Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Fingolimod Hydrochloride

Criteria

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.