Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cerebral Edema
- Intracerebral Hemorrhage
- Intracerebral Hemorrhage Intraparenchymal
- Intracerebral Hemorrhage, Hypertensive
- Stroke Hemorrhagic
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double-blinded, placebo-controlled pilot trial.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Consented participants will be allocated to study groups using fixed allocation randomization and a computer-based random number-generating allocation.The study pharmacist will be the only unblinded member of the study and will provide the appropriate study agent based on the statistician's randomization schema.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 wi...
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.
Tracking Information
- NCT #
- NCT04088630
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stacey Q Wolfe, MD Wake Forest University Health Sciences
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