Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.

Official Title
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Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Dimethyl fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 y of age; acute onset of focal neurological deficit consistent with acute ischemic stroke; measurable neurological deficit (NIHSS ≥ 5); anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI); onset of symptom to admission more than 4.5 h and less than 72 h. Patients who arrived within 0-4.5 h poststroke were treated with other medications according to the best accepted medical treatment guidelines. Exclusion Criteria: Other diseases of the central nervous system There has been neurological disability in the past (mRS score>2) Difficulty swallowing Arrhythmia, atrioventricular block Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs Macular edema MRA shows vertebral basilar artery obstruction Hemorrhagic stroke Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients 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: Single


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>|
| No Intervention: standard management<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Lesion Volume | Measured by MRI. | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 1 | 
| 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 3 | 
| 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 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. | day 90 | 
| Lesion Volume | Measured by MRI. | day 1 | 
| Lesion Volume | Measured by MRI. | day 3 | 
| Lesion Volume | Measured by MRI. | day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dimethyl Fumarate, acute ischemic stroke, immune modulation