Dasotraline Binge Eating Disorder Extension Study

Binge Eating Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684279
• Other study ID #: SEP360-322
• Status: Completed
• Phase: Phase 3
• Start date: February 29, 2016
• Est. completion date: June 24, 2019

Study information

• Verified date: July 2020
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Binge Eating Disorder Extension Study.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 56 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• Dasotraline
Dasotraline 4, 6, 8 mg flexibly dosed once daily

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Akron	Ohio
United States	Lehigh Center For Clinical Research	Allentown	Pennsylvania
United States	Institute of Advanced Medical Research	Alpharetta	Georgia
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Neuotrials Research, Inc.	Atlanta	Georgia
United States	Donald J. Garcia Jr., MD	Austin	Texas
United States	McLean Hospital	Belmont	Massachusetts
United States	Southern California Research	Beverly Hills	California
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
United States	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado
United States	CT Clinical Research	Cromwell	Connecticut
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Weiss and Lytle, PLLC	Denver	Colorado
United States	Pharmacology Research Institute	Encino	California
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Collaborative NeuroScience Network Inc.	Garden Grove	California
United States	Radient Research, Inc.	Greer	South Carolina
United States	NeuroScience, Inc.	Herndon	Virginia
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Goldpoint Clinical Research, Inc.	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Lindner Center Of Hope	Mason	Ohio
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Clinical Neuroscience Solutons, Inc.	Memphis	Tennessee
United States	ActivMed Practices & Research, Inc.	Methuen	Massachusetts
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Radiant Research, Inc.	Murray	Utah
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Noesis Parma	Phoenix	Arizona
United States	Psychiatric Medical Associates	Plano	Texas
United States	Oregon Center for Clinical Investigatons, INC.	Portland	Oregon
United States	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire
United States	Phoenix Medical Research, Inc. Suite 135	Prairie Village	Kansas
United States	Princeton Medical Institute, LCC	Princeton	New Jersey
United States	Wake Research Associates	Raleigh	North Carolina
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Radient Research, Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	Syrentis Clinical Research	Santa Ana	California
United States	Summitt Research Network(Seattle) LLC	Seattle	Washington
United States	Miami Research Associates	South Miami	Florida
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts
United States	Cyress Medical Research Center, LLC	Wichita	Kansas
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Body Weight	Change in body weight	Baseline, Week 52
Secondary	Percent Change in Body Weight (kg)	Percent change in body weight (kg)	Baseline, Week 52
Secondary	Change in Body Mass Index	Change in Body Mass Index	Baseline, Week 52
Secondary	Percent Change in Body Mass Index (kg/m^2)	Percent change in Body Mass Index (kg/m^2)	Baseline, Week 52
Secondary	Change in Fasting Lipid Panel, Triglyceride's	Change in fasting lipid panel, Triglyceride's	Baseline, Week 52
Secondary	Change in Fasting Lipid Panel , Total Cholesterol	Change in fasting lipid panel , total cholesterol	Baseline, Week 52
Secondary	Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,	Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol,	Baseline, Week 52
Secondary	Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)	Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol)	Baseline, Week 52
Secondary	Change in Hemoglobin A1c Levels	Change in hemoglobin A1c levels	Baseline, Week 52
Secondary	Change in Fasting Glucose Levels	Change in fasting glucose levels	Baseline, Week 52
Secondary	Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores	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.	Baseline, Week 52
Secondary	Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores	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 4: Over the past 28 days, how many times have you eaten what other people would regard as an unusually large amount of food (given the circumstances)?; Item 5: On how many of these times did you have a sense of having lost control over your eating (at the time that you were eating)?	Baseline, Week 52
Secondary	Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores	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)?	Baseline, Week 52
Secondary	Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score	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.	Baseline, Week 52
Secondary	Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)	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.	Baseline, Week 52
Secondary	Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score	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.	Baseline, Week 52
Secondary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms	Baseline, Week 52
Secondary	Change in SF-12 Two Component Scores (Physical, Mental Health)	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.	Baseline, Week 52