NCT02930018

Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke

A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,105 (actual)
• Sponsor: NoNO Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the neuroprotectant, Nerinetide (NA-1), in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation who are selected for endovascular revascularization.

Detailed description

Trial Objectives: The primary objective is to determine the efficacy of the neuroprotectant, Nerinetide, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization. The secondary objectives are to determine the efficacy of Nerinetide in: * Reducing functional dependence * Improving neurological outcome * Improving activities of daily living * Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous (IV) infusion of Nerinetide to subject with acute stroke who are selected for endovascular revascularization on serious adverse events (SAEs) and 90-day mortality. Trial Design: This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose design. Subjects harboring an acute ischemic stroke and who are selected for endovascular revascularization in accordance with local institutional practices and who harbor a small established infarct core and with good collateral circulation will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of Nerinetide (NA-1) or placebo as soon as they are deemed to have met the enrollment criteria and with the intention of starting administration within 30 minutes of randomization. The randomization will be by stochastic minimization to balance baseline factors.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DRUG	Nerinetide (NA-1), 2.6 mg/kg	Single intravenous infusion of nerinetide over 10 ± 1 minutes
DRUG	Placebo	Placebo Comparator: Placebo

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-11-20
• Completion: 2019-11-20
• First posted: 2016-10-11
• Last updated: 2022-10-10
• Results posted: 2020-12-14

Locations

50 sites across 8 countries: United States, Australia, Canada, Germany, Ireland, South Korea, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study