Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04890379
• Other study ID #: haojunwei2
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• Dimethyl fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
• Placebo
Placebo 240mg orally twice daily for 3 consecutive days

Locations

Country	Name	City	State
China	Xuanwu Hospital, Beijing	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of Perihematomal edema(PHE)	measured by MRI	day7
Primary	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
Primary	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	Volume of Perihematomal edema(PHE)	measured by MRI	day1
Secondary	Volume of Perihematomal edema(PHE)	measured by MRI	day3
Secondary	Volume of Perihematomal edema(PHE)	measured by MRI	day14
Secondary	Volume of Perihematomal edema(PHE)	measured by MRI	day90
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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