Clinical Trials Register

Summary
EudraCT Number:	2010-022534-84
Sponsor's Protocol Code Number:	SP0978
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:	2011-05-24
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

2010-022534-84

A.3

Full title of the trial

A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO
EVALUATE HORMONE AND LIPID LEVELS IN MALE
SUBJECTS WITH PARTIAL-ONSET SEIZURES AFTER A
SWITCH OF TREATMENT FROM CARBAMAZEPINE AS
ADJUNCTIVE TREATMENT TO LEVETIRACETAM TO
LACOSAMIDE AS ADJUNCTIVE TREATMENT TO
LEVETIRACETAM

ESTUDIO MULTICÉNTRICO, DE ETIQUETA ABIERTA Y BRAZO ÚNICO PARA EVALUAR LOS NIVELES HORMONALES Y LÍPIDOS EN SUJETOS MASCULINOS CON CRISIS CONVULSIVAS DE INICIO PARCIAL TRAS EL CAMBIO DE TRATAMIENTO DE CARBAMAZEPINA COMO TRATAMIENTO ADYUVANTE CON LEVETIRACETAM A LACOSAMIDA COMO TRATAMIENTO ADYUVANTE CON LEVETIRACETAM

A.3.1

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

A.4.1

Sponsor's protocol code number

SP0978

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	UCB Pharma SA
B.1.3.4	Country	Belgium
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 Pharma SA
B.4.2	Country	Belgium
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	Clinical Trial Registries and Resul
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	40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	+492173.48.1515
B.5.5	Fax number	+492173.48.1572
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 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.3.1	Product name	Lacosamida
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	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)	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 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.3.1	Product name	Lacosamida
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	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)	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: partial-onset seizures

Epilepsia: Crisis parciales

E.1.1.1

Medical condition in easily understood language

Epilepsy: treatment of seizures

Epilepsia: tratamiento de crisis

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to evaluate the change in hormonal parameters and lipid parameters in serum after switching from CBZ treatment to LCM treatment as adjunctive
therapy to LEV.

El objetivo de este estudio es evaluar el cambio en los parámetros hormonales y los parámetros de lípidos en suero después de cambiar el tratamiento con Carbamazepina a tratamiento con Lacosamida como terapia adyuvante a levetiracetam.

E.2.2

Secondary objectives of the trial

See section 4.1 of Protocol

Ver sección 4.1 del Protocolo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. An Independent Ethics Committee (IEC) approved written Informed Consent form is
signed and dated by the subject or legal representative.
2. Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the investigator.
3. Subject is male and between 18 and 45 years of age, inclusive.
4. Subject has a diagnosis of epilepsy with partial-onset seizures according to the
International Classification of Epileptic Seizures (1981) (See Section 15.1).
5. Subject is only taking LEV in combination with CBZ as adjunctive treatment for
epilepsy.
6. Subject has been treated with CBZ for at least 12 months before study entry.
7. Subject has been maintained on a stable dose of CBZ and LEV during the 30 days before study entry.
8. The dose of CBZ at Visit 1 is ?600mg/day to ?1200mg/day.
9. The dose of LEV at Visit 1 is ?1000mg/day.
10. Subjects for whom a change from adjunctive treatment of CBZ and LEV to adjunctive treatment of LCM and LEV are expected to benefit according to the clinical judgment of the investigator. These benefits are related to:
? Seizure control and/or
? Tolerability of the treatment and/or
? Endocrine/metabolic function and/or
? Drug-drug interactions

Los requisitos que se deberán reunir para poder participar en el estudio son los siguientes:
1. El sujeto o su representante legal debe firmar y fechar un consentimiento informado por escrito aprobado por un Comité Ético Independiente (CEI).
2. El sujeto o su representante legal deben ser considerados de confianza y estar capacitados para seguir el protocolo, el calendario de visitas y la toma de la medicación según el criterio del investigador.
3. El sujeto es masculino y tiene entre 18 y 45 años, inclusive.
4. El sujeto ha sido diagnosticado con epilepsia con crisis convulsivas de inicio parcial según la Clasificación Internacional de Crisis Epilépticas (1981) (consulte el apartado 15.1).
5. El sujeto toma únicamente LEV en combinación con CBZ como tratamiento adyuvante de la epilepsia.
6. El sujeto ha sido tratado con CBZ durante al menos 12 meses antes de la inscripción en el estudio.
7. Se ha mantenido al sujeto en una dosis estable de CBZ y LEV durante los 30 días anteriores a la inscripción en el estudio.
8. La dosis de CBZ en la Visita 1 está entre 600 mg/día y 1200 mg/día.
9. La dosis de LEV en la Visita 1 es 1000 mg/día.
10. Los sujetos en los que se espera que un cambio del tratamiento adyuvante de CBZ y LEV a un tratamiento adyuvante de LCM y LEV proporcione beneficios, de acuerdo con la opinión clínica del investigador. Estos beneficios están relacionados con:
? El control de las crisis, y/o
? La tolerabilidad del tratamiento, y/o
? La función endocrina/metabólica y/o
? Las interacciones farmacológicas.

E.4

Principal exclusion criteria

1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of LCM.
2. Subject has participated in another study of an investigational medicinal product (IMP) or an experimental medical device within the last 30 days or is currently participating in another study of an IMP or a medical device.
3. Subject has a known hypersensitivity to any components of LCM tablets.
4. Subject has taken an AED other than CBZ and LEV within the last 30 days, excepting 1 time use of benzodiazepines as rescue medication (less than or equal to 3 doses within 24 hours).
5. Subject has taken lipid lowering agents within the last 30 days.
6. Subject has taken any medication known to affect endocrine function within the last 30 days, including exogenous hormones (eg, thyroid hormone, anabolic steroids, androgens, or glucocorticoids).
7. Subject has taken other enzyme inducers within the last 30 days (eg, St. John?s wort, rifampicin).
8. Subject is suffering from a known endocrine disorder where the condition or its treatment might influence SHBG levels, reproductive hormones, thyroid hormones, or serum lipid levels.
9. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion.
10. Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject?s ability to participate in this study.
11. Deleted and no longer applicable beginning with Protocol Amendment 2 (see protocol amendment details in Section 15.3).
12. Subject has an acute or sub-acute progressive central nervous system disease.
13. Subject has a history of chronic alcohol or drug abuse within the last 2 years.
14. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
15. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ?2x the upper limit of normal (ULN) or has alkaline phosphatase levels ?3x ULN at Visit 1.
16. Subject has impaired renal function (ie, creatinine clearance [CLcr] is lower than 30mL/min) at Baseline. Creatinine clearance will be estimated as follows:
Adult males: CLcr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL)
17. Subject has a sick sinus syndrome without a pacemaker, or second or third degree atrioventricular (AV) block.
18. Subject has a known sodium channelopathy, such as Brugada syndrome.
19. Subject has experienced a myocardial infarction in the last 3 months.
20. Subject has New York Heart Association Class III or Class IV heart failure.
21. Subject with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to study entry.
22. Subject with previous or concomitant vigabatrin use.
23. Subject has a lifetime history of suicide attempt (including an active 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 Screening.

1. El sujeto ha participado anteriormente en este estudio o se ha asignado al sujeto anteriormente a un tratamiento en un estudio de LCM.
2. El sujeto ha participado en otro estudio de un medicamento en investigación (MI) o de un dispositivo médico experimental durante los últimos 30 días o participa actualmente en otro estudio de un MI o un dispositivo médico.
3. El sujeto tiene una hipersensibilidad conocida a alguno de los ingredientes de los comprimidos de LCM.
4. El sujeto ha tomado un FAE distinto de CBZ y LEV durante los últimos 30 días, a excepción de una toma única de benzodiazepinas como medicación de rescate (igual o inferior a 3 dosis en un plazo de 24 horas).
5. El sujeto ha tomado fármacos reductores de lípidos durante los últimos 30 días.
6. El sujeto ha tomado medicación que se conoce que afecta a la función endocrina durante los últimos 30 días, incluidas las hormonas exógenas (por ejemplo, hormona tiroidea, esteroides anabólicos, andrógenos o glucocorticoides).
7. El sujeto ha tomado otros inductores de enzimas durante los últimos 30 días (por ejemplo, hipérico, rifampicina).
8. El sujeto padece un trastorno endocrino conocido en el que la enfermedad o su tratamiento pueden influir en los niveles de GTHS, hormonas reproductivas, hormonas tiroideas o en los niveles de lípidos en suero.
9. El sujeto presenta un estado clínico que se podría esperar razonablemente que interfiriera con la absorción, distribución, metabolismo o excreción del fármaco.
10. El sujeto presenta un estado clínico o psiquiátrico que, en opinión del investigador, puede poner en peligro o comprometer la capacidad del sujeto para participar en este estudio.
11. Eliminado y ya no aplicable comenzando con la Enmienda 2 al protocolo (ver detalles de la enmienda al Protocolo en el Apartado 15.3).
12. El sujeto padece un trastorno agudo o semiagudo progresivo del sistema nervioso central.
13. El sujeto presenta un historial de abuso crónico de alcohol o drogas durante los últimos 2 años.
14. El sujeto presenta un historial conocido de reacción anafiláctica grave o discrasias sanguíneas graves.
15. El sujeto presenta unos niveles de alanina-aminotransferasa (AAT), aspartato-aminotransferasa (AST) o bilirrubina total ? 2x el límite superior de la normalidad (LSN) o niveles de fosfatasa alcalina ? 3x LSN en la Visita 1.
16. El sujeto padece insuficiencia renal (es decir, el aclaramiento de creatinina [CLcr] es inferior a 30 ml/min) en el momento basal. El aclaramiento de creatinina se calcula como sigue:
Hombres adultos: CLcr = (140-edad(años)) x peso (kg)/(72 x creatinina en suero en mg/dl)
17. El sujeto padece un síndrome del nodo sinusal sin marcapasos o bloqueo aurículoventricular (AV) de segundo o tercer grado.
18. El sujeto presenta alguna canalopatía de sodio, como por ejemplo, síndrome de Brugada.
19. El sujeto ha experimentado un infarto de miocardio en los últimos 3 meses.
20. El sujeto presenta una insuficiencia cardíaca de Clase III o Clase IV según la clasificación de la Asociación Cardíaca de Nueva York (New York Heart Association).
21. El sujeto tiene un tratamiento concomitante de felbamato o tratamiento con felbamato anterior durante los últimos 6 meses antes de la inscripción en el estudio.
22. El sujeto ha tomado vigabatrina como tratamiento o como medicación concomitante.
23. El sujeto presenta antecedentes de intento de suicidio (incluidos un intento activo, un intento interrumpido o un intento malogrado) o ha experimentado ideas suicidas en los 6 meses anteriores según una respuesta positiva de ?Sí? a las preguntas 4 o 5 de la escala de valoración de la gravedad de la conducta suicida de Columbia (C-SSRS) en la selección.

E.5 End points

E.5.1

Primary end point(s)

The primary safety variable is change in serum SHBG concentration from Baseline to the end of the Maintenance Period.
End of maintenance period (12 weeks from baseline)
The secondary safety variables are the following:
? Change in the sex hormone calculated free androgen index (=100x testosterone/SHBG) levels from Baseline to the end of the Maintenance Period
? Change in the serum thyroid hormone fT4 level from Baseline to the end of the Maintenance Period
? Change in total cholesterol levels from Baseline to the end of the Maintenance Period
End of maintenance period (12 weeks from baseline)

La variable de seguridad primaria es el cambio en la concentración de SHBG en suero desde el momento basal hasta el final de periodo de mantenimiento.
Fin del período de mantenimiento (12 semanas desde el inicio del tratamiento)
Las variables de seguridad secundarias son las siguientes:
Cambio en los niveles del índice androgénico libre de hormonas sexuales (=100 x testosterona/SHBG) desde el momento basal hasta el final de periodo de mantenimiento
Cambio en el nivel de hormona tiroidea fT4 en suero desde el momento basal hasta el final del periodo de mantenimiento
Cambio en los niveles de colesterol totales desde el momento basal hasta el final del periodo de mantenimiento
Fin del período de mantenimiento (12 semanas desde el inicio del tratamiento)

E.5.1.1

Timepoint(s) of evaluation of this end point

End of maintenance period (12 weeks from baseline)

Final del periodo de mantenimiento (12 semanas después del inicio del tratamiento)

E.5.2

Secondary end point(s)

? Change in the sex hormone calculated free androgen index (=100x testosterone/SHBG) levels from Baseline to the end of the Maintenance Period
? Change in the serum thyroid hormone fT4 level from Baseline to the end of the Maintenance Period
? Change in total cholesterol levels from Baseline to the end of the Maintenance Period

Cambio en los niveles del índice androgénico libre de hormonas sexuales (=100 x testosterona/SHBG) desde el momento basal hasta el final de periodo de mantenimiento
?
Cambio en el nivel de hormona tiroidea fT4 en suero desde el momento basal hasta el final del periodo de mantenimiento
?
Cambio en los niveles de colesterol totales desde el momento basal hasta el final del periodo de mantenimiento

E.5.2.1

Timepoint(s) of evaluation of this end point

End of maintenance period (12 weeks from baseline)

Final del periodo de mantenimiento (12 semanas después del inicio del tratamiento)

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

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

Yes

E.6.13.1

Other scope of the trial description

evaluate the change in serum hormone and lipid levels after a switch of treatment from CBZ to LCM

evaluar el cambio en los parámetros hormonales y lípidos en suero después de cambiar de CBZ a LCM

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

Information not present in EudraCT

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

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

F.3.3.1

Women of childbearing potential not using contraception

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

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

F.4.2.2

In the whole clinical trial

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)

Aquellos pacientes que elijan continuar recibiendo Lacosamida comercial LCM tras la finalización,no necesitarán reducir la LCM o volver para una visita de seguim. de seguridad(la LCM está comercialmente disponible en Alemania y en España)A aquellos pacientes que completen o terminen anticipadamente el estudio y elijan no continuar recibiendo la Lacosamida comercial,se les retirará gradualmente la LCM y deberán volver para una visita de seguim. de seguridad a las 2 sem. de la última dosis de LCM

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

2012-02-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-03-01

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