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

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Binge Eating Disorder

Intervention: Lisdexamfetamine dimesylate (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
James I Hudson, MD, ScD, Principal Investigator, Affiliation: Mclean Hospital

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to Relapse of Binge Eating

Secondary outcome:

Number of Binge-Eating Days Per Week

Clinical Global Impression-Severity of Illness (CGI-S) Scale

Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE)

EuroQuol Questionnaire (EQ-5D-5L)

Columbia-Suicide Severity Rating Scale (C-SSRS)

Amphetamine Cessation Symptom Assessment (ACSA)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

EMOVIS GmbH - Klinische Forschung, Berlin 10629, Germany

Klinische Forschung Berlin-Mitte GmbH, Berlin 10117, Germany

Klinische Forschung Dresden GmbH, Dresden 01069, Germany

Klinische Forschung Hannover-Mitte GmbH, Hannover 30159, Germany

Forschung Schwerin GmbH, Friedrichstrasse 1, Schwerin 19055, Germany

Studienzentrum Nordwest, Westerstede 26655, Germany

Hospital de la Santa Creu I Sant Pau, Barcelona 08025, Spain

Hospital del Henares, Madrid 28822, Spain

Hospital Universitario Infanta Leonor, Madrid 28031, Spain

Lakarmottagningen Ekdahl & Kronberg, Malmo 211 52, Sweden

Stockholm Center for Eating Disorders, Stockhold 118 50, Sweden

Sofiahemmet, Stockholm 114 86, Sweden

Gulfcoast Clinical Research Center, Fort Myers, Florida 33912, United States

Innovative Clinical Research, Inc, Lauderhill, Florida 33319, United States

Compass Research LLC North Clinic, Leesburg, Florida 34748, United States

Florida Clinical Research Center, LLC, Maitland, Florida 32751, United States

Scientific Clinical Research, Inc, North Miami, Florida 33161, United States

Clinical Neuroscience Solutions, Inc, Orlando, Florida 32806, United States

Miami Research Associates, South Miami, Florida 33143, United States

NeuroTrials Research, Inc, Atlanta, Georgia 30342, United States

Capstone Clinical Research, Libertyville, Illinois 60048, United States

Goldpoint Clinical Research, Indianapolis, Indiana 46260, United States

Clinical Trials Technology, Inc, Prairie Village, Kansas 66206, United States

Cypress Medical Research Center, Wichita, Kansas 67226, United States

Louisiana Research Associates, Inc, New Orleans, Louisiana 70114, United States

McLean Hospital, Belmont, Massachusetts 02478, United States

Boston Clinical Trials, Boston, Massachusetts 02131, United States

Adams Clinical Trials, LLC, Watertown, Massachusetts 02472, United States

Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States

HBSA-Pacific Institute for Research & Evaluation, Albuquerque, New Mexico 87102, United States

Brooklyn Medical Institute, Brooklyn, New York 11214, United States

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States

Community Research, Cincinnati, Ohio 45227, United States

Patient Priority Clinical Sites, LLC, Cincinnati, Ohio 45215, United States

Midwest Clinical Research Center, Dayton, Ohio 45417, United States

Linder Center of Hope, Mason, Ohio 45040, United States

Anxiety and Mood Disorder Center, Mississauga, Ontario L5< 4N4, Canada

Oregon Center for Clinical Investigations, Inc (OCCI, Inc), Portland, Oregon 97214, United States

Oregon Center for Clinical Investigations, Inc (OCCI, Inc), Salem, Oregon 97301, United States

Lehigh Center for Clinical Research, Allentown, Pennsylvania 18104, United States

Manna Research, Pointe Claire, Quebec H9R 4S3, Canada

Omega Medical Research, Warwick, Rhode Island 02886, United States

Radiant Research, Inc, Anderson, South Carolina 29621, United States

Radiant Research, Inc, Greer, South Carolina 29650, United States

Coastal Carolina Research Center, Mount Pleasant, South Carolina 29464, United States

Clinical Neuroscience Solution, Inc, Memphis, Tennessee 38119, United States

FutureSearch Clinical Trials, LP, Austin, Texas 78731, United States

FutureSearch Trials of Dallas, LP, Dallas, Texas 75231, United States

Texas Center for Drug Development, Inc, Houston, Texas 77081, United States

Research Across America, Plano, Texas 75093, United States

Radiant Research, Inc, San Antonio, Texas 78229, United States

Northwest Clinical Research Center, Bellevue, Washington 98007, United States

Summit Research Network (Seattle) LLC, Seattle, Washington 98104, United States

Additional Information

Starting date: January 2014
Last updated: April 27, 2015

Page last updated: August 23, 2015

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