Dasotraline Binge Eating Disorder Extension Study
- Registration Number
- NCT02684279
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 533
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dasotraline Dasotraline 4, 6, 8 mg flexibly dosed
- Primary Outcome Measures
Name Time Method Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) Baseline to Week 52 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
Frequency and Severity of Suicidal Behavior Using the C-SSRS Baseline to Week 52 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
- Secondary Outcome Measures
Name Time Method Change in Body Weight Baseline, Week 52 Change in body weight
Percent Change in Body Weight (kg) Baseline, Week 52 Percent change in body weight (kg)
Change in Body Mass Index Baseline, Week 52 Change in Body Mass Index
Percent Change in Body Mass Index (kg/m^2) Baseline, Week 52 Percent change in Body Mass Index (kg/m\^2)
Change in Fasting Lipid Panel, Triglyceride's Baseline, Week 52 Change in fasting lipid panel, Triglyceride's
Change in Fasting Lipid Panel , Total Cholesterol Baseline, Week 52 Change in fasting lipid panel , total cholesterol
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, Baseline, Week 52 Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol,
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) Baseline, Week 52 Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol)
Change in Hemoglobin A1c Levels Baseline, Week 52 Change in hemoglobin A1c levels
Change in Fasting Glucose Levels Baseline, Week 52 Change in fasting glucose levels
Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores Baseline, Week 52 Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores.
Item 6: Over the past 28 days, on how many DAYS have such episodes of overeating occurred (i.e., you have eaten an unusually large amount of food and have had a sense of loss of control at the time)?Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score Baseline, Week 52 Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.
Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) Baseline, Week 52 The Sheehan Disability Scale (SDS) 3 subscales (work/school, social life, home life) are rated on the following scale: 0 = not at all; 1-3 = mildly; 4-6 = moderately; 7-9 =markedly; 10 = extremely. The 3 items can be combined into a single global measure of impairment (SDS total score) that ranges from 0 (unimpaired) to 30 (highly impaired). A higher subscale score and total score are associated with greater illness severity.
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Baseline, Week 52 Hamilton Anxiety Rating Scale (HAM-A) total score HAM-A total score ranges from 0 to 56. A higher score is associated with a greater degree of anxiety.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Baseline, Week 52 Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
Change in SF-12 Two Component Scores (Physical, Mental Health) Baseline, Week 52 Change in SF-12 two component scores (physical, mental health) for Subjects Continued from Study SEP360-221 The SF-12 is a 12-item self-report questionnaire. Physical Component Summary (PCS) and Mental Component Summary (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Trial Locations
- Locations (52)
Neuotrials Research, Inc.
🇺🇸Atlanta, Georgia, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Cyress Medical Research Center, LLC
🇺🇸Wichita, Kansas, United States
Phoenix Medical Research, Inc. Suite 135
🇺🇸Prairie Village, Kansas, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Noesis Parma
🇺🇸Phoenix, Arizona, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Collaborative NeuroScience Network Inc.
🇺🇸Garden Grove, 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
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Weiss and Lytle, PLLC
🇺🇸Denver, Colorado, 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
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Goldpoint Clinical Research, Inc.
🇺🇸Indianapolis, Indiana, United States
ActivMed Practices & Research, Inc.
🇺🇸Methuen, Massachusetts, United States
ActivMed Practices and Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
St. Charles Psychiatric Associates - Midwest Research Group
🇺🇸Saint Charles, Missouri, United States
Radiant Research, Inc.
🇺🇸Murray, Utah, United States
Princeton Medical Institute, LCC
🇺🇸Princeton, New Jersey, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Bioscience Research, LLC
🇺🇸Mount Kisco, New York, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Lindner Center Of Hope
🇺🇸Mason, Ohio, United States
Manhattan Behavioral Medicine, PLLC
🇺🇸New York, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Patient Priority Clinical Sites
🇺🇸Cincinnati, Ohio, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
Oregon Center for Clinical Investigatons, INC.
🇺🇸Portland, Oregon, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
Lehigh Center For Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Radient Research, Inc.
🇺🇸San Antonio, Texas, United States
Clinical Neuroscience Solutons, Inc.
🇺🇸Memphis, Tennessee, United States
Donald J. Garcia Jr., MD
🇺🇸Austin, Texas, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Psychiatric Medical Associates
🇺🇸Plano, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
NeuroScience, Inc.
🇺🇸Herndon, Virginia, United States
Summitt Research Network(Seattle) LLC
🇺🇸Seattle, Washington, United States
Southern California Research
🇺🇸Beverly Hills, California, United States
Adams Clinical Trials, LLC
🇺🇸Watertown, Massachusetts, United States