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


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Provisional diagnosis of acute stroke as identified by paramedics using the local stroke triage tool
- Respiratory rate 12-24 breaths per minute
- Oxygen saturation ≥ 90% on room air
- Systolic blood pressure < 90 or > 220 mmHg
- Weight 45-120 kg
- Last seen in usual state of health less than 3 hours before anticipated study drug initiation
- Independently ambulatory with or without devices prior to event
- LAMS score of 2-5 for at least 15 minutes and remains 2-5 at time of randomization

Exclusion Criteria

- Lack of IV access
- Canadian Triage and Acuity Scale Level 1 and/or uncorrected airway, breathing or significant circulatory problem
- Blood sugar < 3 mmol/L (< 55 mg/dL)
- Seizure at onset of symptoms or observed by paramedic
- Glasgow coma score of <10
- Major head trauma in the last three months
- Recent stroke in the last three months with or without residual deficit
- Known or presumptive signs of pregnancy or breastfeeding
- Prisoner
- Long term care facility resident
- Known advance directive to not resuscitate
- Valid Emergency Health Services Do Not Resuscitate Consent Form
- Known participation in a clinical trial with an investigational drug or device within 30 days preceding this trial
- Pre-existing neurologic, psychiatric, or advanced systemic condition that would preclude obtaining the neurological or functional outcome evaluations