Dasotraline Binge Eating Disorder Extension Study

An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder

Binge Eating Disorder Extension Study.

Study Overview

• Status: Completed
• Conditions: Binge Eating Disorder
• Intervention / Treatment: Drug: Dasotraline

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 533
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Noesis Parma
  • California
    • Beverly Hills, California, United States, 90210
      • Southern California Research
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network Inc.
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers, LLC
    • Denver, Colorado, United States, 80209*
      • Weiss and Lytle, PLLC
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Institute of Advanced Medical Research
    • Atlanta, Georgia, United States, 30342
      • Neuotrials Research, Inc.
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Goldpoint Clinical Research, Inc.
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Phoenix Medical Research, Inc. Suite 135
    • Wichita, Kansas, United States, 67226
      • Cyress Medical Research Center, LLC
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc.
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical Trials, LLC
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates - Midwest Research Group
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices and Research, Inc.
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center for Emotional Fitness
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute, LCC
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research, LLC
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine, PLLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • Mason, Ohio, United States, 45040
      • Lindner Center of HOPE
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research, LLC
    • Portland, Oregon, United States, 97214
      • Oregon Center for Clinical Investigatons, INC.
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations, Inc.
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Greer, South Carolina, United States, 29650
      • Radient Research, Inc.
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutons, Inc.
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia Jr., MD
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Plano, Texas, United States, 75023
      • Psychiatric Medical Associates
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Radient Research, Inc.
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research, Inc.
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc.
  • Washington
    • Seattle, Washington, United States, 98104
      • Summitt Research Network(Seattle) LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dasotraline; 4, 6, 8 mg flexibly dosed	Drug: Dasotraline; Dasotraline 4, 6, 8 mg flexibly dosed once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Change in body weight	Baseline, Week 52
Percent Change in Body Weight (kg)	Percent change in body weight (kg)	Baseline, Week 52
Change in Body Mass Index	Change in Body Mass Index	Baseline, Week 52
Percent Change in Body Mass Index (kg/m^2)	Percent change in Body Mass Index (kg/m^2)	Baseline, Week 52
Change in Fasting Lipid Panel, Triglyceride's	Change in fasting lipid panel, Triglyceride's	Baseline, Week 52
Change in Fasting Lipid Panel , Total Cholesterol	Change in fasting lipid panel , total cholesterol	Baseline, Week 52
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,	Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol,	Baseline, Week 52
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)	Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol)	Baseline, Week 52
Change in Hemoglobin A1c Levels	Change in hemoglobin A1c levels	Baseline, Week 52
Change in Fasting Glucose Levels	Change in fasting glucose levels	Baseline, Week 52
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Study Director: Dasotraline Medical Director, Sunovion

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2016
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: SEP360-322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No