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Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dimethyl fumarate
Placebo
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Dimethyl Fumarate, Intracerebral Hemorrhage(ICH), perihematomal edema(PHE), neurologic deficit, immune modulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xuanwu Hospital, Beijing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

standard management plus Dimethyl Fumarate

standard management plus placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2021
Last Updated
October 24, 2023
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT04890379
Brief Title
Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
Official Title
Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
There are no sufficient patients in the hospital.
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Dimethyl Fumarate, Intracerebral Hemorrhage(ICH), perihematomal edema(PHE), neurologic deficit, immune modulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard management plus Dimethyl Fumarate
Arm Type
Experimental
Arm Title
standard management plus placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate
Intervention Description
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 240mg orally twice daily for 3 consecutive days
Primary Outcome Measure Information:
Title
Volume of Perihematomal edema(PHE)
Description
measured by MRI
Time Frame
day7
Title
Glasgow Coma Scale (GCS)
Description
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Time Frame
day7
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
Time Frame
day 7
Secondary Outcome Measure Information:
Title
Volume of Perihematomal edema(PHE)
Description
measured by MRI
Time Frame
day1
Title
Volume of Perihematomal edema(PHE)
Description
measured by MRI
Time Frame
day3
Title
Volume of Perihematomal edema(PHE)
Description
measured by MRI
Time Frame
day14
Title
Volume of Perihematomal edema(PHE)
Description
measured by MRI
Time Frame
day90
Title
Glasgow Coma Scale (GCS)
Description
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Time Frame
day 1
Title
Glasgow Coma Scale (GCS)
Description
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Time Frame
day 3
Title
Glasgow Coma Scale (GCS)
Description
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Time Frame
day 14
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
Time Frame
day1
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
Time Frame
day3
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
Time Frame
day14
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
Time Frame
day90
Title
The Modified Rankin Scale (mRS)
Description
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
Time Frame
day1
Title
The Modified Rankin Scale (mRS)
Description
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
Time Frame
day3
Title
The Modified Rankin Scale (mRS)
Description
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
Time Frame
day7
Title
The Modified Rankin Scale (mRS)
Description
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
Time Frame
day14
Title
The Modified Rankin Scale (mRS)
Description
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
Time Frame
day90
Title
The Modified Barthel Index (mBI)
Description
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Time Frame
day 1
Title
The Modified Barthel Index (mBI)
Description
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Time Frame
day 3
Title
The Modified Barthel Index (mBI)
Description
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Time Frame
day 7
Title
The Modified Barthel Index (mBI)
Description
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Time Frame
day 14
Title
The Modified Barthel Index (mBI)
Description
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and nonpregnant women aged 18 years and older a primary supratentorial ICH of 5 to 30 mL symptom onset less than 72 hours prior to admission a Glasgow Coma Scale (GCS) score of 6 or greater basal ganglia hemorrhage only Exclusion Criteria: patients with a GCS score of 3 to 5 planned surgical evacuation of a large hematoma (>30 mL) various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult patients with hematoma expansion secondary ICH preexisting disability (modified Rankin Scale [mRS] score >1) any history of bradycardia or atrioventricular block concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies macular edema Patients with known hypersensitivity to dimethyl fumarate or to any excipient of this product Pregnant and lactating women
Facility Information:
Facility Name
Xuanwu Hospital, Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Learn more about this trial

Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

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