Field Randomization of NA-1 Therapy in Early Responders "FRONTIER"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Detailed 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, increasing the proportion of subjects whose symptoms fully return to baseline function within 24 hours of symptom onset, and improving activities of daily living.The leading safety objectives are to determine the effect of administering a target dose of 2.60 mg/kg IV infusion of NA-1 early after 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 the Emergency Medical Services (EMS) of Toronto and Peel Region, ON and Vancouver, BC, 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.
The primary hypothesis to be tested is that administration of NA-1 will result in a lower proportion of subjects with global disability at Day 90 as assessed by the Modified Rankin Scale.
An independent, central adjudication committee will be responsible for arriving at a final diagnosis of acute cerebral ischemia versus an alternate diagnosis. An Independent Data Monitoring Committee will perform safety reviews of the clinical data.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo is visually identical to NA-1 and is also administered as a single 10-minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
  • NA-1 Drug
    ARM 1: Kind: Experimental
    Label: NA-1
    Description: 2.60 mg/kg of NA-1 administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale (mRS) 90 days No
Secondary National Institutes of Health Stroke Scale (NIHSS) 90 days No
Secondary Return to baseline function within 24 hours 24 hours No
Secondary Barthel Index 90 days No

Sponsors