Binge Eating Disorder
Conditions
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.
Interventions
DRUGDasotraline
Dasotraline 4, 6, 8 mg flexibly dosed once daily
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 56 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Body Weight | Baseline, Week 52 | Change in body weight |
| 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. |
| 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. |
| Change in Fasting Glucose Levels | Baseline, Week 52 | Change in fasting glucose levels |
| Percent Change in Body Weight (kg) | Baseline, Week 52 | Percent change in body weight (kg) |
Countries
United States
Participant flow
Pre-assignment details
A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Dasotraline 4, 6, 8 mg flexibly dosed | 528 |
| Total | 528 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 87 |
| Overall Study | family emergency | 1 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 61 |
| Overall Study | non-compliance with study drug | 9 |
| Overall Study | non compliance with study visits | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 8 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Site closures | 7 |
| Overall Study | subject to have surgery | 1 |
| Overall Study | Withdrawal by Subject | 92 |
Baseline characteristics
| Characteristic | Dasotraline |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 526 Participants |
| Age, Continuous | 38.8 Years STANDARD_DEVIATION 9.81 |
| Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Double-Blind (DB) Baseline | 4.5 Score STANDARD_DEVIATION 0.54 |
| Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Open Label (OL) Baseline | 2.4 Score STANDARD_DEVIATION 1.38 |
| BMI (kg/m^2) | 33.8 kg/m^2 STANDARD_DEVIATION 6.348 |
| Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Global Score | 3.7 Score STANDARD_DEVIATION 1.522 |
| Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Restraint | 2.21 Score STANDARD_DEVIATION 2.007 |
| Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Shape Concern | 4.38 Score STANDARD_DEVIATION 1.721 |
| Eating Disorder Examination Question(EDE-QM) Modified Score at OL Baseline - Weight Concern | 3.55 Score STANDARD_DEVIATION 1.912 |
| EDE-QM Modified Score at DB Baseline - Weight Concern | 4.5 Score STANDARD_DEVIATION 1.655 |
| EDE-QM Modified Score at OL Baseline - Global Score | 2.9 Score STANDARD_DEVIATION 1.687 |
| EDE-QM Modified Score at OL Baseline - Restraint | 1.71 Score STANDARD_DEVIATION 1.961 |
| EDE-QM Modified Score at OL Baseline - Shape Concern | 3.44 Score STANDARD_DEVIATION 1.944 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 443 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 167.4 cm STANDARD_DEVIATION 8.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 82 Participants |
| Race (NIH/OMB) More than one race | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 420 Participants |
| Sex: Female, Male Female | 440 Participants |
| Sex: Female, Male Male | 88 Participants |
| summary for Body Mass Index (BMI) category at open label baseline Obesity Class I (30 to <35) | 134 Participants |
| summary for Body Mass Index (BMI) category at open label baseline Obesity Class II (35 to <40) | 136 Participants |
| summary for Body Mass Index (BMI) category at open label baseline Obesity Class III (>=40) | 101 Participants |
| summary for Body Mass Index (BMI) category at open label baseline Overweight (25 to <30) | 104 Participants |
| summary for Body Mass Index (BMI) category at open label baseline Underweight/Normal (<25) | 53 Participants |
| Weight (kg) | 95.1 kg STANDARD_DEVIATION 21.52 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 528 |
| other Total, other adverse events | 295 / 528 |
| serious Total, serious adverse events | 21 / 528 |
Outcome results
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
Time frame: Baseline to Week 52
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dasotraline | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Preparatory acts or behavior | 1 Participants |
| Dasotraline | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Aborted attempt | 0 Participants |
| Dasotraline | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Interrupted attempt | 0 Participants |
| Dasotraline | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Actual attempt | 1 Participants |
| Dasotraline | Frequency and Severity of Suicidal Behavior Using the C-SSRS | Completed suicide | 0 Participants |
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
Time frame: Baseline to Week 52
Population: Safety- please note:~one subject had no value for Suicidal Ideation or Suicidal Behavior
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dasotraline | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | 0: No suicidal ideation | 515 Participants |
| Dasotraline | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | 1: Wish to be dead | 7 Participants |
| Dasotraline | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | 4: ideation with some intent to act, no plan | 0 Participants |
| Dasotraline | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | 5: Active ideation with specific plan and intent | 1 Participants |
| Dasotraline | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | 2: Non-specific active suicidal thoughts | 3 Participants |
| Dasotraline | Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | 3: ideation with any methods , no intent to act | 1 Participants |
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.
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change from DB Baseline Endpoint | 0.4 units on a scale |
| Dasotraline | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change from OL Baseline Endpoint | 0.6 units on a scale |
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
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Change from DB Baseline Endpoint | -0.6 units on a scale |
| Dasotraline | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Change from OL Baseline Endpoint | 0.4 units on a scale |
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.
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score | Change from DB Baseline Week 52 Endpoint | -2.7 units on a scale |
| Dasotraline | Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score | Change from OL Baseline Week 52 Endpoint | -0.7 units on a scale |
Secondary
Change in Body Mass Index
Change in Body Mass Index
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Body Mass Index | Change from DB Baseline Week 52 Endpoint | -1.64 kg/m^2 |
| Dasotraline | Change in Body Mass Index | Change from OL Baseline Week 52 Endpoint | -0.75 kg/m^2 |
Secondary
Change in Body Weight
Change in body weight
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Body Weight | Change from OL Baseline Week 52 Endpoint | -2.13 kg |
| Dasotraline | Change in Body Weight | Change from DB Baseline Week 52 Endpoint | -4.65 kg |
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)?
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Item 6 Change from DB Baseline Endpoint | -15.3 number of days |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Item 6 Change from OL Baseline Endpoint | -3.3 number of days |
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.
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Global Score Change from DB Baseline Endpoint | -1.16 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Global Score Change from OL Baseline Endpoint | -0.37 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Restraint Change from DB Baseline Endpoint | -0.63 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Restraint Change from OL Baseline Endpoint | -0.13 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Shape Concern Change from DB Baseline Endpoint | -1.38 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Shape Concern Change from OL Baseline Endpoint | -0.44 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Weight Concern Change from DB Baseline Endpoint | -1.47 units on a scale |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Weight Concern Change from OL Baseline Endpoint | -0.53 units on a scale |
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)?
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Item 4 Change from DB Baseline Endpoint | -17.4 events |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Item 4 Change from OL Baseline Endpoint | -3.9 events |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Item 5 Change from DB Baseline Endpoint | -16.6 events |
| Dasotraline | Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Item 5 Change from OL Baseline Endpoint | -3.5 events |
Secondary
Change in Fasting Glucose Levels
Change in fasting glucose levels
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Fasting Glucose Levels | Change from DB Baseline Week 52 Endpoint | 2.2 mg/dL |
| Dasotraline | Change in Fasting Glucose Levels | Change from OL Baseline Week 52 Endpoint | 1.7 mg/dL |
Secondary
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol,
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, | Change from DB Baseline Week 52 Endpoint | -1.1 mg/dL |
| Dasotraline | Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, | Change from OL Baseline Week 52 Endpoint | 1.1 mg/dL |
Secondary
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol)
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) | Change from DB Baseline Week 52 Endpoint | -3.6 mg/dL |
| Dasotraline | Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) | Change from OL Baseline Week 52 Endpoint | -3.4 mg/dL |
Secondary
Change in Fasting Lipid Panel , Total Cholesterol
Change in fasting lipid panel , total cholesterol
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Fasting Lipid Panel , Total Cholesterol | Change from DB Baseline Week 52 Endpoint | -7.0 mg/dL |
| Dasotraline | Change in Fasting Lipid Panel , Total Cholesterol | Change from OL Baseline Week 52 Endpoint | -3.5 mg/dL |
Secondary
Change in Fasting Lipid Panel, Triglyceride's
Change in fasting lipid panel, Triglyceride's
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Fasting Lipid Panel, Triglyceride's | Change from DB Baseline Week 52 Endpoint | -11.9 mg/dL |
| Dasotraline | Change in Fasting Lipid Panel, Triglyceride's | Change from OL Baseline Week 52 Endpoint | -5.3 mg/dL |
Secondary
Change in Hemoglobin A1c Levels
Change in hemoglobin A1c levels
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Hemoglobin A1c Levels | Change from DB Baseline Week 52 Endpoint | 0.00 Percent change |
| Dasotraline | Change in Hemoglobin A1c Levels | Change from OL Baseline Week 52 Endpoint | 0.00 Percent change |
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.
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in SF-12 Two Component Scores (Physical, Mental Health) | Mental Component Change from DB Baseline Endpoint | 1.25 units on a scale |
| Dasotraline | Change in SF-12 Two Component Scores (Physical, Mental Health) | Mental Component Change from OL Baseline Endpoint | -1.84 units on a scale |
| Dasotraline | Change in SF-12 Two Component Scores (Physical, Mental Health) | Physical Component Change from DB BL Endpoint | 2.56 units on a scale |
| Dasotraline | Change in SF-12 Two Component Scores (Physical, Mental Health) | Physical Component Change from OL BL Endpoint | 0.87 units on a scale |
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.
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Total Score Change from DB Baseline Endpoint | -8.2 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Work/School Change from DB Baseline Endpoint | -2.0 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Work/School Change from OL Baseline Endpoint | -0.4 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Social Life Change from DB Baseline Endpoint | -3.2 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Social Life Change from OL Baseline Endpoint | -0.5 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Family Life Change from DB Baseline Endpoint | -2.9 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Family Life Change from OL Baseline Endpoint | -0.4 units on a scale |
| Dasotraline | Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | Total Score Change from OL Baseline Endpoint | -1.5 units on a scale |
Secondary
Percent Change in Body Mass Index (kg/m^2)
Percent change in Body Mass Index (kg/m\^2)
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Percent Change in Body Mass Index (kg/m^2) | % Change from DB Baseline Week 52 Endpoint | -4.65 percent change |
| Dasotraline | Percent Change in Body Mass Index (kg/m^2) | % Change from OL Baseline Week 52 Endpoint | -2.07 percent change |
Secondary
Percent Change in Body Weight (kg)
Percent change in body weight (kg)
Time frame: Baseline, Week 52
Population: Safety
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dasotraline | Percent Change in Body Weight (kg) | % Change from DB Baseline Week 52 Endpoint | -4.65 percent change |
| Dasotraline | Percent Change in Body Weight (kg) | % Change from OL Baseline Week 52 Endpoint | -2.07 percent change |