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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

October 29, 2012
August 4, 2014
November 2012
September 2013   (final data collection date for primary outcome measure)
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.
Binge Days Per Week [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01718483 on ClinicalTrials.gov Archive Site
  • 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.
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 4-Week Cessation From Binge Eating Behavior [ Time Frame: Last 28 days prior to final visit ] [ Designated as safety issue: No ]
  • Body Weight [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Triglyceride Levels [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Cholesterol Levels [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Glycosolated Hemoglobin (HbA1c) Levels [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Binge Episodes Per Week [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 1-Week Cessation From Binge Eating Behavior [ Time Frame: last 7 days prior to visit ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Eating Inventory Score (also known as the Three-Factor Eating Questionnaire) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Binge Eating Scale (BES) Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Frontal Systems Behavior Score (FrSBe) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Amphetamine Cessation Symptom Assessment (ACSA) Total Score [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Binge Eating Disorder
  • 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
  • Experimental: SPD489 (Lisdexamfetamine dimesylate)
    Intervention: Drug: SPD489 (Lisdexamfetamine dimesylate)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
383
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Spain,   Sweden
 
NCT01718483
SPD489-343, 2012-003309-91
No
Shire
Shire
Not Provided
Principal Investigator: Susan McElroy, MD University of Cincinnati
Shire
August 2014

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