Clinical Trials Register

Summary
EudraCT Number:	2012-005012-26
Sponsor's Protocol Code Number:	EP0034
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:	2013-10-04
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-005012-26

A.3

Full title of the trial

A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS WITH EPILEPSY WITH PARTIAL ONSET SEIZURES

STUDIO DI ESTENSIONE, MULTICENTRICO, IN APERTO, A LUNGO TERMINE PER VALUTARE L’EFFICACIA E LA SICUREZZA DI LACOSAMIDE COME TERAPIA AGGIUNTIVA IN SOGGETTI PEDIATRICI AFFETTI DA EPILESSIA CON CRISI AD ESORDIO PARZIALE

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS AN ADD ON THERAPY IN CHILDREN WITH EPILEPSY WITH PARTIAL ONSET SEIZURES

STUDIO CLINICO PER VALUTARE L'EFFICACIA E LA SICUREZZA DI LACOSAMIDE COME TERAPIA AGGIUNTIVA IN SOGGETTI PEDRIATRICI AFFETTI DA EPILESSIA CON CRISI AD ESORDIO PARZIALE

A.4.1

Sponsor's protocol code number

EP0034

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/132/2013

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	UCB Biosciences Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	UCB Biosciences Inc.
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	UCB BIOSCIENCES GmbH
B.5.2	Functional name of contact point	Clin Trial Reg & Results Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Alfred-Nobel-Strasse 10
B.5.3.2	Town/ city	Monheim
B.5.3.3	Post code	D-40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	492173481515
B.5.5	Fax number	492173481572
B.5.6	E-mail	clinicaltrials@ucb.com

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.2.1.1.1	Trade name	Vimpat
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.1	Product name	Lacosamide
D.3.4	Pharmaceutical form	Syrup
D.3.4.1	Specific paediatric formulation	Yes
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	LACOSAMIDE
D.3.9.1	CAS number	175481-36-4
D.3.9.2	Current sponsor code	SPM927
D.3.9.4	EV Substance Code	SUB25407
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
D.IMP: 2
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.2.1.1.1	Trade name	Vimpat
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma SA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.1	Product name	Lacosamide
D.3.4	Pharmaceutical form	Film-coated 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	LACOSAMIDE
D.3.9.1	CAS number	175481-36-4
D.3.9.2	Current sponsor code	SPM927
D.3.9.4	EV Substance Code	SUB25407
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	50
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	No
D.IMP: 3
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.2.1.1.1	Trade name	Vimpat
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma SA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.1	Product name	Lacosamide
D.3.4	Pharmaceutical form	Film-coated 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	LACOSAMIDE
D.3.9.1	CAS number	175481-36-4
D.3.9.2	Current sponsor code	SPM927
D.3.9.4	EV Substance Code	SUB25407
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	No

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

Epilepsy with Partial Onset Seizures

EPILESSIA CON CRISI AD ESORDIO PARZIALE

E.1.1.1

Medical condition in easily understood language

Epilepsy with partial-onset seizures

EPILESSIA CON CRISI AD ESORDIO PARZIALE

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10015037
E.1.2	Term	Epilepsy
E.1.2	System Organ Class	10029205 - Nervous system 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 long-term safety and tolerability of lacosamide in pediatric subjects

Valutare la sicurezza e la tollerabilità a lungo termine di lacosamide in soggetti pediatrici

E.2.2

Secondary objectives of the trial

To assess the efficacy of lacosamide during long-term exposure in pediatric subjects

Valutare l'efficacia di lacosamide durante l'esposizione a lungo termine in soggetti pediatrici

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors.
2. Subject has completed the Transition Period of SP0967 or SP0969 for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy.
3. Subject is expected to benefit from participation, in the opinion of the investigator.
4. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator.

1. Il soggetto o il rappresentante legale deve firmare e datare un modulo di consenso informato (ICF) scritto, approvato dalla Commissione di Revisione dell’Istituzione (IRB) o dal Comitato Etico Indipendente (IEC). I minori devono firmare e datare l’ICF o un modulo di assenso specifico, ove richiesto.
2. Il soggetto deve aver completato il Periodo di transizione di SP0967 o SP0969 per il trattamento delle crisi convulsive parziali nell’epilessia pediatrica.
3. Lo sperimentatore ritiene che il soggetto beneficerà della partecipazione allo studio.
4. Secondo il giudizio dello sperimentatore, il soggetto/rappresentante legale è ritenuto affidabile e capace di rispettare il protocollo (ad es. è in grado di comprendere e compilare i diari), il programma delle visite e il piano di somministrazione del farmaco.

E.4

Principal exclusion criteria

1. Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide.
2. Subject is experiencing an ongoing serious AE (SAE).
3. For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.
4. Subjects with a major protocol deviation during the primary study (or a deviation related to enrollment criteria for primary study).
5. Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to the International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate <1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme-inducing antiepileptic drugs (EI-AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the World Health Organization recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI-AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study.

1. Il soggetto sta ricevendo altri medicinali sperimentali o sta usando dispositivi sperimentali oltre a lacosamide.
2. Il soggetto ha un AE serio in corso (SAE).
3. Il soggetto di età ≥6 anni è sempre stato caratterizzato da tentativi di suicidio (compreso un tentativo attivo, un tentativo interrotto o un tentativo fallito) o ha avuto idee suicide negli ultimi 6 mesi, come indicato da una risposta positiva (“Sì”) alla Domanda 4 o alla Domanda 5 della Columbia-Suicide Severity Rating Scale (C-SSRS) alla Visita 1.
4. Soggetti caratterizzati da una deviazione grave dal protocollo durante lo studio primario (o una deviazione correlata ai criteri di arruolamento dello studio primario).
5. Il soggetto di sesso femminile è in gravidanza o allattamento e/o un soggetto di sesso femminile potenzialmente fertile non è chirurgicamente sterile o non pratica 1 metodo contraccettivo altamente efficace (definito, secondo le linee guida della Conferenza internazionale per l’armonizzazione [ICH], come un metodo con tasso di fallimento <1% l’anno se usato correttamente e con costanza), a meno che si astenga dai rapporti sessuali per l'intero studio. Soggetto di sesso femminile potenzialmente fertile che assume farmaci antiepilettici a induzione enzimatica (EI-AED: carbamazepina, fenitoina, barbiturici, primidone, topiramato, oxcarbazepina), non è chirurgicamente sterile o non pratica 1 metodo contraccettivo altamente efficace secondo le raccomandazioni dell’Organizzazione Mondiale della Sanità (ovvero, deposito di medrossiprogesterone acetato, noretisterone enantato, dispositivi intrauterini, iniezioni combinate e impianti progestinici) con la somministrazione di EI-AED OPPURE non pratica 2 metodi contraccettivi combinati (ovvero contraccezione ormonale combinata più metodo a barriera con agente spermicida), a meno che si astenga dai rapporti sessuali per l'intero studio.

E.5 End points

E.5.1

Primary end point(s)

1) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study
2) Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study

1) Numero di soggetti che riporta almeno un evento avverso trattamento-emergente (TEAE) durante lo studio
2) Numero di soggetti che riporta almeno un evento avverso trattamento-emergente (TEAE) che ha comportato la sospensione dallo studio

E.5.1.1

Timepoint(s) of evaluation of this end point

1) From Baseline to End of Treatment period
2) From Baseline to End of Treatment

1) Dal basale al termine del periodo di trattamento
2) Dal basale alla fine del trattamento

E.5.2

Secondary end point(s)

1) Percentage of seizure free days at the end of Year 1;
2) Percentage of seizure free days at end of Year 2

1) Percentuale dei giorni di crisi spontanee alla fine del 1° anno;
2) Percentuale dei giorni di crisi spontanee alla fine del 2° anno

E.5.2.1

Timepoint(s) of evaluation of this end point

1) End of Year 1 of the Study (approximately 52 weeks)
2) End of Year 2 of the Study (approximately 96 weeks)

1) Fine del 1° anno di studio (circa 52 settimane)
2) Fine del 2° anno di studio (circa 96 settimane)

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

E.6.4

Safety

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

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

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

European Union

Argentina

Australia

Brazil

Chile

Colombia

Israel

Japan

Korea, Republic of

Mexico

Russian Federation

Serbia

South Africa

Switzerland

Taiwan

Thailand

Turkey

Ukraine

United States

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

500

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

300

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

175

F.1.2

Adults (18-64 years)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children

Bambini

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

114

F.4.2.2

In the whole clinical trial

500

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)

Subjects will revert to standard of care treatment under their physician

I soggetti torneranno al trattamento di cura standard con il proprio medico

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-12-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-23

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

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