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    Summary
    EudraCT Number:2019-001857-13
    Sponsor's Protocol Code Number:NODE-303
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-001857-13
    A.3Full title of the trial
    Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Investigate the Safety of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
    A.4.1Sponsor's protocol code numberNODE-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04072835
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/042/2019
    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 organisationMilestone Pharmaceuticals Inc.
    B.5.2Functional name of contact pointGuy Rousseau
    B.5.3 Address:
    B.5.3.1Street Address1111 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+1514336 0444228
    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.3.10 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Paroxysmal Supraventricular Tachycardia
    E.1.1.1Medical condition in easily understood language
    Sudden and unexpected episodes of rapid heartbeat that start and stop without warning due to an abnormality in the electrical system of the heart.
    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 LLT
    E.1.2Classification code 10034044
    E.1.2Term Paroxysmal supraventricular tachycardia
    E.1.2System Organ Class 100000004849
    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 evaluate the safety of self-administered etripamil nasal spray (NS) outside of the clinical setting.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of self-administered etripamil NS outside of the clinical setting, and
    2. To evaluate the impact of etripamil NS on PSVT disease burden, and
    3. To evaluate the safety and efficacy of etripamil NS when used for multiple PSVT episodes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Has been diagnosed with PSVT by a medical professional and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic SVT that includes the AV node as a critical part of reentrant circuit.
    2) Is of at least 18 years of age
    3) Signed NODE-303 written informed consent
    4) Women of child-bearing potential who are sexually active must be willing to use at least 1 form of contraception from the time of signed informed consent until 7 days after the last administration of study drug, and must be willing to discontinue from the study should they become or plan to become pregnant.
    Approved forms of contraception include hormonal intrauterine devices or hormonal contraceptives (oral birth control pills, DepoProvera,patch, or other injectables) or single barrier methods such as condoms or diaphragms with spermicidal gel or foam;
    The following categories define females who are NOT considered to be of childbearing potential:
    Premenopausal females with 1 of the following:
    a) Documented hysterectomy;
    b) Documented bilateral salpingectomy; or
    c) Documented bilateral oophorectomy; or
    d) Postmenopausal females, defined as having amenorrhea for at least
    12 months without an alternative medical cause.
    All females who do not meet the above criteria are considered to be of childbearing potential.
    5) Willing and able to comply with study procedures
    E.4Principal exclusion criteria
    1) Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.
    2) History of allergic reaction to verapamil
    3) Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is amiodarone which must be stopped 30 days before enrollment.
    4) History of ventricular pre-excitation, e.g., delta waves, Wolff-Parkinson-White syndrome.
    5) History of a second- or third-degree AV block
    6) Symptoms of congestive heart failure New York Heart Association Class II to IV
    7) Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient’s capacity to follow the study procedures
    8) History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope
    9) Is pregnant or breastfeeding
    10) Previously enrolled in a clinical trial for etripamil and received study drug
    11) History of ACS or stroke within 6 months of screening
    12) Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
    a) <60mL/min/1.73m2 for patients <60 years of age
    b) <40mL/min/1.73m2 for patients ≥60 and <70 years of age
    c) <35mL/min/1.73m2 for patients ≥70 years of age
    13) SBP<90 mmHg
    Has known allergies to adhesive materials or hydrogel used in the Cardiac Monitoring Device
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants presenting Adverse Events and/or number of participants with abnormal findings from the Cardiac Monitoring System recordings and physical examinations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    It is estimated that 10 months will be needed to accrue enough documented self-administrations of etripamil NS in the safety database to meet regulatory requirements for the etripamil NS development program. When the criteria for concluding the study have been met, the Sponsor will announce a common study end date (CSED) for the entire study, and sites will be informed in advance to schedule all final patient visits prior to the CSED.
    The common study end date (CSED) for the entire study will depend on the rate of accrual of unique patients with an episode.
    E.5.2Secondary end point(s)
    • Frequency of additional medical intervention to treat PSVT, as measured by emergency department (ED) visits, inpatient and outpatient hospital admissions, and concomitant medication use.
    • Improvement in patient quality of life, as measured by the Patient Reported Outcomes (PRO) System.
    • Patient satisfaction with treatment, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9) and other questions.
    • Termination of PSVT episodes (as measured by mean and median time to conversion and proportion of patients converting at at 3, 5, 10, 15, 20, 30, and 60 minutes after etripamil NS administration.)
    E.5.2.1Timepoint(s) of evaluation of this end point
    It is estimated that 10 months will be needed to accrue enough documented self-administrations of etripamil NS in the safety database to enable assessment of these endpoints.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    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
    Argentina
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Ukraine
    United Kingdom
    United States
    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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 975
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 525
    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 1500
    F.4.2.2In the whole clinical trial 3000
    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)
    Milestone/Sponsor will conduct a named patient program to provide study drug to patients who participate in the NODE-303 study.  Assuming the program is approved by the regional regulatory authority, patients will be given the option to continue receiving study drug after they complete NODE-303.
    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 Decision2019-12-31
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-26
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