Clinical Trials Register

Summary
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:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-05
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001287-22

A.3

Full 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.3.1

Title 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.4.1

Sponsor's protocol code number

FLECAINIDE-1

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01117454

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Vanderbilt University
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione Salvatore Maugeri, IRCCS
B.5.2	Functional name of contact point	UO Cardiologia Riabilitativa - Lab.
B.5.3	Address:
B.5.3.1	Street Address	via Salvatore Maugeri, 10
B.5.3.2	Town/ city	Pavia
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0039-382-592040
B.5.5	Fax number	0039-382-592094
B.5.6	E-mail	nicola.monteforte@fsm.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FLECAINIDE ACETATE
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Flecainide
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Farmaco chimico antiaritmico

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with CPVT and ICD

Pazienti con CPVT e ICD

E.1.1.1

Medical condition in easily understood language

Patients with catecholaminergic ventricular tachycardia and implantable defibrillator

Pazienti con tachicardia ventricolare catecolaminergica e defibrillatore impiantabile

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10028159
E.1.2	Term	Multiform ventricular tachycardia
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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 <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.5.1

Primary end point(s)

VT treated by ICD or death

tachicardie ventricolari (TV) trattate con ICD oppure morte

E.5.1.1

Timepoint(s) of evaluation of this end point

3, 6, 12, 18 months after treatment

3, 6, 12, 18 mesi dalla somministrazione

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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.4.1	Name of Organisation	Vanderbilt University

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-04-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-18

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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