NCT05836740

Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke

Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,724 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke.

Detailed description

The aim of this study was to evaluate the efficacy and safety of 4.5-days Minocycline versus placebo in patients with moderate to severe acute ischemic stroke within 72 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation and thrombo-inflammation at different time points in patients with moderate to severe acute ischemic stroke within 72 hours of onset. The primary objective is to evaluate the effect of Minocycline in improving the level of mRS score to 0-1 in patients with moderate to severe acute ischemic stroke within 72 hours of onset. The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants were interviewed at screening/baseline period, 24±2 hours, 6±1 days, 90±7 days after randomization, and when events occurred.

Conditions

• Ischemic Stroke, Acute

Interventions

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

Timeline

• Start date: 2023-05-19
• Primary completion: 2024-05-20
• Completion: 2024-08-15
• First posted: 2023-05-01
• Last updated: 2025-05-14

Locations

58 sites across 1 country: China