Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanwu Hospital, Beijing
• Treatments: Dimethyl Fumarate

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