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Minocycline treatment for acute spontaneous intracerebral hemorrhage.

Efficacy and Safety of Minocycline in Patients With Acute Spontaneous Intracerebral Hemorrhage: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase III Trial

PHASE3 · Beijing Tiantan Hospital · NCT07338175

This trial will test whether a five-day course of oral minocycline started within 48 hours helps adults with moderate supratentorial intracerebral hemorrhage recover better by 90 days.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1192 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBeijing Tiantan Hospital (other)
Locations41 sites (Beijing, Beijing Municipality and 40 other locations)
Trial IDNCT07338175 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial will randomize 1,192 adults with CT-confirmed supratentorial intracerebral hemorrhage to receive either oral minocycline or matching placebo for five days in addition to guideline-based care. Eligible participants must be enrolled within 48 hours of symptom onset and have hematoma volumes of 15–40 ml and NIHSS scores of 8–24. The primary outcome is the proportion achieving a favorable 90-day modified Rankin Scale score (0–3), with clinical follow-up at 72 hours, 7 days, 90 days, and 180 days. Exploratory analyses will measure markers of neuroinflammation at predefined time points to explore biological effects of minocycline.

Who should consider this trial

Good fit: Adults aged 18–80 with CT-confirmed spontaneous supratentorial intracerebral hemorrhage, hematoma volume 15–40 ml, NIHSS 8–24, and able to start treatment within 48 hours are ideal candidates.

Not a fit: Patients with secondary causes of hemorrhage, large intraventricular or significant subarachnoid/subdural bleeding, planned surgical intervention, uncontrolled hypertension, pre-stroke disability (mRS > 1), hematoma sizes outside 15–40 ml, or presentation after 48 hours are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, minocycline could increase the number of patients who regain useful functional independence after intracerebral hemorrhage.

How similar studies have performed: Minocycline has shown neuroprotective signals in animal models and small clinical studies of stroke, but robust large-scale randomized evidence in intracerebral hemorrhage is limited, so this is a relatively novel large-scale test.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. CT-confirmed spontaneous supratentorial intracerebral hemorrhage;
2. Aged 18 to 80 years;
3. Within 48 hours of symptom onset;
4. Hematoma volume 15-40 ml;
5. NIHSS score 8-24, with item 1a ≤ 2;
6. Signed informed consent by the patient or legal representative.

Exclusion Criteria:

1. Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.);
2. Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles;
3. Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage;
4. Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment);
5. Progressive neurological or other severe systemic diseases;
6. Planned surgical intervention for the intracerebral hemorrhage;
7. Pre-stroke disability (modified Rankin Scale score \> 1);
8. Severe cardiac insufficiency (NYHA Class III-IV), severe liver disease (ALT or AST \> 3 times the normal upper limit value), severe renal insufficiency (serum creatinine \> 2 times the normal upper limit value, or glomerular filtration rate \< 45 ml/min), or malignancy with life expectancy \< 1 year;
9. Moderate to severe anemia (hemoglobin \< 90 g/L), thrombocytopenia (platelet count \< 100×10\^9/L), leukopenia (white blood cell count \< 2×10\^9/L), or coagulopathy (INR \> 1.5);
10. Allergy or intolerance to minocycline or other tetracycline antibiotics;
11. History of pseudomembranous enteritis or antibiotic-associated enteritis;
12. Use of tetracycline antibiotics within the past week;
13. Intracranial or spinal surgery within the past 3 months;
14. Any major surgery or severe physical trauma within the past month;
15. Females who are pregnant, within 30 days postpartum, or in the lactation period.
16. Participated in other interventional clinical trials within the past 3 months;
17. Inability to obtain signed informed consent from the patient or representative;
18. Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.

Where this trial is running

Beijing, Beijing Municipality and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Intracerebral Hemorrhage, Minocycline, Neuroprotection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.