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Completed

NCT Number: NCT02684279

Dasotraline Binge Eating Disorder Extension Study

Binge Eating Disorder Extension Study.

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Key information

Conditions

Binge Eating Disorder Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Noesis Parma, Phoenix, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dasotraline

Drug

Dasotraline 4, 6, 8 mg flexibly dosed once daily

Primary outcomes

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

    Time frame: 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

  2. Frequency and Severity of Suicidal Behavior Using the C-SSRS

    Time frame: 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 outcomes

  1. Change in Body Weight

    Time frame: Baseline, Week 52

    Change in body weight

  2. Percent Change in Body Weight (kg)

    Time frame: Baseline, Week 52

    Percent change in body weight (kg)

  3. Change in Body Mass Index

    Time frame: Baseline, Week 52

    Change in Body Mass Index

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

    Time frame: Baseline, Week 52

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

  5. Change in Fasting Lipid Panel, Triglyceride's

    Time frame: Baseline, Week 52

    Change in fasting lipid panel, Triglyceride's

  6. Change in Fasting Lipid Panel , Total Cholesterol

    Time frame: Baseline, Week 52

    Change in fasting lipid panel , total cholesterol

  7. Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,

    Time frame: Baseline, Week 52

    Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol,

  8. Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)

    Time frame: Baseline, Week 52

    Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol)

  9. Change in Hemoglobin A1c Levels

    Time frame: Baseline, Week 52

    Change in hemoglobin A1c levels

  10. Change in Fasting Glucose Levels

    Time frame: Baseline, Week 52

    Change in fasting glucose levels

  11. Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores

    Time frame: 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.

  12. Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores

    Time frame: 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 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)?

  13. Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores

    Time frame: 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)?

  14. Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score

    Time frame: 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.

  15. Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)

    Time frame: 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.

  16. Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

    Time frame: 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.

  17. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: 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

  18. Change in SF-12 Two Component Scores (Physical, Mental Health)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2016
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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