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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).
This is a double-blinded, placebo-controlled pilot trial of fingolimod in patients with primary spontaneous intracerebral hemorrhage. Eligible participants will be allocated to study groups using fixed allocation randomization and a computer-based random number-generating allocation. For those patients who meet all inclusion criteria without exclusion criteria subjects will receive oral or nasogastric tube (NGT) or Dobhoff feeding tube administration of fingolimod versus placebo. Participants will be monitored at time of enrollment and days 1, 3 5, 7, and 14 (discharge dependent) by 2 blinded assessors (neuroscience subspecialists) and will receive standard of care for the duration of the study. After discharge from the hospital, participants will enter a follow up phase of 12 months, with clinic visits at 30±14 days, 90±14 days, 180±14 days, and 365±14 days. They will receive a standard of care neuroimaging at these follow up time-points and will be assessed with the pre-selected outcome assessments established by the NINDS Common Data Elements for Stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | Experimental | In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset. |
|
| Placebo Control | Placebo Comparator | In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset |
|
| Open-label Fingolimod | Experimental | In addition to standard of care treatment,10 subjects who are unable to be administered oral medication will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Cardiac Events | 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. | up to 30 days post-ictus |
| Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group | up to 90 days post-ictus |
| Rate of Neurologic Decline | 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. | up to 30 days post-ictus |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube | Rate of successful administration of fingolimod through an NGT or Dobhoff tube in Open-label group only | Enrollment |
| Percent Change in Lymphocyte Subpopulations of CD4+ T Cells |
Not provided
Inclusion Criteria:
Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR). When the LAR is not available for consent, Docusign for econsent may be obtained.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Men and non-pregnant women ages 18-80 years old Has a confirmed diagnosis of spontaneous supratentorial ICH. The presence of cerebellar ICH is exclusionary. Presence of hydrocephalus due to mass effect and cerebral edema is not exclusionary. If the patient has hydrocephalus requiring CSF drainage, an external ventricular drain will be placed as standard of care and will not be exclusionary.
Symptoms less than 24 hours prior to enrollment if all eligibility criteria are met. An unknown time of onset is exclusionary. Use the time the patient was last known to be well for patients that awaken from sleep with symptoms.
Has a GCS score ≥ 5 on presentation. Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 on presentation.
Maintenance of SBP < 200 mmHg at the time of enrollment and randomization. Historical Modified Rankin Scale score of 0-2.
Exclusion Criteria:
Men or women < 18 years old Incarcerated patients ICH known as a result of trauma. Primary intraventricular hemorrhage without significant intraparenchymal component.
Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of recent (< 1 year) hemorrhage, neoplasms diagnosed with radiographic imaging.
Patients with unstable mass or evolving intracranial compartment syndrome. Brainstem hemorrhage or irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
Platelet count < 100,000; INR > 1.4. Any irreversible coagulopathy or known clotting disorder. Known history of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome.
Admission within the past 6 months for the following: myocardial infarction, unstable angina, stroke, decompensated heart failure requiring hospitalization, or Class III/IV heart failure.
Baseline QTc interval ≥500 ms. Current treatment with Class Ia or Class III anti-arrhythmic drugs. Implanted cardiac devices that are not compatible with the desired MRI sequences needed for the study (non-contrast T1, T2, SWI/GRE, and FLAIR sequences).
Abnormal liver function or liver failure. Active acute infection that is deemed by the Principal Investigator to be clinically significant.
Chronic viral or fungal infection. Active use of antineoplastic, immunosuppressive, or immunomodulating therapies. Leukopenia with a WBC < 2.0 x 109/L. Not expected to survive to the 365 day visit due to co-morbidities or is DNR/DNI status prior to randomization.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Concomitant enrollment in another interventional study. Inability or unwillingness of participant or legal guardian/representative to give written informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Stacey Q Wolfe, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19427958 | Background | Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8. | |
| 20056489 | Background | van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5. |
| Label | URL |
|---|---|
| Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III | View source |
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There is no plan to make individual participant data available to other researchers.
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Consented participants who can be administered an oral drug will be allocated to Fingolimod or Placebo study groups using a computer-based random number-generating allocation. Consented participants who are unable to be administered the oral drug or placebo are assigned to the open-label group.
Adult patients coming the Emergency Department or direct admitted to the Neurosciences Intensive Care Unit at Wake Forest Baptist Hospital between August 2020 and June 2023 with the diagnosis of spontaneous ICH will be identified as potentially eligible participants and screened by interview.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod | In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset. Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2023 |
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Randomized, double-blinded, placebo-controlled pilot trial.
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Consented participants who can be administered an oral drug will be allocated to Fingolimod or Placebo study groups using a computer-based random number-generating allocation. Consented participants who are unable to be administered the oral drug or placebo are assigned to the open-label group. The study pharmacist will be the only member of the study to be unblinded to oral fingolimod or placebo randomization.
| Placebo |
| Drug |
A single oral placebo pill within 24 hours of symptom onset |
|
| Open-label Fingolimod | Drug | A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset |
|
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells |
| Enrollment to 30 days |
| Percent Change in Lymphocyte Subpopulations of CD8+ T Cells | Percent change in lymphocyte subpopulations of CD8+ T Cells | Enrollment and 30 days |
| Percent Change in Lymphocyte Subpopulations of CD19+ B Cells | Percent change in lymphocyte subpopulations of CD19+ B cells | Enrollment and 30 days |
| Change in Hematoma Volume Obtained by MRI | 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. | Enrollment and 365 days |
| Change in Hematoma Volume Obtained by CT | 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. | Enrollment and 365 days |
| Change in Peri-hematomal Edema Volume Obtained by CT | 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. | Enrollment to 365 days |
| Change in Peri-hematomal Edema Volume Obtained by MRI | 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. | Enrollment to 365 days |
| National Institutes of Health Stroke Scale Total Score (NIHSS) | The scoring range is 0 to 42 points, with higher numbers indicating greater severity. (NIHSS) | 365 days |
| Interviewer-administered Modified Rankin Scale (mRS) | 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. | 365 days post-ictus |
| Patient-Reported Outcomes Measurement Information (PROMIS) 10 Questionnaire | 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. | 365 days |
| Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment (MoCA) will measure recovery (neurocognitive). Scores range from 0 to 30 with higher scores denoting better outcomes. | 365 days |
| Western Aphasia Battery-Revised (WAB-R) | 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. | 365 days |
| Mortality | Mortality at 30 days | 30 days |
| Mortality | Mortality at 90 days | 90 days |
| All Cause Mortality | All cause mortality within 365 days | up to 365 days |
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| 29114096 | Background | Qin C, Fan WH, Liu Q, Shang K, Murugan M, Wu LJ, Wang W, Tian DS. Fingolimod Protects Against Ischemic White Matter Damage by Modulating Microglia Toward M2 Polarization via STAT3 Pathway. Stroke. 2017 Dec;48(12):3336-3346. doi: 10.1161/STROKEAHA.117.018505. Epub 2017 Nov 7. |
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| 25489101 | Background | Fu Y, Zhang N, Ren L, Yan Y, Sun N, Li YJ, Han W, Xue R, Liu Q, Hao J, Yu C, Shi FD. Impact of an immune modulator fingolimod on acute ischemic stroke. Proc Natl Acad Sci U S A. 2014 Dec 23;111(51):18315-20. doi: 10.1073/pnas.1416166111. Epub 2014 Dec 8. |
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| 23104886 | Background | Dobin A, Davis CA, Schlesinger F, Drenkow J, Zaleski C, Jha S, Batut P, Chaisson M, Gingeras TR. STAR: ultrafast universal RNA-seq aligner. Bioinformatics. 2013 Jan 1;29(1):15-21. doi: 10.1093/bioinformatics/bts635. Epub 2012 Oct 25. |
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| 25246651 | Background | Ching T, Huang S, Garmire LX. Power analysis and sample size estimation for RNA-Seq differential expression. RNA. 2014 Nov;20(11):1684-96. doi: 10.1261/rna.046011.114. Epub 2014 Sep 22. |
| Background | Benjamini Y, Hochberg Y. Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. Journal of the Royal Statistical Society Series B (Methodological). 1995;57(1):289-300 |
| 24336805 | Background | Kramer A, Green J, Pollard J Jr, Tugendreich S. Causal analysis approaches in Ingenuity Pathway Analysis. Bioinformatics. 2014 Feb 15;30(4):523-30. doi: 10.1093/bioinformatics/btt703. Epub 2013 Dec 13. |
| 17576678 | Background | Huang DW, Sherman BT, Tan Q, Kir J, Liu D, Bryant D, Guo Y, Stephens R, Baseler MW, Lane HC, Lempicki RA. DAVID Bioinformatics Resources: expanded annotation database and novel algorithms to better extract biology from large gene lists. Nucleic Acids Res. 2007 Jul;35(Web Server issue):W169-75. doi: 10.1093/nar/gkm415. Epub 2007 Jun 18. |
| MIND: Artemis in the Removal of Intracerebral Hemorrhage | View source |
| ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH) | View source |
| Control |
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset Control: A single oral placebo pill within 24 hours of symptom onset |
| FG002 | Open-label Fingolimod | In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube. Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset |
| 24h Post-ictus |
|
| 72h Post-ictus |
|
| 5-7 Days |
|
| 10-14 Days |
|
| 30 Days |
|
| 90 Days |
|
| 180 Days |
|
| 365 Days |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod | In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset. Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset |
| BG001 | Control | In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset Control: A single oral placebo pill within 24 hours of symptom onset |
| BG002 | Open-label Fingolimod | In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube. Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Prior stroke | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Coronary Artery Disease | Count of Participants | Participants |
| ||||||||||||||||
| Hyperlipidemia | Count of Participants | Participants |
| ||||||||||||||||
| Obesity | Count of Participants | Participants |
| ||||||||||||||||
| Atrial Fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||
| Antiplatelet medication | Count of Participants | Participants |
| ||||||||||||||||
| Anticoagulant Medication | 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 | Number of Participants With Clinically Significant Cardiac Events | 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. | All enrolled participants | Posted | Count of Participants | Participants | up to 30 days post-ictus |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group | All enrolled participants by group | Posted | Count of Participants | Participants | up to 90 days post-ictus |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Rate of Neurologic Decline | 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. | All three arms where data were available at 90 days | Posted | Count of Participants | Participants | up to 30 days post-ictus |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube | Rate of successful administration of fingolimod through an NGT or Dobhoff tube in Open-label group only | 11 subjects enrolled in open-label arm | Posted | Count of Participants | Participants | Enrollment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lymphocyte Subpopulations of CD4+ T Cells | Percent Change in Lymphocyte Subpopulations of CD4+ T Cells | Subjects where 30 day labs were obtained are included in this analysis | Posted | Median | Full Range | percent change | Enrollment to 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lymphocyte Subpopulations of CD8+ T Cells | Percent change in lymphocyte subpopulations of CD8+ T Cells | Subjects where 30 day labs were obtained are included in this analysis | Posted | Median | Full Range | percent change | Enrollment and 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lymphocyte Subpopulations of CD19+ B Cells | Percent change in lymphocyte subpopulations of CD19+ B cells | Subjects where 30 day labs were obtained are included in this analysis | Posted | Median | Full Range | percent change | Enrollment and 30 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hematoma Volume Obtained by MRI | 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. | All enrolled subjects included in analysis. Fingolimod group included 18 observations, placebo included 14 observations and open-label included 23 observations across the time period. | Posted | Mean | Standard Error | mm^3 per day | Enrollment and 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hematoma Volume Obtained by CT | 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. | All enrolled subjects included in analysis. Fingolimod group included 46 observations, placebo included 39 observations and open-label included 60 observations across the time period. | Posted | Mean | Standard Error | mm^3 per day | Enrollment and 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Peri-hematomal Edema Volume Obtained by CT | 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. | All enrolled subjects included in analysis. Fingolimod group included 46 observations, placebo included 39 observations and open-label included 60 observations across the time period. | Posted | Mean | Standard Error | mm^3 | Enrollment to 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Peri-hematomal Edema Volume Obtained by MRI | 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. | All enrolled subjects included in analysis. Fingolimod group included 18 observations, placebo included 14 observations and open-label included 23 observations across the time period. | Posted | Mean | Standard Error | mm^3 | Enrollment to 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | National Institutes of Health Stroke Scale Total Score (NIHSS) | The scoring range is 0 to 42 points, with higher numbers indicating greater severity. (NIHSS) | Subjects where score was collected at 365 days. | Posted | Median | Full Range | score on a scale | 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Interviewer-administered Modified Rankin Scale (mRS) | 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. | Subjects where scores were collected at 365 days. | Posted | Median | Full Range | score on a scale | 365 days post-ictus |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient-Reported Outcomes Measurement Information (PROMIS) 10 Questionnaire | 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. | Subjects completing instrument at 365 days. | Posted | Median | Full Range | score on a scale | 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment (MoCA) will measure recovery (neurocognitive). Scores range from 0 to 30 with higher scores denoting better outcomes. | Subjects completing instrument at 365 days. | Posted | Median | Full Range | score on a scale | 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Western Aphasia Battery-Revised (WAB-R) | 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. | Subjects completing instrument at 365 days. | Posted | Median | Full Range | score on a scale | 365 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mortality | Mortality at 30 days | All enrolled subjects | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mortality | Mortality at 90 days | Posted | Count of Participants | Participants | 90 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Cause Mortality | All cause mortality within 365 days | All enrolled subjects | Posted | Count of Participants | Participants | up to 365 days |
|
Enrollment to 365 days
Not provided
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 | Fingolimod | In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset. Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset | 3 | 9 | 3 | 9 | 0 | 9 |
| EG001 | Control | In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset Control: A single oral placebo pill within 24 hours of symptom onset | 1 | 8 | 1 | 8 | 0 | 8 |
| EG002 | Open-label Fingolimod | In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube. Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset | 1 | 11 | 5 | 11 | 0 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac event | Cardiac disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Kittel, Senior Biostatistician | Wake Forest University School of Medicine | 336-399-3832 | c.kittel@wakehealth.edu |
| Nov 20, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2022 | Aug 2, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D001929 | Brain Edema |
| D000083302 | Hemorrhagic Stroke |
| D020299 | Intracranial Hemorrhage, Hypertensive |
| D009461 | Neurologic Manifestations |
| D001930 | Brain Injuries |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Never |
|
| Unknown |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
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In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
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In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
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In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube. Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset |
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