Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

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.

Study Overview

• Status: Withdrawn
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Dimethyl fumarate; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Beijing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard management plus Dimethyl Fumarate	Drug: Dimethyl fumarate; Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Placebo Comparator: standard management plus placebo	Drug: Placebo; Placebo 240mg orally twice daily for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of Perihematomal edema(PHE)	measured by MRI	day1
Volume of Perihematomal edema(PHE)	measured by MRI	day3
Volume of Perihematomal edema(PHE)	measured by MRI	day14
Volume of Perihematomal edema(PHE)	measured by MRI	day90
Glasgow Coma Scale (GCS)	The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.	day 1
Glasgow Coma Scale (GCS)	The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.	day 3
Glasgow Coma Scale (GCS)	The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.	day 14
National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day1
National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day3
National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day14
National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.	day90
The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day1
The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day3
The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day7
The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day14
The Modified Rankin Scale (mRS)	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.	day90
The Modified Barthel Index (mBI)	The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.	day 1
The Modified Barthel Index (mBI)	The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.	day 3
The Modified Barthel Index (mBI)	The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.	day 7
The Modified Barthel Index (mBI)	The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.	day 14
The Modified Barthel Index (mBI)	The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.	day 90

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2021
• Primary Completion (Estimated): December 31, 2021
• Study Completion (Estimated): December 31, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Dimethyl Fumarate; Intracerebral Hemorrhage(ICH); perihematomal edema(PHE); neurologic deficit; immune modulator
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: haojunwei2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No