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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890366
• Other study ID #: haojunwei3
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao, PhD,MD
• Phone: 010-83199270
• Email: haojunwei[@]vip.163.com
• 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 alteplase in patients with Acute Ischemic Stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. more than 18years old

2. NIHSS score=5

3. MRI shows anterior circulation infarction

4. Patients who meet Alteplase thrombolytic therapy within 4.5h

5. The time from onset to DMF application was less than 24 hours

Exclusion Criteria:

1. Hemorrhagic stroke

2. Patients who have received or plan to receive endovascular therapy

3. Other diseases of the central nervous system

4. Pre-existing neurological disability (mRS Score >2)

5. Vertebrobasilar artery obstruction

6. Difficulty swallowing

7. Patients who cannot accept MRI examination

8. Abnormal liver function (transaminase higher than 2 times the normal upper limit)

9. The lymphocyte count was lower than the lower limit of normal value

10. Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used

11. Patients known to have hypersensitivity to dimethyl fumarate or any excipients

12. 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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in lesion volume	measured by MRI	baseline to day 7
Primary	changes in hemorrhage volume	measured by MRI	baseline to day 7
Primary	changes in 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.	baseline to day 7
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
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.	day 3
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.	day 7
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.	day 14
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.	day 90