NCT06087965

Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.

Detailed description

40 ICH patients who meet the inclusion criteria will be enrolled in the present study. All ICH patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review. After obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. Patients assigned to the control group will not receive fingolimod. All patients will receive minimal invasive puncture and drainage of hematoma. The investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. CT scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Fingolimod	0.5mg/day oral fingolimod over a course of 3 consecutive days

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2023-10-18
• Last updated: 2023-10-18