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Trial record 1 of 1 for:    NCT02315443
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Field Randomization of NA-1 Therapy in Early Responders (FRONTIER)

This study is currently recruiting participants.
Verified October 2017 by NoNO Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02315443
First Posted: December 11, 2014
Last Update Posted: October 31, 2017
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.
Collaborators:
Brain Canada
Djavad Mowafaghian Centre for Brain Health
Canadian Stroke Network
Vancouver General Hospital
University of Calgary
Dalhousie University
University of Toronto
University of British Columbia
Genome Canada
Royal Columbian Hospital
St. Michael's Hospital, Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Trillium Health Centre
Peel Regional Paramedic Services
Toronto Paramedic Services
BC Emergency Health Services
Rescu
Information provided by (Responsible Party):
NoNO Inc.
  Purpose
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 Intervention Phase
Acute Cerebral Ischemia Drug: NA-1 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by NoNO Inc.:

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


Secondary Outcome Measures:
  • 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

  • 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


  • 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

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


Estimated Enrollment: 558
Actual Study Start Date: March 26, 2015
Estimated Study Completion Date: May 31, 2019
Estimated Primary Completion Date: March 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NA-1
2.60 mg/kg of NA-1 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

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 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.

  Eligibility

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.


Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
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
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
Contact: Jim Christenson, M.D. 604 806 8263 jim.christenson@ubc.ca

Locations
Canada, British Columbia
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: Jim Christenson, M.D.       jim.christenson@ubc.ca   
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
Vancouver General Hospital
University of Calgary
Dalhousie University
University of Toronto
University of British Columbia
Genome Canada
Royal Columbian Hospital
St. Michael's Hospital, Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Trillium Health Centre
Peel Regional Paramedic Services
Toronto Paramedic Services
BC Emergency Health Services
Rescu
Investigators
Principal Investigator: Jim Christenson, M.D. University of British Columbia
Principal Investigator: Richard Swartz, M.D. Sunnybrook Health Sciences Centre
  More Information

Responsible Party: NoNO Inc.
ClinicalTrials.gov Identifier: NCT02315443     History of Changes
Other Study ID Numbers: NA-1-005
171820 ( Other Identifier: Health Canada )
First Submitted: December 5, 2014
First Posted: December 11, 2014
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke