Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

Summary

Participation Requirements

Description

This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose, adaptive design with a single interim analysis for unblinded sample size re-estimation. Because AIS (acute ischemic stroke) is a medical emergency, the trial is designed to enable the administ...

This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose, adaptive design with a single interim analysis for unblinded sample size re-estimation. Because AIS (acute ischemic stroke) is a medical emergency, the trial is designed to enable the administration of standard-of-care treatments without delay in order to save the life of the person concerned, restore good health or alleviate suffering. Participants harboring an acute ischemic stroke who are selected for endovascular revascularization without intravenous or intra-arterial thrombolytic therapy will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of nerinetide or placebo. Outcomes of the main trial will be evaluated throughout a 90 day observation period. Participants will be followed at 1-Year for the analytic sub-trial for further outcome assessment by telemedicine or telephone interview conducted by individuals blinded to the outcome of the main trial. This sub-trial will be conducted to explore the independent functioning and quality of life at 1-Year.

Tracking Information