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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02315443
Recruitment Status : Recruiting
First Posted : December 11, 2014
Last Update Posted : December 18, 2019
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 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: NA-1 Drug: Placebo Phase 3

Detailed Description:

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 (up to a maximum dose of 270 mg) 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 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 : May 2021
Estimated Study Completion Date : May 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: NA-1
2.60 mg/kg of NA-1 (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: 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. Key secondary endpoint: Modified Rankin Scale (mRS) scale [ Time Frame: 90 days ]
    The primary endpoint analysis (i.e. percentage of responders, using a sliding dichotomy on the mRS scale at Day 90) performed in the confirmed acute cerebral ischemia subset of subjects.

  2. 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

  3. Proportion of subjects with functional independence [ Time Frame: 90 Days or the last rating ]

    Proportion of subjects with functional independence, as defined by a score of a) 0-2 and b) 0-

    1 on the mRS


  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

  6. Eligibility for endovascular recanalization [ Time Frame: 24 hours ]
    Proportion of subjects who are deemed to be candidates for endovascular recanalization therapy


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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
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: John Tallon, 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: December 18, 2019
Last Verified: June 2019
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
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