Intracerebral Hemorrhage
Conditions
Keywords
Dimethyl Fumarate, Intracerebral Hemorrhage(ICH), perihematomal edema(PHE), neurologic deficit, immune modulator
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 alleviating PHE and neurologic deficits in patients with ICH.
Interventions
DRUGDimethyl fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
DRUGPlacebo
Placebo 240mg orally twice daily for 3 consecutive days
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Perihematomal edema(PHE) | day7 | measured by MRI |
| Glasgow Coma Scale (GCS) | day7 | The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is. |
| National Institutes of Health Stroke Scale (NIHSS) | day 7 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Perihematomal edema(PHE) | day1 | measured by MRI |
| Glasgow Coma Scale (GCS) | day 1 | The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is. |
| National Institutes of Health Stroke Scale (NIHSS) | day1 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
| The Modified Rankin Scale (mRS) | day1 | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. |
| The Modified Barthel Index (mBI) | day 1 | The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients. |
Countries
China
Outcome results
None listed