Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
NCT ID: NCT04890379
Last Updated: 2023-10-25
Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-06-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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standard management plus Dimethyl Fumarate
Dimethyl fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
standard management plus placebo
Placebo
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
Placebo
Placebo 240mg orally twice daily for 3 consecutive days
Eligibility Criteria
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Inclusion Criteria
2. a primary supratentorial ICH of 5 to 30 mL
3. symptom onset less than 72 hours prior to admission
4. a Glasgow Coma Scale (GCS) score of 6 or greater
5. basal ganglia hemorrhage only
Exclusion Criteria
2. planned surgical evacuation of a large hematoma (\>30 mL)
3. various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult
4. patients with hematoma expansion
5. secondary ICH
6. preexisting disability (modified Rankin Scale \[mRS\] score \>1)
7. any history of bradycardia or atrioventricular block
8. concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies
9. macular edema
10. Patients with known hypersensitivity to dimethyl fumarate or to any excipient of this product
11. Pregnant and lactating women
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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haojunwei2
Identifier Type: -
Identifier Source: org_study_id
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