An Early Phase 1 interventional study of Fingolimod and Placebo in Intracerebral Hemorrhage, Cerebral Edema and Stroke Hemorrhagic, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Treatment
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.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's enrollment of 28 is below the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has given written 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.
count \< 100,000; > 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 ≥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 .
Chronic viral or fungal infection. Active use of antineoplastic, , 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 .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Fingolimod
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
Drug: Placebo
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.
Drug: Open-label Fingolimod
A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
A single oral placebo pill within 24 hours of symptom onset
A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
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.
Time frame: up to 30 days post-ictus
Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia)
Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group
Time frame: 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.
Time frame: up to 30 days post-ictus
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
Time frame: Enrollment
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
Time frame: Enrollment to 30 days
Percent Change in Lymphocyte Subpopulations of CD8+ T Cells
Percent change in lymphocyte subpopulations of CD8+ T Cells
Time frame: Enrollment and 30 days
Percent Change in Lymphocyte Subpopulations of CD19+ B Cells
Percent change in lymphocyte subpopulations of CD19+ B cells
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 365 days
Mortality
Mortality at 30 days
Time frame: 30 days
Mortality
Mortality at 90 days
Time frame: 90 days
All Cause Mortality
All cause mortality within 365 days
Time frame: up to 365 days
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.
| Milestone | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Started | 9 | 8 | 11 |
| 24h post-ictus | 8 | 7 | 11 |
| 72h post-ictus | 9 | 7 | 10 |
| 5-7 days | 9 | 6 | 7 |
| 10-14 days | 4 | 2 | 7 |
| 30 days | 9 | 5 | 7 |
| 90 days | 9 | 5 | 8 |
| 180 days | 6 | 5 | 5 |
| 365 days | 3 | 4 | 6 |
| Completed | 3 | 4 | 3 |
| Not completed | 6 | 4 | 8 |
| Withdrew: Lost to follow-up | 3 | 2 | 6 |
| Withdrew: Death | 3 | 1 | 1 |
| Withdrew: Physician decision | 0 | 1 | 1 |
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.
| Participants | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Number of Participants With Clinically Significant Cardiac Events | 3 | 0 | 0 |
Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group
| Participants | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia) | 1 | 1 | 5 |
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.
| Participants | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Rate of Neurologic Decline | 2 | 0 | 0 |
Rate of successful administration of fingolimod through an NGT or Dobhoff tube in Open-label group only
| Participants | Open-label Fingolimod |
|---|---|
| Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube | 11 |
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
| percent change | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Percent Change in Lymphocyte Subpopulations of CD4+ T Cells | 19.6 (-18.8 to 81.9) | -2.56 (-10.3 to 3.52) | -5.00 (-14.7 to 40.5) |
Percent change in lymphocyte subpopulations of CD8+ T Cells
| percent change | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Percent Change in Lymphocyte Subpopulations of CD8+ T Cells | 19.3 (-20.4 to 59.0) | 21.4 (-6.09 to 113) | 21.6 (-61.5 to 82.9) |
Percent change in lymphocyte subpopulations of CD19+ B cells
| percent change | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Percent Change in Lymphocyte Subpopulations of CD19+ B Cells | 121 (-39.4 to 186) | 0.230 (-16.9 to 16.5) | 9.22 (-84.1 to 43.8) |
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.
| mm^3 per day | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Change in Hematoma Volume Obtained by MRI | -247.19 ± 75.68 | -86.29 ± 17.74 | -210.03 ± 23.81 |
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.
| mm^3 per day | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Change in Hematoma Volume Obtained by CT | -156.84 ± 46.35 | -90.56 ± 54.89 | -86.73 ± 15.95 |
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.
| mm^3 | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Change in Peri-hematomal Edema Volume Obtained by CT | -65.85 ± 47.50 | -62.21 ± 64.76 | -64.93 ± 16.33 |
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.
| mm^3 | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Change in Peri-hematomal Edema Volume Obtained by MRI | -327.12 ± 89.61 | -118.36 ± 31.75 | -74.96 ± 55.84 |
The scoring range is 0 to 42 points, with higher numbers indicating greater severity. (NIHSS)
| score on a scale | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| National Institutes of Health Stroke Scale Total Score (NIHSS) | 0 (0 to 0) | 1 (1 to 2) | 5 (0 to 8) |
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.
| score on a scale | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Interviewer-administered Modified Rankin Scale (mRS) | 1.5 (1 to 2) | 1.5 (1 to 2) | 2.5 (1 to 3) |
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.
| score on a scale | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Physical T Score | 48.2 (42.3 to 54.1) | 55.9 (44.9 to 61.9) | 47.7 (39.8 to 50.8) |
| Mental T Score | 53.4 (47.7 to 59.0) | 47.7 (33.8 to 62.5) | 41.1 (41.1 to 50.8) |
Montreal Cognitive Assessment (MoCA) will measure recovery (neurocognitive). Scores range from 0 to 30 with higher scores denoting better outcomes.
| score on a scale | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 25 (24 to 26) | 24 (21 to 25) | 20 (17 to 25) |
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.
| score on a scale | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Language score | 98.8 (97.5 to 100) | 96.9 (86.9 to 98.8) | 90.0 (70.6 to 93.1) |
| Aphasia score | 100 (100 to 100) | 98.3 (94.2 to 100) | 95.0 (73.3 to 95.8) |
Mortality at 30 days
| Participants | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Mortality | 0 | 1 | 0 |
Mortality at 90 days
| Participants | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| Mortality | 1 | 1 | 0 |
All cause mortality within 365 days
| Participants | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| All Cause Mortality | 3 | 1 | 1 |
Collected over Enrollment to 365 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fingolimod | 3/9 (33.3%) | 3/9 (33.3%) | 0/9 (0%) |
| Control | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) |
| Open-label Fingolimod | 1/11 (9.1%) | 5/11 (45.5%) | 0/11 (0%) |
| Event | Fingolimod | Control | Open-label Fingolimod |
|---|---|---|---|
| InfectionInfections and infestations | 1/9 | 1/8 | 5/11 |
| Cardiac eventCardiac disorders | 3/9 | 0/8 | 0/11 |
| Age, Continuous(years) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Median | 71.0 (67.0 to 77.0) | 67.0 (64.8 to 69.0) | 59.0 (48.5 to 67.5) | 66.0 (54.8 to 74.3) |
| Sex: Female, Male(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 6 | 10 |
| Male | 7 | 6 | 5 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 4 | 7 |
| Not Hispanic or Latino | 8 | 6 | 7 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 2 | 6 |
| White | 7 | 6 | 9 | 22 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Prior stroke(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Count of participants | 0 | 2 | 1 | 3 |
| Hypertension(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Count of participants | 5 | 8 | 8 | 21 |
| Diabetes(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Count of participants | 2 | 0 | 4 | 6 |
| Coronary Artery Disease(Participants) | Fingolimod | Control | Open-label Fingolimod | Total |
|---|---|---|---|---|
| Count of participants | 1 | 2 | 2 | 5 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to make individual participant data available to other researchers.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fingolimod
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