Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02930018
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2016-10-06
Brief Title:
Safety and Efficacy of Nerinetide NA-1 in Subjects Undergoing Endovascular Thrombectomy for Stroke
Sponsor:
NoNO Inc
Organization:
NoNO Inc
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCAPE-NA1
Brief 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 26 mgkg 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 26 mgkg 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
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 26 mgkg 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 26 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None