Efficacy and safety of minocycline in the treatment of intracerebral haemorrhage: study design and protocol for a multicentre, randomised, open-label, blinded endpoint clinical trial.

BACKGROUND

Although minocycline is a multi-target neuroprotective drug, its potential benefit in patients with ICH remains unclear. This study primarily aims to assess the efficacy and safety of minocycline for the treatment of ICH.

STUDY

DESIGN

Efficacy and Safety of Minocycline in the Treatment of ICH (ENHANCE) is an ongoing prospective, multicentre, randomised, open-label, blinded-endpoint clinical trial. A total of 1248 patients with ICH within 24 h of onset will be randomly assigned to the minocycline or control group at a ratio of 1:1. The minocycline group will receive an initial dose of 200 mg minocycline hydrochloride capsules in addition to the guideline-based treatment, followed by 100 mg orally every 12 h for 7 days, resulting in a total of 14 administrations. The control group will receive only the guideline-based treatment.

STUDY ENDPOINTS: The primary efficacy outcome measure will be the proportion of patients with good functional outcomes (mRS score, 0-2) at 180 days. Safety outcome measures will include all adverse events and severe adverse events occurring during the study period.

SUMMARY: The ENHANCE trial is designed to evaluate the effectiveness and safety of minocycline in the treatment of ICH.

TRIAL REGISTRATION: Chinese Clinical Trials Registry identifier: ChiCTR2500114607.