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    Summary
    EudraCT Number:2010-022534-84
    Sponsor's Protocol Code Number:SP0978
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-022534-84
    A.3Full 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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.4.1Sponsor's protocol code numberSP0978
    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.1.1Name of SponsorUCB Pharma SA
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB Pharma SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClinical Trial Registries and Resul
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+492173.48.1515
    B.5.5Fax number+492173.48.1572
    B.5.6E-mailclinicaltrials@ucb.com
    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.2.1.1.1Trade name VIMPAT 50 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product nameLacosamida
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNLACOSAMIDA
    D.3.9.3Other descriptive nameLACOSAMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    D.IMP: 2
    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.2.1.1.1Trade name VIMPAT 100 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product nameLacosamida
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNLACOSAMIDA
    D.3.9.3Other descriptive nameLACOSAMIDA
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 No
    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
    Epilepsy: partial-onset seizures
    Epilepsia: Crisis parciales
    E.1.1.1Medical condition in easily understood language
    Epilepsy: treatment of seizures
    Epilepsia: tratamiento de crisis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary objectives of the trial
    See section 4.1 of Protocol
    Ver sección 4.1 del Protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other 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.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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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