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Acute Cerebral IschemiaPhase 3FRONTIERNCT02315443

Field Randomization of Nerinetide (NA-1) Therapy in Early Responders

A Phase 3 study testing Nerinetide (NA-1) in people with Acute Cerebral Ischemia, run by NoNO Inc. at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 95 years
Conditions the study is for
Acute Cerebral Ischemia
What is being tested?
Nerinetide (NA-1)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
532 participants
Where
4 sitesCanada
Study dates
26 Mar 2015to 27 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y 1T2

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

  • British Columbia Ambulance Service and British Columbia Emergency Health Services

    Vancouver, British Columbia, V5M 4X6

  • Vancouver General Hospital, Vancouver Coastal Health

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Nerinetide (NA-1), Placebo
Keywords
Stroke, Ischemia, Prehospital, NA-1, Modified Rankin Scale, Haemorrhagic stroke, Transient ischemic attack, Nerinetide
Medical subject headings
Stroke, Ischemia, Hemorrhagic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerinetide (NA-1)Drug

  • PlaceboDrug

Study groups in NCT02315443
Study groupRoleWhat they receive
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.
Receives: Drug: Nerinetide (NA-1)
PlaceboPlacebo comparatorPlacebo administered as a single 10 minute IV infusion using an ambulatory infusion pump early after stroke symptom onset.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale (mRS) scale

    The percentage of responders, using a sliding dichotomy on the mRS

    Measured: 90 days

Secondary outcomes (5)

  1. mRS shift analysis

    Shift to reduced functional dependence analyzed across the whole distribution of scores on the mRS

    Measured: 90 Days or the last rating

  2. Mortality rate

    A reduction in mortality as defined by event rate (proportion, expressed as a percentage)

    Measured: 90 Days

  3. Worsening of stroke rate

    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.

    Measured: 90 Days

  4. National Institutes of Health Stroke Scale (NIHSS)

    Proportion of subjects with good neurological outcome, as defined by a score of 0-1 on the NIHSS

    Measured: 90 Days or the last rating

  5. Barthel Index

    Proportion of subjects with functional independence in activities of daily living, as defined by a score of ≥ 95 on the Barthel Index

    Measured: 90 Days or the last rating

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2014 (estimated)
  2. Study start26 Mar 2015
  3. Primary completion27 Mar 2023
  4. Study completion27 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02315443
Sponsor's protocol ID
NA-1-005
Other IDs
HC6-24-c 195121
Acronym
FRONTIER
Status last verified
May 2023
First submitted
5 Dec 2014
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39955120

  • Fladt 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.

    PubMed 37548010

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nerinetide (NA-1) in people with Acute Cerebral Ischemia, run by NoNO Inc. at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (mRS) scale (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02315443, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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