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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04891497
• Other study ID #: haojunwei5
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 combination with intraarterial treatment in patients with Acute Ischemic Stroke.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Dimethyl Fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
• Placebo
Placebo 240mg orally twice daily for 3 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lesion volume	measured by MRI	day 1
Primary	hemorrhage volume	measured by MRI	day 1
Primary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day 1
Secondary	lesion volume	measured by MRI	day3
Secondary	lesion volume	measured by MRI	day7
Secondary	lesion volume	measured by MRI	day90
Secondary	hemorrhage volume	measured by MRI	day3
Secondary	hemorrhage volume	measured by MRI	day7
Secondary	hemorrhage volume	measured by MRI	day14
Secondary	hemorrhage volume	measured by MRI	day90
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day3
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day7
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day14
Secondary	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day90
Secondary	The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day1
Secondary	The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day3
Secondary	The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day7
Secondary	The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day14
Secondary	The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day90