Acute Ischemic StrokePhase 1/2NCT04890366
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
A Phase 1/2 study testing Dimethyl Fumarate in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
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 alteplase in patients with Acute Ischemic Stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Junwei Hao, PhD,MD, haojunwei@vip.163.com
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 alteplase in patients with Acute Ischemic Stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Dimethyl Fumarate
- Keywords
- Dimethyl Fumarate, immune modulator, Alteplase, Acute Ischemic Stroke, edema
- Medical subject headings
- Ischemic Stroke, Edema
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
| Study group | Role | What they receive |
|---|---|---|
| Alteplase plus Dimethyl Fumarate | Experimental | Not described Receives: Drug: Dimethyl Fumarate |
| Alteplase | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in lesion volume
measured by MRI
Measured: baseline to day 7
changes in hemorrhage volume
measured by MRI
Measured: baseline to day 7
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.
Measured: baseline to day 7
Secondary outcomes (9)
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
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 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.
Measured: day 7
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 14
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 90
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 Dec 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junwei Hao, PhD,MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890366
- Sponsor's protocol ID
- haojunwei3
- Status last verified
- Jun 2022
- First submitted
- 11 May 2021
- Last updated
- 6 Jun 2022
- 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 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04890366
- Acronym / sponsor ID
- haojunwei3
- Conditions
- Acute Ischemic Stroke
- Keywords
- Dimethyl Fumarate, immune modulator, Alteplase, Acute Ischemic Stroke, edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (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 alteplase in patients with Acute Ischemic Stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase plus Dimethyl Fumarate | Experimental | Drug: Dimethyl Fumarate |
| Alteplase | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 | Alteplase plus Dimethyl Fumarate |
Primary outcome
changes in lesion volume
Time frame: baseline to day 7
measured by MRI
changes in hemorrhage volume
Time frame: baseline to day 7
measured by MRI
changes in National Institutes of Health Stroke Scale (NIHSS)
Time frame: baseline to day 7
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
9 secondary outcomes
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
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 3
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 7
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 14
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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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.
Junwei Hao, PhD,MD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dimethyl Fumarate in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, PhD,MD (010-83199270, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in lesion volume (time frame: baseline to day 7). 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 6 Jun 2022.