Acute Ischemic Stroke
Conditions
Keywords
Dimethyl Fumarate, acute ischemic stroke, immune modulation
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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.
Interventions
DRUGDimethyl fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 y of age; 2. acute onset of focal neurological deficit consistent with acute ischemic stroke; 3. measurable neurological deficit (NIHSS ≥ 5); 4. anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI); 5. 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
1. Other diseases of the central nervous system 2. There has been neurological disability in the past (mRS score\>2) 3. Difficulty swallowing 4. Arrhythmia, atrioventricular block 5. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs 6. Macular edema 7. MRA shows vertebral basilar artery obstruction 8. Hemorrhagic stroke 9. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product 10. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Lesion Volume | day 7 | Measured by MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Volume | day 1 | Measured by MRI. |
| 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. |
| National Institutes of Health Stroke Scale (NIHSS) | day 1 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
Countries
China
Outcome results
None listed