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

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

Study Overview

• Status: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Drug: lisdexamfetamine dimesylate (SPD489); Drug: lisdexamfetamine dimesylate (SPD489); Drug: lisdexamfetamine dimesylate (SPD489); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Clinical Study Centers, LLC
  • California
    • Beverly Hills, California, United States, 90210
      • Southwestern Research, Inc.
    • La Jolla, California, United States, 92037
      • Scripps Clinical Research Services
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • San Diego, California, United States, 92108
      • PCSD - Feighner Research
  • Florida
    • Bradenton, Florida, United States, 32408
      • Florida Clinical Research
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Atlanta Institute of Medicine and Research
    • Smyrna, Georgia, United States, 30080
      • Carman Research
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Assoc. Research
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc.
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc.
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Marc Hertzman, MD, PC
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Boston, Massachusetts, United States, 02135
      • Boston Clinical Trials
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Unniversity of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Weight Disorders Washington University School of Medicine, Dept of Psychiatry
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Robert Lynn Horne, MD
  • New York
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Neuropsychiatric Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Mason, Ohio, United States, 45040
      • Lindner City of Hope
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Weight Management Center, Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Clinical Trials
    • Houston, Texas, United States, 77081
      • Drug Development, Inc.
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo capsule taken once daily for up to 11 weeks
Experimental: SPD489 30 mg	Drug: lisdexamfetamine dimesylate (SPD489); SPD489-30mg capsules taken once daily for up to 11 weeks; Other Names: LDX, Vyvanse; Drug: lisdexamfetamine dimesylate (SPD489); SPD489 50mg capsules taken once-daily for up to 11 weeks; Other Names: LDX, Vyvanse; Drug: lisdexamfetamine dimesylate (SPD489); SPD489 70mg capsule taken once-daily for up to 11 weeks; Other Names: LDX, Vyvanse
Experimental: SPD489 50 mg	Drug: lisdexamfetamine dimesylate (SPD489); SPD489-30mg capsules taken once daily for up to 11 weeks; Other Names: LDX, Vyvanse; Drug: lisdexamfetamine dimesylate (SPD489); SPD489 50mg capsules taken once-daily for up to 11 weeks; Other Names: LDX, Vyvanse; Drug: lisdexamfetamine dimesylate (SPD489); SPD489 70mg capsule taken once-daily for up to 11 weeks; Other Names: LDX, Vyvanse
Experimental: SPD489 70 mg	Drug: lisdexamfetamine dimesylate (SPD489); SPD489-30mg capsules taken once daily for up to 11 weeks; Other Names: LDX, Vyvanse; Drug: lisdexamfetamine dimesylate (SPD489); SPD489 50mg capsules taken once-daily for up to 11 weeks; Other Names: LDX, Vyvanse; Drug: lisdexamfetamine dimesylate (SPD489); SPD489 70mg capsule taken once-daily for up to 11 weeks; Other Names: LDX, Vyvanse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
4-Week Binge Response	Subjects are free from binge episodes for 4 weeks.	Last 28 days on study
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
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
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
Change From Baseline in Montgomery-Ǻsberg 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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2011
• Primary Completion (Actual): January 30, 2012
• Study Completion (Actual): January 30, 2012

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: SPD489-208