Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
533 participants
INTERVENTIONAL
2016-02-29
2019-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dasotraline
4, 6, 8 mg flexibly dosed
Dasotraline
Dasotraline 4, 6, 8 mg flexibly dosed once daily
Interventions
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Dasotraline
Dasotraline 4, 6, 8 mg flexibly dosed once daily
Eligibility Criteria
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Inclusion Criteria
* Subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator.
* Subject has not taken any medication other than the study drug for the purpose of controlling BED symptoms during the core study.
* Female subject must have a negative urine pregnancy test at open label (OL) Baseline; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
* Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control (see Section 22, Appendix III) throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
* Subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment.
* Subject can read well enough to understand the informed consent form and other subject materials.
Exclusion Criteria
* Subject is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months.
* Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at OL Baseline. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
* Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
* Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
* Subject is breastfeeding.
* Subject is at high risk of non-compliance in the investigator's opinion.
18 Years
56 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dasotraline Medical Director
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Noesis Parma
Phoenix, Arizona, United States
Southern California Research
Beverly Hills, California, United States
Pharmacology Research Institute
Encino, California, United States
Collaborative NeuroScience Network Inc.
Garden Grove, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States
Weiss and Lytle, PLLC
Denver, Colorado, United States
CT Clinical Research
Cromwell, Connecticut, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Institute of Advanced Medical Research
Alpharetta, Georgia, United States
Neuotrials Research, Inc.
Atlanta, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Goldpoint Clinical Research, Inc.
Indianapolis, Indiana, United States
Phoenix Medical Research, Inc. Suite 135
Prairie Village, Kansas, United States
Cyress Medical Research Center, LLC
Wichita, Kansas, United States
McLean Hospital
Belmont, Massachusetts, United States
Boston Clinical Trials
Boston, Massachusetts, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Princeton Medical Institute, LCC
Princeton, New Jersey, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Radiant Research, Inc.
Akron, Ohio, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Lindner Center Of Hope
Mason, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Oregon Center for Clinical Investigatons, INC.
Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Radient Research, Inc.
Greer, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solutons, Inc.
Memphis, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Donald J. Garcia Jr., MD
Austin, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Psychiatric Medical Associates
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Radient Research, Inc.
San Antonio, Texas, United States
Radiant Research, Inc.
Murray, Utah, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Summitt Research Network(Seattle) LLC
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SEP360-322
Identifier Type: -
Identifier Source: org_study_id
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