Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Xuanwu Hospital, Beijing

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Intracerebral Hemorrhage

Interventions

Dimethyl fumarateDRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

PlaceboDRUG

Placebo 240mg orally twice daily for 3 consecutive days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Volume of Perihematomal edema(PHE)

measured by MRI

Time frame: day7

Glasgow Coma Scale (GCS)

The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.

Time frame: day7

National Institutes of Health Stroke Scale (NIHSS)

The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Time frame: day 7

Secondary Outcomes

Volume of Perihematomal edema(PHE)

measured by MRI

Time frame: day1

Volume of Perihematomal edema(PHE)

measured by MRI

Time frame: day3

Volume of Perihematomal edema(PHE)

measured by MRI

Time frame: day14

Volume of Perihematomal edema(PHE)

measured by MRI

Time frame: day90

Glasgow Coma Scale (GCS)

The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.

Time frame: day 1

Glasgow Coma Scale (GCS)

The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.

Data from ClinicalTrials.gov

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Glasgow Coma Scale (GCS)

The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.

Time frame: day 14

National Institutes of Health Stroke Scale (NIHSS)

The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Time frame: day1

National Institutes of Health Stroke Scale (NIHSS)

The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Time frame: day3

National Institutes of Health Stroke Scale (NIHSS)

The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Time frame: day14

National Institutes of Health Stroke Scale (NIHSS)

The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Time frame: day90