Clinical trial

Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

Name
haojunwei5
Description
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 combination with intraarterial treatment in patients with Acute Ischemic Stroke.
Trial arms
Trial start
2021-06-01
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Withdrawn
Phase
Early phase I
Treatment
Dimethyl Fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Arms:
Intraarterial Treatment plus Dimethyl Fumarate
Placebo
Placebo 240mg orally twice daily for 3 consecutive days
Arms:
Intraarterial Treatment plus placebo
Primary endpoint
lesion volume
day 1
hemorrhage volume
day 1
National Institutes of Health Stroke Scale (NIHSS)
day 1
Eligibility criteria
Inclusion Criteria: 1.18-80 years old 2. NIHSS score\>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours Exclusion Criteria: 1. Patients receiving Alteplase thrombolysis 2. Other diseases of the central nervous system 3. There has been a neurological disability in the past (mRS score\>2) 4. Difficulty swallowing 5. Arrhythmia, atrioventricular block 6. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs 7. Macular edema 8. Magnetic resonance angiography shows vertebra-basilar artery obstruction 9. Hemorrhagic stroke 10. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product 11. Pregnant and lactating women
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-10-25

1 organization

1 product

1 drug

1 indication

Organization
Xuanwu Hospital
Indication
Stroke