Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
BED
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder
1 other identifier
interventional
271
1 country
31
Brief Summary
To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedStudy Start
First participant enrolled
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2012
CompletedResults Posted
Study results publicly available
December 31, 2012
CompletedJune 10, 2021
May 1, 2021
9 months
February 4, 2011
October 26, 2012
May 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Log Transformed Binge Days Per Week at Week 11
Binge day is defined as a day during which at least 1 binge episode occurs.
Baseline and week 11
Secondary Outcomes (13)
Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks
Baseline and up to 11 weeks
1-Week Binge Response, Last Observation Carried Forward (LOCF)
Last 7 days on study
4-Week Binge Response
Last 28 days on study
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Baseline
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
up to 11 weeks
- +8 more secondary outcomes
Study Arms (4)
SPD489 30 mg
EXPERIMENTALSPD489 50 mg
EXPERIMENTALSPD489 70 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
SPD489-30mg capsules taken once daily for up to 11 weeks
Eligibility Criteria
You may qualify if:
- Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED).
- Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.
- Subject has a body mass index (BMI) of \>24 and \<46.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (31)
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205, United States
Southwestern Research, Inc.
Beverly Hills, California, 90210, United States
Scripps Clinical Research Services
La Jolla, California, 92037, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
PCSD - Feighner Research
San Diego, California, 92108, United States
Florida Clinical Research
Bradenton, Florida, 32408, United States
Gulfcoast Clinical Research
Fort Myers, Florida, 33912, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Vince and Assoc. Research
Overland Park, Kansas, 66212, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Marc Hertzman, MD, PC
Rockville, Maryland, 20852, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Boston Clinical Trials
Boston, Massachusetts, 02135, United States
Unniversity of Minnesota
Minneapolis, Minnesota, 55454, United States
Weight Disorders Washington University School of Medicine, Dept of Psychiatry
St Louis, Missouri, 63110, United States
Robert Lynn Horne, MD
Las Vegas, Nevada, 89102, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Neuropsychiatric Research Institute
Fargo, North Dakota, 58103, United States
Community Research
Cincinnati, Ohio, 45227, United States
Lindner City of Hope
Mason, Ohio, 45040, United States
Weight Management Center, Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Clinical Trials
Austin, Texas, 78731, United States
Drug Development, Inc.
Houston, Texas, 77081, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Related Publications (1)
McElroy SL, Hudson JI, Mitchell JE, Wilfley D, Ferreira-Cornwell MC, Gao J, Wang J, Whitaker T, Jonas J, Gasior M. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):235-46. doi: 10.1001/jamapsychiatry.2014.2162.
PMID: 25587645DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
External investigation at a site was initiated for reasons unrelated to the study. Lacking information on the investigation, it was deemed prudent to exclude data from subjects enrolled at site (n=11) from the primary analyses of efficacy and safety.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 8, 2011
Study Start
May 10, 2011
Primary Completion
January 30, 2012
Study Completion
January 30, 2012
Last Updated
June 10, 2021
Results First Posted
December 31, 2012
Record last verified: 2021-05