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Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

NCT04088630 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-01-23

Study results available
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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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Stacey Q Wolfe, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2023-06-30
Completion
2024-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088630 on ClinicalTrials.gov