Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04890353
• Other study ID #: haojunwei4
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: February 28, 2023

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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 28, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 7
Primary	Lesion Volume	Measured by MRI.	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 1
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 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
Secondary	Lesion Volume	Measured by MRI.	day 1
Secondary	Lesion Volume	Measured by MRI.	day 3
Secondary	Lesion Volume	Measured by MRI.	day 90