Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Phase 2

Withdrawn

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: Placebo; Drug: Dimethyl fumarate

• Registration Number: NCT04890379
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard management plus placebo	Placebo	-
standard management plus Dimethyl Fumarate	Dimethyl fumarate	-

Primary Outcome Measures

Name	Time	Method
Volume of Perihematomal edema(PHE)	day7	measured by MRI
Glasgow Coma Scale (GCS)	day7	The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
National Institutes of Health Stroke Scale (NIHSS)	day 7	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

Secondary Outcome Measures

Name	Time	Method
The Modified Barthel Index (mBI)	day 90	The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
National Institutes of Health Stroke Scale (NIHSS)	day90	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
The Modified Rankin Scale (mRS)	day90	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
Glasgow Coma Scale (GCS)	day 14	The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Volume of Perihematomal edema(PHE)	day90	measured by MRI

Trial Locations

Locations (1)

Xuanwu Hospital, Beijing; 🇨🇳 Beijing, Beijing, China