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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
Sponsor:
Collaborators:
Brain Canada
Djavad Mowafaghian Centre for Brain Health
Canadian Stroke Network
University of Calgary
University of Toronto
University of British Columbia
Genome British Columbia
Information provided by (Responsible Party):
NoNO Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Cerebral Ischemia Drug: Nerinetide (NA-1) Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Modified Rankin Scale (mRS) scale [ Time Frame: 90 days ]
    The percentage of responders, using a sliding dichotomy on the mRS


Secondary Outcome Measures :
  1. 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

  2. Mortality rate [ Time Frame: 90 Days ]
    A reduction in mortality as defined by event rate (proportion, expressed as a percentage)

  3. 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.

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Michael Tymaisnki, M.D. (416) 603-5899 mtymianski@nonoinc.ca
Contact: Kathy Heard, M.Sc. (416) 603-5899 kheard@nonoinc.ca

Locations
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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         
Sponsors and Collaborators
NoNO Inc.
Brain Canada
Djavad Mowafaghian Centre for Brain Health
Canadian Stroke Network
University of Calgary
University of Toronto
University of British Columbia
Genome British Columbia
Investigators
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Principal Investigator: Jim Christenson, M.D. University of British Columbia
Principal Investigator: Richard Swartz, M.D. Sunnybrook Health Sciences Centre
More Information
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Responsible Party: NoNO Inc.
ClinicalTrials.gov Identifier: NCT02315443    
Other Study ID Numbers: NA-1-005
HC6-24-c 195121 ( Other Identifier: Health Canada )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NoNO Inc.:
Stroke
Ischemia
Prehospital
NA-1
 Modified Rankin Scale
Haemorrhagic stroke
Transient ischemic attack
Nerinetide
Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke
Infarction
Necrosis