Status:
WITHDRAWN
Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in alle...
Eligibility Criteria
Inclusion
- Men and nonpregnant women aged 18 years and older
- a primary supratentorial ICH of 5 to 30 mL
- symptom onset less than 72 hours prior to admission
- a Glasgow Coma Scale (GCS) score of 6 or greater
- basal ganglia hemorrhage only
Exclusion
- patients with a GCS score of 3 to 5
- planned surgical evacuation of a large hematoma (\>30 mL)
- various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult
- patients with hematoma expansion
- secondary ICH
- preexisting disability (modified Rankin Scale \[mRS\] score \>1)
- any history of bradycardia or atrioventricular block
- concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies
- macular edema
- Patients with known hypersensitivity to dimethyl fumarate or to any excipient of this product
- Pregnant and lactating women
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04890379
Start Date
June 1 2021
End Date
December 31 2021
Last Update
October 25 2023
Active Locations (1)
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1
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China, 100053