Clinical trial NCT02684279: Dasotraline Binge Eating Disorder Extension Study
Official title: An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Binge Eating Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-17
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Binge Eating Disorder Extension Study.

Detailed description: This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to Week 52
measure: Frequency and Severity of Suicidal Behavior Using the C-SSRS
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, Week 52
measure: Percent Change in Body Weight (kg)
timeFrame: Baseline, Week 52
measure: Change in Body Mass Index
timeFrame: Baseline, Week 52
measure: Percent Change in Body Mass Index (kg/m^2)
timeFrame: Baseline, Week 52
measure: Change in Fasting Lipid Panel, Triglyceride's
timeFrame: Baseline, Week 52
measure: Change in Fasting Lipid Panel , Total Cholesterol
timeFrame: Baseline, Week 52
measure: Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
timeFrame: Baseline, Week 52
measure: Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
timeFrame: Baseline, Week 52
measure: Change in Hemoglobin A1c Levels
timeFrame: Baseline, Week 52
measure: Change in Fasting Glucose Levels
timeFrame: Baseline, Week 52
measure: Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores
timeFrame: Baseline, Week 52
measure: Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores
timeFrame: Baseline, Week 52
measure: Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores
timeFrame: Baseline, Week 52
measure: Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score
timeFrame: Baseline, Week 52
measure: Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline, Week 52
measure: Change in SF-12 Two Component Scores (Physical, Mental Health)
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Noesis Parma
state: Arizona
city: Beverly Hills
country: United States
facility: Southern California Research
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network Inc.
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers, LLC
state: Colorado
city: Denver
country: United States
facility: Weiss and Lytle, PLLC
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research
state: Connecticut
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Alpharetta
country: United States
facility: Institute of Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Neuotrials Research, Inc.
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, Inc.
state: Indiana
city: Prairie Village
country: United States
facility: Phoenix Medical Research, Inc. Suite 135
state: Kansas
city: Wichita
country: United States
facility: Cyress Medical Research Center, LLC
state: Kansas
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Portsmouth
country: United States
facility: ActivMed Practices and Research, Inc.
state: New Hampshire
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute, LCC
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Lindner Center Of Hope
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigatons, INC.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center For Clinical Research
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Greer
country: United States
facility: Radient Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutons, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Donald J. Garcia Jr., MD
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Plano
country: United States
facility: Psychiatric Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radient Research, Inc.
state: Texas
city: Murray
country: United States
facility: Radiant Research, Inc.
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Seattle
country: United States
facility: Summitt Research Network(Seattle) LLC
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Dasotraline Medical Director
role: STUDY_DIRECTOR
References: