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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-002360-30
    Sponsor's Protocol Code Number:NA-1-009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2020-002360-30
    A.3Full title of the trial
    A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Nerinetide in Participants with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis
    (ESCAPE-NEXT Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test if a single dose of nerinetide can reduce neurological disability in people who have had a stroke and who are selected for endovascular therapy (a procedure using a device that removes the blood clot (thrombus) from a blood vessel in the brain)
    A.3.2Name or abbreviated title of the trial where available
    ESCAPE-NEXT
    A.4.1Sponsor's protocol code numberNA-1-009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04462536
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/208/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNoNO Inc.
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNoNO Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNoNO Inc.
    B.5.2Functional name of contact pointYatika Kohli
    B.5.3 Address:
    B.5.3.1Street Address479A Wellington Street West
    B.5.3.2Town/ cityToronto, Ontario
    B.5.3.3Post codeM5V 1E7
    B.5.3.4CountryCanada
    B.5.4Telephone number+16473092950
    B.5.5Fax number+14165831856
    B.5.6E-mailykohli@nonoinc.ca
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNerinetide
    D.3.2Product code NA-1
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNerinetide
    D.3.9.1CAS number 500992-11-0
    D.3.9.2Current sponsor codeNA-1/Tat-NR2B9c
    D.3.9.3Other descriptive nameNerinetide hydrochloride
    D.3.9.4EV Substance CodeSUB187626
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute ischemic stroke (AIS)
    E.1.1.1Medical condition in easily understood language
    Stroke
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10023027
    E.1.2Term Ischaemic stroke NOS
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10074321
    E.1.2Term Nonhaemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10074318
    E.1.2Term Nonhemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the efficacy of the neuroprotectant, nerinetide in:

    • Reducing global disability in participants with acute ischemic
    stroke (AIS)
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine the efficacy of nerinetide in:
    1) Reducing mortality rate
    2) Reducing worsening of stroke*
    3) Reducing functional dependence
    4) Improving neurological outcome
    * Worsening of stroke is defined as (A) progression, or hemorrhagic
    transformation of the index stroke, as documented by medical imaging
    that is (a) life-threatening requiring intervention and/or (b) results in
    increased disability as gauged by a >/= 4 point increase from lowest NIHSS
    during hospitalization or (B) results in death from the index stroke.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analytic One-Year sub-trial.
    An analytic One-Year follow-up sub-trial component investigating the long-term effects of nerinetide treatment. This One-Year follow-up will be reported separately from the main trial.
    E.3Principal inclusion criteria
    1) Acute ischemic stroke (AIS) selected for emergency endovascular treatment
    2) Age 18 years or greater
    3) Onset (last-known-well) time to randomization time within 12 hours
    4) Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS)
    a. NIHSS > 5 for internal carotid artery (ICA) and M1-middle cerebral artery (MCA) occlusion or
    b. NIHSS > 10 for M2-MCA occlusion
    5) Confirmed symptomatic intracranial occlusion at one or more of the following locations: Intracranial carotid I/T/L, M1 or M2 segment MCA. Tandem extracranial carotid and intracranial occlusions are permitted
    6) Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) ≥ 95. Patient must be living without requiring nursing care
    7) Qualifying imaging performed less than 2 hours prior to randomization
    8) Consent process completed as per national laws and regulation and the applicable ethics committee requirements
    E.4Principal exclusion criteria
    1) Treated with a tissue plasminogen activator (e.g., alteplase or
    tenecteplase) within 24 hours before randomization
    2) Determination by the treating physician, based on current treatment guidelines and medical evidence, that treatment with a plasminogen activator is indicated
    3) Large core of established infarction defined as ASPECTS 0-4
    4) Absent or poor collateral circulation on qualifying imaging (e.g.
    Collateral score of 0 or 1)
    5) Any intracranial hemorrhage on the qualifying imaging
    6) Planned use of an endovascular device not having approval or clearance by the relevant regulatory authority
    7) Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c/3 reperfusion or completion of groin / arterial closure
    8) Clinical history, past imaging or clinical judgment suggesting that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention
    9) Estimated or known weight > 120 kg (264 lbs)
    10) Pregnancy/Lactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding
    11) Known prior receipt of nerinetide for any reason, including prior enrolment in this ESCAPE-NEXT trial
    12) Severe known renal impairment defined as requiring renal replacement therapy (hemo- or peritoneal dialysis)
    13) Severe or fatal comorbid illness that will prevent improvement or follow up
    14) Inability to complete follow-up treatment to Day 90
    15) Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding trial inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Reducing global disability in participants with acute ischemic stroke (AIS).

    The proportion of participants with independent functioning on the modified Rankin Scale (mRS), as defined by a score of 0-2 at Day 90.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    E.5.2Secondary end point(s)
    1) A reduction in mortality rate, as defined by event rate (proportion, expressed as a
    percentage) for mortality over the 90-day study period.
    2) Proportion of participants with worsening of stroke over the 90-day study period.
    3) A shift of one or more categories to reduced functional dependence analyzed across the
    whole distribution of outcomes on the mRS at Day 90 post randomization.
    4) Proportion of participants with good neurological outcome, as defined by a score of 0-2 on
    the NIHSS at Day 90 post randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 90
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Singapore
    United States
    Switzerland
    Germany
    Italy
    Netherlands
    Norway
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 425
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 425
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with acute ischemic stroke may be incapable of giving consent personally at the time of enrollment because their acute neurological disability may preclude them from understanding the consent process.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 355
    F.4.2.2In the whole clinical trial 850
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There will be an analytic One-Year follow-up sub-trial component investigating the long-term effects of nerinetide treatment. Participants will be contacted by telemedicine or telephone.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-19
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