Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

October 24, 2023 updated by: Xuanwu Hospital, Beijing
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Xuanwu Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard management plus Dimethyl Fumarate
Drug: Dimethyl fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
No Intervention: standard management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day 7
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day 7
Lesion Volume
Time Frame: day 7
Measured by MRI.
day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Modified Rankin Scale (mRS)
Time Frame: day1
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day1
The Modified Rankin Scale (mRS)
Time Frame: day3
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day3
The Modified Rankin Scale (mRS)
Time Frame: day7
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day7
The Modified Rankin Scale (mRS)
Time Frame: day14
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day14
The Modified Rankin Scale (mRS)
Time Frame: day90
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day90
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day 1
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day 1
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day 3
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day 3
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day 14
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day 14
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day 90
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day 90
Lesion Volume
Time Frame: day 1
Measured by MRI.
day 1
Lesion Volume
Time Frame: day 3
Measured by MRI.
day 3
Lesion Volume
Time Frame: day 90
Measured by MRI.
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

February 8, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • haojunwei4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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