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
2 other identifiers
interventional
532
1 country
4
Brief Summary
The purpose of this study is to determine whether nerinetide (NA-1) is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2015
Longer than P75 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 11, 2014
CompletedStudy Start
First participant enrolled
March 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2023
CompletedMay 12, 2023
May 1, 2023
8 years
December 5, 2014
May 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale (mRS) scale
The percentage of responders, using a sliding dichotomy on the mRS
90 days
Secondary Outcomes (5)
mRS shift analysis
90 Days or the last rating
Mortality rate
90 Days
Worsening of stroke rate
90 Days
National Institutes of Health Stroke Scale (NIHSS)
90 Days or the last rating
Barthel Index
90 Days or the last rating
Study Arms (2)
Nerinetide (NA-1)
EXPERIMENTAL2.60 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
PLACEBO COMPARATORPlacebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NoNO Inc.lead
- Brain Canadacollaborator
- Djavad Mowafaghian Centre for Brain Healthcollaborator
- Canadian Stroke Networkcollaborator
- University of Calgarycollaborator
- University of Torontocollaborator
- University of British Columbiacollaborator
- Genome British Columbiacollaborator
Study Sites (4)
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2, Canada
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7, Canada
British Columbia Ambulance Service and British Columbia Emergency Health Services
Vancouver, British Columbia, V5M 4X6, Canada
Vancouver General Hospital, Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (2)
Christenson J, Hill MD, Swartz RH, Adams C, Benavente O, Casaubon LK, Cheskes S, Ganesh A, Garman JD, Harris C, Harris DR, Heard K, Jenneson S, Kohli Y, Leroux M, Mayor-Nunez D, Medvedev G, Mehdiratta M, Morrison LJ, Ospel JM, Pennington S, Perez Y, Selchen D, Stebner A, Tallon J, Tkach A, Verbeek PR, Tymianski M. Efficacy and safety of intravenous nerinetide initiated by paramedics in the field for acute cerebral ischaemia within 3 h of symptom onset (FRONTIER): a phase 2, multicentre, randomised, double-blind, placebo-controlled study. Lancet. 2025 Feb 15;405(10478):571-582. doi: 10.1016/S0140-6736(25)00193-X.
PMID: 39955120DERIVEDFladt J, Ospel JM, Singh N, Saver JL, Fisher M, Goyal M. Optimizing Patient-Centered Stroke Care and Research in the Prehospital Setting. Stroke. 2023 Sep;54(9):2453-2460. doi: 10.1161/STROKEAHA.123.044169. Epub 2023 Aug 7.
PMID: 37548010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jim Christenson, M.D.
University of British Columbia
- PRINCIPAL INVESTIGATOR
Richard Swartz, M.D.
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 11, 2014
Study Start
March 26, 2015
Primary Completion
March 27, 2023
Study Completion
March 27, 2023
Last Updated
May 12, 2023
Record last verified: 2023-05