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    Summary
    EudraCT Number:2018-000308-41
    Sponsor's Protocol Code Number:MSP-2017-1138
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-000308-41
    A.3Full title of the trial
    Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia

    The RAPID Study (NODE-301 Part 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Investigate the Efficacy and Safety of Etripamil for the Termination of Spontaneous episodes of rapid heartbeat, for patients with Paroxysmal Supraventricular Tachycardia (PSVT).
    A.4.1Sponsor's protocol code numberMSP-2017-1138
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04072835
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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+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.3.10 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 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 of the RAPID study is to determine whether Etripamil nasal spray (NS) self-administered by patients is superior to placebo at terminating episodes of PSVT in an at-home setting.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the safety of Etripamil when self administered by patients without medical supervision.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who meet all of the following criteria will be eligible to participate in the study:
    1. Male or female patients at least 18 years of age;
    2. Electrographically documented history of PSVT (e.g., ECG obtained during an episode of
    PSVT, Holter monitoring, loop recorder, etc.). If patient had a prior ablation for PSVT, patient
    must have documented ECG evidence of PSVT post-ablation;
    3. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or
    longer);
    4. Females of childbearing potential who are sexually active with a male partner who is not
    surgically sterile (i.e., vasectomy) must agree to use an approved highly effective form of
    contraception from the time of signed informed consent until 30 days after the last
    administration of study drug. Females of childbearing potential should have a negative serum
    pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine
    pregnancy test at the Test Dose Randomization Visit and must use an approved form of
    contraception between the visits. Approved forms of contraception include hormonal
    intrauterine devices or hormonal contraceptives (oral birth control pills, Depo-Provera, patch,
    or other injectables) together with a supplementary barrier method, 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:
    Documented hysterectomy;
    Documented bilateral salpingectomy or tubal ligation; or
    Documented bilateral oophorectomy; or
    • Postmenopausal females, defined as having amenorrhea for at least 12 months without an
    alternative medical cause;
    5. Male patients, except those who are surgically sterile, must use an approved highly effective
    form of contraception during the 3 days after any study drug administration; and
    6. Signed written informed consent.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from participation in the study:
    1. Systolic blood pressure <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half-lives and patients may be rescreened once;
    2. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
    3. History of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
    4. History of allergic reaction to verapamil;
    5. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;
    6. Current chronic therapy with oral amiodarone, or have taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
    7. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval <100 msec, Wolff-Parkinson-White syndrome) on the ECG performed at the Screening Visit or before the test dose administration;
    8. Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;
    9. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia);
    10. Current congestive heart failure defined by the New York Heart Association Class II to IV;
    11. History of Acute Coronary Syndrome or stroke within 6 months of Screening;
    12. Evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN at the
    Screening Visit, unless due to Gilbert syndrome;
    13. Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
    <60 mL/min/1.73 m2 for patients <60 years of age;
    <40 mL/min/1.73 m2 for patients ≥60 and <70 years of age; or
    <35 mL/min/1.73 m2 for patients ≥70 years of age;
    14. Females who are pregnant or lactating;
    15. Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of patients or affect their participation in the study. Additionally, the Investigator has the ability to exclude a patient if for any reason the Investigator judges the patient is not a good candidate for the study or will not be able to follow study procedures;
    16. Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days of the Screening Visit; or
    17. Previously enrolled in a clinical trial for etripamil and received study drug during a perceived
    episode of PSVT.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as time to an adjudicated termination of a positively
    adjudicated episode of PSVT and conversion to SR for at least 30 seconds within 30 minutes of
    start of study drug dosing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint will be evaluated using the time to conversion of an episode of
    PSVT to SR after start of study drug administration as the primary efficacy variable.
    E.5.2Secondary end point(s)
    Study secondary Endpoints are the Sensitivity estimators, and are defined in the statistical analysis plan, and details are in the protocol v7.0 section 9.2.4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    United States
    Belgium
    France
    Germany
    Hungary
    Netherlands
    Poland
    Spain
    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 months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 389
    F.4.2.2In the whole clinical trial 700
    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 Decision2021-07-22
    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 trial2023-01-20
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