Intracerebral HemorrhagePhase 2NCT04890379
Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
A Phase 2 study testing Dimethyl fumarate in people with Intracerebral Hemorrhage, 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 alleviating PHE and neurologic deficits in patients with ICH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- 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
- 1 siteChina
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and nonpregnant women aged 18 years and older
- a primary supratentorial ICH of 5 to 30 mL
- symptom onset less than 72 hours prior to admission
- a Glasgow Coma Scale (GCS) score of 6 or greater
- basal ganglia hemorrhage only
Who cannot join
- patients with a GCS score of 3 to 5
- planned surgical evacuation of a large hematoma (>30 mL)
- various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult
- patients with hematoma expansion
- secondary ICH
- preexisting disability (modified Rankin Scale [mRS] score >1)
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- any history of bradycardia or atrioventricular block
- concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies
- macular edema
- Patients with known hypersensitivity to dimethyl fumarate or to any excipient 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 alleviating PHE and neurologic deficits in patients with ICH.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Dimethyl fumarate, Placebo
- Keywords
- Dimethyl Fumarate, Intracerebral Hemorrhage(ICH), perihematomal edema(PHE), neurologic deficit, immune modulator
- Medical subject headings
- Cerebral Hemorrhage, Neurologic Manifestations
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 |
|---|---|---|
| standard management plus Dimethyl Fumarate | Experimental | Not described Receives: Drug: Dimethyl fumarate |
| standard management plus placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Perihematomal edema(PHE)
measured by MRI
Measured: day7
Glasgow Coma Scale (GCS)
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
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: day 7
Secondary outcomes (21)
Volume of Perihematomal edema(PHE)
measured by MRI
Measured: day1
Volume of Perihematomal edema(PHE)
measured by MRI
Measured: day3
Volume of Perihematomal edema(PHE)
measured by MRI
Measured: day14
Volume of Perihematomal edema(PHE)
measured by MRI
Measured: day90
Glasgow Coma Scale (GCS)
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Measured: day 1
Glasgow Coma Scale (GCS)
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
Measured: day 3
Glasgow Coma Scale (GCS)
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
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: day1
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: 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
The Modified Barthel Index (mBI)
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Measured: day 1
The Modified Barthel Index (mBI)
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Measured: day 3
The Modified Barthel Index (mBI)
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Measured: day 7
The Modified Barthel Index (mBI)
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
Measured: day 14
The Modified Barthel Index (mBI)
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
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 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: There are no sufficient patients in the hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies 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
- NCT04890379
- Sponsor's protocol ID
- haojunwei2
- Status last verified
- May 2021
- First submitted
- 10 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
- Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT04890379
- Acronym / sponsor ID
- haojunwei2
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Dimethyl Fumarate, Intracerebral Hemorrhage(ICH), perihematomal edema(PHE), neurologic deficit, immune modulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There are no sufficient patients in the hospital.
- 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 alleviating PHE and neurologic deficits in patients with ICH.
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 |
|---|---|---|
| standard management plus Dimethyl Fumarate | Experimental | Drug: Dimethyl fumarate |
| standard management plus placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and nonpregnant women aged 18 years and older
- a primary supratentorial ICH of 5 to 30 mL
- symptom onset less than 72 hours prior to admission
- a Glasgow Coma Scale (GCS) score of 6 or greater
- basal ganglia hemorrhage only
Key exclusion criteria (11 listed)
- patients with a GCS score of 3 to 5
- planned surgical evacuation of a large hematoma (>30 mL)
- various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult
- patients with hematoma expansion
- secondary ICH
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 |
| PlaceboPlacebo 240mg orally twice daily for 3 consecutive days | Drug | standard management plus placebo |
Primary outcome
Volume of Perihematomal edema(PHE)
Time frame: day7
measured by MRI
Glasgow Coma Scale (GCS)
Time frame: day7
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
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.
21 secondary outcomes
Volume of Perihematomal edema(PHE)
Time frame: day1
Volume of Perihematomal edema(PHE)
Time frame: day3
Volume of Perihematomal edema(PHE)
Time frame: day14
Volume of Perihematomal edema(PHE)
Time frame: day90
Glasgow Coma Scale (GCS)
Time frame: day 1
Glasgow Coma Scale (GCS)
Time frame: day 3
Glasgow Coma Scale (GCS)
Time frame: day 14
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day1
National Institutes of Health Stroke Scale (NIHSS)
Time frame: day3
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
The Modified Barthel Index (mBI)
Time frame: day 1
The Modified Barthel Index (mBI)
Time frame: day 3
The Modified Barthel Index (mBI)
Time frame: day 7
The Modified Barthel Index (mBI)
Time frame: day 14
The Modified Barthel Index (mBI)
Time frame: day 90
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dimethyl fumarate in people with Intracerebral Hemorrhage, 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 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.
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. 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?
Volume of Perihematomal edema(PHE) (time frame: day7). 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.