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

Completed · Phase 3 · Has a placebo group

Conditions studied: Binge Eating Disorder

In brief

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.

Key facts

Study ID

NCT02009163

Run by

Shire

People needed

418

Starts

2014-01-27

Expected to finish

2015-04-08

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Innovative Clinical Research, Inc — Lauderhill, Florida, United States
• Compass Research LLC North Clinic — Leesburg, Florida, United States
• Florida Clinical Research Center, LLC — Maitland, Florida, United States
• Scientific Clinical Research, Inc — North Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• NeuroTrials Research, Inc — Atlanta, Georgia, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Goldpoint Clinical Research — Indianapolis, Indiana, United States
• Clinical Trials Technology, Inc — Prairie Village, Kansas, United States
• Cypress Medical Research Center — Wichita, Kansas, United States
• Louisiana Research Associates, Inc — New Orleans, Louisiana, United States
• McLean Hospital — Belmont, Massachusetts, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Adams Clinical Trials, LLC — Watertown, Massachusetts, United States
• Rochester Center for Behavioral Medicine — Rochester Hills, Michigan, United States
• HBSA-Pacific Institute for Research & Evaluation — Albuquerque, New Mexico, United States
• Brooklyn Medical Institute — Brooklyn, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Patient Priority Clinical Sites, LLC — Cincinnati, Ohio, United States
• Community Research — Cincinnati, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Linder Center of Hope — Mason, Ohio, United States
• Oregon Center for Clinical Investigations, Inc (OCCI, Inc) — Portland, Oregon, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States

Full record on ClinicalTrials.gov

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