Status:
TERMINATED
Impact of an Immune Modulator Dimethyl Fumarate on 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 in a...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04890353
Start Date
December 1 2021
End Date
February 28 2023
Last Update
October 25 2023
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China