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    Summary
    EudraCT Number:2022-001854-49
    Sponsor's Protocol Code Number:MSP-2017-5001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-08-30
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-001854-49
    A.3Full title of the trial
    Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial Fibrillation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The ReVeRA-201 Trial : Etripamil in Atrial Fibrillation
    A.4.1Sponsor's protocol code numberMSP-2017-5001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04467905
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMilestone Pharmaceuticals 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 supportMilestone Pharmaceuticals Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Milestone Pharmaceuticals Inc.
    B.5.2Functional name of contact pointGuy Rousseau
    B.5.3 Address:
    B.5.3.1Street Address 1111 Dr. Frederik-Philips Boulevard, Suite 420
    B.5.3.2Town/ cityMontreal, Quebec
    B.5.3.3Post codeH4M 2X6
    B.5.3.4CountryCanada
    B.5.4Telephone number +1514803-2668
    B.5.6E-mailgrousseau@milestonepharma.com
    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 nameEtripamil Nasal Spray
    D.3.2Product code MSP-2017
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtripamil
    D.3.9.1CAS number 1593673-23-4
    D.3.9.2Current sponsor codeMSP-2017
    D.3.9.3Other descriptive nameKN6
    D.3.9.4EV Substance CodeSUB201173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    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 Yes
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Atrial Fibrillation
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation is a heart condition that causes an irregular and often abnormally fast heart rate.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac 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 of this study is to demonstrate the superiority
    of etripamil NS over placebo in reducing ventricular rate in patients
    with AF.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety and efficacy of
    etripamil NS in patients with AF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 years and over
    2. Has provided written informed consent
    3. Patients with episodes of paroxysmal, persistent or permanent AF,
    presenting with AF and a ventricular rate ≥110 bpm measured over
    1 minute
    4. Patients should receive appropriate antithrombotic therapy as per
    the applicable guidelines for AF management (e.g. Canadian
    Cardiovascular Society (CCS) / European Society of Cardiology
    (ESC) guidelines).
    a. Etripamil (a calcium channel blocker) is intended for acute
    rate control only. If rhythm control is desired (outside of
    the present protocol), anticoagulation as per guidelines may
    start after the administration of study drug.
    E.4Principal exclusion criteria
    1. Has evidence of atrial flutter (ECG) at presentation
    2. Has a history of stroke, transient ischemic attack or peripheral
    embolism within the last 3 months
    3. Has received by IV route any of the following within one hour
    before study drug administration: flecainide, procainamide,
    digoxin, beta-blocker, or calcium channel blocker
    4. Has signs and symptoms of severe congestive heart failure at
    presentation (e.g. tachypnea, oxygen desaturation <90% unless due
    to known pulmonary disease, pulmonary rales, sign of peripheral
    hypoperfusion)
    5. Hemodynamic instability, with systolic blood pressure <90 mmHg
    or diastolic blood pressure <60 mmHg
    6. Known uncorrected severe aortic or mitral stenosis
    7. Hypertrophic cardiomyopathy with outflow tract obstruction
    8. Has a history of second- or third-degree atrioventricular block
    9. Regular rhythm suggesting a complete AV block
    10. Has a history or evidence of torsades de pointes, sick sinus
    syndrome, or Brugada syndrome
    11. Evidence of Acute Coronary Syndrome within the last 12 months
    except if patient was successfully revascularized
    12. Positive pregnancy test result at screening, and females of
    childbearing potential who do not agree to use adequate method of
    contraception for the duration of the study.
    13. Has evidence of any clinically significant acute or chronic condition
    of the nasal cavity (e.g., rhinitis or deviated septum) which could
    interfere with administration of the study drug in either or both
    nasal cavities
    14. Has a history of sensitivity to verapamil
    15. Has previously participated in a clinical study for etripamil
    16. Has a history of sensitivity to any components of the investigational
    product
    17. Signs of alcohol or drug intoxication at the time of presentation
    which, in the opinion of the Investigator, would impact the validity
    of study results
    18. Is currently participating in another drug or device study, or has
    received an investigational drug or device within 30 days of
    Screening
    19. Has evidence of clinically significant cardiovascular, endocrine,
    gastrointestinal, hematologic, hepatic, immunologic, neurologic,
    oncologic, pulmonary, psychiatric, or renal disease or any other
    condition which, in the opinion of the Investigator, would
    jeopardize the safety of the patient or impact the validity of study
    results
    E.5 End points
    E.5.1Primary end point(s)
    Ventricular rate reduction
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy variables will be obtained from the Holter recordings measured by a central core
    laboratory. In case of conversion to sinus rhythm, only heart rate measurements prior to sinus
    conversion will be used to derive efficacy variables.
    The maximum reduction in ventricular rate, measured on Holter monitoring, within 60
    minutes from drug administration.
    E.5.2Secondary end point(s)
    • Elapsed time from drug administration to nadir
    • Percentage of patients achieving ventricular rate of <100 bpm in the 60 minutes post drug
    administration.
    • Percentage of patients with 10% reduction from baseline ventricular rate in the 60 minutes
    post drug administration.
    • Percentage of patients with 20% reduction from baseline ventricular rate in the 60 minutes
    post drug administration.
    • Percentage of patients cardioverting into sinus rhythm (for at least 30 seconds) in the 60
    minutes post drug administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 minutes pre-administration to 60 minutes after drug administration.
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States No
    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
    Canada
    Netherlands
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation WCN ( Werkgroep Cardiologische centra Nederland)
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-10
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