Intracerebral HemorrhageNCT07305896
Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage
A study testing Minocycline in people with Intracerebral Hemorrhage, run by The First Hospital of Jilin University.
Trial summary
This study plans to enroll 1248 patients with supratentorial ICH within 24 hours of onset across multiple stroke centers. After randomization, the control group will only receive medical therapy. 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?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,248 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years, regardless of gender;
- Supratentorial ICH confirmed by brain CT scan;
- No disability in the community before ICH (premorbid mRS≤1);
- Neurological deficits related to the hematoma, with NIHSS score ≥ 6 and single-limb motor item score ≥ 2;
- GCS score ≥ 6;
- Able to initiate the first dose of minocycline within 24 hours of onset;
- Signed and dated informed consent.
Who cannot join
- Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, use of thrombolytic drugs;
- Allergy to tetracycline antibiotics;
- Use of vitamin A derivatives or steroid therapy within the past 3 months;
- Concomitant infection requiring antibiotic treatment at admission;
- Planned surgical intervention;
- Life expectancy of less than 6 months due to comorbid conditions;
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- Severe hepatic and renal dysfunction, or AST and/or ALT >3 times the upper limit of reference range, or serum creatinine >265 μmol/L (> 3 mg/dL);
- Bleeding tendency, including heparin use within the past 48 hours (APTT ≥ 35 s), oral warfarin (INR > 2), platelet count < 100 × 10⁹/L, or hereditary hemorrhagic diseases;
- Known pregnancy or breastfeeding;
- Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
- A high likelihood that the patient will not adhere to the study treatment and follow-up regimen;
- Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage: a Multicenter, Randomized, Open-label, Blinded Endpoint Clinical Study
This study plans to enroll 1248 patients with supratentorial ICH within 24 hours of onset across multiple stroke centers. After randomization, the control group will only receive medical therapy. The experimental group, after randomization, will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical ttherapy, followed by 100 mg orally every 12 hours for 7 days, resulting in a total of 14 administrations. Both groups will be followed for 180 days to evaluate the efficacy and safety of minocycline in the treatment of ICH.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Minocycline
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
The experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations. Receives: Drug: Minocycline |
| Control group | No intervention | The control group will only receive medical therapy after randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days.
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 180 days
Secondary outcomes (5)
The proportion of patients with an mRS score of 0-1 at 180 days.
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 180 days
The proportion of patients with favorable functional outcome (mRS score of 0-2) at 90 days.
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days
The proportion of patients with an mRS score of 0-1 at 90 days.
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days
The distribution of mRS scores at 90 days and 180 days.
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days and 180 days
The NIHSS scores after 7 days of treatment.
The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 The First Hospital of Jilin UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305896
- Sponsor's protocol ID
- Enhance
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage: a Multicenter, Randomized, Open-label, Blinded Endpoint Clinical Study
- ClinicalTrials.gov ID
- NCT07305896
- Acronym / sponsor ID
- Enhance
- Conditions
- Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,248 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Dec 2025 (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.
This study plans to enroll 1248 patients with supratentorial ICH within 24 hours of onset across multiple stroke centers. After randomization, the control group will only receive medical therapy. The experimental group, after randomization, will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical ttherapy, followed by 100 mg orally every 12 hours for 7 days, resulting in a total of 14 administrations. Both groups will be followed for 180 days to evaluate the efficacy and safety of minocycline in the treatment of ICH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: MinocyclineThe experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations. |
| Control group | No intervention | –The control group will only receive medical therapy after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years, regardless of gender;
- Supratentorial ICH confirmed by brain CT scan;
- No disability in the community before ICH (premorbid mRS≤1);
- Neurological deficits related to the hematoma, with NIHSS score ≥ 6 and single-limb motor item score ≥ 2;
- GCS score ≥ 6;
Key exclusion criteria (12 listed)
- Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, use of thrombolytic drugs;
- Allergy to tetracycline antibiotics;
- Use of vitamin A derivatives or steroid therapy within the past 3 months;
- Concomitant infection requiring antibiotic treatment at admission;
- Planned surgical intervention;
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 |
|---|---|---|
| MinocyclineThe experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations. | Drug | Experimental group |
Primary outcome
The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days.
Time frame: 180 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
5 secondary outcomes
The proportion of patients with an mRS score of 0-1 at 180 days.
Time frame: 180 days
The proportion of patients with favorable functional outcome (mRS score of 0-2) at 90 days.
Time frame: 90 days
The proportion of patients with an mRS score of 0-1 at 90 days.
Time frame: 90 days
The distribution of mRS scores at 90 days and 180 days.
Time frame: 90 days and 180 days
The NIHSS scores after 7 days of treatment.
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline in people with Intracerebral Hemorrhage, run by The First Hospital of Jilin University.
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 7 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: opening soon, as of the sponsor's last update on 26 Dec 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, Pro (88782378 ext. 0431, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days. (time frame: 180 days). 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 26 Dec 2025.