Clinical Trials Register

Summary
EudraCT Number:	2010-019765-28
Sponsor's Protocol Code Number:	SP0993
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-12-07
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

Spain - AEMPS

A.2

EudraCT number

2010-019765-28

A.3

Full title of the trial

ESTUDIO MULTICÉNTRICO, DOBLE CIEGO Y DOBLE SIMULACIÓN, ALEATORIZADO Y CONTROLADO CON PRINCIPIO ACTIVO, PARA COMPARAR LA EFICACIA Y LA SEGURIDAD DE LACOSAMIDA (200 A 600 MG/DÍA) FRENTE A CARBAMAZEPINA DE LIBERACIÓN CONTROLADA (400 A 1.200 MG/DÍA), ADMINISTRADA EN MONOTERAPIA EN SUJETOS (IGUAL O MAYOR DE 16 AÑOS) CON EPILEPSIA DE DIAGNÓSTICO NUEVO O RECIENTE Y AFECTOS DE CRISIS TÓNICO-CLÓNICAS DE COMIENZO PARCIAL O GENERALIZADAS. //

A MULTICENTER, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS (FROM 16 YEARS) NEWLY OR RECENTLY DIAGNOSED WITH EPILEPSY AND EXPERIENCING PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES.

A.4.1

Sponsor's protocol code number

SP0993

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SCHWARZ BIOSCIENCES GmbH
B.1.3.4	Country	Germany
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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 50 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	LACOSAMIDA
D.3.9.3	Other descriptive name	LACOSAMIDA
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Comparator
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	Tegretol Retard
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharmaceuticals UK limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Carbamazepine controlled release // Carmapazepina de liberación controlada
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	298-46-4
D.3.9.3	Other descriptive name	CARBAMAZEPINE
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	200
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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 100 mg comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA SA
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	LACOSAMIDA
D.3.9.3	Other descriptive name	LACOSAMIDA
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Over encapsulated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Epilepsia de diagnóstico nuevo o reciente y afectos de crisis tónico-clónicas de comienzo parcial o generalizadas. //

Epilepsy, partial onset or generalised tonic-clonic seizures.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10015037
E.1.2	Term	Epilepsy

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparar la eficacia y la seguridad de LCM (200 a 600 mg/día) con las CBZ-CR(400 a 1.200 mg/día)administrada en monoterapia, 1 año como mínimo, midiendo la eficacia como criterio de valoración principal mediante la ausencia de crisis durante 6 meses, en sujetos con epilepsia de diagnóstico nuevo o reciente. En este estudio se utilizará un diseño de no inferioridad, para demostrar que el equilibrio entre beneficio y riesgo de LCM es cuando menos similar al de CBZ-CR, utilizando la ausencia de crisis durante 6 meses como criterio de valoración principal. //
To compare efficacy and safety of Lacosamide(200 to 600mg/day)to Carbamazepine Controlled release (400 to 1200mg/day)used as monotherapy for at least 1 year, efficacy as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZCR, using 6month seizure freedom as primary endpoint

E.2.2

Secondary objectives of the trial

Por favor, ver secciones 4.1.2 y 4.2.2.del protocolo.//
Please see 4.1.2 and 4.2.2 sections in the protocol.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.El sujeto, su progenitor o su representante han firmado y fechado un documento de consentimiento informado por escrito, aprobado por un CEIC. Los menores firmarán y fecharán el documento de consentimiento u otro de asentimiento específico, en su caso. /
2.El sujeto está dispuesto a cumplir todos los requisitos del estudio y es capaz de hacerlo./
3.El sujeto es un hombre o una mujer igual o mayor de 16 años./
4.El sujeto ha recibido un diagnóstico nuevo o reciente de epilepsia y ha experimentado crisis tónico-clónicas POS no provocadas (IA, IB, IC con focalidad precisa) o generalizadas (sin focalidad precisa) que se pueden clasificar con arreglo a la Clasificación de las crisis epilépticas de la ILAE de 1981. No es preciso diferenciar los grados IC y IIE para la inclusión. /
5.El sujeto ha experimentado al menos 2 crisis no provocadas (con 48 horas de diferencia, como mínimo) en el año previo a la aleatorización, una de las cuales tuvo lugar en los 3 meses previos a la aleatorización./
6.El sujeto presenta un electroencefalograma (EEG) (normal o compatible con el diagnóstico de epilepsia de inicio parcial) y una TC o RM cerebral compatibles con el diagnóstico de crisis tónico-clónicas de inicio parcial o generalizadas (sin focalidad precisa), obtenidos en el año previo. Si no se han obtenido el EEG y la TC o RM cerebral antes de la visita 1, se obtendrán dichas pruebas, y sus resultados deberán estar disponibles antes de la aleatorización en la visita 2.//
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Consent form or a specific Assent form, where required, will be signed and dated by minors./
2. Subject is willing and able to comply with all study requirements./
3. Subject is male or female and from 16 years of age.
4. Subject has newly or recently diagnosed epilepsy having experienced unprovoked POS (IA, IB, IC with clear focal origin) or generalized tonic-clonic seizures (without clear focal origin) that are classifiable according to the ILAE Classification of Epileptic
Seizures, 1981. The discrimination between IC and IIE is not requested for inclusion./
5. Subject has experienced at least 2 unprovoked seizures (separated by a minimum of 48 hours) in the year preceding randomization out of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization./
6. Subject has had an electroencephalogram and a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) exam of the brain consistent with the diagnosis of partial-onset or generalized tonic-clonic seizures (without clear focal origin) within the past year. If the EEG and brain CT scan or MRI exam were not performed prior to
Visit 1, they need to be completed and results must be available prior to randomization at Visit 2.

E.4

Principal exclusion criteria

1. El sujeto ha participado antes en este estudio o ha sido asignado anteriormente al tratamiento en un estudio sobre los fármacos que se investigan en el presente estudio./
2. El sujeto está participando actualmente o ha participado en los últimos 2 meses en algún estudio de un medicamento en investigación o producto sanitario (dispositivo) experimental./
3. El sujeto tiene antecedentes de crisis de tipos distintos que las tónico-clónicas de inicio parcial (IA, IIB, IC con focalidad precisa) y generalizadas (sin focalidad precisa) (p. ej., mioclónicas, ausencia) o las presenta en la actualidad./
4.El sujeto tiene antecedentes de crisis que se dan sólo agrupadas, lo que se define por crisis repetidas que se producen en un período corto de tiempo (es decir, <20 minutos) tanto si se recupera la función entre 2 episodios como si no se recupera, o presenta dichas crisis en la actualidad./
5.El sujeto tiene antecedentes de hallazgos de la historia, clínicos o del EEG indicativos de epilepsia generalizada idiopática (IGE) en la aleatorización (de acuerdo con la Clasificación de las crisis epilépticas de la ILAE, 1989)./
6.El sujeto presenta o ha presentado diagnóstico de pseudocrisis, trastornos de conversión u otros episodios ictales no epilépticos que pueden confundirse con crisis.
Por favor, ver sección 6.2 del protocolo para más información. //
1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the drugs under investigation in this study./
2. Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device./
3. Subject has a history or presence of seizures of other types than partial-onset (IA, IIB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)./
4. Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events./
5. Subject has a history, clinical, or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization (according to the ILAE classification of Epileptic Seizures, 1989)./
6. Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures.
Please see section 6.2 of protocol for further information.

E.5 End points

E.5.1

Primary end point(s)

1.Variable de eficacia principal:
Porcentaje de sujetos que no presenten crisis durante 6 meses consecutivos (26 semanas consecutivas) de tratamiento tras la estabilización con la última dosis evaluada en cada sujeto.
2.Variables de seguridad principales:
- AE notificados de manera espontánea por el sujeto y/o el cuidador, u observados por el investigador.
- Retiradas de sujetos debido a AE.
- AE graves (SAE).//
1.Primary efficacy variable:
Proportion of subjects remaining seizure free for 6 consecutive months(26 consecutive weeks) of treatment following stabilization at the last
evaluated dose for each subject.
2.The primary safety variables:
-AEs reported spontaneously by the subject and/or caregiver or observed by the investigator.
-Subject withdrawals due to AEs.
-Serious AEs (SAEs).

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Doble simulación // Double dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

100

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

Information not present in EudraCT

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

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

El final del estudio se define como la fecha de la última visita del último sujeto en el estudio.//

The end of the study is defined as the date of the last visit of the last subject in the study.

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.1.1.1

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)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

825

F.4.2.2

In the whole clinical trial

1000

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)

See section 8.6 End of study phase of the protocol.

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

2010-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-11-05

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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