Acute Ischemic StrokePhase 1/2NCT04890353
Impact of an Immune Modulator Dimethyl Fumarate on 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 in alleviating neurologic deficits 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
- 2 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 28 Feb 2023
- 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
- >18 y of age;
- acute onset of focal neurological deficit consistent with acute ischemic stroke;
- measurable neurological deficit (NIHSS ≥ 5);
- anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI);
- 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.
Who cannot join
- Other diseases of the central nervous system
- There has been neurological disability in the past (mRS score>2)
- Difficulty swallowing
- Arrhythmia, atrioventricular block
- Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
- Macular edema
Show all 10Show fewer
- MRA shows vertebral 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
Trial locations and contacts
1 site in 1 country.
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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Dimethyl fumarate
- Keywords
- Dimethyl Fumarate, acute ischemic stroke, immune modulation
- 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
| Study group | Role | What they receive |
|---|---|---|
| standard management plus Dimethyl Fumarate | Experimental | Not described Receives: Drug: Dimethyl fumarate |
| standard management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Lesion Volume
Measured by MRI.
Measured: day 7
Secondary outcomes (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.
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 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 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 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
Lesion Volume
Measured by MRI.
Measured: day 1
Lesion Volume
Measured by MRI.
Measured: day 3
Lesion Volume
Measured by MRI.
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 completion8 Feb 2023
- Study completion28 Feb 2023
Why it stopped: The interim analysis of another associated study is not very effective
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
- 2 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
- NCT04890353
- Sponsor's protocol ID
- haojunwei4
- Status last verified
- May 2021
- First submitted
- 11 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
- Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04890353
- Acronym / sponsor ID
- haojunwei4
- Conditions
- Acute Ischemic Stroke
- Keywords
- Dimethyl Fumarate, acute ischemic stroke, immune modulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The interim analysis of another associated study is not very effective
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- 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 in alleviating neurologic deficits 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 |
|---|---|---|
| standard management plus Dimethyl Fumarate | Experimental | Drug: Dimethyl fumarate |
| standard management | 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)
- >18 y of age;
- acute onset of focal neurological deficit consistent with acute ischemic stroke;
- measurable neurological deficit (NIHSS ≥ 5);
- anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI);
- 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.
Key exclusion criteria (10 listed)
- Other diseases of the central nervous system
- There has been neurological disability in the past (mRS score>2)
- Difficulty swallowing
- Arrhythmia, atrioventricular block
- Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
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 | standard management plus Dimethyl Fumarate |
Primary outcome
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.
Lesion Volume
Time frame: day 7
Measured by MRI.
12 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 1
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 3
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 14
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day 90
Lesion Volume
Time frame: day 1
Lesion Volume
Time frame: day 3
Lesion Volume
Time frame: day 90
Results and safety
The study was stopped early (reason given: The interim analysis of another associated study is not very effective). Results are not available in the source record.
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.
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 10 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: stopped early, 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.
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?
The study was stopped early (reason given: The interim analysis of another associated study is not very effective). Results are not available in the source record.
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?
National Institutes of Health Stroke Scale (NIHSS) (time frame: day 7). The study lists 2 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.