Intracerebral HemorrhagePhase 1/2FMIICHNCT06087965
Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
A Phase 1/2 study testing Fingolimod in people with Intracerebral Hemorrhage, run by Tang-Du Hospital.
Trial summary
Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Fingolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2023to 30 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spontaneous basal ganglia ICH with volume larger than 20ml;
- age: 18-80 years;
- admission Glasgow Coma Scale score: 5-12;
- admitting to hospital with 24 hours after injury;
- no fever or signs infection on admission to hospital;
- admission heart rate≥60/min on admission.
Who cannot join
- refuse follow-up;
- received operation before admitting to hospital;
- hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury;
- severe vomiting;
- mRS>1 before ICH;
- prior history of bradycardia;
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- prior history of Atrioventricular block;
- prior history of traumatic brain injury, craniotomy or stroke;
- expected lifetime less than 1 year;
- undergoing antitumor, antiepileptic, immunomodulatory or immunosuppressive therapy;
- admitting to other ongoing study;
- systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence;
- received anticoagulant or antiplatelet therapy within 7 days;
- intraventricular hemorrhage requires intraventricular catheterization.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.
Read the detailed description
40 ICH patients who meet the inclusion criteria will be enrolled in the present study.
All ICH patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.
After obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. Patients assigned to the control group will not receive fingolimod. All patients will receive minimal invasive puncture and drainage of hematoma. The investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. CT scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Fingolimod
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
0.5mg/day oral fingolimod over a course of 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod group | Experimental | 0.5mg/day oral fingolimod over a course of 3 consecutive days Receives: Drug: Fingolimod |
| Control group | No intervention | No fingolimod will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
Neurological outcome, range: 0-6. The higher scores mean a worse outcome.
Measured: 90 days and 180 days after ICH
Secondary outcomes (4)
The National Institutes of Health Stroke Scale
Neurological outcome, range: 0-42. The higher scores mean a worse outcome.
Measured: 90 days and 180 days after ICH
Modified Barthel Index
Neurological outcome, range: 0-100. The higher scores mean a better outcome.
Measured: 90 days and 180 days after ICH
Montreal Cognitive Assessment Scale
Neurological outcome, range: 0-30. The higher scores mean a better outcome.
Measured: 90 days and 180 days after ICH
Volume of perihematomal edema
Volume of perihematomal edema measured on head Computerised Tomography
Measured: Baseline on admission, 7 days and 14 days after ICH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start11 Oct 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
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 Tang-Du HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Qu, Study chair, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087965
- Sponsor's protocol ID
- 202307-11
- Acronym
- FMIICH
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the baseline characteristic, treatments and functional outcomes will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06087965
- Acronym / sponsor ID
- FMIICH / 202307-11
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 11 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Oct 2023 (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.
Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.
Detailed description
40 ICH patients who meet the inclusion criteria will be enrolled in the present study.
All ICH patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.
After obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. Patients assigned to the control group will not receive fingolimod. All patients will receive minimal invasive puncture and drainage of hematoma. The investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. CT scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod group | Experimental | Drug: Fingolimod0.5mg/day oral fingolimod over a course of 3 consecutive days |
| Control group | No intervention | –No fingolimod will be administered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- spontaneous basal ganglia ICH with volume larger than 20ml;
- age: 18-80 years;
- admission Glasgow Coma Scale score: 5-12;
- admitting to hospital with 24 hours after injury;
- no fever or signs infection on admission to hospital;
Key exclusion criteria (14 listed)
- refuse follow-up;
- received operation before admitting to hospital;
- hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury;
- severe vomiting;
- mRS>1 before 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 |
|---|---|---|
| Fingolimod0.5mg/day oral fingolimod over a course of 3 consecutive days | Drug | Fingolimod group |
Primary outcome
modified Rankin Scale
Time frame: 90 days and 180 days after ICH
Neurological outcome, range: 0-6. The higher scores mean a worse outcome.
4 secondary outcomes
The National Institutes of Health Stroke Scale
Time frame: 90 days and 180 days after ICH
Modified Barthel Index
Time frame: 90 days and 180 days after ICH
Montreal Cognitive Assessment Scale
Time frame: 90 days and 180 days after ICH
Volume of perihematomal edema
Time frame: Baseline on admission, 7 days and 14 days after ICH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. the baseline characteristic, treatments and functional outcomes will be shared with other researchers
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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.
Yan Qu study chair
Tang-Du Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fingolimod in people with Intracerebral Hemorrhage, run by Tang-Du Hospital.
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 6 inclusion and 14 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 18 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. 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 Zhihong Li (+86-13709183909, 409615390@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 90 days and 180 days after ICH). 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 18 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.