Status:
UNKNOWN
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 comb...
Eligibility Criteria
Inclusion
- more than 18years old
- NIHSS score≥5
- MRI shows anterior circulation infarction
- Patients who meet Alteplase thrombolytic therapy within 4.5h
- The time from onset to DMF application was less than 24 hours
Exclusion
- Hemorrhagic stroke
- Patients who have received or plan to receive endovascular therapy
- Other diseases of the central nervous system
- Pre-existing neurological disability (mRS Score \>2)
- Vertebrobasilar artery obstruction
- Difficulty swallowing
- Patients who cannot accept MRI examination
- Abnormal liver function (transaminase higher than 2 times the normal upper limit)
- The lymphocyte count was lower than the lower limit of normal value
- Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used
- Patients known to have hypersensitivity to dimethyl fumarate or any excipients
- Pregnant and lactating women
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04890366
Start Date
December 1 2021
End Date
December 31 2022
Last Update
June 6 2022
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053