Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT02009163
First received: December 6, 2013
Last updated: June 4, 2014
Last verified: May 2014
  Purpose

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, 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 and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.


Condition Intervention Phase
Binge Eating Disorder
Drug: Lisdexamfetamine dimesylate
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy 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:
  • Time to Relapse of Binge Eating [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Binge-Eating Days Per Week [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Severity of Illness (CGI-S) Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • EuroQuol Questionnaire (EQ-5D-5L) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Amphetamine Cessation Symptom Assessment (ACSA) [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 412
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisdexamfetamine dimesylate
Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM.
Drug: Lisdexamfetamine dimesylate
Other Name: SPD489, LDX
Placebo Comparator: Placebo
Administer one capsule orally daily at approximately 7:00 AM.
Other: Placebo

  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, inclusive.
  2. Subject meets the following 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 is consistently able to swallow a capsule.

Exclusion Criteria:

  1. Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
  2. Subject is receiving psychotherapy or weight loss support within the past 3 months.
  3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
  4. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
  5. Subject has abnormal thyroid function.
  6. Subject initiated treatment with a lipid lowering medication within the past 3 months.
  7. Subject has a history of moderate or severe hypertension.
  8. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
  9. Subject has glaucoma.
  10. Subject is female and pregnant or nursing.
  11. Subjects who have 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: NCT02009163

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

  Show 53 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: James I Hudson, MD, ScD Mclean Hospital
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02009163     History of Changes
Other Study ID Numbers: SPD489-346
Study First Received: December 6, 2013
Last Updated: June 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
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 July 28, 2014