- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02315443
Field Randomization of Nerinetide (NA-1) Therapy in Early Responders (FRONTIER)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Michael Tymaisnki, M.D.
- Phone Number: (416) 603-5899
- Email: mtymianski@nonoinc.ca
Study Contact Backup
- Name: Kathy Heard, M.Sc.
- Phone Number: (416) 603-5899
- Email: kheard@nonoinc.ca
Study Locations
-
-
British Columbia
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Kelowna, British Columbia, Canada, V1Y 1T2
- Kelowna General Hospital
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New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
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Vancouver, British Columbia, Canada, V5M 4X6
- British Columbia Ambulance Service and British Columbia Emergency Health Services
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital, Vancouver Coastal Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Known or presumptive signs of pregnancy or breastfeeding
- Prisoner
- Long term care facility resident
- Known advance directive to not resuscitate
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
Placebo Comparator: Placebo
Placebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin Scale (mRS) scale
Time Frame: 90 days
|
The percentage of responders, using a sliding dichotomy on the mRS
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
90 Days or the last rating
|
Mortality rate
Time Frame: 90 Days
|
A reduction in mortality as defined by event rate (proportion, expressed as a percentage)
|
90 Days
|
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.
|
90 Days
|
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
|
90 Days or the last rating
|
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
|
90 Days or the last rating
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jim Christenson, M.D., University of British Columbia
- Principal Investigator: Richard Swartz, M.D., Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA-1-005
- HC6-24-c 195121 (Other Identifier: Health Canada)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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