Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

NCT ID: NCT04890353

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-02-28

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard management plus Dimethyl Fumarate

Group Type: EXPERIMENTAL

Dimethyl fumarate

Intervention Type: DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

standard management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dimethyl fumarate

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

haojunwei4

Identifier Type: -

Identifier Source: org_study_id