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Withdrawn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• Status: WITHDRAWN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

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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

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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
Volume of Perihematomal edema(PHE)	day90	measured by MRI
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.

Trial Locations

Locations (1)

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