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:
NCT01718509
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 SPD489-344, 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

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 Up to 12 Weeks [ Time Frame: Baseline and up to 12 weeks ] [ 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 ]
  • EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • 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: 390
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

Detailed Description:

Not Required

  Eligibility

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

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.
  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: NCT01718509

  Show 48 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Susan McElroy, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01718509     History of Changes
Other Study ID Numbers: SPD489-344, 2012-003310-14
Study First Received: October 29, 2012
Results First Received: July 17, 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 27, 2014