drugset / Trial / NCT04088630
Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
Phase 0
Completed
28 enrolled
Wake Forest University Health Sciences
National Center for Advancing Translational Sciences (NCATS) · collab
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2020-08-07
- Primary completion
- 2023-06-30
- Completion
- 2024-06-05
Outcome
Missed primary endpoint
registry COUNT_OF_PARTICIPANTS Fingolimod: 3 Participants COUNT_OF_PARTICIPANTS Control: 0 Participants NCT04088630 ↗
registry analysis (superiority test); Fingolimod vs Control vs Open-label Fingolimod; p = 0.0427; Fisher Exact NCT04088630 ↗
registry analysis (superiority test); Fingolimod vs Control vs Open-label Fingolimod; p = 0.19; Fisher Exact NCT04088630 ↗
registry analysis (superiority test); Fingolimod vs Control vs Open-label Fingolimod; p = 0.30; Fisher Exact NCT04088630 ↗
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fingolimod | Small molecule | 0.5 mg | Oral |