CNS Clinica

    New York, New York, 10023

  • Deaconess Health Center

    Newburgh, Indiana, 47630

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Scientific Clinical Research, Inc

    North Miami, Florida, 33161

  • American Medical Research, Inc

    Oak Brook, Illinois, 60523

  • Pacific Research Partners, LLC

    Oakland, California, 94612

  • Excell Research, Inc

    Oceanside, California, 92056

  • Advanced Research Institute

    Ogden, Utah, 84405

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32806

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • Psychiatric Medical Associates

    Plano, Texas, 75093

  • Oregon Center for Clinical Research, Inc

    Portland, Oregon, 97210

  • Clinical Trials Technology, Inc

    Prairie Village, Kansas, 66206

  • Global Medical Institues, LLC

    Princeton, New Jersey, 08540

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan, 48307

  • St. Charles Psychiatric Associates-Midwest Research Group

    Saint Charles, Missouri, 63304

  • Oregon Center for Clinical Investigations, Inc

    Salem, Oregon, 97301

  • Radiant Research, Inc

    San Antonio, Texas, 78229

  • PCSD - Feighner Research

    San Diego, California, 92108

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Miami Research Associates

    South Miami, Florida, 33143

  • Radiant Research

    Tucson, Arizona, 85710

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Adams Clinical Trials, LLC

    Watertown, Massachusetts, 02472

  • Cypress Medical Research Center, LLC

    Wichita, Kansas, 67226

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • Neuropsychiatric Associates

    Woodstock, Vermont, 05091

Other trials in United States

Germany4 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Ernovis GmbH

    Berlin, 10629

  • Klinische Forschung Dresden GmbH

    Dresden, 1069

  • Klinische Forschung Hannover-Mitte

    Hanover, 30159

Other trials in Germany

Spain1 site

  • Hospital Infanta Leonor

    Madrid, 28031

Other trials in Spain

About this study

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

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

Being tested
Lisdexamfetamine dimesylate
Medical subject headings
Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lisdexamfetamine dimesylateDrug

    Also called Vyvanse, SPD489, LDX

    50 or 70 mg administered orally, once a day for 52 weeks

Study groups in NCT01657019
Study groupRoleWhat they receive
Lisdexamfetamine dimesylateExperimentalNot described
Receives: Drug: Lisdexamfetamine dimesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety

    Measured: 52 weeks

  2. 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.

    Measured: 53 weeks

Secondary outcomes (7)

  1. 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.

    Measured: Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)

  2. 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.

    Measured: Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)

  3. 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.

    Measured: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)

  4. 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.

    Measured: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)

  5. 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.

    Measured: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)

  6. 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.

    Measured: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)

  7. 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.

    Measured: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2012 (estimated)
  2. Study start21 Aug 2012
  3. Primary completion21 Oct 2014
  4. Study completion21 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
604 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01657019
Sponsor's protocol ID
SPD489-345
Other IDs
2012-003313-34
Status last verified
May 2021
First submitted
1 Aug 2012
Last updated
9 Jun 2021

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.

    PubMed 28383364

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lisdexamfetamine dimesylate in people with Binge Eating Disorder, run by Shire at 89 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01657019, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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