Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage (FITCH)

January 13, 2025 updated by: Wake Forest University Health Sciences
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Fingolimod
A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
Placebo Comparator: Placebo 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
Drug: Placebo
A single oral placebo pill within 24 hours of symptom onset
Experimental: Open-label Fingolimod
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 fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinically Significant Cardiac Events
Time Frame: 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.
up to 30 days post-ictus
Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia)
Time Frame: up to 90 days post-ictus
Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group
up to 90 days post-ictus
Rate of Neurologic Decline
Time Frame: 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.
up to 30 days post-ictus

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
Mortality at 90 days
90 days
Mortality
Time Frame: 30 days
Mortality at 30 days
30 days
Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube
Time Frame: Enrollment
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
Time Frame: Enrollment to 30 days
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
Enrollment to 30 days
Percent Change in Lymphocyte Subpopulations of CD8+ T Cells
Time Frame: Enrollment and 30 days
Percent change in lymphocyte subpopulations of CD8+ T Cells
Enrollment and 30 days
Percent Change in Lymphocyte Subpopulations of CD19+ B Cells
Time Frame: Enrollment and 30 days
Percent change in lymphocyte subpopulations of CD19+ B cells
Enrollment and 30 days
Change in Hematoma Volume Obtained by MRI
Time Frame: 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.
Enrollment and 365 days
Change in Hematoma Volume Obtained by CT
Time Frame: 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.
Enrollment and 365 days
Change in Peri-hematomal Edema Volume Obtained by CT
Time Frame: 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.
Enrollment to 365 days
Change in Peri-hematomal Edema Volume Obtained by MRI
Time Frame: 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.
Enrollment to 365 days
National Institutes of Health Stroke Scale Total Score (NIHSS)
Time Frame: 365 days
The scoring range is 0 to 42 points, with higher numbers indicating greater severity. (NIHSS)
365 days
Interviewer-administered Modified Rankin Scale (mRS)
Time Frame: 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.
365 days post-ictus
Patient-Reported Outcomes Measurement Information (PROMIS) 10 Questionnaire
Time Frame: 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.
365 days
Montreal Cognitive Assessment (MoCA)
Time Frame: 365 days
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)
Time Frame: 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.
365 days
All Cause Mortality
Time Frame: up to 365 days
All cause mortality within 365 days
up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Stacey Q Wolfe, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 5, 2024

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00060619
  • UL1TR001420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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