Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinically Significant Cardiac Events	up to 30 days post-ictus	Number of participants with clinically significant cardiac events. Clinically significant cardiac events include myocardial infarction, unstable angina, stroke, transient ischemic attack, any heart failure, bradycardia and heart block. Cardiac events were monitored with telemetry up to and after 72 hours while hospitalized. A check in was performed at 30 days with an in-person clinical or hospital visit to ascertain any cardiac events via patient discussion and medical record review.
Primary	Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia)	up to 90 days post-ictus	Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group
Primary	Rate of Neurologic Decline	up to 30 days post-ictus	considered a change ≥ 4 points of the NIHSS between enrollment and 30 days post-ictus. A higher score indicates higher severity and poorer prognosis. Scale is 0-42.
Secondary	Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube	Enrollment	Rate of successful administration of fingolimod through an NGT or Dobhoff tube in Open-label group only
Secondary	Percent Change in Lymphocyte Subpopulations of CD4+ T Cells	Enrollment to 30 days	Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
Secondary	Percent Change in Lymphocyte Subpopulations of CD8+ T Cells	Enrollment and 30 days	Percent change in lymphocyte subpopulations of CD8+ T Cells
Secondary	Percent Change in Lymphocyte Subpopulations of CD19+ B Cells	Enrollment and 30 days	Percent change in lymphocyte subpopulations of CD19+ B cells
Secondary	Change in Hematoma Volume Obtained by MRI	Enrollment and 365 days	Average decrease per day by group in volumetric measurement calculations of hematoma obtained by MRI between enrollment and 365 days. All MRI imaging data obtained on hematoma volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Secondary	Change in Hematoma Volume Obtained by CT	Enrollment and 365 days	Average decrease per day by group in volumetric measurement calculations of hematoma obtained by CT between enrollment and 365 days. All CT imaging data obtained on hematoma volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Secondary	Change in Peri-hematomal Edema Volume Obtained by CT	Enrollment to 365 days	Average decrease per day by group in volumetric measurement calculations of peri-hematomal edema volume between enrollment and 365 days. All CT imaging data obtained on peri-hematomal edema volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Secondary	Change in Peri-hematomal Edema Volume Obtained by MRI	Enrollment to 365 days	Average decrease per day by group in volumetric measurement calculations of peri-hematomal edema obtained from radiographic imaging (MRI) between enrollment and 365 days. All MRI imaging data obtained on peri-hematomal edema volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Secondary	National Institutes of Health Stroke Scale Total Score (NIHSS)	365 days	The scoring range is 0 to 42 points, with higher numbers indicating greater severity. (NIHSS)
Secondary	Interviewer-administered Modified Rankin Scale (mRS)	365 days post-ictus	The modified Rankin Scale (mRS) will measure functional recovery and ability to perform activities of daily living. The mRS is a 6 point disability scale with scores ranging from 0 (no symptoms) to 5 (severe disability) with 6 indicating death. Lower scores denote better outcome.
Secondary	Patient-Reported Outcomes Measurement Information (PROMIS) 10 Questionnaire	365 days	Patient-Reported Outcomes Measurement Information System (PROMIS) 10 questionnaire will measure patient self-reporting of physical and neurobehavioral functions. Mean T-score for general population is 50 with standard deviation of 10. Higher T-scores indicate better physical and mental health. Typically, T-score ranges from 20 to 80.
Secondary	Montreal Cognitive Assessment (MoCA)	365 days	Montreal Cognitive Assessment (MoCA) will measure recovery (neurocognitive). Scores range from 0 to 30 with higher scores denoting better outcomes.
Secondary	Western Aphasia Battery-Revised (WAB-R)	365 days	Western Aphasia Battery-Revised (WAB-R) will measure recovery (neurocognitive and speech). Language and Aphasia subscale scores both range from 0 to 100. Higher scores denote better outcome.
Secondary	Mortality	30 days	Mortality at 30 days
Secondary	Mortality	90 days	Mortality at 90 days
Secondary	All Cause Mortality	up to 365 days	All cause mortality within 365 days

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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