Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Capital Medical University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Drug: Dimethyl fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT04890353

haojunwei4

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

standard management plus Dimethyl Fumarate

Experimental group

Treatment:

Drug: Dimethyl fumarate

standard management

No Intervention group