Field Randomization of NA-1 Therapy in Early Responders

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NoNO Inc.
• Collaborators: Brain Canada; Canadian Stroke Network; Dalhousie University; Djavad Mowafaghian Centre for Brain Health; Genome British Columbia; St. Michael's Hospital, Toronto; Sunnybrook Health Sciences Centre; Trillium Health Centre; University Health Network, Toronto; University of British Columbia; University of Calgary; University of Toronto; Vancouver General Hospital

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