Field Randomization of Nerinetide (NA-1) Therapy in Early Responders (FRONTIER)
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|ClinicalTrials.gov Identifier: NCT02315443|
Recruitment Status : Recruiting
First Posted : December 11, 2014
Last Update Posted : June 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Cerebral Ischemia||Drug: Nerinetide (NA-1) Drug: Placebo||Phase 3|
Nerinetide (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 nerinetide in reducing global disability in patients with acute stroke. The secondary objectives are to determine the efficacy of nerinetide in reducing functional dependence, reducing mortality rate, reducing worsening of stroke, improving neurological outcome 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 (up to a maximum dose of 270 mg) IV infusion of nerinetide 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||586 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous NA-1 Initiated by Paramedics in the Field for Acute Cerebral Ischemia Within Three Hours of Symptom Onset|
|Actual Study Start Date :||March 26, 2015|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Nerinetide (NA-1)
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.
Drug: Nerinetide (NA-1)
Placebo Comparator: Placebo
Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
- Modified Rankin Scale (mRS) scale [ Time Frame: 90 days ]The percentage of responders, using a sliding dichotomy on the mRS
- mRS shift analysis [ Time Frame: 90 Days or the last rating ]Shift to reduced functional dependence analyzed across the whole distribution of scores on the mRS
- Mortality rate [ Time Frame: 90 Days ]A reduction in mortality as defined by event rate (proportion, expressed as a percentage)
- Worsening of stroke rate [ Time Frame: 90 Days ]A reduction in proportion of participants with worsening of stroke. Worsening of stroke is defined as progression, or hemorrhagic transformation, of the index stroke as documented in the study CRF that (i) is deemed life-threatening and/or (ii) results in increased disability as gauged by a ≥4 point increase from lowest NIHSS during hospitalization and/or (iii) results in death.
- National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 90 Days or the last rating ]Proportion of subjects with good neurological outcome, as defined by a score of 0-1 on the NIHSS
- Barthel Index [ Time Frame: 90 Days or the last rating ]Proportion of subjects with functional independence in activities of daily living, as defined by a score of ≥ 95 on the Barthel Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315443
|Contact: Michael Tymaisnki, M.D.||(416) email@example.com|
|Contact: Kathy Heard, M.Sc.||(416) firstname.lastname@example.org|
|Canada, British Columbia|
|Kelowna General Hospital||Recruiting|
|Kelowna, British Columbia, Canada, V1Y 1T2|
|Contact: Aleksander Tkach, MD|
|Royal Columbian Hospital||Recruiting|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Contact: George Medvedev, MD|
|British Columbia Ambulance Service and British Columbia Emergency Health Services||Recruiting|
|Vancouver, British Columbia, Canada, V5M 4X6|
|Contact: Sandra Jenneson, M.D.|
|Vancouver General Hospital, Vancouver Coastal Health||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Oscar Benavente, MD|
|Principal Investigator:||Jim Christenson, M.D.||University of British Columbia|
|Principal Investigator:||Richard Swartz, M.D.||Sunnybrook Health Sciences Centre|