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    Summary
    EudraCT Number:2015-001243-36
    Sponsor's Protocol Code Number:BIA-2093-311/EXT
    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:2015-09-11
    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 number2015-001243-36
    A.3Full title of the trial
    EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES: A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY. OPEN-LABEL ESL EXTENSION.
    EFICACIA Y SEGURIDAD DEL ACETATO DE ESLICARBAZEPINA (BIA 2-093) COMO MONOTERAPIA PARA PACIENTES CON NUEVO DIAGNÓSTICO DE CRISIS DE COMIENZO PARCIAL: ESTUDIO DOBLE CIEGO, ALEATORIZADO, COMPARADO CON FÁRMACO ACTIVO, DE GRUPOS PARALELOS Y MULTICÉNTRICO. FASE DE EXTENSIÓN EN ABIERTO CON ESL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES - OPEN LABEL EXTENSION STUDY WITH ESLICARBAZEPINE ACETATE
    EFICACIA Y SEGURIDAD DEL ACETATO DE ESLICARBAZEPINA (BIA 2-093) COMO MONOTERAPIA PARA PACIENTES CON NUEVO DIAGNÓSTICO-CRISIS DE COMIENZO PARCIAL- FASE DE EXTENSIÓN EN ABIERTO CON ACETATO DE ESLICARBACEPINA
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberBIA-2093-311/EXT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02484001
    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 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 supportEuropean Investment Bank
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIAL - Portela & Ca, S.A.
    B.5.2Functional name of contact pointsponsor
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number00351229866100
    B.5.5Fax number00351229866192
    B.5.6E-mailjose.rocha@bial.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 No
    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 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 INNESLICARBAZEPINE ACETATE
    D.3.9.1CAS number 236395-14-5
    D.3.9.2Current sponsor codeBIA 2-093
    D.3.9.3Other descriptive nameESLICARBAZEPINE ACETATE
    D.3.9.4EV Substance CodeSUB30424
    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) 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
    Adult patients with recently diagnosed partial-onset seizures
    Pacientes adultos con diagnóstico reciente de crisis de comienzo parcial
    E.1.1.1Medical condition in easily understood language
    Adult patients with recently diagnosed partial epilepsy
    Pacientes adultos con diagnóstico reciente de epilepsia parcial
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial epilepsy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm maintenance of efficacy of eslicarbazepine acetate (ESL, 800 mg to 1600 mg once daily [QD]) monotherapy during long-term treatment in adults (older or equal to 18 years) with recently diagnosed epilepsy experiencing partial-onset seizures.
    Confirmar el mantenimiento de la eficacia del acetato de eslicarbazepina (ESL, 800 mg a 1.600 mg una vez al día [1 v/d]) como monoterapia durante un tratamiento prolongado en adultos (igual o mayor 18 años) con diagnóstico reciente de epilepsia que presentan crisis de comienzo parcial.
    E.2.2Secondary objectives of the trial
    1. To further demonstrate the efficacy of ESL in subjects switching from carbamazepine controlled-release (CBZ-CR) treatment.
    2. To demonstrate the safety of ESL in subjects switching from CBZ-CR treatment and in subjects already treated with ESL monotherapy for at least one year (i.e. during long-term treatment).
    1. Demostrar la eficacia de ESL en sujetos que cambian su tratamiento con carbamazepina de liberación controlada (CBZ-LC).
    2. Demostrar la seguridad de ESL en sujetos que cambian su tratamiento con CBZ-LC y en sujetos que ya han sido tratados con ESL en monoterapia durante al menos un año (es decir, durante el tratamiento prolongado).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study):
    1. Participated in the preceding double-blind study and were still ongoing at the time of unblinding.
    2. Have signed informed consent before undergoing any activities related to the open-label extension study.
    3. Demonstrated cooperation and willingness to complete all aspects of the study.
    4. Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV).
    Para la inclusión en el estudio de extensión, los sujetos deben cumplir todos los requisitos siguientes en la visita 1 (día 1, inicio del estudio abierto de extensión):
    1.Haber participado en el estudio doble ciego anterior y seguir participando en el momento de la apertura del ciego.
    2.Haber firmado un formulario de consentimiento informado antes de la realización de las actividades relacionadas con el estudio abierto de extensión.
    3.Haber demostrado disposición y voluntad para completar todos los aspectos del estudio.
    4.Las mujeres que no pueden quedarse embarazadas (2 años posmenopáusicas, ooforectomía bilateral o ligadura de trompas, o histerectomía completa) son idóneas. Las mujeres en edad fértil deben obtener un resultado negativo en la prueba de la fracción beta de la gonadotropina coriónica humana (GCH) en sangre para confirmar que no están embarazas, y las mujeres sexualmente activas deben emplear un método anticonceptivo no hormonal eficaz clínicamente aceptable durante el estudio y hasta la visita posterior al estudio (PSV, por sus siglas en inglés).
    E.4Principal exclusion criteria
    Subjects having any of the following at Visit 1 are to be excluded from the study:
    1. Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double-blind study.
    2. Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study.
    3. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS).
    4. Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study.
    5. Events of alcohol, drug, or medication abuse during the preceding double-blind study.
    6. Relevant clinical laboratory abnormalities (e.g. sodium <125 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (as reported at Visit 1).
    7. Pregnancy or lactating.
    8. Any oth r condition or circumstance that, in the opinion of the investigator, could compromise the subject?s ability to comply with the extension-study protocol.
    Los sujetos serán excluidos del estudio si cumplen cualquiera de los siguientes criterios en la visita 1:
    1.Hayan sido excluidos del estudio doble ciego debido a la aparición de crisis en la fase de extensión o mantenimiento, o a un nivel de dosis C (CBZ-LC o ESL), o hayan abandonado el estudio prematuramente por cualquier otro motivo en el estudio doble ciego.
    2.La presencia de violaciones importantes del protocolo durante el estudio doble ciego que pueden afectar a su cumplimiento durante el estudio de extensión.
    3.Riesgo de suicidio en opinión del investigador en base a una entrevista clínica y al resultado en la escala Columbia para evaluar el riesgo de suicidio (Columbia Suicide-Severity Rating Scale [C-SSRS]).
    4.Aparición de un acontecimiento adverso (AA) que indique sospecha de bloqueo auriculoventricular (segundo grado o superior) o cualquier otro AA durante el estudio doble ciego que en opinión del investigador constituya una contraindicación para seguir participando en el estudio abierto de extensión.
    5.Episodios de abuso de alcohol, drogas o medicamentos durante el estudio doble ciego anterior.
    6.Anomalías en los análisis de laboratorio clínicas relevantes (p. ej., sodio <125 mmol/l, alanina-aminotransferasa o aspartato-aminotransferasa >2 x el límite superior de la normalidad, recuento de leucocitos <3.000 células/mm3) (tal como se informó en la visita 1).
    7.Embarazo o lactancia.
    8.Cualquier otra enfermedad o circunstancia que, en opinión del investigador, podría comprometer la capacidad del sujeto para completar el protocolo del estudio de extensión.
    E.5 End points
    E.5.1Primary end point(s)
    Time to treatment failure, defined as time from start of open-label ESL treatment at Visit 1 until withdrawal due to AE or due to lack of efficacy (i.e. inadequate seizure control).
    El tiempo hasta el fracaso terapéutico definido como el tiempo desde el inicio del estudio de extensión hasta la retirada por AA o falta de eficacia (es decir, control inadecuado de las crisis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 1 year
    Al menos un año
    E.5.2Secondary end point(s)
    Treatment retention time (overall, i.e. including previously CBZ-CR treated subjects, and by reason) at the last evaluated dose during open-label treatment, where treatment retention time is defined as the time from start of the extension study until withdrawal of ESL due to AEs or due to lack of efficacy (i.e. inadequate seizure control).

    Time to withdrawal for any reason at the last evaluated dose.

    Changes in quality of life assessed using the QOLIE-31.

    Changes in overall treatment satisfaction as assessed on a 4-point scale.
    Tiempo de retención en el tratamiento (en general, es decir, incluidos los sujetos tratados previamente con CBZ-LC, y por motivo de retirada) en la última dosis evaluada durante el tratamiento sin enmascaramiento, que se define como el tiempo desde el inicio del estudio de extensión hasta la retirada de ESL por AA o falta de eficacia (es decir, control inadecuado de las crisis).

    Tiempo hasta la retirada por cualquier motivo en la última dosis evaluada.

    Cambios en la calidad de vida según el QOLIE-31.

    Cambios en la satisfacción terapéutica global según una escala de 4 puntos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at least 1 year
    Al menos un año
    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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA53
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Chile
    Croatia
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Latvia
    Lithuania
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Ukraine
    United Kingdom
    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
    The complete study duration including treatment with ESL under open-label conditions and follow-up is expected to last approximately 2 years (105 weeks).
    In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
    Se prevé que la duración completa del estudio ? incluido el tratamiento con ESL en abierto y el seguimiento? sea de 2 años aproximadamente (105 semanas).En caso de que la AC de ESL como monoterapia se recibiera antes de finales de 2017, el estudio podría interrumpirse de forma prematura en los 42 días siguientes a la obtención de la AC.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 279
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 300
    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)
    After the Trial subjects will be treated according to local standard medical 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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-11
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