Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage — FITCH  

Intracerebral Hemorrhage Clinical Trial

Official title: Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Edema
• Cerebral Edema
• Cerebral Hemorrhage
• Edema
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage
• Intracerebral Hemorrhage Intraparenchymal
• Intracerebral Hemorrhage, Hypertensive
• Intracranial Hemorrhage, Hypertensive
• Stroke Hemorrhagic

• NCT number: NCT04088630
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 7, 2020
• Completion date: June 2024