Clinical trial NCT04890379: Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
Official title: Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Dimethyl Fumarate
Intracerebral Hemorrhage(ICH)
perihematomal edema(PHE)
neurologic deficit
immune modulator
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 alleviating PHE and neurologic deficits in patients with ICH.


Eligibility criteria: Inclusion Criteria:

1. Men and nonpregnant women aged 18 years and older
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:

1. patients with a GCS score of 3 to 5
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

Primary outcomes:
measure: Volume of Perihematomal edema(PHE)
timeFrame: day7
measure: Glasgow Coma Scale (GCS)
timeFrame: day7
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day 7
Secondary outcomes:
measure: Volume of Perihematomal edema(PHE)
timeFrame: day1
measure: Volume of Perihematomal edema(PHE)
timeFrame: day3
measure: Volume of Perihematomal edema(PHE)
timeFrame: day14
measure: Volume of Perihematomal edema(PHE)
timeFrame: day90
measure: Glasgow Coma Scale (GCS)
timeFrame: day 1
measure: Glasgow Coma Scale (GCS)
timeFrame: day 3
measure: Glasgow Coma Scale (GCS)
timeFrame: day 14
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day1
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day3
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day14
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day90
measure: The Modified Rankin Scale (mRS)
timeFrame: day1
measure: The Modified Rankin Scale (mRS)
timeFrame: day3
measure: The Modified Rankin Scale (mRS)
timeFrame: day7
measure: The Modified Rankin Scale (mRS)
timeFrame: day14
measure: The Modified Rankin Scale (mRS)
timeFrame: day90
measure: The Modified Barthel Index (mBI)
timeFrame: day 1
measure: The Modified Barthel Index (mBI)
timeFrame: day 3
measure: The Modified Barthel Index (mBI)
timeFrame: day 7
measure: The Modified Barthel Index (mBI)
timeFrame: day 14
measure: The Modified Barthel Index (mBI)
timeFrame: day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Beijing
state: Beijing
Study officials:
References: