Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04462536
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2020-07-02
Brief Title:
Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
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 Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
Status:
COMPLETED
Status Verified Date:
2023-09
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-NEXT
Brief Summary:
The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator alteplase tenecteplase or equivalent
Detailed Description:
This study is a Phase 3 randomized multicentre blinded placebo-controlled parallel group single-dose with a single interim analysis 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 26 mgkg 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
Participants harboring an acute ischemic stroke who are selected for endovascular revascularization without intravenous or intra-arterial thrombolytic therapy will be given a single 26 mgkg 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
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