Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02315443
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2014-12-05
Brief Title:
Field Randomization of Nerinetide NA-1 Therapy in Early Responders
Sponsor:
NoNO Inc
Organization:
NoNO Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous NA-1 Initiated by Paramedics in the Field for Acute Cerebral Ischemia Within Three Hours of Symptom Onset
Status:
COMPLETED
Status Verified Date:
2023-05
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:
FRONTIER
Brief Summary:
The purpose of this study is to determine whether nerinetide NA-1 is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset
Detailed Description:
Nerinetide NA-1 is being developed as an emergency drug aimed at reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset
The primary objective is to determine the efficacy of nerinetide in reducing global disability in patients with acute stroke The secondary objectives are to determine the efficacy of nerinetide in reducing functional dependence reducing mortality rate reducing worsening of stroke improving neurological outcome and improving activities of daily living
The leading safety objectives are to determine the effect of administering a target dose of 260 mgkg up to a maximum dose of 270 mg IV infusion of nerinetide within three hours of symptom onset by paramedics in the field on serious adverse events and 90-day mortality
This trial is a multicenter randomized double-blind placebo-controlled single dose study initiated prehospital in the ambulance It is being conducted using Emergency Medical Services EMS in Canada Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system and further screened for eligibility and approval by an on-call trial physician The paramedics will administer the study drug Upon arrival at the emergency department subjects will receive standard-of-care
An Independent Data Monitoring Committee will perform safety reviews of the clinical data
The primary objective is to determine the efficacy of nerinetide in reducing global disability in patients with acute stroke The secondary objectives are to determine the efficacy of nerinetide in reducing functional dependence reducing mortality rate reducing worsening of stroke improving neurological outcome and improving activities of daily living
The leading safety objectives are to determine the effect of administering a target dose of 260 mgkg up to a maximum dose of 270 mg IV infusion of nerinetide within three hours of symptom onset by paramedics in the field on serious adverse events and 90-day mortality
This trial is a multicenter randomized double-blind placebo-controlled single dose study initiated prehospital in the ambulance It is being conducted using Emergency Medical Services EMS in Canada Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system and further screened for eligibility and approval by an on-call trial physician The paramedics will administer the study drug Upon arrival at the emergency department subjects will receive standard-of-care
An Independent Data Monitoring Committee will perform safety reviews of the clinical data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HC6-24-c 195121 | OTHER | Health Canada | None |