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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01718509
Recruitment Status : Completed
First Posted : October 31, 2012
Results First Posted : August 21, 2014
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE October 29, 2012
First Posted Date  ICMJE October 31, 2012
Results First Submitted Date  ICMJE July 17, 2014
Results First Posted Date  ICMJE August 21, 2014
Last Update Posted Date November 30, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 [ Time Frame: Baseline and 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
Binge Days Per Week [ Time Frame: up to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2014)
  • Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: Up to 12 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.
  • Percent of Participants With a 4-Week Cessation From Binge Eating [ Time Frame: Up to 12 weeks ]
    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 [ Time Frame: Baseline and week 12 ]
  • Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ]
  • Binge Eating Response [ Time Frame: Up to 12 weeks ]
    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 [ Time Frame: Baseline and Visit 8 Which Spans Weeks 11/12 ]
  • Change From Baseline in Eating Inventory Scores at Week 12 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Up to 12 weeks ]
    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 [ Time Frame: Up to 12 weeks ]
  • EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities [ Time Frame: Up to 12 weeks ]
  • EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort [ Time Frame: Up to 12 weeks ]
  • EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression [ Time Frame: Up to 12 weeks ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 12 weeks ]
    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.
  • Amphetamine Cessation Symptom Assessment (ACSA) Total Score [ Time Frame: Up to 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 12 weeks ]
  • 4-Week Cessation From Binge Eating Behavior [ Time Frame: last 28 days prior to final visit ]
  • Body weight [ Time Frame: up to 12 weeks ]
  • Triglyceride levels [ Time Frame: up to 12 weeks ]
  • Cholesterol levels [ Time Frame: up to 12 weeks ]
  • Glycosolated Hemoglobin (HbA1c) Levels [ Time Frame: up to 12 weeks ]
  • Binge Episodes Per Week [ Time Frame: up to 12 weeks ]
  • 1-Week Cessation From Binge Eating Behavior [ Time Frame: last 7 days prior to visit ]
  • Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Score [ Time Frame: up to 12 weeks ]
  • Eating Inventory Score (also known as the Three-Factor Eating Questionnaire) [ Time Frame: Up to 12 weeks ]
  • Binge Eating Scale (BES) Score [ Time Frame: Up to 12 weeks ]
  • Frontal Systems Behavior Score (FrSBe) [ Time Frame: Up to 12 weeks ]
  • EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) [ Time Frame: Up to 12 weeks ]
  • Amphetamine Cessation Symptom Assessment (ACSA) Total Score [ Time Frame: Up to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Binge Eating Disorder
Intervention  ICMJE
  • Drug: SPD489 (Lisdexamfetamine dimesylate)
    50 or 70 mg administered orally, once-daily for up to 12 weeks
    Other Name: Vyvanse, Venvanse, LDX
  • Drug: Placebo
    Administered once-daily, orally, for up to 12 weeks
Study Arms  ICMJE
  • Experimental: SPD489 (Lisdexamfetamine dimesylate)
    Intervention: Drug: SPD489 (Lisdexamfetamine dimesylate)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2013)
390
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2012)
356
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01718509
Other Study ID Numbers  ICMJE SPD489-344
2012-003310-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan McElroy, MD University of Cincinnati
PRS Account Shire
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP