Binge Eating DisorderPhase 3NCT02684279
Dasotraline Binge Eating Disorder Extension Study
A Phase 3 study testing Dasotraline in people with Binge Eating Disorder, run by Sumitomo Pharma America, Inc. at 57 sites in United States.
Trial summary
Binge Eating Disorder Extension Study. Read more about this study
- Who is it for?
- Ages 18 to 56 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Dasotraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 57 sitesUnited States
- Study dates
- 29 Feb 2016to 24 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104
Institute of Advanced Medical Research
Alpharetta, Georgia, 30005
Radiant Research, Inc.
Anderson, South Carolina, 29621
Neuotrials Research, Inc.
Atlanta, Georgia, 30342
Donald J. Garcia Jr., MD
Austin, Texas, 78737
McLean Hospital
Belmont, Massachusetts, 02478
Southern California Research
Beverly Hills, California, 90210
Boston Clinical Trials
Boston, Massachusetts, 02131
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
CT Clinical Research
Cromwell, Connecticut, 06416
Midwest Clinical Research Center
Dayton, Ohio, 45417
Weiss and Lytle, PLLC
Denver, Colorado, 80209*
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Collaborative NeuroScience Network Inc.
Garden Grove, California, 92845
Radient Research, Inc.
Greer, South Carolina, 29650
NeuroScience, Inc.
Herndon, Virginia, 20170
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Goldpoint Clinical Research, Inc.
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Capstone Clinical Research
Libertyville, Illinois, 60048
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Lindner Center Of Hope
Mason, Ohio, 45040
Sunstone Medical Research, LLC
Medford, Oregon, 97504
Clinical Neuroscience Solutons, Inc.
Memphis, Tennessee, 38119
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, 01844
Bioscience Research, LLC
Mount Kisco, New York, 10549
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Radiant Research, Inc.
Murray, Utah, 84123
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036
The Medical Research Network, LLC
New York, New York, 10128
Pharmacology Research Institute
Newport Beach, California, 92660
Segal Institute for Clinical Research
North Miami, Florida, 33161
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Noesis Parma
Phoenix, Arizona, 85032
Psychiatric Medical Associates
Plano, Texas, 75023
Oregon Center for Clinical Investigatons, INC.
Portland, Oregon, 97214
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, 03801
Phoenix Medical Research, Inc. Suite 135
Prairie Village, Kansas, 66208
Princeton Medical Institute, LCC
Princeton, New Jersey, 08540
Wake Research Associates
Raleigh, North Carolina, 27612
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Radient Research, Inc.
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Marcos, California, 92078
Syrentis Clinical Research
Santa Ana, California, 92705
Summitt Research Network(Seattle) LLC
Seattle, Washington, 98104
Miami Research Associates
South Miami, Florida, 33143
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472
Cyress Medical Research Center, LLC
Wichita, Kansas, 67226
Neuropsychiatric Associates
Woodstock, Vermont, 05091
About this study
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
Binge Eating Disorder Extension Study.
Read the detailed description
This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.
- Conditions
- Binge Eating Disorder
- Being tested
- Dasotraline
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasotralineDrug
Dasotraline 4, 6, 8 mg flexibly dosed once daily
| Study group | Role | What they receive |
|---|---|---|
| Dasotraline | Experimental | 4, 6, 8 mg flexibly dosed Receives: Drug: Dasotraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to Week 52
Secondary outcomes (18)
Change in Body Weight
Change in body weight
Measured: Baseline, Week 52
Percent Change in Body Weight (kg)
Percent change in body weight (kg)
Measured: Baseline, Week 52
Change in Body Mass Index
Change in Body Mass Index
Measured: Baseline, Week 52
Percent Change in Body Mass Index (kg/m^2)
Percent change in Body Mass Index (kg/m^2)
Measured: Baseline, Week 52
Change in Fasting Lipid Panel, Triglyceride's
Change in fasting lipid panel, Triglyceride's
Measured: Baseline, Week 52
Change in Fasting Lipid Panel , Total Cholesterol
Change in fasting lipid panel , total cholesterol
Measured: Baseline, Week 52
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
Change in fasting lipid panel, high-density lipoprotein [HDL] cholesterol,
Measured: Baseline, Week 52
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
Change in fasting lipid panel, low-density lipoprotein [LDL] cholesterol)
Measured: Baseline, Week 52
Change in Hemoglobin A1c Levels
Change in hemoglobin A1c levels
Measured: Baseline, Week 52
Change in Fasting Glucose Levels
Change in fasting glucose levels
Measured: 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.
Measured: 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)?
Measured: 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)?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start29 Feb 2016
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dasotraline Medical Director, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684279
- Sponsor's protocol ID
- SEP360-322
- Status last verified
- Jul 2020
- First submitted
- 28 Jan 2016
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02684279
- Acronym / sponsor ID
- SEP360-322
- Conditions
- Binge Eating Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Binge Eating Disorder Extension Study.
Detailed description
This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasotraline | Experimental | Drug: Dasotraline4, 6, 8 mg flexibly dosed |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasotralineDasotraline 4, 6, 8 mg flexibly dosed once daily | Drug | Dasotraline |
Primary outcome
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to Week 52
Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior
Frequency and Severity of Suicidal Behavior Using the C-SSRS
Time frame: Baseline to Week 52
Columbia-suicide severity rating scale (C-SSRS) Severity of suicidal ideation is rated on a 6-point scale from 0='No ideation present' to 5='Active ideation with plan and intent'. A score of 4 or 5 on this scale indicates serious suicidal ideation. Suicidal behavior is collected as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior
18 secondary outcomes
Change in Body Weight
Time frame: Baseline, Week 52
Percent Change in Body Weight (kg)
Time frame: Baseline, Week 52
Change in Body Mass Index
Time frame: Baseline, Week 52
Percent Change in Body Mass Index (kg/m^2)
Time frame: Baseline, Week 52
Change in Fasting Lipid Panel, Triglyceride's
Time frame: Baseline, Week 52
Change in Fasting Lipid Panel , Total Cholesterol
Time frame: Baseline, Week 52
Change in Fasting Lipid Panel , High-density Lipoprotein [HDL] Cholesterol,
Time frame: Baseline, Week 52
Change in Fasting Lipid Panel, Low-density Lipoprotein [LDL] Cholesterol)
Time frame: Baseline, Week 52
Change in Hemoglobin A1c Levels
Time frame: Baseline, Week 52
Change in Fasting Glucose Levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 52
Change in Binge Eating Clinical Global Impression-Severity (BE-CGI S) Score
Time frame: Baseline, Week 52
Change in Sheehan Disability Scale (SDS) Total Score and Subscale Scores (School/Work Disability, Social Life Disability, and Family Life Disability)
Time frame: Baseline, Week 52
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline, Week 52
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline, Week 52
Change in SF-12 Two Component Scores (Physical, Mental Health)
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dasotraline Medical Director study director
Sumitomo Pharma America, Inc.
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dasotraline in people with Binge Eating Disorder, run by Sumitomo Pharma America, Inc. at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS) (time frame: Baseline to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.