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SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPD489 (Lisdexamfetamine dimesylate)
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 Criteria -

  1. Subject is between 18-55 years of age.

  2. Subject meets the following DSM-IV-TR criteria for a diagnosis of BED:

    Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating).

    The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.

    Marked distress regarding binge eating. The binge eating occurs, on average, at least 2 days a week for 6 months. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.

  3. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as documented in the subject's binge diary. A binge day is a day during which at least 1 binge eating episode occurs.
  4. Female subjects must have a negative serum B HCG pregnancy test and a negative urine pregnancy test.

Exclusion Criteria-

  1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
  2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED within 3 months.
  3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months.
  4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
  5. Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
  6. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
  7. Subject has recently initiated treatment with a lipid-lowering medication (within the past 3 months).
  8. Subject has a history of moderate or severe hypertension.
  9. Subject is female and pregnant or nursing.
  10. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Sites / Locations

  • Birmingham Research Group
  • Clinical Study Centers, LLC
  • Trimed Clinical Trials
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Pacific Research Partners, LLC
  • Research Across America
  • Western Affiliated Research Institute, Inc.
  • Gulfcoast Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Fidelity Clinical Research, Inc.
  • Compass Research LLC
  • Scientific Clinical Research Inc.
  • Uptown Research Institute
  • Alexian Brothers Behavioral Health Hospital
  • AMR Baber Research, Inc.
  • Goldpoint Clinical Research, LLC
  • Cypress Medical Research Center, LLC
  • McLean Hospital
  • St. Charles Psychiatric Associates/Midwest Research Group
  • Center for Psychiatry and Behavioral Medicine, Inc.
  • Pacific Research for Research and Evaluation
  • Wake Research Associates, LLC
  • Community Research
  • Midwest Clinical Research Center, LLC
  • North Star Medical Research
  • IPS Research Company
  • Oregon Center for Clinical Investigations, Inc.
  • The Clinical Trials Center, LLC
  • Suburban Research Associates
  • Clinical Trials Research Services, LLC
  • Radiant Research, Inc.
  • Coastal Carolina Research Center
  • Clinical Neuroscience Solutions, Inc.
  • Future Search Trials
  • Futuresearch Trials of Dallas, L.P.
  • Grayline Clinical Drug Trials
  • Radiant Research, Inc.
  • Neuropsychiatric Associates, LLC
  • Charlottesville Medical Research Center, LLC
  • Alliance Research Group
  • Northwest Clinical Research Center
  • Dean Foundation for Health, Research and Educations, Inc.
  • Ernovis GmbH
  • Klinische Forschung Dresden GmbH
  • Studienzentrum Nordwest, Gemeinschaftspraxis
  • Hospital Universitario Infanta Leonor
  • Lakarmottagning Ekdahl & Kronberg
  • Sophiahemmet
  • Stockholm Center for Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SPD489 (Lisdexamfetamine dimesylate)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.

Secondary Outcome Measures

Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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.
Percentage of Participants With a 4-Week Cessation From Binge Eating
4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
Percent Change From Baseline in Body Weight at Week 12
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
The Y-BOCS-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. Reduction in total score indicates improvement.
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Binge Eating Response
Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows: 1-week Cessation = 100% reduction in binge episodes during the preceding 7 days. Marked Reduction = 99% to 75% reduction during the time since the previous visit. Moderate Reduction = 74% to 50% reduction during the time since the previous visit. Negative to Minimal Reduction = <50% reduction during the time since the previous visit.
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)
Change From Baseline in Eating Inventory Scores at Week 12
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. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.
Change From Baseline in Binge Eating Scale (BES) Score at Week 12
The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.

Full Information

First Posted
October 29, 2012
Last Updated
May 16, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01718483
Brief Title
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Official Title
The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2012 (Actual)
Primary Completion Date
September 25, 2013 (Actual)
Study Completion Date
September 25, 2013 (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
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD489 (Lisdexamfetamine dimesylate)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD489 (Lisdexamfetamine dimesylate)
Other Intervention Name(s)
Vyvanse, Venvanse, LDX
Intervention Description
50 or 70 mg administered orally, once-daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered once-daily, orally, for up to 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)
Description
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
Time Frame
Baseline and Visit 8 (Weeks 11-12)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Description
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 12 weeks
Title
Percentage of Participants With a 4-Week Cessation From Binge Eating
Description
4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
Time Frame
Up to 12 weeks
Title
Percent Change From Baseline in Body Weight at Week 12
Time Frame
Baseline and Week 12
Title
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
Description
The Y-BOCS-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. Reduction in total score indicates improvement.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
Time Frame
Baseline and Week 12/Early termination (ET)
Title
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Time Frame
Baseline and Week 12/ET
Title
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Time Frame
Baseline and Week 12/ET
Title
Binge Eating Response
Description
Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows: 1-week Cessation = 100% reduction in binge episodes during the preceding 7 days. Marked Reduction = 99% to 75% reduction during the time since the previous visit. Moderate Reduction = 74% to 50% reduction during the time since the previous visit. Negative to Minimal Reduction = <50% reduction during the time since the previous visit.
Time Frame
Week 12/ET
Title
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)
Time Frame
Baseline and Visit 8 (Weeks 11-12)
Title
Change From Baseline in Eating Inventory Scores at Week 12
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. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Binge Eating Scale (BES) Score at Week 12
Description
The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.
Time Frame
Baseline and Week 12
Title
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
Description
The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.
Time Frame
Baseline and Week 12
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
Description
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Description
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Description
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Description
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Description
Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.
Time Frame
Up to 12 weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.
Time Frame
Up to 12 weeks
Title
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
Description
ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Time Frame
Up to 12 weeks

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 Criteria - Subject is between 18-55 years of age. Subject meets the following DSM-IV-TR criteria for a diagnosis of BED: Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating). The binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating. Marked distress regarding binge eating. The binge eating occurs, on average, at least 2 days a week for 6 months. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as documented in the subject's binge diary. A binge day is a day during which at least 1 binge eating episode occurs. Female subjects must have a negative serum B HCG pregnancy test and a negative urine pregnancy test. Exclusion Criteria- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED within 3 months. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD. Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Subject has recently initiated treatment with a lipid-lowering medication (within the past 3 months). Subject has a history of moderate or severe hypertension. Subject is female and pregnant or nursing. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Research Group
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Trimed Clinical Trials
City
Corona
State/Province
California
ZIP/Postal Code
92880
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94812
Country
United States
Facility Name
Research Across America
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Western Affiliated Research Institute, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
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
32256
Country
United States
Facility Name
Fidelity Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Compass Research LLC
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Scientific Clinical Research Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Uptown Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alexian Brothers Behavioral Health Hospital
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
AMR Baber Research, Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Goldpoint Clinical Research, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cypress Medical Research Center, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
St. Charles Psychiatric Associates/Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pacific Research for Research and Evaluation
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Midwest Clinical Research Center, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
North Star Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
The Clinical Trials Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Future Search Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Futuresearch Trials of Dallas, L.P.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Radiant Research, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Neuropsychiatric Associates, LLC
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Alliance Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Dean Foundation for Health, Research and Educations, Inc.
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Ernovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Studienzentrum Nordwest, Gemeinschaftspraxis
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Lakarmottagning Ekdahl & Kronberg
City
Malmo
ZIP/Postal Code
22152
Country
Sweden
Facility Name
Sophiahemmet
City
Stockholm
ZIP/Postal Code
11486
Country
Sweden
Facility Name
Stockholm Center for Eating Disorders
City
Stockholm
ZIP/Postal Code
11850
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26346638
Citation
McElroy SL, Hudson J, Ferreira-Cornwell MC, Radewonuk J, Whitaker T, Gasior M. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials. Neuropsychopharmacology. 2016 Apr;41(5):1251-60. doi: 10.1038/npp.2015.275. Epub 2015 Sep 9.
Results Reference
result
PubMed Identifier
32237290
Citation
Robertson B, Wu J, Fant RV, Schnoll SH, McElroy SL. Assessment of Amphetamine Withdrawal Symptoms of Lisdexamfetamine Dimesylate Treatment for Adults With Binge-Eating Disorder. Prim Care Companion CNS Disord. 2020 Mar 26;22(2):19m02540. doi: 10.4088/PCC.19m02540.
Results Reference
derived
PubMed Identifier
30817099
Citation
Kornstein SG, Bliss C, Kando J, Madhoo M. Clinical Characteristics and Treatment Response to Lisdexamfetamine Dimesylate Versus Placebo in Adults With Binge Eating Disorder: Analysis by Gender and Age. J Clin Psychiatry. 2019 Feb 26;80(2):18m12378. doi: 10.4088/JCP.18m12378.
Results Reference
derived
PubMed Identifier
30013816
Citation
Sheehan DV, Gasior M, McElroy SL, Radewonuk J, Herman BK, Hudson J. Effects of Lisdexamfetamine Dimesylate on Functional Impairment Measured on the Sheehan Disability Scale in Adults With Moderate-to-severe Binge Eating Disorder: Results from Two Randomized, Placebo-controlled Trials. Innov Clin Neurosci. 2018 Jun 1;15(5-6):22-29.
Results Reference
derived
PubMed Identifier
29497297
Citation
Citrome L, Kando JC, Bliss C. Relationships between clinical scales and binge eating days in adults with moderate to severe binge eating disorder in two Phase III studies. Neuropsychiatr Dis Treat. 2018 Feb 15;14:537-546. doi: 10.2147/NDT.S158395. eCollection 2018.
Results Reference
derived

Learn more about this trial

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

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