Acute Ischemic StrokePhase 2NCT04891497
Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke
A Phase 2 study testing Dimethyl Fumarate in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Dimethyl Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Dimethyl Fumarate, Placebo
- Keywords
- Acute Ischemic Stroke, Immune Modulator, Dimethyl Fumarate, Intraarterial Treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl FumarateDrug
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
PlaceboDrug
Placebo 240mg orally twice daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Intraarterial Treatment plus Dimethyl Fumarate | Experimental | Dimethyl fumarate 240mg orally twice daily for 3 consecutive days Receives: Drug: Dimethyl Fumarate |
| Intraarterial Treatment plus placebo | Placebo comparator | Placebo 240mg orally twice daily for 3 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lesion volume
measured by MRI
Measured: day 1
hemorrhage volume
measured by MRI
Measured: day 1
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.
Measured: day 1
Secondary outcomes (16)
lesion volume
measured by MRI
Measured: day3
lesion volume
measured by MRI
Measured: day7
lesion volume
measured by MRI
Measured: day90
hemorrhage volume
measured by MRI
Measured: day3
hemorrhage volume
measured by MRI
Measured: day7
hemorrhage volume
measured by MRI
Measured: day14
hemorrhage volume
measured by MRI
Measured: day90
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.
Measured: day3
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.
Measured: day7
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.
Measured: day14
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.
Measured: day90
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.
Measured: day1
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.
Measured: day3
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.
Measured: day7
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.
Measured: day14
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.
Measured: day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: There are no suitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891497
- Sponsor's protocol ID
- haojunwei5
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04891497
- Acronym / sponsor ID
- haojunwei5
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Immune Modulator, Dimethyl Fumarate, Intraarterial Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There are no suitable patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraarterial Treatment plus Dimethyl Fumarate | Experimental | Drug: Dimethyl FumarateDimethyl fumarate 240mg orally twice daily for 3 consecutive days |
| Intraarterial Treatment plus placebo | Placebo comparator | Drug: PlaceboPlacebo 240mg orally twice daily for 3 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl FumarateDimethyl fumarate 240mg orally twice daily for 3 consecutive days | Drug | Intraarterial Treatment plus Dimethyl Fumarate |
| PlaceboPlacebo 240mg orally twice daily for 3 consecutive days | Drug | Intraarterial Treatment plus placebo |
Primary outcome
lesion volume
Time frame: day 1
measured by MRI
hemorrhage volume
Time frame: day 1
measured by MRI
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.
16 secondary outcomes
lesion volume
Time frame: day3
lesion volume
Time frame: day7
lesion volume
Time frame: day90
hemorrhage volume
Time frame: day3
hemorrhage volume
Time frame: day7
hemorrhage volume
Time frame: day14
hemorrhage volume
Time frame: day90
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day3
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day7
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day14
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day90
The Modified Rankin Scale (mRS)
Time frame: day1
The Modified Rankin Scale (mRS)
Time frame: day3
The Modified Rankin Scale (mRS)
Time frame: day7
The Modified Rankin Scale (mRS)
Time frame: day14
The Modified Rankin Scale (mRS)
Time frame: day90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dimethyl Fumarate in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lesion volume (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.