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

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine dimesylate (SPD489)
lisdexamfetamine dimesylate (SPD489)
lisdexamfetamine dimesylate (SPD489)
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Study Centers, LLC
  • Southwestern Research, Inc.
  • Scripps Clinical Research Services
  • Pharmacology Research Institute
  • PCSD - Feighner Research
  • Florida Clinical Research
  • Gulfcoast Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Atlanta Institute of Medicine and Research
  • Carman Research
  • Capstone Clinical Research
  • Vince and Assoc. Research
  • Clinical Trials Technology, Inc.
  • Louisiana Research Associates, Inc.
  • Marc Hertzman, MD, PC
  • McLean Hospital
  • Boston Clinical Trials
  • Unniversity of Minnesota
  • Weight Disorders Washington University School of Medicine, Dept of Psychiatry
  • Robert Lynn Horne, MD
  • Richmond Behavioral Associates
  • Wake Research Associates
  • Neuropsychiatric Research Institute
  • Community Research
  • Lindner City of Hope
  • Weight Management Center, Medical University of South Carolina
  • Clinical Neuroscience Solutions, Inc.
  • FutureSearch Clinical Trials
  • Drug Development, Inc.
  • Charlottesville Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SPD489 30 mg

SPD489 50 mg

SPD489 70 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
4-Week Binge Response
Subjects are free from binge episodes for 4 weeks.
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)
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)
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.
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
February 4, 2011
Last Updated
May 29, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01291173
Brief Title
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2011 (Actual)
Primary Completion Date
January 30, 2012 (Actual)
Study Completion Date
January 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD489 30 mg
Arm Type
Experimental
Arm Title
SPD489 50 mg
Arm Type
Experimental
Arm Title
SPD489 70 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine dimesylate (SPD489)
Other Intervention Name(s)
LDX, Vyvanse
Intervention Description
SPD489-30mg capsules taken once daily for up to 11 weeks
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine dimesylate (SPD489)
Other Intervention Name(s)
LDX, Vyvanse
Intervention Description
SPD489 50mg capsules taken once-daily for up to 11 weeks
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine dimesylate (SPD489)
Other Intervention Name(s)
LDX, Vyvanse
Intervention Description
SPD489 70mg capsule taken once-daily for up to 11 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule taken once daily for up to 11 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Log Transformed Binge Days Per Week at Week 11
Description
Binge day is defined as a day during which at least 1 binge episode occurs.
Time Frame
Baseline and week 11
Secondary Outcome Measure Information:
Title
Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks
Description
The number of binge episodes per week as assessed by clinical interview based on subject diary.
Time Frame
Baseline and up to 11 weeks
Title
1-Week Binge Response, Last Observation Carried Forward (LOCF)
Description
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.
Time Frame
Last 7 days on study
Title
4-Week Binge Response
Description
Subjects are free from binge episodes for 4 weeks.
Time Frame
Last 28 days on study
Title
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Description
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)
Time Frame
Baseline
Title
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
Description
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)
Time Frame
up to 11 weeks
Title
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks
Description
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.
Time Frame
Up to 11 weeks
Title
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11
Description
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.
Time Frame
Baseline and week 11
Title
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11
Description
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.
Time Frame
Baseline and week 11
Title
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11
Description
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.
Time Frame
Baseline and week 11
Title
Change From Baseline in Eating Inventory Score at Week 11
Description
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.
Time Frame
Baseline and week 11
Title
Change From Baseline in Binge Eating Scale (BES) Score at Week 11
Description
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.
Time Frame
Baseline and week 11
Title
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11
Description
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.
Time Frame
Baseline and week 11
Title
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11
Description
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).
Time Frame
Baseline and week 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southwestern Research, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Scripps Clinical Research Services
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
PCSD - Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Florida Clinical Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
32408
Country
United States
Facility Name
Gulfcoast Clinical Research
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Atlanta Institute of Medicine and Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Vince and Assoc. Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Clinical Trials Technology, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Marc Hertzman, MD, PC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Unniversity of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Weight Disorders Washington University School of Medicine, Dept of Psychiatry
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Robert Lynn Horne, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Neuropsychiatric Research Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Lindner City of Hope
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Weight Management Center, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25587645
Citation
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.
Results Reference
derived

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

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