search
Back to results

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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
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, immune modulator, Alteplase, Acute Ischemic Stroke, edema

Eligibility Criteria

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

Inclusion Criteria:

  1. more than 18years old
  2. NIHSS score≥5
  3. MRI shows anterior circulation infarction
  4. Patients who meet Alteplase thrombolytic therapy within 4.5h
  5. The time from onset to DMF application was less than 24 hours

Exclusion Criteria:

  1. Hemorrhagic stroke
  2. Patients who have received or plan to receive endovascular therapy
  3. Other diseases of the central nervous system
  4. Pre-existing neurological disability (mRS Score >2)
  5. Vertebrobasilar artery obstruction
  6. Difficulty swallowing
  7. Patients who cannot accept MRI examination
  8. Abnormal liver function (transaminase higher than 2 times the normal upper limit)
  9. The lymphocyte count was lower than the lower limit of normal value
  10. Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used
  11. Patients known to have hypersensitivity to dimethyl fumarate or any excipients
  12. Pregnant and lactating women

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alteplase plus Dimethyl Fumarate

Alteplase

Arm Description

Outcomes

Primary Outcome Measures

changes in lesion volume
measured by MRI
changes in hemorrhage volume
measured by MRI
changes in 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

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.

Full Information

First Posted
May 11, 2021
Last Updated
June 2, 2022
Sponsor
Xuanwu Hospital, Beijing
search

1. Study Identification

Unique Protocol Identification Number
NCT04890366
Brief Title
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
Official Title
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (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 alteplase 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, immune modulator, Alteplase, Acute Ischemic Stroke, edema

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alteplase plus Dimethyl Fumarate
Arm Type
Experimental
Arm Title
Alteplase
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
changes in lesion volume
Description
measured by MRI
Time Frame
baseline to day 7
Title
changes in hemorrhage volume
Description
measured by MRI
Time Frame
baseline to day 7
Title
changes in 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
baseline to 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 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 7
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: more than 18years old NIHSS score≥5 MRI shows anterior circulation infarction Patients who meet Alteplase thrombolytic therapy within 4.5h The time from onset to DMF application was less than 24 hours Exclusion Criteria: Hemorrhagic stroke Patients who have received or plan to receive endovascular therapy Other diseases of the central nervous system Pre-existing neurological disability (mRS Score >2) Vertebrobasilar artery obstruction Difficulty swallowing Patients who cannot accept MRI examination Abnormal liver function (transaminase higher than 2 times the normal upper limit) The lymphocyte count was lower than the lower limit of normal value Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used Patients known to have hypersensitivity to dimethyl fumarate or any excipients Pregnant and lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junwei Hao, PhD,MD
Phone
010-83199270
Email
haojunwei@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junwei Hao, PhD,MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junwei Hao, PhD,MD
Email
haojunwei@vip.163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs