Dasotraline Binge Eating Disorder Extension Study

NCT02684279 | Completed Phase 3 Results DMC

• 1 other identifier: SEP360-322
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 57

Brief Summary

Binge Eating Disorder Extension Study.

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (2)

• Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)

  Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior

  Baseline to Week 52

• Frequency and Severity of Suicidal Behavior Using the C-SSRS

  Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior

  Baseline to Week 52

Secondary Outcomes (18)

• Change in Body Weight

  Baseline, Week 52

• Percent Change in Body Weight (kg)

  Baseline, Week 52

• Change in Body Mass Index

  Baseline, Week 52

• Percent Change in Body Mass Index (kg/m^2)

  Baseline, Week 52

• Change in Fasting Lipid Panel, Triglyceride's

  Baseline, Week 52

Study Arms (1)

Dasotraline

EXPERIMENTAL

4, 6, 8 mg flexibly dosed

Drug: Dasotraline

Interventions

Dasotraline DRUG

Dasotraline 4, 6, 8 mg flexibly dosed once daily

Dasotraline

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completion of the treatment period of a dasotraline core study (ie, SEP360 221 or SEP360-321) for the treatment of BED.
• 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.

You may not qualify if:

• Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (57)

Noesis Parma

Phoenix, Arizona, 85032, United States

Location

Southern California Research

Beverly Hills, California, 90210, United States

Location

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Collaborative NeuroScience Network Inc.

Garden Grove, California, 92845, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Weiss and Lytle, PLLC

Denver, Colorado, 80209*, United States

Location

CT Clinical Research

Cromwell, Connecticut, 06416, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Institute of Advanced Medical Research

Alpharetta, Georgia, 30005, United States

Location

Neuotrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Goldpoint Clinical Research, Inc.

Indianapolis, Indiana, 46260, United States

Location

Phoenix Medical Research, Inc. Suite 135

Prairie Village, Kansas, 66208, United States

Location

Cyress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, 01844, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, 03801, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Princeton Medical Institute, LCC

Princeton, New Jersey, 08540, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Manhattan Behavioral Medicine, PLLC

New York, New York, 10036, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Patient Priority Clinical Sites

Cincinnati, Ohio, 45215, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Lindner Center Of Hope

Mason, Ohio, 45040, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

Oregon Center for Clinical Investigatons, INC.

Portland, Oregon, 97214, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

Lehigh Center For Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Radiant Research, Inc.

Anderson, South Carolina, 29621, United States

Location

Radient Research, Inc.

Greer, South Carolina, 29650, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutons, Inc.

Memphis, Tennessee, 38119, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Donald J. Garcia Jr., MD

Austin, Texas, 78737, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Psychiatric Medical Associates

Plano, Texas, 75023, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Radient Research, Inc.

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

Murray, Utah, 84123, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

NeuroScience, Inc.

Herndon, Virginia, 20170, United States

Location

Summitt Research Network(Seattle) LLC

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

ClinicalTrialDisclosure@sunovion.com

1-866-503-6351

Study Officials

• Dasotraline Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 17, 2016
• Study Start: February 29, 2016
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-07

Locations

US (57)