Dasotraline Binge Eating Disorder Extension Study

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02684279
• Collaborator: (none)
• Enrollment: 533
• Locations: 57
• Arm: 1
• Actual Duration (Months): 39.8
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Binge Eating Disorder Extension Study.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder	Drug: Dasotraline	Phase 3

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 533 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: open-label
• Primary Purpose: Treatment
• Official Title: An Open-label, Flexibly-dosed, Multicenter, Extension Study of Dasotraline to Evaluate Long-term Safety and Tolerability in Adults With Binge-eating Disorder
• Actual Study Start Date: Feb 29, 2016
• Actual Primary Completion Date: Jun 24, 2019
• Actual Study Completion Date: Jun 24, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. Change in Body Weight [Baseline, Week 52]

   Change in body weight

2. Percent Change in Body Weight (kg) [Baseline, Week 52]

   Percent change in body weight (kg)

3. Change in Body Mass Index [Baseline, Week 52]

   Change in Body Mass Index

4. Percent Change in Body Mass Index (kg/m^2) [Baseline, Week 52]

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

5. Change in Fasting Lipid Panel, Triglyceride's [Baseline, Week 52]

   Change in fasting lipid panel, Triglyceride's

6. Change in Fasting Lipid Panel , Total Cholesterol [Baseline, Week 52]

   Change in fasting lipid panel , total cholesterol

7. Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, [Baseline, Week 52]

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

8. Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) [Baseline, Week 52]

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

9. Change in Hemoglobin A1c Levels [Baseline, Week 52]

   Change in hemoglobin A1c levels

10. Change in Fasting Glucose Levels [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 [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 [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 [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 [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) [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 [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 [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 56 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Noesis Parma	Phoenix	Arizona	United States	85032
2	Southern California Research	Beverly Hills	California	United States	90210
3	Pharmacology Research Institute	Encino	California	United States	91316
4	Collaborative NeuroScience Network Inc.	Garden Grove	California	United States	92845
5	Pharmacology Research Institute	Newport Beach	California	United States	92660
6	Artemis Institute for Clinical Research	San Marcos	California	United States	92078
7	Syrentis Clinical Research	Santa Ana	California	United States	92705
8	MCB Clinical Research Centers, LLC	Colorado Springs	Colorado	United States	80910
9	Weiss and Lytle, PLLC	Denver	Colorado	United States	80209*
10	CT Clinical Research	Cromwell	Connecticut	United States	06416
11	Gulfcoast Clinical Research Center	Fort Myers	Florida	United States	33912
12	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida	United States	32256
13	Segal Institute for Clinical Research	North Miami	Florida	United States	33161
14	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
15	Miami Research Associates	South Miami	Florida	United States	33143
16	Institute of Advanced Medical Research	Alpharetta	Georgia	United States	30005
17	Neuotrials Research, Inc.	Atlanta	Georgia	United States	30342
18	Northwest Behavioral Research Center	Marietta	Georgia	United States	30060
19	Capstone Clinical Research	Libertyville	Illinois	United States	60048
20	Goldpoint Clinical Research, Inc.	Indianapolis	Indiana	United States	46260
21	Phoenix Medical Research, Inc. Suite 135	Prairie Village	Kansas	United States	66208
22	Cyress Medical Research Center, LLC	Wichita	Kansas	United States	67226
23	McLean Hospital	Belmont	Massachusetts	United States	02478
24	Boston Clinical Trials	Boston	Massachusetts	United States	02131
25	ActivMed Practices & Research, Inc.	Methuen	Massachusetts	United States	01844
26	Adams Clinical Trials, LLC	Watertown	Massachusetts	United States	02472
27	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri	United States	63304
28	ActivMed Practices and Research, Inc.	Portsmouth	New Hampshire	United States	03801
29	Center for Emotional Fitness	Cherry Hill	New Jersey	United States	08002
30	Princeton Medical Institute, LCC	Princeton	New Jersey	United States	08540
31	Bioscience Research, LLC	Mount Kisco	New York	United States	10549
32	Manhattan Behavioral Medicine, PLLC	New York	New York	United States	10036
33	The Medical Research Network, LLC	New York	New York	United States	10128
34	Wake Research Associates	Raleigh	North Carolina	United States	27612
35	Radiant Research, Inc.	Akron	Ohio	United States	44311
36	Patient Priority Clinical Sites	Cincinnati	Ohio	United States	45215
37	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
38	Lindner Center Of Hope	Mason	Ohio	United States	45040
39	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
40	Sunstone Medical Research, LLC	Medford	Oregon	United States	97504
41	Oregon Center for Clinical Investigatons, INC.	Portland	Oregon	United States	97214
42	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon	United States	97301
43	Lehigh Center For Clinical Research	Allentown	Pennsylvania	United States	18104
44	Radiant Research, Inc.	Anderson	South Carolina	United States	29621
45	Radient Research, Inc.	Greer	South Carolina	United States	29650
46	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
47	Clinical Neuroscience Solutons, Inc.	Memphis	Tennessee	United States	38119
48	Clinical Research Associates, Inc.	Nashville	Tennessee	United States	37203
49	Donald J. Garcia Jr., MD	Austin	Texas	United States	78737
50	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
51	Psychiatric Medical Associates	Plano	Texas	United States	75023
52	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
53	Radient Research, Inc.	San Antonio	Texas	United States	78229
54	Radiant Research, Inc.	Murray	Utah	United States	84123
55	Neuropsychiatric Associates	Woodstock	Vermont	United States	05091
56	NeuroScience, Inc.	Herndon	Virginia	United States	20170
57	Summitt Research Network(Seattle) LLC	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: Dasotraline Medical Director, Sunovion

Study Documents (Full-Text)

• Study Protocol - Jun 13, 2017
• Statistical Analysis Plan - Jun 20, 2019

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT02684279
• Other Study ID Numbers: SEP360-322
• First Posted: Feb 17, 2016
• Last Update Posted: Aug 12, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder

Study Results

Participant Flow

Pre-assignment Detail	A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Period Title: Overall Study
STARTED	528
COMPLETED	249
NOT COMPLETED	279

Baseline Characteristics

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Overall Participants	528
Age (Count of Participants)
<=18 years	2 0.4%
Between 18 and 65 years	526 99.6%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.8 (9.81)
Sex: Female, Male (Count of Participants)
Female	440 83.3%
Male	88 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	85 16.1%
Not Hispanic or Latino	443 83.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%
Asian	14 2.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	82 15.5%
White	420 79.5%
More than one race	11 2.1%
Unknown or Not Reported	0 0%
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	167.4 (8.77)
Weight (kg) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	95.1 (21.52)
BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	33.8 (6.348)
Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Double-Blind (DB) Baseline (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	4.5 (0.54)
Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Open Label (OL) Baseline (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	2.4 (1.38)
Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Global Score (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	3.7 (1.522)
Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Restraint (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	2.21 (2.007)
Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Shape Concern (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	4.38 (1.721)
EDE-QM Modified Score at DB Baseline - Weight Concern (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	4.5 (1.655)
EDE-QM Modified Score at OL Baseline - Global Score (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	2.9 (1.687)
EDE-QM Modified Score at OL Baseline - Restraint (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	1.71 (1.961)
EDE-QM Modified Score at OL Baseline - Shape Concern (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	3.44 (1.944)
Eating Disorder Examination Question(EDE-QM) Modified Score at OL Baseline - Weight Concern (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	3.55 (1.912)
summary for Body Mass Index (BMI) category at open label baseline (Count of Participants)
Underweight/Normal (<25)	53 10%
Overweight (25 to <30)	104 19.7%
Obesity Class I (30 to <35)	134 25.4%
Obesity Class II (35 to <40)	136 25.8%
Obesity Class III (>=40)	101 19.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety- please note: one subject had no value for Suicidal Ideation or Suicidal Behavior

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	527
0: No suicidal ideation	515 97.5%
1: Wish to be dead	7 1.3%
2: Non-specific active suicidal thoughts	3 0.6%
3: ideation with any methods , no intent to act	1 0.2%
4: ideation with some intent to act, no plan	0 0%
5: Active ideation with specific plan and intent	1 0.2%

2. Primary Outcome

Title	Frequency and Severity of Suicidal Behavior Using the C-SSRS
Description	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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	527
Preparatory acts or behavior	1 0.2%
Aborted attempt	0 0%
Interrupted attempt	0 0%
Actual attempt	1 0.2%
Completed suicide	0 0%

3. Secondary Outcome

Title	Change in Body Weight
Description	Change in body weight
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-4.65
Change from OL Baseline Week 52 Endpoint	-2.13

4. Secondary Outcome

Title	Percent Change in Body Weight (kg)
Description	Percent change in body weight (kg)
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
% Change from DB Baseline Week 52 Endpoint	-4.65
% Change from OL Baseline Week 52 Endpoint	-2.07

5. Secondary Outcome

Title	Change in Body Mass Index
Description	Change in Body Mass Index
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-1.64
Change from OL Baseline Week 52 Endpoint	-0.75

6. Secondary Outcome

Title	Percent Change in Body Mass Index (kg/m^2)
Description	Percent change in Body Mass Index (kg/m^2)
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
% Change from DB Baseline Week 52 Endpoint	-4.65
% Change from OL Baseline Week 52 Endpoint	-2.07

7. Secondary Outcome

Title	Change in Fasting Lipid Panel, Triglyceride's
Description	Change in fasting lipid panel, Triglyceride's
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-11.9
Change from OL Baseline Week 52 Endpoint	-5.3

8. Secondary Outcome

Title	Change in Fasting Lipid Panel , Total Cholesterol
Description	Change in fasting lipid panel , total cholesterol
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-7.0
Change from OL Baseline Week 52 Endpoint	-3.5

9. Secondary Outcome

Title	Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
Description	Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol,
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-1.1
Change from OL Baseline Week 52 Endpoint	1.1

10. Secondary Outcome

Title	Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
Description	Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol)
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-3.6
Change from OL Baseline Week 52 Endpoint	-3.4

11. Secondary Outcome

Title	Change in Hemoglobin A1c Levels
Description	Change in hemoglobin A1c levels
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	0.00
Change from OL Baseline Week 52 Endpoint	0.00

12. Secondary Outcome

Title	Change in Fasting Glucose Levels
Description	Change in fasting glucose levels
Time Frame	Baseline, Week 52

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	2.2
Change from OL Baseline Week 52 Endpoint	1.7

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Global Score Change from DB Baseline Endpoint	-1.16
Global Score Change from OL Baseline Endpoint	-0.37
Restraint Change from DB Baseline Endpoint	-0.63
Restraint Change from OL Baseline Endpoint	-0.13
Shape Concern Change from DB Baseline Endpoint	-1.38
Shape Concern Change from OL Baseline Endpoint	-0.44
Weight Concern Change from DB Baseline Endpoint	-1.47
Weight Concern Change from OL Baseline Endpoint	-0.53

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Item 4 Change from DB Baseline Endpoint	-17.4
Item 4 Change from OL Baseline Endpoint	-3.9
Item 5 Change from DB Baseline Endpoint	-16.6
Item 5 Change from OL Baseline Endpoint	-3.5

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Item 6 Change from DB Baseline Endpoint	-15.3
Item 6 Change from OL Baseline Endpoint	-3.3

16. Secondary Outcome

Title	Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score
Description	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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Week 52 Endpoint	-2.7
Change from OL Baseline Week 52 Endpoint	-0.7

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Total Score Change from DB Baseline Endpoint	-8.2
Total Score Change from OL Baseline Endpoint	-1.5
Work/School Change from DB Baseline Endpoint	-2.0
Work/School Change from OL Baseline Endpoint	-0.4
Social Life Change from DB Baseline Endpoint	-3.2
Social Life Change from OL Baseline Endpoint	-0.5
Family Life Change from DB Baseline Endpoint	-2.9
Family Life Change from OL Baseline Endpoint	-0.4

18. Secondary Outcome

Title	Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Description	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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Endpoint	0.4
Change from OL Baseline Endpoint	0.6

19. Secondary Outcome

Title	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description	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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	528
Change from DB Baseline Endpoint	-0.6
Change from OL Baseline Endpoint	0.4

20. Secondary Outcome

Title	Change in SF-12 Two Component Scores (Physical, Mental Health)
Description	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

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
Measure Participants	204
Mental Component Change from DB Baseline Endpoint	1.25
Mental Component Change from OL Baseline Endpoint	-1.84
Physical Component Change from DB BL Endpoint	2.56
Physical Component Change from OL BL Endpoint	0.87

Adverse Events

Time Frame	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)
Adverse Event Reporting Description	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).
Arm/Group Title	Dasotraline
Arm/Group Description	4, 6, 8 mg flexibly dosed
All Cause Mortality
	Dasotraline
	Affected / at Risk (%)	# Events
Total	0/528 (0%)
Serious Adverse Events
	Dasotraline
	Affected / at Risk (%)	# Events
Total	21/528 (4%)
Blood and lymphatic system disorders
Anaemia	1/528 (0.2%)	1
Iron deficiency anaemia	1/528 (0.2%)	1
Gastrointestinal disorders
Abdominal adhesions	1/528 (0.2%)	1
Colitis	1/528 (0.2%)	1
Rectal haemorrhage	1/528 (0.2%)	1
Hepatobiliary disorders
Cholecystitis	1/528 (0.2%)	1
Cholelithiasis	1/528 (0.2%)	1
Immune system disorders
Hypersensitivity	1/528 (0.2%)	1
Infections and infestations
Cellulitis	1/528 (0.2%)	1
Localised infection	1/528 (0.2%)	1
Injury, poisoning and procedural complications
Laceration	1/528 (0.2%)	1
Lumbar vertebral fracture	1/528 (0.2%)	1
Post procedural inflammation	1/528 (0.2%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/528 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma	1/528 (0.2%)	1
Nervous system disorders
Hemiplegic migraine	1/528 (0.2%)	1
Partial seizures	1/528 (0.2%)	1
Seizure	1/528 (0.2%)	1
Psychiatric disorders
Panic attack	1/528 (0.2%)	1
Paranoia	1/528 (0.2%)	1
Psychotic disorder	1/528 (0.2%)	1
Substance-induced mood disorder	1/528 (0.2%)	1
Suicide attempt	1/528 (0.2%)	1
Renal and urinary disorders
Nephrolithiasis	1/528 (0.2%)	1
Reproductive system and breast disorders
Menorrhagia	1/528 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Dasotraline
	Affected / at Risk (%)	# Events
Total	295/528 (55.9%)
Gastrointestinal disorders
Dry mouth	73/528 (13.8%)	81
Nausea	27/528 (5.1%)	30
Infections and infestations
Nasopharyngitis	30/528 (5.7%)	39
Upper respiratory tract infection	51/528 (9.7%)	69
Investigations
Weight decreased	77/528 (14.6%)	96
Nervous system disorders
Headache	52/528 (9.8%)	60
Psychiatric disorders
Anxiety	70/528 (13.3%)	77
Insomnia	103/528 (19.5%)	114
Irritability	27/528 (5.1%)	28

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.