Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Capital Medical University

Status and phase: Withdrawn; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Placebo; Drug: Dimethyl fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT04890379

haojunwei2

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 alleviating PHE and neurologic deficits in patients with ICH.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

standard management plus Dimethyl Fumarate

Experimental group

Treatment:

Drug: Dimethyl fumarate

standard management plus placebo

Placebo Comparator group

Treatment:

Drug: Placebo