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Binge Eating Disorder Extension Study.
This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasotraline | Experimental | 4, 6, 8 mg flexibly dosed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasotraline | Drug | Dasotraline 4, 6, 8 mg flexibly dosed once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) | Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior | Baseline to Week 52 |
| Frequency and Severity of Suicidal Behavior Using the C-SSRS | Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight | Baseline, Week 52 |
| Percent Change in Body Weight (kg) | Percent change in body weight (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dasotraline Medical Director | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noesis Parma | Phoenix | Arizona | 85032 | United States | ||
| Southern California Research |
A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dasotraline | 4, 6, 8 mg flexibly dosed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2017 | Jun 17, 2020 |
Not provided
Not provided
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open-label
Not provided
| Baseline, Week 52 |
| Change in Body Mass Index | Change in Body Mass Index | Baseline, Week 52 |
| Percent Change in Body Mass Index (kg/m^2) | Percent change in Body Mass Index (kg/m^2) | Baseline, Week 52 |
| Change in Fasting Lipid Panel, Triglyceride's | Change in fasting lipid panel, Triglyceride's | Baseline, Week 52 |
| Change in Fasting Lipid Panel , Total Cholesterol | Change in fasting lipid panel , total cholesterol | Baseline, Week 52 |
| Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, | Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol, | Baseline, Week 52 |
| Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) | Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol) | Baseline, Week 52 |
| Change in Hemoglobin A1c Levels | Change in hemoglobin A1c levels | Baseline, Week 52 |
| Change in Fasting Glucose Levels | Change in fasting glucose levels | Baseline, Week 52 |
| Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores. | Baseline, Week 52 |
| Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores. Item 4: Over the past 28 days, how many times have you eaten what other people would regard as an unusually large amount of food (given the circumstances)? Item 5: On how many of these times did you have a sense of having lost control over your eating (at the time that you were eating)? | Baseline, Week 52 |
| Change in Eating Disorder Examination Questionnaire (EDE Q) Modified Global Score and Subscale Scores (Restraint, Shape, Concern, Weight Concern), and Items 4-6 Scores | Eating Disorder Examination Questionnaire (EDE-Q) Modified global and subscale scores 4 subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) range from 0- 6, where 0 represents absence of the feature and 6 represents an extreme degree. An EDE-Q global score is calculated as average of 4 EDE-Q subscale scores. Item 6: Over the past 28 days, on how many DAYS have such episodes of overeating occurred (i.e., you have eaten an unusually large amount of food and have had a sense of loss of control at the time)? | Baseline, Week 52 |
| Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score | Binge-eating Clinical Global Impression-Severity (BE-CGI-S) The BE-CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity. | Baseline, Week 52 |
| Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability) | The Sheehan Disability Scale (SDS) 3 subscales (work/school, social life, home life) are rated on the following scale: 0 = not at all; 1-3 = mildly; 4-6 = moderately; 7-9 =markedly; 10 = extremely. The 3 items can be combined into a single global measure of impairment (SDS total score) that ranges from 0 (unimpaired) to 30 (highly impaired). A higher subscale score and total score are associated with greater illness severity. | Baseline, Week 52 |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Hamilton Anxiety Rating Scale (HAM-A) total score HAM-A total score ranges from 0 to 56. A higher score is associated with a greater degree of anxiety. | Baseline, Week 52 |
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Montgomery-Asberg Depression Rating Scale (MADRS) total score The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms | Baseline, Week 52 |
| Change in SF-12 Two Component Scores (Physical, Mental Health) | Change in SF-12 two component scores (physical, mental health) for Subjects Continued from Study SEP360-221 The SF-12 is a 12-item self-report questionnaire. Physical Component Summary (PCS) and Mental Component Summary (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline, Week 52 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Pharmacology Research Institute | Encino | California | 91316 | United States |
| Collaborative NeuroScience Network Inc. | Garden Grove | California | 92845 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Weiss and Lytle, PLLC | Denver | Colorado | 80209* | United States |
| CT Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Institute of Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Neuotrials Research, Inc. | Atlanta | Georgia | 30342 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Goldpoint Clinical Research, Inc. | Indianapolis | Indiana | 46260 | United States |
| Phoenix Medical Research, Inc. Suite 135 | Prairie Village | Kansas | 66208 | United States |
| Cyress Medical Research Center, LLC | Wichita | Kansas | 67226 | United States |
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | United States |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| ActivMed Practices and Research, Inc. | Portsmouth | New Hampshire | 03801 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Princeton Medical Institute, LCC | Princeton | New Jersey | 08540 | United States |
| Bioscience Research, LLC | Mount Kisco | New York | 10549 | United States |
| Manhattan Behavioral Medicine, PLLC | New York | New York | 10036 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Radiant Research, Inc. | Akron | Ohio | 44311 | United States |
| Patient Priority Clinical Sites | Cincinnati | Ohio | 45215 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Lindner Center Of Hope | Mason | Ohio | 45040 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | United States |
| Oregon Center for Clinical Investigatons, INC. | Portland | Oregon | 97214 | United States |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | 97301 | United States |
| Lehigh Center For Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Radiant Research, Inc. | Anderson | South Carolina | 29621 | United States |
| Radient Research, Inc. | Greer | South Carolina | 29650 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Neuroscience Solutons, Inc. | Memphis | Tennessee | 38119 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Donald J. Garcia Jr., MD | Austin | Texas | 78737 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Psychiatric Medical Associates | Plano | Texas | 75023 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Radient Research, Inc. | San Antonio | Texas | 78229 | United States |
| Radiant Research, Inc. | Murray | Utah | 84123 | United States |
| Neuropsychiatric Associates | Woodstock | Vermont | 05091 | United States |
| NeuroScience, Inc. | Herndon | Virginia | 20170 | United States |
| Summitt Research Network(Seattle) LLC | Seattle | Washington | 98104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
safety
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dasotraline | 4, 6, 8 mg flexibly dosed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||
| Height (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||||||||
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||||
| Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Double-Blind (DB) Baseline | DB Baseline (ie, Baseline assessment of the double-blind core studies [SEP 360-221, or SEP360-321]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies. | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| Binge-eating Clinical Global Impression-Severity (BE-CGI-S) Score at Open Label (OL) Baseline | The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study [SEP 360-322] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies [SEP 360-221, or SEP 360-321], otherwise). | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Global Score | DB Baseline (ie, Baseline assessment of the double-blind core studies [SEP 360-221, or SEP360-321]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies. | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Restraint | DB Baseline (ie, Baseline assessment of the double-blind core studies [SEP 360-221, or SEP360-321]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies. | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| Eating Disorder Examination Question(EDE-QM) Modified Score at DB Baseline - Shape Concern | DB Baseline (ie, Baseline assessment of the double-blind core studies [SEP 360-221, or SEP360-321]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies. | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| EDE-QM Modified Score at DB Baseline - Weight Concern | DB Baseline (ie, Baseline assessment of the double-blind core studies [SEP 360-221, or SEP360-321]) is defined as the last assessment made on or before the 1st dose of double-blind study medication as described in the SAPs of the core studies. | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| EDE-QM Modified Score at OL Baseline - Global Score | The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study [SEP 360-322] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies [SEP 360-221, or SEP 360-321], otherwise). | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| EDE-QM Modified Score at OL Baseline - Restraint | The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study [SEP 360-322] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies [SEP 360-221, or SEP 360-321], otherwise). | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| EDE-QM Modified Score at OL Baseline - Shape Concern | The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study [SEP 360-322] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies [SEP 360-221, or SEP 360-321], otherwise). | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| Eating Disorder Examination Question(EDE-QM) Modified Score at OL Baseline - Weight Concern | The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study [SEP 360-322] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies [SEP 360-221, or SEP 360-321], otherwise). | Mean | Standard Deviation | Score |
| ||||||||||||||||||||
| summary for Body Mass Index (BMI) category at open label baseline | The OL Baseline is defined as the last assessment made on or before Day 1 of the extension study (ie, Baseline assessment in the open-label study [SEP 360-322] for demographic and EDE-Q modified, and height at the screening and the Endpoint assessment of the double-blind studies [SEP 360-221, or SEP 360-321], otherwise). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Safety- please note: one subject had no value for Suicidal Ideation or Suicidal Behavior | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| 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 | Safety | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change in Body Weight | Change in body weight | Safety | Posted | Mean | 95% Confidence Interval | kg | Baseline, Week 52 |
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| Secondary | Percent Change in Body Weight (kg) | Percent change in body weight (kg) | Safety | Posted | Mean | 95% Confidence Interval | percent change | Baseline, Week 52 |
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| Secondary | Change in Body Mass Index | Change in Body Mass Index | Safety | Posted | Mean | 95% Confidence Interval | kg/m^2 | Baseline, Week 52 |
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| Secondary | Percent Change in Body Mass Index (kg/m^2) | Percent change in Body Mass Index (kg/m^2) | Safety | Posted | Mean | 95% Confidence Interval | percent change | Baseline, Week 52 |
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| Secondary | Change in Fasting Lipid Panel, Triglyceride's | Change in fasting lipid panel, Triglyceride's | Safety | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, Week 52 |
|
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| |||||||||||||||||||||||||||||
| Secondary | Change in Fasting Lipid Panel , Total Cholesterol | Change in fasting lipid panel , total cholesterol | Safety | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, Week 52 |
|
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| Secondary | Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol, | Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol, | Safety | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, Week 52 |
|
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| Secondary | Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol) | Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol) | Safety | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, Week 52 |
|
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| Secondary | Change in Hemoglobin A1c Levels | Change in hemoglobin A1c levels | Safety | Posted | Mean | 95% Confidence Interval | Percent change | Baseline, Week 52 |
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| Secondary | Change in Fasting Glucose Levels | Change in fasting glucose levels | Safety | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, Week 52 |
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| 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. | Safety | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||
| 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)? | Safety | Posted | Mean | 95% Confidence Interval | events | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||
| 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)? | Safety | Posted | Mean | 95% Confidence Interval | number of days | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||
| 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. | Safety | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||
| 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. | Safety | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||
| 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. | Safety | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 52 |
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| 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 | Safety | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||||||
| 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. | Safety | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 52 |
|
|
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).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasotraline | 4, 6, 8 mg flexibly dosed | 0 | 528 | 21 | 528 | 295 | 528 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Hemiplegic migraine | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Substance-induced mood disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CNS Medical Director | Sunovion Pharmaceuticals Inc. | 1-866-503-6351 | ClinicalTrialDisclosure@sunovion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2019 | Jun 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609455 | 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Obesity Class I (30 to <35) |
|
| Obesity Class II (35 to <40) |
|
| Obesity Class III (>=40) |
|
| 3: ideation with any methods , no intent to act |
|
| 4: ideation with some intent to act, no plan |
|
| 5: Active ideation with specific plan and intent |
|
|
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|---|---|---|---|---|---|---|
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