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Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Withdrawn
Phase
Phase 2
Locations
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 Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Immune Modulator, Dimethyl Fumarate, Intraarterial Treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.18-80 years old 2. NIHSS score>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours

Exclusion Criteria:

  1. Patients receiving Alteplase thrombolysis
  2. Other diseases of the central nervous system
  3. There has been a neurological disability in the past (mRS score>2)
  4. Difficulty swallowing
  5. Arrhythmia, atrioventricular block
  6. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
  7. Macular edema
  8. Magnetic resonance angiography shows vertebra-basilar artery obstruction
  9. Hemorrhagic stroke
  10. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product
  11. Pregnant and lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intraarterial Treatment plus Dimethyl Fumarate

    Intraarterial Treatment plus placebo

    Arm Description

    Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

    Placebo 240mg orally twice daily for 3 consecutive days

    Outcomes

    Primary Outcome Measures

    lesion volume
    measured by MRI
    hemorrhage volume
    measured by MRI
    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

    lesion volume
    measured by MRI
    lesion volume
    measured by MRI
    lesion volume
    measured by MRI
    hemorrhage volume
    measured by MRI
    hemorrhage volume
    measured by MRI
    hemorrhage volume
    measured by MRI
    hemorrhage volume
    measured by MRI
    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.

    Full Information

    First Posted
    May 17, 2021
    Last Updated
    October 24, 2023
    Sponsor
    Xuanwu Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04891497
    Brief Title
    Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke
    Official Title
    Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    There are no suitable patients
    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 combination with intraarterial treatment in patients with Acute Ischemic Stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke
    Keywords
    Acute Ischemic Stroke, Immune Modulator, Dimethyl Fumarate, Intraarterial Treatment

    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
    Intraarterial Treatment plus Dimethyl Fumarate
    Arm Type
    Experimental
    Arm Description
    Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
    Arm Title
    Intraarterial Treatment plus placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo 240mg orally twice daily for 3 consecutive days
    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
    lesion volume
    Description
    measured by MRI
    Time Frame
    day 1
    Title
    hemorrhage volume
    Description
    measured by MRI
    Time Frame
    day 1
    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 1
    Secondary Outcome Measure Information:
    Title
    lesion volume
    Description
    measured by MRI
    Time Frame
    day3
    Title
    lesion volume
    Description
    measured by MRI
    Time Frame
    day7
    Title
    lesion volume
    Description
    measured by MRI
    Time Frame
    day90
    Title
    hemorrhage volume
    Description
    measured by MRI
    Time Frame
    day3
    Title
    hemorrhage volume
    Description
    measured by MRI
    Time Frame
    day7
    Title
    hemorrhage volume
    Description
    measured by MRI
    Time Frame
    day14
    Title
    hemorrhage volume
    Description
    measured by MRI
    Time Frame
    day90
    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
    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
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.18-80 years old 2. NIHSS score>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours Exclusion Criteria: Patients receiving Alteplase thrombolysis Other diseases of the central nervous system There has been a neurological disability in the past (mRS score>2) Difficulty swallowing Arrhythmia, atrioventricular block Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs Macular edema Magnetic resonance angiography shows vertebra-basilar artery obstruction Hemorrhagic stroke Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product Pregnant and lactating women

    12. IPD Sharing Statement

    Learn more about this trial

    Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

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