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.
Verified March 2014 by Shire
Information provided by (Responsible Party):
First received: December 6, 2013
Last updated: March 5, 2014
Last verified: March 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.
Binge Eating Disorder
Drug: Lisdexamfetamine dimesylate
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2015 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject is between 18-55 years of age, inclusive.
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.
- Subject is consistently able to swallow a capsule.
- Subject has current diagnosis of bulimia nervosa or anorexia nervosa.
- Subject is receiving psychotherapy or weight loss support within the past 3 months.
- Subject has used psychostimulants to facilitate fasting or dieting within the past 6 months.
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease.
- Subject has abnormal thyroid function.
- Subject initiated treatment with a lipid lowering medication within the past 3 months.
- Subject has a history of moderate or severe hypertension.
- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder.
- Subject has glaucoma.
- Subject is female and pregnant or nursing.
- Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009163
|Contact: Shire Call Center
||James I Hudson, MD, ScD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 6, 2013
||March 5, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Signs and Symptoms, Digestive
Signs and Symptoms
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents