Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

haojunwei2

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 alleviating PHE and neurologic deficits in patients with ICH.

2021-06-01

2021-12-31

2021-12-31

Withdrawn

Early phase I

Inclusion Criteria: 1. Men and nonpregnant women aged 18 years and older 2. a primary supratentorial ICH of 5 to 30 mL 3. symptom onset less than 72 hours prior to admission 4. a Glasgow Coma Scale (GCS) score of 6 or greater 5. basal ganglia hemorrhage only Exclusion Criteria: 1. patients with a GCS score of 3 to 5 2. planned surgical evacuation of a large hematoma (\>30 mL) 3. various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult 4. patients with hematoma expansion 5. secondary ICH 6. preexisting disability (modified Rankin Scale \[mRS\] score \>1) 7. any history of bradycardia or atrioventricular block 8. concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies 9. macular edema 10. Patients with known hypersensitivity to dimethyl fumarate or to any excipient of this product 11. Pregnant and lactating women

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-10-25