Trial record 2 of 6 for:    Lisdexamfetamine binge eating

Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder (BED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01291173
First received: February 4, 2011
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week


Condition Intervention Phase
Binge Eating Disorder
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in Log Transformed Binge Days Per Week at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    Binge day is defined as a day during which at least 1 binge episode occurs.


Secondary Outcome Measures:
  • Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks [ Time Frame: Baseline and up to 11 weeks ] [ Designated as safety issue: No ]
    The number of binge episodes per week as assessed by clinical interview based on subject diary.

  • 1-Week Binge Response, Last Observation Carried Forward (LOCF) [ Time Frame: Last 7 days on study ] [ Designated as safety issue: No ]
    The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.

  • 4-Week Binge Response, Last Observation Carried Forward [ Time Frame: Last 28 days on study ] [ Designated as safety issue: No ]
    Subjects are free from binge episodes for 4 weeks.

  • Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  • Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks [ Time Frame: Up to 11 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.

  • Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    The YBOCS-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. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.

  • Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.

  • Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.

  • Change From Baseline in Eating Inventory Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.

  • Change From Baseline in Binge Eating Scale (BES) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.

  • Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.

  • Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).


Enrollment: 271
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD489 30 mg Drug: lisdexamfetamine dimesylate (SPD489)
SPD489-30mg capsules taken once daily for up to 11 weeks
Other Name: LDX, Vyvanse
Experimental: SPD489 50 mg Drug: lisdexamfetamine dimesylate (SPD489)
SPD489 50mg capsules taken once-daily for up to 11 weeks
Other Name: LDX, Vyvanse
Experimental: SPD489 70 mg Drug: lisdexamfetamine dimesylate (SPD489)
SPD489 70mg capsule taken once-daily for up to 11 weeks
Other Name: LDX, Vyvanse
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule taken once daily for up to 11 weeks

  Eligibility

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

Inclusion

  • Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED).
  • Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.
  • Subject has a body mass index (BMI) of >24 and <46.

Exclusion

  • Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
  • Subject is considered a suicide risk or risk to harm others.
  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: NCT01291173

  Show 31 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Susan McElroy, MD University of Cincinnati College of Medicine Lindner Ctr of HOPE
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01291173     History of Changes
Other Study ID Numbers: SPD489-208
Study First Received: February 4, 2011
Results First Received: October 26, 2012
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014