Trial record 3 of 6 for:    Lisdexamfetamine binge eating

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01718483
First received: October 29, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Binge Eating Disorder
Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]
  • Binge Eating Response [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Eating Inventory Scores at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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): Usual Activities [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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): Pain/Discomfort [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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): Anxiety/Depression [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 383
Study Start Date: November 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD489 (Lisdexamfetamine dimesylate) Drug: SPD489 (Lisdexamfetamine dimesylate)
50 or 70 mg administered orally, once-daily for up to 12 weeks
Other Name: Vyvanse, Venvanse, LDX
Placebo Comparator: Placebo Drug: Placebo
Administered once-daily, orally, for up to 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718483

  Hide Study Locations
Locations
United States, Alabama
Birmingham Research Group
Birmingham, Alabama, United States, 35216
United States, Arkansas
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72211
United States, California
Trimed Clinical Trials
Corona, California, United States, 92880
Pharmacology Research Institute
Encino, California, United States, 91316
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pacific Research Partners, LLC
Oakland, California, United States, 94812
Research Across America
Santa Ana, California, United States, 92705
United States, Colorado
Western Affiliated Research Institute, Inc.
Denver, Colorado, United States, 80209
United States, Florida
Gulfcoast Clinical Research
Fort Myers, Florida, United States, 33912
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
Compass Research LLC
Leesburg, Florida, United States, 34748
Scientific Clinical Research Inc.
North Miami, Florida, United States, 33161
United States, Illinois
Uptown Research Institute
Chicago, Illinois, United States, 60640
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States, 60169
AMR Baber Research, Inc.
Naperville, Illinois, United States, 60563
United States, Indiana
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States, 46260
United States, Kansas
Cypress Medical Research Center, LLC
Wichita, Kansas, United States, 67226
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
United States, Missouri
St. Charles Psychiatric Associates/Midwest Research Group
St. Charles, Missouri, United States, 63304
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, New Mexico
Pacific Research for Research and Evaluation
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45227
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States, 45417
North Star Medical Research
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States, 97301
United States, Pennsylvania
The Clinical Trials Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Radiant Research, Inc.
Anderson, South Carolina, United States, 29621
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Future Search Trials
Austin, Texas, United States, 78731
Futuresearch Trials of Dallas, L.P.
Dallas, Texas, United States, 75231
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Utah
Radiant Research, Inc.
Murray, Utah, United States, 84123
United States, Vermont
Neuropsychiatric Associates, LLC
Woodstock, Vermont, United States, 05091
United States, Virginia
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Alliance Research Group
Richmond, Virginia, United States, 23230
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
United States, Wisconsin
Dean Foundation for Health, Research and Educations, Inc.
Middleton, Wisconsin, United States, 53562
Germany
Ernovis GmbH
Berlin, Germany, 10629
Klinische Forschung Dresden GmbH
Dresden, Germany, 01069
Studienzentrum Nordwest, Gemeinschaftspraxis
Westerstede, Germany, 26655
Spain
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Sweden
Lakarmottagning Ekdahl & Kronberg
Malmo, Sweden, 22152
Stockholm Center for Eating Disorders
Stockholm, Sweden, 11850
Sophiahemmet
Stockholm, Sweden, 11486
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Susan McElroy, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01718483     History of Changes
Other Study ID Numbers: SPD489-343, 2012-003309-91
Study First Received: October 29, 2012
Results First Received: March 18, 2014
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014