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

Recruiting

Phase 3 Results N/A

Update History

1 Nov '17
The description was updated.
New
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.
Old
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, increasing the proportion of subjects whose symptoms fully return to baseline function within 24 hours of symptom onset, 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 IV infusion of NA-1 early after 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 the Emergency Medical Services (EMS) of Toronto and Peel Region, ON and Vancouver, BC, 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. The primary hypothesis to be tested is that administration of NA-1 will result in a lower proportion of subjects with global disability at Day 90 as assessed by the Modified Rankin Scale. An independent, central adjudication committee will be responsible for arriving at a final diagnosis of acute cerebral ischemia versus an alternate diagnosis. An Independent Data Monitoring Committee will perform safety reviews of the clinical data.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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
Old
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 - 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 - 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 condition that would preclude obtaining the neurological or functional outcome evaluations at 30 and 90 days
6 May '16
A location was updated in Vancouver.
New
The overall status was updated to "Recruiting" at British Columbia Ambulance Service and British Columbia Emergency Health Services.
A location was updated in Etobicoke.
New
The overall status was updated to "Active, not recruiting" at Peel Regional Paramedic Services and Sunnybrook Centre for Prehospital Medicine.
A location was updated in Toronto.
New
The overall status was updated to "Active, not recruiting" at Toronto Paramedic Services and Sunnybrook Centre for Prehospital Medicine.
9 Jan '16
A location was updated in Vancouver.
New
The overall status was updated to "Recruiting" at British Columbia Ambulance Service and British Columbia Emergency Health Services.
A location was updated in Etobicoke.
New
The overall status was updated to "Active, not recruiting" at Peel Regional Paramedic Services and Sunnybrook Centre for Prehospital Medicine.
A location was updated in Toronto.
New
The overall status was updated to "Active, not recruiting" at Toronto Paramedic Services and Sunnybrook Centre for Prehospital Medicine.
21 Oct '15
The description was updated.
New
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, increasing the proportion of subjects whose symptoms fully return to baseline function within 24 hours of symptom onset, 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 IV infusion of NA-1 early after 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 the Emergency Medical Services (EMS) of Toronto and Peel Region, ON and Vancouver, BC, 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. The primary hypothesis to be tested is that administration of NA-1 will result in a lower proportion of subjects with global disability at Day 90 as assessed by the Modified Rankin Scale. An independent, central adjudication committee will be responsible for arriving at a final diagnosis of acute cerebral ischemia versus an alternate diagnosis. An Independent Data Monitoring Committee will perform safety reviews of the clinical data.
Old
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, increasing the proportion of subjects whose symptoms fully return to baseline function within 24 hours of symptom onset, 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 IV infusion of NA-1 early after 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 the Emergency Medical Services (EMS) of Toronto and Peel Region, ON and Vancouver, BC, 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. The primary hypothesis to be tested is that administration of NA-1 will result in a lower proportion of subjects with global disability at Day 90 as assessed by the Modified Rankin Scale. An independent, central adjudication committee will be responsible for arriving at a final diagnosis of acute cerebral ischemia versus an alternate diagnosis. An Independent Data Monitoring Committee will perform safety reviews of the clinical data.
A location was updated in Vancouver.
New
The overall status was updated to "Recruiting" at British Columbia Ambulance Service and British Columbia Emergency Health Services.
26 Mar '15
A location was updated in Etobicoke.
New
The overall status was updated to "Active, not recruiting" at Peel Regional Paramedic Services and Sunnybrook Centre for Prehospital Medicine.
25 Mar '15
A location was updated in Toronto.
New
The overall status was updated to "Active, not recruiting" at Toronto Paramedic Services and Sunnybrook Centre for Prehospital Medicine.