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

This study is currently recruiting participants.
Verified May 2013 by Shire Development LLC
Sponsor:
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01718509
First received: October 29, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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 ]

Estimated Enrollment: 356
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718509

Contacts
Contact: Shire Call Center 1-866-842-5335

  Show 47 Study Locations
Sponsors and Collaborators
Shire Development LLC
Investigators
Principal Investigator: Susan McElroy, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Shire Development LLC
ClinicalTrials.gov Identifier: NCT01718509     History of Changes
Other Study ID Numbers: SPD489-344
Study First Received: October 29, 2012
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Binge-Eating Disorder
Eating Disorders
Bulimia
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 May 16, 2013