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Trial record 1 of 1 for:    NCT02930018
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Safety and Efficacy of NA-1 in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) (ESCAPE-NA1)

This study is currently recruiting participants.
Verified October 2017 by NoNO Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02930018
First Posted: October 11, 2016
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.
Collaborator:
University of Calgary
Information provided by (Responsible Party):
NoNO Inc.
  Purpose
The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation who are selected for endovascular revascularization.

Condition Intervention Phase
Stroke, Acute Drug: NA-1, 2.6 mg/kg 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 Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy

Further study details as provided by NoNO Inc.:

Primary Outcome Measures:
  • Modified Rankin Score (mRS) [ Time Frame: 90 Days ]
    Overall proportion of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS


Secondary Outcome Measures:
  • mRS Shift Analysis [ Time Frame: 90 Days or the last rating ]
    Shift of one or more categories to reduced functional dependence analyzed across the whole distribution of scores on the mRS at Day 90 or the last rating.

  • NIHSS [ Time Frame: 90 Days or the last rating ]
    Proportion of subjects with good neurological outcome, as defined by a score of 0-2 on the NIHSS at Day 90 or the last rating.

  • 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 BI at Day 90 or the last rating.

  • Mortality Rate [ Time Frame: 90 Days ]
    A reduction in mortality rate, as defined by event rate (%) for mortality over the 90-day study period

  • Functional Independence based on mRS [ Time Frame: 90 Days or the last rating ]
    Proportion of subjects with functional independence, as defined by a score of 0-1 on the mRS at Day 90 or the last rating.


Other Outcome Measures:
  • EQ-5D-5L [ Time Frame: 90 Days or the last rating ]
    Health-related quality of life, as measured by the EQ-5D-5L at Day 90 or the last rating.

  • Stroke Volume [ Time Frame: 24 hour follow up ]
    Volume of stroke as measured by MRI. If NCCT was done instead of MRI, Volume of stroke will be derived from hypodense areas.

  • Test of language function [ Time Frame: 90 Days ]
    Cognitive outcome - The 15-item Boston Naming Test (BNT15)

  • Test of hemi-spatial neglect [ Time Frame: 90 Days ]
    Cognitive Outcome - Sunnybrook hemi-spatial neglect procedure (SNAP)

  • Global test of cognitive function. Scale from 0 to 30 points. [ Time Frame: 90 Days ]
    Cognitive outcome - The Montreal Cognitive Assessment (MoCA)

  • Functional outcome based on mRS [ Time Frame: 30 days ]
    The proportion of subjects experiencing a favorable functional outcome 30 days post-randomization, defined as 0 to 2 on the mRS.


Estimated Enrollment: 1120
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug vehicle only
Drug: Placebo
Placebo Comparator: Placebo
Other Name: Drug vehicle only
Experimental: NA-1, 2.6 mg/kg
Single intravenous infusion of NA-1 over 10 ± 1 minutes
Drug: NA-1, 2.6 mg/kg
Single intravenous infusion of NA-1 over 10 ± 1 minutes
Other Name: Tat-NR2B9c

Detailed Description:

Trial Objectives:

The primary objective is to determine the efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization.

The secondary objectives are to determine the efficacy of NA-1 in:

  • Reducing functional dependence
  • Improving neurological outcome
  • Improving activities of daily living
  • Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg intravenous (IV) infusion of NA-1 to subject with acute stroke who are selected for endovascular revascularization on serious adverse events (SAEs) and 90-day mortality.

Trial Design:

This study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose design. Subjects harboring an acute ischemic stroke and who are selected for endovascular revascularization in accordance with local institutional practices and who harbor a small established infarct core and with good collateral circulation will be given a single, 2.6 mg/kg intravenous dose of NA-1 or placebo as soon as they are deemed to have met the enrollment criteria and started within 30 minutes of randomization. The randomization will be by stochastic minimization to balance baseline factors.

  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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute ischemic stroke (AIS) for immediate endovascular treatment
  2. Age 18 or greater.
  3. Onset (last-seen-well) time to randomization time within 12 hours.
  4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) > 5 at the time of randomization.
  5. Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) > 90 (95 or 100). Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
  6. Confirmed symptomatic intracranial occlusion, based on multiphase or dynamic computerized tomographic angiography (CTA), at one or more of the following locations: Intracranial carotid T/L, M1 middle cerebral artery (MCA). Functionally, when defining the M1 or the M2, the bulk of the MCA territory must be ischemic.
  7. Non-contrast computed tomography (NCCT) and CTA* for trial eligibility performed or repeated at ESCAPE-NA1 stroke centre with endovascular suite on-site.
  8. Endovascular treatment with declared first endovascular approach as either stent retriever or aspiration device, and intended to be initiated (arterial access) within 60 minutes of baseline/qualifying NCCT and to first recanalization of 90 minutes. Study drug intended to be administered within 60 minutes of the baseline/qualifying NCCT.
  9. Signed informed consent from subject or legally authorized representative.

Exclusion Criteria:

  1. Evidence of a large core of established infarction defined as ASPECTS 0-4.
  2. Evidence of absence of collateral circulation on CTA (Collateral score of 0 or 1).
  3. Intent to use any endovascular device other than a stent retriever or clot aspiration device or intra-arterial medications as the initial thrombectomy approach.
  4. Intent to use any intravenous thrombolytic other than alteplase if intravenous thrombolysis is planned.
  5. No femoral pulses, very difficult endovascular access or extreme tortuosity of great vessels that is predicted to result in an inability to deliver timely endovascular therapy. Direct common carotid or radial/brachial/axillary access is permissible.
  6. Estimated or known weight > 120 kg or < 45 kg.
  7. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive, or breastfeeding.
  8. Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
  9. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.
  10. Prior enrolment in the ESCAPE-NA1 trial or prior receipt of NA-1 for any reason.
  11. Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or if known a creatinine clearance < 29 mL/min.
  12. Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up.
  13. Patient cannot complete follow-up treatment due to co-morbid non-fatal illness or they are known to be a visitor to the city or any other known reason for which follow-up would be impossible (e.g. incarcerated in a federal prison).
  14. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding study inclusion.
  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): NCT02930018


Contacts
Contact: Michael Tymianski, MD PhD 416-603-5899 mtymianski@nonoinc.ca
Contact: Kathy Heard, MSc 416-603-5481 kheard@nonoinc.ca

  Show 29 Study Locations
Sponsors and Collaborators
NoNO Inc.
University of Calgary
Investigators
Principal Investigator: Michael D Hill, MD MSc University of Calgary
  More Information

Publications:

Responsible Party: NoNO Inc.
ClinicalTrials.gov Identifier: NCT02930018     History of Changes
Other Study ID Numbers: NA-1-007
First Submitted: October 6, 2016
First Posted: October 11, 2016
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: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NoNO Inc.:
Acute Ischemic Stroke
Endovascular Thrombectomy
Neuroprotection
Tat-NR2B9c
NA-1

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases