| Registry | NCT04890379 |
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| Status | Withdrawn - There are no sufficient patients in the hospital. |
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| Phase | Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: triple, treatment |
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| Sponsor | Xuanwu Hospital, Beijing (Other) |
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| Conditions | Intracerebral Hemorrhage |
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| Interventions | Dimethyl fumarate, Placebo (Drug) |
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| Dates | start 2021-06-01 (estimated), primary completion 2021-12-31 (estimated), completion 2021-12-31 (estimated), first posted 2021-05-18, last updated 2023-10-25 |
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| Locations | 1 site in China |
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Related Papers Related Patents Related Grants Related Experts
All trials for Intracerebral Hemorrhage All trials of Dimethyl fumarate All trials of Placebo
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| standard management plus Dimethyl Fumarate | Experimental | Drug: Dimethyl fumarate | |
| standard management plus placebo | Placebo comparator | Drug: Placebo | |
- Dimethyl fumarate (Drug): Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
- Placebo (Drug): Placebo 240mg orally twice daily for 3 consecutive days
+Outcome measures
Primary outcomes
- 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 outcomes
- Volume of Perihematomal edema(PHE) [day1]: measured by MRI
- Volume of Perihematomal edema(PHE) [day3]: measured by MRI
- Volume of Perihematomal edema(PHE) [day14]: measured by MRI
- Volume of Perihematomal edema(PHE) [day90]: measured by MRI
- Glasgow Coma Scale (GCS) [day 1]: The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
- Glasgow Coma Scale (GCS) [day 3]: The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
- 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.
- National Institutes of Health Stroke Scale (NIHSS) [day1]: The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
- National Institutes of Health Stroke Scale (NIHSS) [day3]: The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
- National Institutes of Health Stroke Scale (NIHSS) [day14]: The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
- 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) [day1]: The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
- The Modified Rankin Scale (mRS) [day3]: The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
- The Modified Rankin Scale (mRS) [day7]: The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
- The Modified Rankin Scale (mRS) [day14]: The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
- 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.
- The Modified Barthel Index (mBI) [day 1]: The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
- The Modified Barthel Index (mBI) [day 3]: The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
- The Modified Barthel Index (mBI) [day 7]: The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
- The Modified Barthel Index (mBI) [day 14]: The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
- 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.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Xuanwu Hospital, Beijing | Beijing, Beijing Municipality | China | |