Field Randomization of NA-1 Therapy in Early Responders

  • STATUS
    Recruiting
  • participants needed
    558
  • sponsor
    NoNO Inc.
Updated on 20 June 2021
Investigator
Michael Tymianski, MD PhD
Primary Contact
Kelowna General Hospital (1.0 mi away) Contact
+3 other location

Summary

The purpose of this study is to determine whether NA-1 is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.

Description

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 NA-1 in reducing global disability in patients with acute stroke. The secondary objectives are to determine the efficacy of NA-1 in reducing functional dependence, improving neurological outcome, improving activities of daily living, and increasing the proportion of subjects who are candidates for endovascular recanalization therapy.

The leading safety objectives are to determine the effect of administering a target dose of 2.60 mg/kg (up to a maximum dose of 270 mg) IV infusion of NA-1 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.

Details
Condition Acute Cerebral Ischemia
Treatment Placebo, NA-1
Clinical Study IdentifierNCT02315443
SponsorNoNO Inc.
Last Modified on20 June 2021

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