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.
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 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.
- 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.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|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|
|Primary||Modified Rankin Scale (mRS) scale||90 days|
|Secondary||mRS shift analysis||90 Days or the last rating|
|Secondary||Proportion of subjects with functional independence||90 Days or the last rating|
|Secondary||Eligibility for endovascular recanalization||24 hours|
- NoNO Inc. Lead
- Brain Canada
- Canadian Stroke Network
- Sunnybrook Health Sciences Centre
- University of Calgary
- University Health Network, Toronto
- BC Emergency Health Services
- Peel Regional Paramedic Services
- Genome Canada
- Djavad Mowafaghian Centre for Brain Health
- Vancouver General Hospital
- St. Michael's Hospital, Toronto
- University of British Columbia
- Dalhousie University
- University of Toronto
- Toronto Paramedic Services
- Royal Columbian Hospital
- Trillium Health Centre