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    Summary
    EudraCT Number:2009-012587-14
    Sponsor's Protocol Code Number:BIA-2093-401
    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:2009-10-23
    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 number2009-012587-14
    A.3Full title of the trial
    SEGURIDAD Y EFICACIA DEL ACETATO DE ESLICARBAZEPINA (ESL) COMO TERAPIA ADYUVANTE PARA CRISIS PARCIALES EN PACIENTES MAYORES/ SAFETY AND EFFICACY OF ESLICARBAZEPINE ACETATE (ESL) AS ADJUNCTIVE THERAPY FOR PARTIAL SEIZURES IN ELDERLY PATIENTS
    A.4.1Sponsor's protocol code numberBIA-2093-401
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIAL - Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Zebinix
    D.2.1.1.2Name of the Marketing Authorisation holderBIAL - Portela & Ca, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameEslicarbazepine Acetate
    D.3.2Product code BIA 2-093
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEslicarbazepine Acetate
    D.3.9.1CAS number 236395-14-5
    D.3.9.2Current sponsor codeBIA 2-093
    D.3.9.3Other descriptive nameZebinix
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Terapia adyuvante de crisis parciales en pacientes mayores / Adjunctive therapy of partial-onset seizures in elderly patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la seguridad y tolerabilidad del ESL como tratamiento adyuvante en pacientes de 65 años de edad o más con epilepsia parcial durante un periodo de tratamiento de 26 semanas.
    The primary objective of this study is to evaluate the safety and tolerability of ESL as adjunctive therapy in patients aged 65 years or older with partial epilepsy, over a 26-week Treatment Period.
    E.2.2Secondary objectives of the trial
    Investigar la eficacia del ESL como tratamiento adyuvante en pacientes de 65 años de edad o más on epilepsia parcial durante un periodo de tratamiento de 26 semanas.
    The secondary objective of this study is to explore the efficacy of ESL as adjunctive therapy in patients aged 65 years or older with partial epilepsy, over a 26-week Treatment Period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    En la visita 1 (Selección), el paciente deberá:
    1.firmar o haber firmado su consentimiento informado por escrito;
    2.tener 65 años de edad o más;
    3.disponer de un diagnóstico documentado de epilepsia de un mínimo de12 meses;
    4.sufrir o haber sufrido al menos 2 crisis de inicio parcial (incluidos los subtipos de crisis parcial simple, parcial compleja y/o parcial, que evolucionan a generalizadas secundarias) en las 4 semanas anteriores a la selección;
    5.estar en tratamiento actual con 1 ó 2 FAE (cualquiera excepto oxcarbazepina) con un régimen de dosis estable durante al menos 4 semanas antes de la selección. La estimulación del nervio vago (ENV) ha de considerarse como un FAE (es decir, en los pacientes con ENV sólo se permite el uso de un FAE concomitante);
    6.estar dispuesto y ser capaz de cumplir todos los requisitos del ensayo, a juicio del investigador.
    En la Visita 2 (inicio del tratamiento con ESL), el paciente debe/debe tener:
    7.al menos 2 crisis de inicio parcial (documentadas en el diario) en 4 semanas durante el periodo basal de 8 semanas;
    8.cumplir satisfactoriamente los requisitos del estudio durante el periodo basal.//

    Inclusion criteria at Screening (V1).
    Patient must be /have:
    1) written informed consent;
    2) of age 65 years or older;
    3) a documented diagnosis of epilepsy for at least 12 months;
    4) at least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to Screening;
    5) currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to Screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
    6) willing and able to comply with all trial requirements, in the judgement of the investigator.
    At Visit 2 (start of ESL treatment), patient must have:
    7) at least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week Baseline Period.
    8) satisfactorily complied with the study requirements during the Baseline Period.
    E.4Principal exclusion criteria
    En la visita 1 (Selección), el paciente no debe/no debe tener:
    1.únicamente crisis parciales simples sin sintomatología motora (clasificadas como A2-4 de acuerdo con la Clasificación Internacional de las Crisis Epilépticas);
    2.crisis generalizadas primarias;
    3.trastornos neurológicos progresivos conocidos (enfermedad cerebral progresiva, epilepsia secundaria a una lesión progresiva en el sistema nervioso central) y demencia progresiva;
    4.crisis demasiado próximas como para poder contarlas de forma precisa;
    5.antecedentes de estado epiléptico o crisis en racimo (es decir, 3 o más crisis en 30 minutos) en los 3 meses anteriores a la selección;
    6.crisis de origen no epiléptico;
    7.trastorno psiquiátrico importante;
    8.antecedentes de intento de suicidio;
    9.tratamiento actual con oxcarbazepina;
    10.tratamiento anterior con ESL o participación en un estudio clínico con ESL;
    11.hipersensibilidad conocida a otros derivados de la carboxamida (p. ej., oxcarbazepina, carbamazepina), o a cualquiera de los excipientes;
    12.trastorno no controlado de tipo cardíaco, renal, hepático, endocrino, gastrointestinal, metabólico, hematológico u oncológico, hipo o hiper tiroidismo de cualquier tipo;
    13.bloqueo auriculoventricular de segundo o tercer grado o cualquier anomalía clínicamente significativa en el electrocardiograma (ECG) de 12 derivaciones según lo determine el investigador;
    14.anomalías relevantes en los análisis clínicos según lo determine el investigador (p. ej., niveles de sodio en plasma <130 mmol/l, alanina o aspartato aminotransferasas >2,0 veces por encima del límite superior de la normalidad, o recuento de glóbulos blancos <3.000 células/mm3);
    15.cálculo del aclaramiento de creatinina < 30 ml/min en la visita de selección
    16.cualquier otra afección o circunstancia que, en opinión del investigador, pueda comprometer la capacidad por parte del paciente de seguir el protocolo del estudio.
    17.haber recibido un fármaco (o dispositivo médico) en investigación en los
    3 meses anteriores a la selección o estar participando actualmente en otro ensayo con un fármaco (o dispositivo médico) en investigación.//

    At Visit 1 (Screening), patients must not be / have:
    1. only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures);
    2. primarily generalised seizures;
    3. known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
    4. occurrence of seizures too close to count accurately;
    5. history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to Screening;
    6. seizures of non-epileptic origin;
    7. major psychiatric disorders;
    8. history of suicide attempt;
    9. currently treated with oxcarbazepine;
    10. previous use of ESL or participation in a clinical study with ESL;
    11. known hypersensitivity to other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine) or to any of the excipients;
    12. uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo ? or hyper thyroidism of any type;
    13. second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
    14. relevant clinical laboratory abnormalities as determined by the investigator (e.g., plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the normal range, or white blood cell count <3,000 cells/mm3);
    15. calculated creatinine clearance values < 30 mL/min at screening;
    16. any other condition or circumstance that, in the opinion of the investigator, may compromise the patient?s ability to comply with the study protocol;
    17. received an investigational drug (or a medical device) within 3 months of Screening or is currently participating in another trial of an investigational drug (or medical device) trial.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal es evaluar la seguridad a partir de la incidencia de eventos adversos, los análisis clínicos de seguridad de laboratorio, ECG, presión arterial y frecuencia cardíaca. Los parámetros de eficacia son avaluados como objetivos secundarios.//

    The primary endpoint is safety assessed by incidence of adverse events, clinical laboratory safety tests, ECG, blood pressure and heart rate. Efficacy parameters are evaluated as secondary endpoints.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El ensayo terminará tan pronto como los 100 pacientes evaluables hayan completado el ensayo habiendo realizado la última visita.
    The trial will end as soon as the 100 evaluable patients have completed the trial with the last visit.
    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 months4
    E.8.9.1In the Member State concerned days0
    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 days0
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 100
    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)
    Después del final del ensayo, los sujetos serán tratados de acuerdo con la práctica clínica habitual.
    After the end of the trial, the subject will be treated according to the local standard practice.
    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 Decision2010-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-08
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