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WithdrawnNCT04891497Updated Oct 25, 2023

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

A Phase 2 interventional study of Dimethyl Fumarate and Placebo in Acute Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by Xuanwu Hospital, Beijing · Phase 2, Interventional, and Treatment

Why this study was withdrawn
There are no suitable patients
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • Acute Ischemic Stroke
  • Immune Modulator
  • Dimethyl Fumarate
  • Intraarterial Treatment
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

Browse Ischemic Stroke studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.

Browse Xuanwu Hospital, Beijing studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intraarterial Treatment plus Dimethyl Fumarate

    Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

    Drug: Dimethyl Fumarate

  • Placebo comparator
    Intraarterial Treatment plus placebo

    Placebo 240mg orally twice daily for 3 consecutive days

    Drug: Placebo

Interventions

  • DrugDimethyl Fumarate

    Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

  • DrugPlacebo

    Placebo 240mg orally twice daily for 3 consecutive days

06

What researchers measure

Primary outcomes

  1. lesion volume

    measured by MRI

    Time frame: day 1

  2. hemorrhage volume

    measured by MRI

    Time frame: day 1

  3. 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.

    Time frame: day 1

Secondary outcomes

  1. lesion volume

    measured by MRI

    Time frame: day3

  2. lesion volume

    measured by MRI

    Time frame: day7

  3. lesion volume

    measured by MRI

    Time frame: day90

  4. hemorrhage volume

    measured by MRI

    Time frame: day3

  5. hemorrhage volume

    measured by MRI

    Time frame: day7

  6. hemorrhage volume

    measured by MRI

    Time frame: day14

  7. hemorrhage volume

    measured by MRI

    Time frame: day90

  8. 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.

    Time frame: day3

  9. 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.

    Time frame: day7

  10. 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.

    Time frame: day14

  11. 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.

    Time frame: day90

  12. 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.

    Time frame: day1

  13. 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.

    Time frame: day3

  14. 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.

    Time frame: day7

  15. 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.

    Time frame: day14

  16. 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.

    Time frame: day90

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2021; primary completion for Dec 2021, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2021
First posted
May 18, 2021
StartEst.
Jun 1, 2021
Primary completionEst.
Dec 31, 2021
CompletionEst.
Dec 31, 2021
Last update
Oct 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04891497
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
May 18, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Oct 25, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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