Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: Dimethyl fumarate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard management plus Dimethyl Fumarate<br> | Drug: Dimethyl fumarate<br>* Dimethyl fumarate 240mg orally twice daily for 3 consecutive days<br>|
| Placebo Comparator: standard management plus placebo<br> | Drug: Placebo<br>* Placebo 240mg orally twice daily for 3 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Perihematomal edema(PHE) | measured by MRI | 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. | 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. | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Perihematomal edema(PHE) | measured by MRI | day1 | 
| Volume of Perihematomal edema(PHE) | measured by MRI | day3 | 
| Volume of Perihematomal edema(PHE) | measured by MRI | day14 | 
| Volume of Perihematomal edema(PHE) | measured by MRI | 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. | 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. | day 3 | 
| 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. | 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. | 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. | 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. | 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. | day90 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day1 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day3 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day7 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day14 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day90 | 
| The Modified Barthel Index (mBI) | The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients. | day 1 | 
| The Modified Barthel Index (mBI) | The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients. | day 3 | 
| The Modified Barthel Index (mBI) | The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients. | day 7 | 
| The Modified Barthel Index (mBI) | The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients. | day 14 | 
| The Modified Barthel Index (mBI) | The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients. | day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perihematomal edema(PHE), neurologic deficit, immune modulator, Dimethyl Fumarate, Intracerebral Hemorrhage(ICH)