Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Phase 1

Terminated

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

• Registration Number: NCT04890353
• 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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-12-01
• Primary Completion: 2023-02-08
• Study Completion: 2023-02-28
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard management plus Dimethyl Fumarate	Dimethyl fumarate	-

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS)	day 7	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
Lesion Volume	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.
Lesion Volume	day 90	Measured by MRI.

Trial Locations

Locations (1)

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