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

February 22, 2024 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

Active, not recruiting

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. 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 MRI scan at the 30 day visit and standard of care CT of the brain at the 90 and 365 day visit and will be assessed with the pre-selected outcome assessments established by the NINDS Common Data Elements for Stroke at these time points.

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).
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Has a confirmed diagnosis of spontaneous ICH ≥ 15 mL measured utilizing ABC/2 method using radiographic imaging (computed tomography (CT), CT angiogram (CTA), etc). The presence of cerebellar ICH is exclusionary. Presence of hydrocephalus due to mass effect an cerebral edema is not exclusionary. If the patient has hydrocephalus requiring cerebrospinal fluid (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 Glasgow Coma Scale (GCS) score ≥ on presentation.
  • Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ on presentation.
  • Maintenance of systolic blood pressure (SBP) < 200 mmHg at the time of enrollment and randomization.
  • Historical Modified Rankin Scale (mRS) score of 0 or 1.

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 imagining.
  • 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.
  • Various degrees of dysphagia (determined by either formal speech and swallow or bedside swallow evaluation) or nausea/vomiting that could render oral administration of fingolimod difficult.
  • 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 Cass 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 or chronic viral infections
  • Active use of antineoplastic, immunosuppressive, or immunomodulating therapies.
  • Not expected to survive to the 180 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 Group
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 0.5 mg
A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
Other Names:
  • Gilenya
Other: Standard of care
Standard of care protocol for the treatment of spontaneous ICH
Placebo Comparator: Control Group
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
Other: Standard of care
Standard of care protocol for the treatment of spontaneous ICH
Drug: Placebo
A single oral placebo pill within 24 hours of symptom onset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinically significant cardiac events
Time Frame: up to 30 days post-ictus
up to 30 days post-ictus
Rate of nosocomial infections (UTI, sepsis, and pneumonia)
Time Frame: up to 90 days post-ictus
nosocomial infections (UTI, sepsis, and pneumonia)
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
up to 30 days post-ictus

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30 days
Mortality
Time Frame: 90 days
90 days
Change in lymphocyte subpopulations
Time Frame: 30 days
The lymphocyte subsets of CD4+ T, CD8+ T, and CD19+ B cells will be compared between the two treatment groups and the trends will be followed over time in all participants.
30 days
Hematoma volume - CT
Time Frame: Enrollment
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (CT).
Enrollment
Peri-hematomal edema volume - CT
Time Frame: Enrollment
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (CT).
Enrollment
Hematoma volume - MRI
Time Frame: Enrollment
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (MRI).
Enrollment
Peri-hematomal edema volume - MRI
Time Frame: Enrollment
Volumetric measurement calculations of the peri-hematoma area will be obtained from radiographic imaging (MRI).
Enrollment
Hematoma volume- CT
Time Frame: 24 hours post-ictus
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (CT).
24 hours post-ictus
Peri-hematomal edema volume- CT
Time Frame: 24 hours post-ictus
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (CT).
24 hours post-ictus
Hematoma volume - MRI
Time Frame: 72 hours post-ictus
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (MRI).
72 hours post-ictus
Peri-hematomal edema volume - MRI
Time Frame: 72 hours post-ictus
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (MRI).
72 hours post-ictus
Hematoma volume - CT
Time Frame: Between days 5 to 7 post-ictus
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (CT).
Between days 5 to 7 post-ictus
Peri-hematomal edema volume - CT
Time Frame: Between days 5 to 7 post-ictus
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (CT).
Between days 5 to 7 post-ictus
Hematoma volume - CT
Time Frame: Between days 10 to 14 post-ictus
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (CT).
Between days 10 to 14 post-ictus
Peri-hematomal edema volume - CT
Time Frame: Between days 10 to 14 post-ictus
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (CT).
Between days 10 to 14 post-ictus
Hematomal volume- MRI
Time Frame: Follow-Up visit 1 - Between days 16 to 44
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (MRI).
Follow-Up visit 1 - Between days 16 to 44
Peri-hematomal edema volume- MRI
Time Frame: Follow-Up visit 1 - Between days 16 to 44
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (MRI).
Follow-Up visit 1 - Between days 16 to 44
Hematoma volume- CT
Time Frame: Follow-Up visit 2- Between days 76 to 104
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (CT).
Follow-Up visit 2- Between days 76 to 104
Peri-hematomal edema volume- CT
Time Frame: Follow-Up visit 2- Between days 76 to 104
Volumetric measurement calculations of peri- hematoma will be obtained from radiographic imaging (CT).
Follow-Up visit 2- Between days 76 to 104
Hematoma volume- CT
Time Frame: Follow-Up visit 4 Between days 351 and 379
Volumetric measurement calculations of hematoma will be obtained from radiographic imaging (CT).
Follow-Up visit 4 Between days 351 and 379
Peri-hematomal edema volume- CT
Time Frame: Follow-Up visit 4 Between days 351 and 379
Volumetric measurement calculations of peri-hematoma will be obtained from radiographic imaging (CT).
Follow-Up visit 4 Between days 351 and 379
National Institutes of Health Stroke Scale
Time Frame: 365 days
As per ischemia stroke criteria, a change ≥ 4 in the NIHSS will be considered a neurologic change and will be followed over time. 0 being normal functioning and 4 being completely impaired. Lower scores denote better outcome.
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). Lower scores denote better outcome.
365 days post-ictus
Patient-Reported Outcomes Measurement Information (PROMIS) 10 questionnaire
Time Frame: up to 365 days
Patient-Reported Outcomes Measurement Information System (PROMIS) 10 questionnaire will measure patient self reporting of physical and neurobehavioral functions.Qualitative methods will be used to analyze this data.
up to 365 days
Montreal Cognitive Assessment (MoCA)
Time Frame: up to 365 days
Montreal Cognitive Assessment (MoCA) will measure recovery (neurocognitive). Scores range from 0 to 30 with higher scores denoting better outcomes.
up to 365 days
Western Aphasia Battery-Revised (WAB-R)
Time Frame: up to 365 days
Western Aphasia Battery-Revised (WAB-R) will measure recovery (neurocognitive and speech). Scores range from 0 to 76+. Higher scores denote better outcome.
up to 365 days
All cause mortality
Time Frame: up to 365 days
up to 365 days
Number of home days
Time Frame: up to 365 days
This will be an assessment of the participant's discharge disposition, followed by length of stay at a facility (inpatient rehabilitation, skilled nursing facility, assisted living facility), compared to number of days at home.
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

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 (Estimated)

June 1, 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 (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00060619

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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