Trial Outcomes & Findings for Dasotraline Binge Eating Disorder Extension Study (NCT NCT02684279)
NCT ID: NCT02684279
Last Updated: 2020-08-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
533 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2020-08-12
Participant Flow
A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.
Participant milestones
| Measure |
Dasotraline
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Overall Study
STARTED
|
528
|
|
Overall Study
COMPLETED
|
249
|
|
Overall Study
NOT COMPLETED
|
279
|
Reasons for withdrawal
| Measure |
Dasotraline
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Overall Study
Adverse Event
|
87
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Lost to Follow-up
|
61
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Pregnancy
|
8
|
|
Overall Study
Withdrawal by Subject
|
92
|
|
Overall Study
non-compliance with study drug
|
9
|
|
Overall Study
non compliance with study visits
|
2
|
|
Overall Study
subject to have surgery
|
1
|
|
Overall Study
family emergency
|
1
|
|
Overall Study
Site closures
|
7
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Dasotraline Binge Eating Disorder Extension Study
Baseline characteristics by cohort
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
526 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
38.8 Years
STANDARD_DEVIATION 9.81 • n=93 Participants
|
|
Sex: Female, Male
Female
|
440 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
85 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
443 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
420 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Height (cm)
|
167.4 cm
STANDARD_DEVIATION 8.77 • n=93 Participants
|
|
Weight (kg)
|
95.1 kg
STANDARD_DEVIATION 21.52 • n=93 Participants
|
|
BMI (kg/m^2)
|
33.8 kg/m^2
STANDARD_DEVIATION 6.348 • n=93 Participants
|
|
Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Double-Blind (DB) Baseline
|
4.5 Score
STANDARD_DEVIATION 0.54 • n=93 Participants
|
|
Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Open Label (OL) Baseline
|
2.4 Score
STANDARD_DEVIATION 1.38 • n=93 Participants
|
|
Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Global Score
|
3.7 Score
STANDARD_DEVIATION 1.522 • n=93 Participants
|
|
Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Restraint
|
2.21 Score
STANDARD_DEVIATION 2.007 • n=93 Participants
|
|
Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Shape Concern
|
4.38 Score
STANDARD_DEVIATION 1.721 • n=93 Participants
|
|
EDE-QM Modified Score at DB Baseline - Weight Concern
|
4.5 Score
STANDARD_DEVIATION 1.655 • n=93 Participants
|
|
EDE-QM Modified Score at OL Baseline - Global Score
|
2.9 Score
STANDARD_DEVIATION 1.687 • n=93 Participants
|
|
EDE-QM Modified Score at OL Baseline - Restraint
|
1.71 Score
STANDARD_DEVIATION 1.961 • n=93 Participants
|
|
EDE-QM Modified Score at OL Baseline - Shape Concern
|
3.44 Score
STANDARD_DEVIATION 1.944 • n=93 Participants
|
|
Eating Disorder Examination Question(EDE-QM) Modified Score at OL Baseline - Weight Concern
|
3.55 Score
STANDARD_DEVIATION 1.912 • n=93 Participants
|
|
summary for Body Mass Index (BMI) category at open label baseline
Underweight/Normal (<25)
|
53 Participants
n=93 Participants
|
|
summary for Body Mass Index (BMI) category at open label baseline
Overweight (25 to <30)
|
104 Participants
n=93 Participants
|
|
summary for Body Mass Index (BMI) category at open label baseline
Obesity Class I (30 to <35)
|
134 Participants
n=93 Participants
|
|
summary for Body Mass Index (BMI) category at open label baseline
Obesity Class II (35 to <40)
|
136 Participants
n=93 Participants
|
|
summary for Body Mass Index (BMI) category at open label baseline
Obesity Class III (>=40)
|
101 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Safety- please note: one subject had no value for Suicidal Ideation or Suicidal Behavior
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
Outcome measures
| Measure |
Dasotraline
n=527 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
0: No suicidal ideation
|
515 Participants
|
|
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
1: Wish to be dead
|
7 Participants
|
|
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
2: Non-specific active suicidal thoughts
|
3 Participants
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Safety
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
Outcome measures
| Measure |
Dasotraline
n=527 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Preparatory acts or behavior
|
1 Participants
|
|
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Aborted attempt
|
0 Participants
|
|
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Interrupted attempt
|
0 Participants
|
|
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Actual attempt
|
1 Participants
|
|
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Completed suicide
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in body weight
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Body Weight
Change from DB Baseline Week 52 Endpoint
|
-4.65 kg
Interval -5.36 to -3.93
|
|
Change in Body Weight
Change from OL Baseline Week 52 Endpoint
|
-2.13 kg
Interval -2.77 to -1.49
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Percent change in body weight (kg)
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Percent Change in Body Weight (kg)
% Change from DB Baseline Week 52 Endpoint
|
-4.65 percent change
Interval -5.35 to -3.95
|
|
Percent Change in Body Weight (kg)
% Change from OL Baseline Week 52 Endpoint
|
-2.07 percent change
Interval -2.71 to -1.43
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in Body Mass Index
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Body Mass Index
Change from DB Baseline Week 52 Endpoint
|
-1.64 kg/m^2
Interval -1.89 to -1.39
|
|
Change in Body Mass Index
Change from OL Baseline Week 52 Endpoint
|
-0.75 kg/m^2
Interval -0.97 to -0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Percent change in Body Mass Index (kg/m\^2)
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Percent Change in Body Mass Index (kg/m^2)
% Change from DB Baseline Week 52 Endpoint
|
-4.65 percent change
Interval -5.35 to -3.95
|
|
Percent Change in Body Mass Index (kg/m^2)
% Change from OL Baseline Week 52 Endpoint
|
-2.07 percent change
Interval -2.71 to -1.43
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in fasting lipid panel, Triglyceride's
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Fasting Lipid Panel, Triglyceride's
Change from DB Baseline Week 52 Endpoint
|
-11.9 mg/dL
Interval -17.5 to -6.3
|
|
Change in Fasting Lipid Panel, Triglyceride's
Change from OL Baseline Week 52 Endpoint
|
-5.3 mg/dL
Interval -10.4 to -0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in fasting lipid panel , total cholesterol
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Fasting Lipid Panel , Total Cholesterol
Change from DB Baseline Week 52 Endpoint
|
-7.0 mg/dL
Interval -9.3 to -4.8
|
|
Change in Fasting Lipid Panel , Total Cholesterol
Change from OL Baseline Week 52 Endpoint
|
-3.5 mg/dL
Interval -5.6 to -1.4
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in fasting lipid panel, high-density lipoprotein \[HDL\] cholesterol,
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
Change from DB Baseline Week 52 Endpoint
|
-1.1 mg/dL
Interval -2.0 to -0.2
|
|
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
Change from OL Baseline Week 52 Endpoint
|
1.1 mg/dL
Interval 0.2 to 1.9
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in fasting lipid panel, low-density lipoprotein \[LDL\] cholesterol)
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
Change from DB Baseline Week 52 Endpoint
|
-3.6 mg/dL
Interval -5.5 to -1.6
|
|
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
Change from OL Baseline Week 52 Endpoint
|
-3.4 mg/dL
Interval -5.2 to -1.5
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in hemoglobin A1c levels
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Hemoglobin A1c Levels
Change from DB Baseline Week 52 Endpoint
|
0.00 Percent change
Interval -0.02 to 0.02
|
|
Change in Hemoglobin A1c Levels
Change from OL Baseline Week 52 Endpoint
|
0.00 Percent change
Interval -0.02 to 0.02
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Change in fasting glucose levels
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in Fasting Glucose Levels
Change from DB Baseline Week 52 Endpoint
|
2.2 mg/dL
Interval 0.9 to 3.5
|
|
Change in Fasting Glucose Levels
Change from OL Baseline Week 52 Endpoint
|
1.7 mg/dL
Interval 0.3 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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.
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
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
Interval -1.3 to -1.02
|
|
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
Interval -0.48 to -0.26
|
|
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
Interval -0.81 to -0.45
|
|
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
Interval -0.27 to 0.01
|
|
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
Interval -1.54 to -1.22
|
|
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
Interval -0.57 to -0.31
|
|
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
Interval -1.63 to -1.31
|
|
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
Interval -0.66 to -0.39
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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)?
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
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
Interval -18.2 to -16.6
|
|
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
Interval -4.6 to -3.1
|
|
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
Interval -17.4 to -15.8
|
|
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
Interval -4.2 to -2.8
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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)?
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
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
Interval -15.9 to -14.7
|
|
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
Interval -3.8 to -2.7
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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.
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
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
Interval -2.8 to -2.6
|
|
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
Interval -0.8 to -0.5
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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.
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
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
Interval -9.0 to -7.4
|
|
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
Interval -2.1 to -0.9
|
|
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
Interval -2.3 to -1.8
|
|
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
Interval -0.6 to -0.2
|
|
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
Interval -3.5 to -2.9
|
|
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
Interval -0.7 to -0.3
|
|
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
Interval -3.2 to -2.6
|
|
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
Interval -0.6 to -0.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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.
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Change from DB Baseline Endpoint
|
0.4 units on a scale
Interval 0.0 to 0.9
|
|
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Change from OL Baseline Endpoint
|
0.6 units on a scale
Interval 0.2 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
Outcome measures
| Measure |
Dasotraline
n=528 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Change from DB Baseline Endpoint
|
-0.6 units on a scale
Interval -1.1 to -0.1
|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Change from OL Baseline Endpoint
|
0.4 units on a scale
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Safety
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.
Outcome measures
| Measure |
Dasotraline
n=204 Participants
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Change in SF-12 Two Component Scores (Physical, Mental Health)
Mental Component Change from DB Baseline Endpoint
|
1.25 units on a scale
Interval -0.44 to 2.95
|
|
Change in SF-12 Two Component Scores (Physical, Mental Health)
Mental Component Change from OL Baseline Endpoint
|
-1.84 units on a scale
Interval -3.27 to -0.4
|
|
Change in SF-12 Two Component Scores (Physical, Mental Health)
Physical Component Change from DB BL Endpoint
|
2.56 units on a scale
Interval 1.32 to 3.8
|
|
Change in SF-12 Two Component Scores (Physical, Mental Health)
Physical Component Change from OL BL Endpoint
|
0.87 units on a scale
Interval -0.16 to 1.9
|
Adverse Events
Dasotraline
Serious events: 21 serious events
Other events: 295 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dasotraline
n=528 participants at risk
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Gastrointestinal disorders
Colitis
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Immune system disorders
Hypersensitivity
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Infections and infestations
Cellulitis
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Infections and infestations
Localised infection
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Nervous system disorders
Hemiplegic migraine
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Nervous system disorders
Partial seizures
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Nervous system disorders
Seizure
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Panic attack
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Paranoia
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Psychotic disorder
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Suicide attempt
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.19%
1/528 • Number of events 1 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
Other adverse events
| Measure |
Dasotraline
n=528 participants at risk
4, 6, 8 mg flexibly dosed
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
13.8%
73/528 • Number of events 81 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Gastrointestinal disorders
Nausea
|
5.1%
27/528 • Number of events 30 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
30/528 • Number of events 39 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
51/528 • Number of events 69 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Investigations
Weight decreased
|
14.6%
77/528 • Number of events 96 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Nervous system disorders
Headache
|
9.8%
52/528 • Number of events 60 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Anxiety
|
13.3%
70/528 • Number of events 77 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Insomnia
|
19.5%
103/528 • Number of events 114 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
|
Psychiatric disorders
Irritability
|
5.1%
27/528 • Number of events 28 • An AE onset on or after the start of the open-label treatment period (treatment duration: 52 weeks) through 7 days after study drug discontinuation (14 days for serious adverse events and deaths)
Treatment-emergent adverse events (TEAEs) are those reported adverse events with onset date on or after the first day of the open-label treatment period through 7 days after study drug discontinuation (14 days for serious adverse events and deaths).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER