Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder

Binge Eating Disorder Clinical Trial

— BED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291173
• Other study ID #: SPD489-208
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2011
• Est. completion date: January 30, 2012

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: January 30, 2012
• Est. primary completion date: January 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion

• 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.

Exclusion

• Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.

• Subject is considered a suicide risk or risk to harm others.

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• lisdexamfetamine dimesylate (SPD489)
SPD489-30mg capsules taken once daily for up to 11 weeks
• lisdexamfetamine dimesylate (SPD489)
SPD489 50mg capsules taken once-daily for up to 11 weeks
• lisdexamfetamine dimesylate (SPD489)
SPD489 70mg capsule taken once-daily for up to 11 weeks
• Placebo
Placebo capsule taken once daily for up to 11 weeks

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	FutureSearch Clinical Trials	Austin	Texas
United States	McLean Hospital	Belmont	Massachusetts
United States	Southwestern Research, Inc.	Beverly Hills	California
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Florida Clinical Research	Bradenton	Florida
United States	Weight Management Center, Medical University of South Carolina	Charleston	South Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Community Research	Cincinnati	Ohio
United States	Neuropsychiatric Research Institute	Fargo	North Dakota
United States	Gulfcoast Clinical Research	Fort Myers	Florida
United States	Drug Development, Inc.	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Scripps Clinical Research Services	La Jolla	California
United States	Robert Lynn Horne, MD	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Lindner City of Hope	Mason	Ohio
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Unniversity of Minnesota	Minneapolis	Minnesota
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	Pharmacology Research Institute	Newport Beach	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Vince and Assoc. Research	Overland Park	Kansas
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Wake Research Associates	Raleigh	North Carolina
United States	Marc Hertzman, MD, PC	Rockville	Maryland
United States	Weight Disorders Washington University School of Medicine, Dept of Psychiatry	Saint Louis	Missouri
United States	PCSD - Feighner Research	San Diego	California
United States	Carman Research	Smyrna	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks	The number of binge episodes per week as assessed by clinical interview based on subject diary.	Baseline and up to 11 weeks
Secondary	1-Week Binge Response, Last Observation Carried Forward (LOCF)	The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.	Last 7 days on study
Secondary	4-Week Binge Response	Subjects are free from binge episodes for 4 weeks.	Last 28 days on study
Secondary	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)	Baseline
Secondary	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)	up to 11 weeks
Secondary	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	Up to 11 weeks
Secondary	Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11	The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.	Baseline and week 11
Secondary	Change From Baseline in Montgomery-?sberg Depression Rating Scale (MADRS) Score at Week 11	MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.	Baseline and week 11
Secondary	Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11	The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.	Baseline and week 11
Secondary	Change From Baseline in Eating Inventory Score at Week 11	The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.	Baseline and week 11
Secondary	Change From Baseline in Binge Eating Scale (BES) Score at Week 11	The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.	Baseline and week 11
Secondary	Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11	The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.	Baseline and week 11
Secondary	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11	The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).	Baseline and week 11