NCT04088630

Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Fingolimod	A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
DRUG	Placebo	A single oral placebo pill within 24 hours of symptom onset
DRUG	Open-label Fingolimod	A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset

Timeline

• Start date: 2020-08-07
• Primary completion: 2023-06-30
• Completion: 2024-06-05
• First posted: 2019-09-13
• Last updated: 2025-01-23
• Results posted: 2025-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study