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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 6, 2013
Last updated: April 27, 2015
Last verified: August 2014
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 ]

Enrollment: 148
Study Start Date: January 2014
Study Completion Date: April 2015
Primary Completion Date: March 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


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

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02009163

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Sponsors and Collaborators
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  2012-004457-88 
Study First Received: December 6, 2013
Last Updated: April 27, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Binge-Eating Disorder
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
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 February 11, 2016