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Neuroprotectant
Field Randomization of Nerinetide (NA-1) Therapy in Early Responders (FRONTIER Trial)
Phase 3
Waitlist Available
Led By Jim Christenson, M.D.
Research Sponsored by NoNO Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
Pivotal Trial
Summary
This trial is testing whether nerinetide can reduce disability in stroke patients if given soon after symptoms start. The drug aims to protect brain cells from damage. The study involves paramedics giving the drug to patients in the ambulance before they reach the hospital.
Eligible Conditions
- Stroke
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Modified Rankin Scale (mRS) scale
Secondary study objectives
Barthel Index
Mortality rate
National Institutes of Health Stroke Scale (NIHSS)
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nerinetide (NA-1)Experimental Treatment1 Intervention
2.60 mg/kg of nerinetide (up to a maximum dose of 270 mg) administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nerinetide (NA-1)
2015
Completed Phase 3
~540
Find a Location
Who is running the clinical trial?
NoNO Inc.Lead Sponsor
6 Previous Clinical Trials
2,823 Total Patients Enrolled
4 Trials studying Stroke
2,740 Patients Enrolled for Stroke
Brain CanadaOTHER
19 Previous Clinical Trials
5,420 Total Patients Enrolled
4 Trials studying Stroke
190 Patients Enrolled for Stroke
Djavad Mowafaghian Centre for Brain HealthUNKNOWN
Canadian Stroke NetworkOTHER
9 Previous Clinical Trials
3,156 Total Patients Enrolled
5 Trials studying Stroke
855 Patients Enrolled for Stroke
University of CalgaryOTHER
810 Previous Clinical Trials
885,762 Total Patients Enrolled
36 Trials studying Stroke
40,557 Patients Enrolled for Stroke
University of TorontoOTHER
721 Previous Clinical Trials
1,114,727 Total Patients Enrolled
24 Trials studying Stroke
4,404 Patients Enrolled for Stroke
University of British ColumbiaOTHER
1,472 Previous Clinical Trials
2,489,088 Total Patients Enrolled
33 Trials studying Stroke
26,752 Patients Enrolled for Stroke
Genome British ColumbiaIndustry Sponsor
12 Previous Clinical Trials
222,710 Total Patients Enrolled
Jim Christenson, M.D.Principal InvestigatorUniversity of British Columbia
Richard Swartz, M.D.Principal InvestigatorSunnybrook Health Sciences Centre