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

NCT ID: NCT04891497

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

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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 intraarterial treatment in patients with Acute Ischemic Stroke.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intraarterial Treatment plus Dimethyl Fumarate

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Group Type EXPERIMENTAL

Dimethyl Fumarate

Intervention Type DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Intraarterial Treatment plus placebo

Placebo 240mg orally twice daily for 3 consecutive days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 240mg orally twice daily for 3 consecutive days

Interventions

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Dimethyl Fumarate

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Intervention Type DRUG

Placebo

Placebo 240mg orally twice daily for 3 consecutive days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1.18-80 years old 2. NIHSS score\>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours

Exclusion Criteria

1. Patients receiving Alteplase thrombolysis
2. Other diseases of the central nervous system
3. There has been a neurological disability in the past (mRS score\>2)
4. Difficulty swallowing
5. Arrhythmia, atrioventricular block
6. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
7. Macular edema
8. Magnetic resonance angiography shows vertebra-basilar artery obstruction
9. Hemorrhagic stroke
10. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product
11. Pregnant and lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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haojunwei5

Identifier Type: -

Identifier Source: org_study_id

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