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

NCT01657019 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3452012-003313-34
• Study Type: interventional
• Target: 604
• Locations: 3 countries
• Sites: 89

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

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale

  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)

  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

  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

  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

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

Study Arms (1)

Lisdexamfetamine dimesylate

EXPERIMENTAL

Drug: Lisdexamfetamine dimesylate

Interventions

Lisdexamfetamine dimesylate DRUG

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

Also known as: Vyvanse, SPD489, LDX

Lisdexamfetamine dimesylate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shire: lead

Study Sites (89)

Birmingham Research Group

Birmingham, Alabama, 35216, United States

Location

Radiant Research

Tucson, Arizona, 85710, United States

Location

Clinical Study Centers, LLC

Little Rock, Arkansas, 72211, United States

Location

Southwestern Research, Inc.

Beverly Hills, California, 90210, United States

Location

TRIMED Clinical Trials

Corona, California, 92880, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Scripps Clinical Research Services

La Jolla, California, 92037, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94612, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

PCSD - Feighner Research

San Diego, California, 92108, United States

Location

Western Affiliated Research Institute, Inc

Denver, Colorado, 80209, United States

Location

Radiant Research, Inc

Denver, Colorado, 80239, United States

Location

Florida Clinical Research

Bradenton, Florida, 34201, United States

Location

Gulfcoast Clinical Research

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32216, United States

Location

Fidelity Clinical Research, Inc

Lauderhill, Florida, 33319, United States

Location

Compass Research, LLC

Leesburg, Florida, 34748, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Scientific Clinical Research, Inc

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32806, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Atlanta Institute of Medicine and Research

Atlanta, Georgia, 30328, United States

Location

Neurotrials Research, Inc

Atlanta, Georgia, 30342, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

American Medical Research, Inc

Oak Brook, Illinois, 60523, United States

Location

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, 46260, United States

Location

Deaconess Health Center

Newburgh, Indiana, 47630, United States

Location

Clinical Trials Technology, Inc

Prairie Village, Kansas, 66206, United States

Location

Cypress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

Location

Louisana Research Associates, Inc

New Orleans, Louisiana, 70114, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Activmed Practices & Research

Methuen, Massachusetts, 01844, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

St. Charles Psychiatric Associates-Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Robert Lynne Horne, MD

Las Vegas, Nevada, 89102, United States

Location

Center for Psychiatry & Behavioral Medicine, Inc

Las Vegas, Nevada, 89128, United States

Location

Global Medical Institues, LLC

Princeton, New Jersey, 08540, United States

Location

Pacific Institute for Research & Evaluation

Albuquerque, New Mexico, 87102, United States

Location

Brooklyn Medical Institute

Brooklyn, New York, 11214, United States

Location

Comprehensive Clinical Development

Jamaica, New York, 11432, United States

Location

Bioscience Research LLC

Mount Kisco, New York, 10549, United States

Location

CNS Clinica

New York, New York, 10023, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Radiant Research, Inc

Akron, Ohio, 44311, United States

Location

Patient Priority Clinical Sites

Cincinnati, Ohio, 45215, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Lindner Center of Hope

Mason, Ohio, 45040, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Oregon Psychiatric Partners, Llp

Eugene, Oregon, 97401, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

Oregon Center for Clinical Research, Inc

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations, Inc

Salem, Oregon, 97301, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

The Clinical Trial Center, LLC.

Jenkintown, Pennsylvania, 19046, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Radiant Research, Inc

Anderson, South Carolina, 29621, United States

Location

Radiant Research, Inc

Greer, South Carolina, 29650, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutions, Inc (CNS Healthcare)

Memphis, Tennessee, 38119, United States

Location

Clinical Research Associates, Inc

Nashville, Tennessee, 37203, United States

Location

Futuresearch Clinical Trials

Austin, Texas, 78731, United States

Location

Futuresearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

Texas Center for Drug Development, Inc

Houston, Texas, 77081, United States

Location

Psychiatric Medical Associates

Plano, Texas, 75093, United States

Location

Radiant Research, Inc

San Antonio, Texas, 78229, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, 76309, United States

Location

Radiant Research, Inc

Murray, Utah, 84123, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Neuroscience, Inc

Herndon, Virginia, 20170, United States

Location

Northwest Clinical Research

Bellevue, Washington, 98007, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10117, Germany

Location

Ernovis GmbH

Berlin, 10629, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 1069, Germany

Location

Klinische Forschung Hannover-Mitte

Hanover, 30159, Germany

Location

Hospital Infanta Leonor

Madrid, 28031, Spain

Location

Related 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. 2017 Jun;37(3):315-322. doi: 10.1097/JCP.0000000000000702.

  PMID: 28383364 RESULT

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 3, 2012
• Study Start: August 21, 2012
• Primary Completion: October 21, 2014
• Study Completion: October 21, 2014
• Last Updated: June 9, 2021
• Results First Posted: December 15, 2015

Record last verified: 2021-05

Locations

DE (4); US (84); ES (1)