CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 28 enrolled
Drug / intervention
Fingolimod +2 moredrug
Likely dose
Fingolimod 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04088630
NCT04088630Early Ph 1Completed
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Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

Wake Forest University Health Sciences·interventional·Posted Sep 13, 2019·Updated Jan 23, 2025

In Brief

A Early Phase 1 clinical trial evaluating Fingolimod, Placebo, and 1 other intervention for Intracerebral Hemorrhage and 4 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracerebral Hemorrhage, Cerebral Edema, Stroke Hemorrhagic, Intracerebral Hemorrhage, Hypertensive, Intracerebral Hemorrhage Intraparenchymal
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedSep 13, 2019
Enrollment StartAug 7, 2020
Primary CompletionJun 30, 2023
Study CompletionJun 5, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.8 years ago

Interventions

Fingolimoddrug

A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset

Placebodrug

A single oral placebo pill within 24 hours of symptom onset

Open-label Fingolimoddrug

A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset