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    Summary
    EudraCT Number:2019-001857-13
    Sponsor's Protocol Code Number:NODE-303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-01-23
    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 ConcernedSpain - AEMPS
    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
    Estudio abierto, multicéntrico y multinacional sobre la seguridad de etripamil en aerosol nasal para pacientes con taquicardia supraventricular paroxística
    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
    Estudio para investigar la seguridad del aerosol nasal de etripamil en pacientes con taquicardia supraventricular paroxística
    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+34955 00 80 00
    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
    Tratamiento de la taquicardia supraventricular paroxística
    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.
    Episodios repentinos e inesperados de latidos cardíacos rápidos que comienzan y se detienen sin previo aviso debido a una anormalidad en el sistema eléctrico del corazón.
    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.
    El objetivo principal es evaluar la seguridad de la autoadministración de etripamil en aerosol nasal (NS) fuera del ámbito clínico.
    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
    1. Evaluar la eficacia de la autoadministración de etripamil en NS fuera del ámbito clínico.
    2. Evaluar el impacto de etripamil en NS en la carga de la PSVT.
    3. Evaluar la seguridad y la eficacia de etripamil en NS cuando se usa en varios episodios de PSVT.
    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. See Section 6.4 for details on diagnostic criteria.
    2) Is 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 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
    1) Ha sido diagnosticado con PSVT por un profesional sanitario y declara que ha padecido al menos un episodio previo de PSVT. Para mayor claridad, la PSVT hace referencia a la SVT que incluye el nódulo AV como una parte fundamental del circuito de reentrada.
    2) Tiene al menos 18 años.
    3) Firma del consentimiento informado por escrito NODE-303.
    4) Las mujeres en edad fértil que sean sexualmente activas deben estar dispuestas a usar al menos un anticonceptivo desde el momento en que se firma el consentimiento informado hasta 7 días después de la administración de la última dosis del fármaco del estudio y a
    interrumpir su participación en el estudio si se quedan embarazadas o planean estarlo. Los métodos anticonceptivos aprobados incluyen
    dispositivos intrauterinos de hormonas, anticonceptivos hormonales (anticonceptivos orales, DepoProvera, parches u otros inyectables)
    o métodos anticonceptivos de una sola barrera, como preservativos o diafragmas con espuma o gel espermicida.
    Las siguientes categorías definen a la mujeres que NO se considera que estén en edad fértil:
    Mujeres premenopaúsicas que presentan uno de los siguientes acontecimientos:
    a) histerectomía documentada;
    b) salpingectomía bilateral documentada u
    c) ovariectomía bilateral documentada o
    d) mujeres posmenopaúsicas, es decir, mujeres que han tenido
    amenorrea durante al menos 12 meses sin una causa médica alternativa.
    Se considerará que están en edad fértil todas aquellas mujeres que no cumplan los criterios anteriormente expuestos.
    5) Está dispuesto y capacitado para cumplir con los procedimientos del estudio.
    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
    14) Has known allergies to adhesive materials or hydrogel used in the Cardiac Monitoring Device
    1) No serán aptos los pacientes con tan solo un antecedente de arritmia atrial que no implique el nódulo atrioventricular (AV) como parte del circuito de taquicardia (p. ej., fibrilación auricular, aleteo auricular,
    taquicardia intraauricular). Serán aptos los pacientes con un antecedente de estas taquicardias que hayan sido diagnosticados con PSVT.
    2) Antecedentes de reacción alérgica a verapamilo.
    3) Tratamiento actual con digoxina o cualquier fármaco antiarrítmico de clase I o III. Los pacientes pueden ser aptos si interrumpen la administración de dichos fármacos al menos 5 semividas antes de la
    administración de etripamil en NS. La única excepción es amiodarona, que se debe interrumpir 30 días antes de la inscripción.
    4) Antecedentes de preexcitación ventricular; p. ej.: ondas delta, síndrome de Wolff-Parkinson-White.
    5) Antecedentes de un bloqueo AV de segundo o tercer grado.
    6) Síntomas de insuficiencia cardíaca congestiva (clases II a IV de la New York Heart Association).
    7) Trastorno psiquiátrico o físico importante, incluidos el alcoholismo o drogadicción, que, en opinión del investigador, pueda poner en peligro la seguridad del paciente o impedir la capacidad del paciente para seguir
    los procedimientos del estudio.
    8) Antecedentes de síncopes debidos a una etiología arrítmica en cualquier momento o síncopes sin explicación en los últimos 5 años.
    9) Está embarazada o en periodo de lactancia.
    10) Inscrito previamente en un ensayo clínico de etripamil y recibiendo el fármaco del estudio.
    11) Antecedentes de SCA o accidente cerebrovascular en los 6 meses previos a la selección.
    12) Evidencia de disfunción renal según lo determinado por una tasa de filtración glomerular estimada evaluada en la visita de selección de la siguiente forma:
    a) <60 ml/min/1,73 m 2 para pacientes de <60 años
    b) <40 ml/min/1,73 m 2 para pacientes de ≥60 y <70 años
    c) <35 ml/min/1,73 m 2 para pacientes de ≥70 años
    13) Presión sistólica <90 mmHg
    14) Alérgias conocidas a material adhesivo o a hidrogel usado en el dispositvo de monitorización cardíaca
    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.
    Número de participantes que presentan acontecimientos adversos y/o número de participantes con hallazgos anormales según sistema de monitorización cardíaca y exploraciones físicas.
    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.
    Se estima que se necesitarán 10 meses para acumular suficientes autoadministraciones documentadas de etripamil en la base de datos de seguridad para cumplir con los requisitos reglamentarios para el programa de desarrollo de etripamil . Cuando se cumplan los criterios para concluir el estudio, el Promotor anunciará una fecha de finalización del estudio común (CSED) para todo el estudio, y se informará a los centros con anticipación para programar todas las visitas finales de los pacientes antes del CSED.
    La fecha de finalización del estudio común (CSED) para todo el estudio dependerá de la tasa de acumulación de pacientes únicos con un episodio.
    Aprende a pronunciar
    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.)
    • Frecuencia de intervención médica adicional para tratar PSVT, según lo medido por las visitas a urgencias, los ingresos hospitalarios de pacientes hospitalizados y ambulatorios, y el uso concomitante de medicamentos.
    • Mejora en la calidad de vida del paciente, medida por el Sistema de Resultados Informados por el Paciente (PRO).
    • Satisfacción del paciente con el tratamiento, medido por el Cuestionario de satisfacción del tratamiento para medicamentos (TSQM-9) y otras preguntas.
    • Terminación de los episodios de PSVT (medido por el tiempo medio y medio de conversión y la proporción de pacientes que se convierten a los 3, 5, 10, 15, 20, 30 y 60 minutos después de la administración de etripamilo NS).
    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.
    Se estima que se necesitarán 10 meses para acumular suficientes autoadministraciones documentadas de etripamil NS en la base de datos de seguridad para permitir la evaluación de estos puntos finales.
    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 concerned17
    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
    Última visita del último paciente
    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.
    Milestone (el Promotor) llevará a cabo un programa de uso compasivo ara proporcionar el medicamento a pacientes que participan en el estudio NODE-303. Suponiendo que el programa sea aprobado por la autoridad reguladora regional, los pacientes tendrán la opción de continuar recibiendo el medicamento del estudio después de completar 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 Decision2020-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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