Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

haojunwei4

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.

2021-12-01

2023-02-08

2023-02-28

Terminated

Early phase I

2

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

2023-10-25