Last updated on February 2018

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


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

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LeeAnn Kelley, MD

NoesisPharma, LLC
Phoenix, AZ United States

Brock Summers, MD

Southern California Research
Beverly Hills, CA United States

Daniel Grosz, MD

Pharmacology Research Institute
Encino, CA United States

David Walling, PhD

Collaborative NeuroScience Network, LLC
Garden Grove, CA United States

Don DeFrancisco, MD

Pharmacology Research Institute
Newport Beach, CA United States

Michael McManus, MD

PCSD- Feighner Research
San Diego, CA United States

Ildiko Kovacs, MD

Artemis Institute for Clinical Research
San Marcos, CA United States

John Duffy, MD

Syrentis Clinical Research
Santa Ana, CA United States

Andrew Sedillo, MD

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

David Weiss

Lytle and Weiss PLLC
Denver, CO United States

C. Brendan Montano, MD

Connecticut Clinical Research
Cromwell, CT United States

John Prater, DO

Gulfcoast Clinical Research Center
Fort Myers, FL United States

John Joyce, MD

Clinical Neuroscience Solutions, Inc.
Jacksonville, FL United States

Americo Padilla, MD

Miami Research Associates
South Miami, FL United States

Angelo Sambunaris, MD

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

Russell Rosenberg, MD

Neurotrials Research, Inc.
Atlanta, GA United States

Michael Banov, MD

Northwest ehavioral Research Center
Marietta, GA United States

Michael Greenbaum, MD

Capstone Clinical Research
Libertyville, IL United States

Jeffrey Davis, MD

Prairie Health and Wellness
Wichita, KS United States

Irina Mezhebovsky, MD

Boston Clinical Trials
Boston, MA United States

Michael McCartney, MD

ActivMed Practices and Research, Inc
Methuen, MA United States

Daniel Rutrick, MD

Adams Clinical Trials, LLC
Watertown, MA United States

Greg Mattingly, MD

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

Marc Shay, MD

ActivMed Practice and Research, Inc
Portsmouth, NH United States

Leon Rosenberg, MD

Center for Emotional Fitness
Cherry Hill, NJ United States

David Krakow, MD

Bioscience Research, LLC
Mount Kisco, NY United States

Judith Joseph, MD

Manhattan Behavior Medicine
New York, NY United States

Michael Liebowitz, MD

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

Wayne Harper, MD

Wake Research Associates
Raleigh, NC United States

Margaret Rhee, MD

Radient Research
Akron, OH United States

Janell Lundgren, MD

Patient Priority Clinical Sites, LLC
Cincinnati, OH United States

Otto Dueno, MD

Midwest Clinical Research Center
Dayton, OH United States

Susan McElroy, MD

Linder Center of Hope
Mason, OH United States

Beal Essink, MD

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

Drissana Tran, MD

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

Paul Gross, MD

Lehigh Center for Clinical Research
Allentown, PA United States

William Ellison, MD

Radiant Research
Greer, SC United States

Paul Robbins, MD

Costal Carolina Research Center
Mount Pleasant, SC United States

Lora McGill, MD

Clinical Neuroscience Solutions, Inc.
Memphis, TN United States

Stephan Sharp, MD

Clinical Research Associates, Inc
Nashville, TN United States

Donald Garcia, MD,PA

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

Shonna Piegari, MD

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

Scott Bartley, MD

Pillar Clinical Research
Richardson, TX United States

Jason Miller, DO

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

William Jennings, MD

Radiant Research, Inc.
San Antonio, TX United States

Mark Johnston, MD

Radiant Research, Inc.
Murray, UT United States

Alicia Groft, MD

Neuropsychiatric Associates
Woodstock, VT United States

Mikel Thomas, MD

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

James Hudson, MD

McLean Hospital Harvard Medical School
Belmont, MA United States

Joel Young, MD

Rocheser Center for Behavioral Medicine
Rochester Hills, MI United States