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Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dimethyl fumarate
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 Dimethyl Fumarate, acute ischemic stroke, immune modulation

Eligibility Criteria

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

Inclusion Criteria:

  1. >18 y of age;
  2. acute onset of focal neurological deficit consistent with acute ischemic stroke;
  3. measurable neurological deficit (NIHSS ≥ 5);
  4. anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI);
  5. onset of symptom to admission more than 4.5 h and less than 72 h. Patients who arrived within 0-4.5 h poststroke were treated with other medications according to the best accepted medical treatment guidelines.

Exclusion Criteria:

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

Sites / Locations

  • Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

standard management plus Dimethyl Fumarate

standard management

Arm Description

Outcomes

Primary Outcome Measures

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.
Lesion Volume
Measured by MRI.

Secondary Outcome Measures

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.
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.
Lesion Volume
Measured by MRI.
Lesion Volume
Measured by MRI.
Lesion Volume
Measured by MRI.

Full Information

First Posted
May 11, 2021
Last Updated
October 24, 2023
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT04890353
Brief Title
Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke
Official Title
Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
The interim analysis of another associated study is not very effective
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

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 in alleviating neurologic deficits 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
Dimethyl Fumarate, acute ischemic stroke, immune modulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard management plus Dimethyl Fumarate
Arm Type
Experimental
Arm Title
standard management
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate
Intervention Description
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Primary Outcome Measure Information:
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
Title
Lesion Volume
Description
Measured by MRI.
Time Frame
day 7
Secondary Outcome Measure Information:
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
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
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 3
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 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
day 90
Title
Lesion Volume
Description
Measured by MRI.
Time Frame
day 1
Title
Lesion Volume
Description
Measured by MRI.
Time Frame
day 3
Title
Lesion Volume
Description
Measured by MRI.
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 y of age; acute onset of focal neurological deficit consistent with acute ischemic stroke; measurable neurological deficit (NIHSS ≥ 5); anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI); onset of symptom to admission more than 4.5 h and less than 72 h. Patients who arrived within 0-4.5 h poststroke were treated with other medications according to the best accepted medical treatment guidelines. Exclusion Criteria: Other diseases of the central nervous system There has been 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 MRA shows vertebral 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
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
Country
China

12. IPD Sharing Statement

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Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

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