NCT07338175

Efficacy and Safety of Minocycline in 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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,192 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy and safety of oral minocycline in patients with acute spontaneous intracerebral hemorrhage within 48 hours of onset.

Detailed description

The aim of this study was to evaluate the efficacy and safety of 5-day Minocycline versus placebo in patients with acute intracerebral hemorrhage within 48 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation at different time points in patients with acute intracerebral hemorrhage within 48 hours of onset. A total of 1192 participants will be randomized 1:1 to receive either minocycline or matching placebo for 5 days, in addition to guideline-based standard medical care. The primary objective is to evaluate the effect of Minocycline in improving the level of 90-day mRS score to 0-3 in patients with acute intracerebral hemorrhage within 48 hours of onset. The trial is divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants are interviewed at screening/baseline period, 72±12 hours, 7±1 days, 90±7 days,180±7 days after randomization, and when events occur.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Minocycline hydrochloride capsules	50 mg per capsule, containing 50mg of Minocycline Hydrochloride
DRUG	Placebo capsules of Minocycline hydrochloride capsules	50 mg per capsule, containing 0 mg of Minocycline Hydrochloride

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: China