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    EudraCT Number:2011-001287-22
    Sponsor's Protocol Code Number:FLECAINIDE-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001287-22
    A.3Full title of the trial
    A Prospective Randomized Crossover trial of Oral Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
    Studio prospettico, randomizzato, crossover sulla somministrazione orale di Flecainide nella tachicardia ventricolare polimorfa catecolaminergica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of Flecainide for Catecholaminergic Ventricular Tachycardia
    Studio clinico sulla somministrazione di Flecainide nella tachicardia ventricolare catecolaminergica
    A.4.1Sponsor's protocol code numberFLECAINIDE-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01117454
    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.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVanderbilt University
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Salvatore Maugeri, IRCCS
    B.5.2Functional name of contact pointUO Cardiologia Riabilitativa - Lab.
    B.5.3 Address:
    B.5.3.1Street Addressvia Salvatore Maugeri, 10
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.4Telephone number0039-382-592040
    B.5.5Fax number0039-382-592094
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameFlecainide
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeFarmaco chimico antiaritmico
    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
    Patients with CPVT and ICD
    Pazienti con CPVT e ICD
    E.1.1.1Medical condition in easily understood language
    Patients with catecholaminergic ventricular tachycardia and implantable defibrillator
    Pazienti con tachicardia ventricolare catecolaminergica e defibrillatore impiantabile
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028159
    E.1.2Term Multiform ventricular tachycardia
    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
    To assess the efficacy of flecainide in reducing cardiac events in CPVT
    Valutare l'efficacia della Flecainide nel ridurre gli eventi cardiaci nella CPVT.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of flecainide in reducing ventricular ectopy and VT during exercise treadmill testing in CPVT - To correlate ventricular ectopy and VT during exercise treadmill testing with cardiac events in CPVT
    - valutare l'efficacia della Flecainide nel ridurre le extrasistoli ventricolari e le TV durante test da sforzo nella CPVT - correlare l’extrasistolia ventricolare e la TV durante il test da sforzo con gli eventi cardiaci nella CPVT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical diagnosis of CPVT, based on: reproducible polymorphic or bidirectional ventricular tachycardia with exercise or Ventricular ectopy on exercise test with RYR2 or CASQ2 mutation - Functioning ICD in place - On stable dose of standard therapy defined as the maximal tolerated dose of beta-blocker and may include a calcium channel blocker (Patients on flecainide or mexiletine are also eligible for enrollment after a 1 week “washout” period during which flecainide or mexiletine is discontinued, and standard therapy alone is used).
    - Diagnosi clinica di CPVT, sulla base di: tachicardia ventricolare polimorfica bidirezionale riproducibile con l'esercizio o extrasistolia ventricolare durante test da sforzo con mutazione RYR2 o CASQ2 - ICD funzionante - In terapia standard con dosaggio stabile definita come la dose massima tollerata di beta-bloccante e può includere un bloccante del canale del calcio (I pazienti in terapia con Flecainide o mexiletina sono ammissibili per l’arruolamento dopo una settimana di ''washout'', durante il quale viene interrotta la flecainide o la mexiletina, e viene utilizzata solo la terapia standard).
    E.4Principal exclusion criteria
    • Females who are pregnant or plan to be pregnant during the study period • Children < 5 years of age • Patients unable to perform treadmill exercise • Patients with significant structural heart disease • Patients with features consistent with Andersen-Tawil syndrome • Patients with known hypersensitivity to flecainide • Patients on amiodarone • Patients not expected to comply with follow-up
    • Le donne incinte o che hanno programmato una gravidanza durante il periodo di studio • Bambini &lt;5 anni di età • I pazienti non in grado di eseguire esercizio al treadmill • I pazienti con significativa malattia cardiaca strutturale • I pazienti con caratteristiche tipiche della sindrome di Andersen-Tawil • I pazienti con nota ipersensibilità alla flecainide • I pazienti in amiodarone • I pazienti che non sono in grado di rispettare il follow-up
    E.5 End points
    E.5.1Primary end point(s)
    VT treated by ICD or death
    tachicardie ventricolari (TV) trattate con ICD oppure morte
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6, 12, 18 months after treatment
    3, 6, 12, 18 mesi dalla somministrazione
    E.5.2Secondary end point(s)
    - VT leading to syncope but not treated by ICD; symptomatic VT not treated by ICD - exercise duration; peak heart rate during exercise test
    - TV che provocano sincope ma non trattate con ICD; TV sintomatiche non trattate con ICD - durata dello sforzo, frequenza cardiaca massima durante test da sforzo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 12, 18 months after treatment
    3, 6, 12, 18 mesi dalla somministrazione
    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 Yes
    E.6.4Safety No
    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. 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    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) Yes
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) No
    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 state10
    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)
    Further treatment will be determined by the treating physician
    I trattamenti successivi saranno determinati dal medico curante
    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 Vanderbilt University
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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