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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:

The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:

  1. Subject is between 18-55 years of age.
  2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
  3. Subject has a BED diagnosis.
  4. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
  5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.

Exclusion Criteria:

Subjects are excluded from the study if any of the following exclusion criteria are met:

  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.
  3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
  4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
  5. Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
  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 a history of moderate or severe hypertension.
  8. Subject is female and pregnant or nursing.
  9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Sites / Locations

  • Radiant Research, Inc.
  • Southern California Research, LLC
  • Scripps Clinical Research Services
  • Pharmacology Research Institute
  • Excel Research, Inc.
  • PCSD - Feighner Research
  • Radiant Research, Inc.
  • Florida Clinical Research Center, LLC
  • Florida Clinical Research Center, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Miami Research Associates
  • NeuroTrials Research, Inc.
  • Capstone Clinical Research
  • American Medical Research
  • Deaconess Clinic Gateway Health Center
  • Clinical Trials Technology, Inc.
  • Louisiana Research Associates, Inc.
  • Potomac Grove Clinical Research Center
  • Boston Clinical Trials
  • Activmed Practices and Research
  • Adams Clinical Trials, LLC
  • Rochester Center for Behavioral Medicine
  • UMN Medical School, Dept of Psychiatry
  • Scientella, LLA
  • Robert Lynn Horne, MD, LTD
  • Global Medical Inst LLC; Princeton Medical Institute
  • Bioscience Research, LLC
  • CNS Clinica at the Brain Resource Center
  • Radiant Research, Inc.
  • Patient Priority Clinical Sites, LLC
  • The Craig and Frances Lindner Center of Hope
  • Clinical Trials of America, Inc.
  • Sunstone Medical Research, LLC
  • Oregon Center for Clinical Investigators (OCCI, Inc)
  • Lehigh Center for Clinical Research
  • CRI Lifetree
  • Omega Medical Reserach
  • Radiant Research, Inc.
  • Clinical Research Associates, Inc.
  • Texas Center for Drug Development, Inc.
  • Psychiatric Medical Associates
  • Radiant Research, Inc.
  • Advanced Research Institute
  • NeuroScience, Inc.
  • Summit Research Network (Seattle), LLC
  • Klinische Forschung Berlin-Mitte GmbH
  • Klinische Forschung Berlin Buch GmbH
  • Klinische Forschung Schwerin GmbH

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 Which Spans Weeks 11/12
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.

Secondary Outcome Measures

Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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.
Percent 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 (kg) 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. 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 Which Spans Weeks 11/12
Change From Baseline in Eating Inventory Scores at Week 12
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 subject has greater control over eating behavior and 4 denoting that a subject 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 Up to 12 Weeks
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. Subjects 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.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurence, 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.
Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.
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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.

Full Information

First Posted
October 29, 2012
Last Updated
June 24, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01718509
Brief Title
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Official Title
The SPD489-344, 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
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2012 (Actual)
Primary Completion Date
September 20, 2013 (Actual)
Study Completion Date
September 20, 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
Detailed Description
Not Required

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
390 (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 Which Spans Weeks 11/12
Description
Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
Time Frame
Baseline and Visit 8 Which Spans Weeks 11/12
Secondary Outcome Measure Information:
Title
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
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 12 weeks
Title
Percent 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 (kg) 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 up to 12 weeks
Title
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Time Frame
Baseline and up to 12 weeks
Title
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Time Frame
Baseline and up to 12 weeks
Title
Binge Eating Response
Description
Response is based on the reduction in the number of binge eating episodes. 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
Up to 12 weeks
Title
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
Time Frame
Baseline and Visit 8 Which Spans Weeks 11/12
Title
Change From Baseline in Eating Inventory Scores at Week 12
Description
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 subject has greater control over eating behavior and 4 denoting that a subject 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 Up to 12 Weeks
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. Subjects 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 up to 12 weeks
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.
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Time Frame
Up to 12 weeks
Title
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
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 occurence, 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.
Time Frame
Up to 12 weeks
Title
Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.
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. Calculated as Baseline (Day 0) - Week 12 ACSA scores.
Time Frame
Baseline and Week 12

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: The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met: Subject is between 18-55 years of age. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED: Subject has a BED diagnosis. Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements. Exclusion Criteria: Subjects are excluded from the study if any of the following exclusion criteria are met: 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. Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD. Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. 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 a history of moderate or severe hypertension. Subject is female and pregnant or nursing. Subject has 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
Radiant Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Southern California Research, LLC
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
Excel Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
PCSD - Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
American Medical Research
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Deaconess Clinic Gateway Health Center
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
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
Potomac Grove Clinical Research Center
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Activmed Practices and Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Adams Clinical Trials, LLC
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Rochester Center for Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
UMN Medical School, Dept of Psychiatry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Scientella, LLA
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Robert Lynn Horne, MD, LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Global Medical Inst LLC; Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Bioscience Research, LLC
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
CNS Clinica at the Brain Resource Center
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
The Craig and Frances Lindner Center of Hope
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Center for Clinical Investigators (OCCI, Inc)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
CRI Lifetree
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Omega Medical Reserach
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Psychiatric Medical Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
NeuroScience, Inc.
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Summit Research Network (Seattle), LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany

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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