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

Phase 1

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Dimethyl Fumarate

• Registration Number: NCT04890366
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-12-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alteplase plus Dimethyl Fumarate	Dimethyl Fumarate	-

Primary Outcome Measures

Name	Time	Method
changes in lesion volume	baseline to day 7	measured by MRI
changes in National Institutes of Health Stroke Scale (NIHSS)	baseline to day 7	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
changes in hemorrhage volume	baseline to day 7	measured by MRI

Secondary Outcome Measures

Name	Time	Method
The Modified Rankin Scale (mRS)	day90	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
National Institutes of Health Stroke Scale (NIHSS)	day 90	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China