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: September 20, 2013
Last verified: September 2013
  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:
  • Binge Days Per Week [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 383
Study Start Date: November 2012
Study Completion Date: September 2013
Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718483

  Show 50 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: NCT01718483     History of Changes
Other Study ID Numbers: SPD489-343
Study First Received: October 29, 2012
Last Updated: September 20, 2013
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
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014