Last updated on June 2018

A Phase 3 clinical study for patients with Binge eating

Brief description of study

A study to evaluate a drug (dasotraline) on the safety, effectiveness and how well the body tolerates it, in adults with moderate to severe binge eating disorder

Detailed Study Description

This is a randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of 2 doses of dasotraline (4 and 6 mg/day) versus placebo over a 12-week treatment period in adults with BED. This study is projected to randomize approximately 480 subjects to 3 treatment groups in a 1:1:1 ratio (4 mg/day dasotraline, 6 mg/day dasotraline, and placebo).

Subjects randomized to placebo will receive placebo for the duration of the treatment period.

Subjects randomized to 4 mg/day dasotraline will receive 4 mg/day for the duration of the treatment period.

Subjects randomized to 6 mg/day dasotraline will be dosed with 4 mg/day dasotraline for the first 2 weeks of the treatment period and will be increased to 6 mg/day at Week 2.

If, in the judgment of the Investigator, the subject does not tolerate the assigned dose, he or she will be discontinued from the study.

The study will consist of 3 periods: Screening (up to 3 weeks), 12-weeks of treatment, and a 3-week study drug withdrawal period. Subjects who complete the 12-week double-blind treatment period in this study may be eligible to enroll and continue treatment for an additional 12 months in an open-label extension study (Study SEP360-322). Subjects who do not enter the extension study will complete the study drug withdrawal period in this study.

Clinical Study Identifier: NCT03107026

Contact Investigators or Research Sites near you

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NoesisPharma, LLC
Phoenix, AZ United States

Southern California Research
Beverly Hills, CA United States

Pharmacology Research Institute
Encino, CA United States

Collaborative NeuroScience Network, LLC
Garden Grove, CA United States

Pharmacology Research Institute
Newport Beach, CA United States

PCSD- Feighner Research
San Diego, CA United States

Artemis Institute for Clinical Research
San Marcos, CA United States

Syrentis Clinical Research
Santa Ana, CA United States

MCB Clinical Research Centers, LLC
Colorado Springs, CO United States

Lytle and Weiss PLLC
Denver, CO United States

Connecticut Clinical Research
Cromwell, CT United States

Gulfcoast Clinical Research Center
Fort Myers, FL United States

Clinical Neuroscience Solutions, Inc.
Jacksonville, FL United States

Miami Research Associates
South Miami, FL United States

Institute for Advanced Medical Research at Mercer University
Atlanta, GA United States

Neurotrials Research, Inc.
Atlanta, GA United States

Northwest ehavioral Research Center
Marietta, GA United States

Capstone Clinical Research
Libertyville, IL United States

Prairie Health and Wellness
Wichita, KS United States

Boston Clinical Trials
Boston, MA United States

ActivMed Practices and Research, Inc
Methuen, MA United States

Adams Clinical Trials, LLC
Watertown, MA United States

Midwest Research Group - St. Charles Psychiatric Associates
Saint Charles, MO United States

ActivMed Practice and Research, Inc
Portsmouth, NH United States

Center for Emotional Fitness
Cherry Hill, NJ United States

Bioscience Research, LLC
Mount Kisco, NY United States

Manhattan Behavior Medicine
New York, NY United States

The Medical Research Network, LLC
New York, NY United States

Wake Research Associates
Raleigh, NC United States

Radient Research
Akron, OH United States

Patient Priority Clinical Sites, LLC
Cincinnati, OH United States

Midwest Clinical Research Center
Dayton, OH United States

Linder Center of Hope
Mason, OH United States

Oregon Center for Clinical Investigations, Inc.
Portland, OR United States

Oregon Center for Clinical Investigations, Inc.
Salem, OR United States

Lehigh Center for Clinical Research
Allentown, PA United States

Radiant Research
Greer, SC United States

Costal Carolina Research Center
Mount Pleasant, SC United States

Clinical Neuroscience Solutions, Inc.
Memphis, TN United States

Clinical Research Associates, Inc
Nashville, TN United States

Donald J. Garcia, MD, PA
Austin, TX United States

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

Pillar Clinical Research
Richardson, TX United States

Clinical Trials of Texas, Inc
San Antonio, TX United States

Radiant Research, Inc.
San Antonio, TX United States

Radiant Research, Inc.
Murray, UT United States

Neuropsychiatric Associates
Woodstock, VT United States

Phoenix Medical Research, Inc.
Prairie Village, KS United States

McLean Hospital Harvard Medical School
Belmont, MA United States

Rocheser Center for Behavioral Medicine
Rochester Hills, MI United States

Recruitment Status: Closed

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