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Not yet recruitingNCT07305896Updated Dec 26, 2025

Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

An interventional study of Minocycline in Intracerebral Hemorrhage, sponsored by The First Hospital of Jilin University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,248
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Intracerebral Hemorrhage

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03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's planned enrollment of 1,248 is above the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years, regardless of gender;
  2. Supratentorial ICH confirmed by brain CT scan;
  3. No disability in the community before ICH (premorbid mRS≤1);
  4. Neurological deficits related to the hematoma, with NIHSS score ≥ 6 and single-limb motor item score ≥ 2;
  5. GCS score ≥ 6;
  6. Able to initiate the first dose of minocycline within 24 hours of onset;
  7. Signed and dated informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, use of thrombolytic drugs;
  2. Allergy to tetracycline antibiotics;
  3. Use of vitamin A derivatives or steroid therapy within the past 3 months;
  4. Concomitant infection requiring antibiotic treatment at admission;
  5. Planned surgical intervention;
  6. Life expectancy of less than 6 months due to comorbid conditions;
  7. 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);
  8. 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;
  9. Known pregnancy or breastfeeding;
  10. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
  11. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen;
  12. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,248 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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.

    Drug: Minocycline

  • No intervention
    Control group

    The control group will only receive medical therapy after randomization.

Interventions

  • DrugMinocycline

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 180 days

Secondary outcomes

  1. 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.

    Time frame: 180 days

  2. 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.

    Time frame: 90 days

  3. 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.

    Time frame: 90 days

  4. 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.

    Time frame: 90 days and 180 days

  5. 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.

    Time frame: 7 days

Other outcomes

  1. The incidence of any adverse events during the study period.

    Adverse events.

    Time frame: 180 days

  2. The incidence of serious adverse events during the study period.

    Serious adverse events.

    Time frame: 180 days

  3. The incidence of minocycline-related adverse events during the study period.

    Minocycline-related adverse events.

    Time frame: 180 days

  4. Mortality during the study period.

    Mortality.

    Time frame: 180 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07305896
Lead sponsor
The First Hospital of Jilin University
Responsible party
Sponsor
First posted
Dec 26, 2025
Start date
Dec 31, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Dec 26, 2025

Study contacts

Yi Yang, Pro
Contact
doctoryangyi@163.com
88782378 ext. 0431

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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