Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Minocycline

• Study Type: Interventional
• Enrollment (Estimated): 1248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, Pro; Phone Number: 0431 88782378; Email: doctoryangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: Control group; The control group will only receive medical therapy after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of any adverse events during the study period.	Adverse events.	180 days
The incidence of serious adverse events during the study period.	Serious adverse events.	180 days
The incidence of minocycline-related adverse events during the study period.	Minocycline-related adverse events.	180 days
Mortality during the study period.	Mortality.	180 days

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Naphthacenes; Tetracyclines; Minocycline
• Other Study ID Numbers: Enhance

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No