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    Summary
    EudraCT Number:2011-005177-23
    Sponsor's Protocol Code Number:N01395
    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:2012-05-24
    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 number2011-005177-23
    A.3Full title of the trial
    An Open-Label, Multicenter, Single-Arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects with Epilepsy Switching from Levetiracetam to Brivaracetam due to Nonpsychotic Behavioral Side Effects
    ESTUDIO ABIERTO, MULTICÉNTRICO Y DE UN SOLO BRAZO PARA EVALUAR LA REDUCCIÓN DE LOS EFECTOS SECUNDARIOS CONDUCTUALES NO PSICÓTICOS EN PACIENTES CON EPILEPSIA QUE CAMBIAN DE LEVETIRACETAM A BRIVARACETAM DEBIDO A EFECTOS SECUNDARIOS CONDUCTUALES NO PSICÓTICOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label trial to evaluate the reduction in nonpsychotic behavioral side effects in patients who switched to brivaracetam treatment after discontinuing levetiracetam due to nonpsychotic behavioral side effects.
    Estudio abierto para evaluar la reducción de los efectos secundarios conductuales no psicóticos en pacientes que cambiaron a tratamiento de Brivaracetam después de discontinuar Levetiracetam debido a efectos secundarios conductuales no psicóticos.
    A.4.1Sponsor's protocol code numberN01395
    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 pointClin Trial Reg & Results disclosure
    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+49 2173 48 1515
    B.5.5Fax number+49 2173 48 1573
    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 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 nameBrivaracetam
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameBrivaracetam
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 32714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Nonpyschotic Behavioural Side Effects in Subjects With Epilepsy
    Efectos secundarios conductuales no psicóticos en pacientes con epilepsia
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilepsia
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the reduction of nonpsychotic behavioral side effects in subjects with epilepsy who switched to BRV 200mg/day after discontinuing LEV 1g/day to 3g/day due to these nonpsychotic behavioral side effects
    Evaluar la reducción de los efectos secundarios conductuales no psicóticos en pacientes con epilepsia que han cambiado a BRV 200 mg/día tras interrumpir LEV de 1 g/día a 3 g/día debido a dichos efectos secundarios conductuales no psicóticos.
    E.2.2Secondary objectives of the trial
    ? To evaluate the reduction in intensity of nonpsychotic behavioral side effects in subjects with epilepsy who switched to BRV 200mg/day after discontinuing LEV use due to these nonpsychotic behavioral side effects
    ? To evaluate the efficacy of BRV compared to a retrospective Baseline
    ? To assess the overall safety and tolerability of BRV 200mg/day as adjunctive treatment in adult subjects with epilepsy after they have switched from LEV to BRV treatment
    ? Evaluar la reducción de la intensidad de los efectos secundarios conductuales no psicóticos en pacientes con epilepsia que han cambiado a BRV 200mg/día tras interrumpir la utilización de LEV debido a dichos efectos secundarios conductuales no psicóticos
    ? Evaluar la eficacia de BRV en comparación con un valor basal retrospectivo
    ? Evaluar la seguridad y tolerabilidad globales de BRV 200 mg/día como tratamiento adyuvante en pacientes adultos con epilepsia tras haber cambiado de LEV a tratamiento con BRV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator.
    3. Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted.
    4. Subject has a family member/caregiver or close contact person who is knowledgeable on a daily basis regarding the subject?s side effects. This family member/caregiver or close contact person should accompany the subject to the study visits or be available for discussion by telephone.
    5. Subject with well-characterized epilepsy according to the 1989 ILAE classification.
    6. Subject with epilepsy who the Investigator expects would have benefitted from LEV but for whom the Investigator has decided to discontinue LEV due to nonpsychotic behavioral side effects following the introduction of LEV.
    7. Subject is currently receiving LEV at a dose between 1g/day and 3g/day.
    8. Subject currently treated with 2 to 3 AEDs, including LEV. Vagal nerve stimulation (VNS) is allowed provided it has been implanted for at least 9 months prior to V1. VNS will be counted as a concomitant AED.
    9. Permitted concomitant AED(s) (with the exception of LEV) and VNS are stable and at optimal dosage for the subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) before V1 and are expected to be kept stable during the Screening and Treatment Periods.
    10. Subject with a body weight ?40kg.
    11. Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least ethinylestradiol 30?g per intake (or ethinylestradiol 50?g per intake if associated with any strong enzyme inducer [eg carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John?s Wort, rifampicin]), monogamous relationship with vasectomized partner, or double-barrier contraception are acceptable methods. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status. Abstinence will be considered as an acceptable method of contraception if the Investigator can document that the subject agrees to be compliant.
    1. El paciente o su(s) padre(s) o su representante legal firman y fechan un formulario de Consentimiento Informado por escrito aprobado por el Consejo Institucional de Revisión (CIR)/Comité Ético Independiente (CEI). Además, los menores firmarán y fecharán un formulario de Consentimiento Informado o un formulario específico de Conformidad, si es necesario.
    2. Se considera que el paciente/representante legal es fiable y capaz de cumplir con el protocolo (p. ej., capaz de entender y rellenar los diarios), el calendario de visitas o la toma de medicación de acuerdo con el criterio del investigador.
    3. El paciente es hombre o mujer y tiene 16 años de edad o más. Sólo pueden incluirse pacientes menores de 18 años de edad cuando esté permitido legalmente y acepado desde el punto de vista ético.
    4. El paciente tiene un pariente/cuidador o una persona de contacto cercana que está al tanto diariamente de los efectos secundarios del paciente. Este pariente/cuidador o persona de contacto cercana deberá acompañar al paciente a las visitas del estudio o estar disponible para hablar por teléfono.
    5. Paciente con epilepsia bien caracterizada de acuerdo con la clasificación de la ILAE de 1989.
    6. Paciente con epilepsia que el Investigador espera que se habría beneficiado de LEV pero al que el Investigador ha decidido retirar LEV debido a efectos secundarios conductuales no psicóticos tras la introducción de LEV.
    7. El paciente está recibiendo en la actualidad LEV a una dosis de entre 1 g/día y 3 g/día.
    8. El paciente recibe en la actualidad tratamiento con 2 a 3 FAE, incluyendo LEV. Se permite la estimulación del nervio vago (ENV) siempre que se haya implantado al menos 9 meses antes de la V1. La ENV se considerará como FAE concomitante.
    9. Los FAE concomitantes permitidos (excepto LEV) y la ENV deben estar estables y a una dosis óptima para el paciente desde al menos 4 semanas (12 semanas si son fenobarbital, fenitoína y primidona) antes de la V1 y se espera que permanezcan estables durante los Periodos de Selección y de Tratamiento.
    10. Paciente con un peso corporal ?40 kg.
    11. Son elegibles las pacientes sin capacidad fértil (posmenopáusicas desde hace al menos 2 años, ooforectomía bilateral o ligadura de trompas, histerectomía completa). Las pacientes potencialmente fértiles son elegibles si utilizan un método anticonceptivo médicamente aceptado. Son métodos aceptables los anticonceptivos orales o en forma depot con al menos 30 µg de etinilestradiol por toma (o 50 µg de etinilestradiol por toma si se asocia a un inductor enzimático potente [p. ej., carbamazepina, fenobarbital, primidona, fenitoína, oxcarbazepina, hierba de San Juan, rifampicina]), relación monógama con pareja vasectomizada o anticonceptivos de doble barrera. La paciente debe entender las consecuencias y posibles riesgos de la actividad sexual con protección insuficiente, debe ser instruida al respecto y debe entender el uso correcto de los métodos anticonceptivos y comprometerse a informar al Investigador acerca de cualquier posible cambio en su estado. La abstinencia se considerará un método anticonceptivo aceptable si el Investigador puede documentar que la paciente se compromete a cumplirla.
    E.4Principal exclusion criteria
    1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study.
    2. Subject has participated in another study of an investigational medication (or a medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device).
    3. Subject has a history of chronic alcohol or drug abuse within the last year.
    4. 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.
    5. Subject has a lifetime history of suicide attempt (including an active, interrupted or aborted attempt), or has had 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 V1.
    6. Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol.
    7. Subject has history of severe adverse hematologic reaction to any drug.
    8. Subject has been receiving LEV at any dose for more than 12 weeks prior to V1.
    9. Subject taking any drug that may significantly influence the metabolism of BRV, such as cytochrome P450 potent inducers, except if the dose has been kept stable at least 1 month
    before V1, and is expected to be kept stable during the Treatment Period.
    10. Subject on felbamate with less than 18 months exposure before V1.
    11. Subject not able to understand the Informed Consent form, Assent form, or daily record card (DRC) instructions.
    12. Subject has obvious cognitive impairment or mental retardation as per Investigator assessment.
    13. Subject whose seizures cannot be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries).
    14. Subject has history or presence of status epilepticus during the year preceding V1 or during the Screening Period.
    15. Subject has history or presence of known psychogenic nonepileptic seizures.
    16. Subject has presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (ie, not expected to stay stable during study participation) brain disorder or brain tumor. Stable arteriovenous malformations, meningiomas, or other benign tumors may be acceptable.
    17. Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease,a nd/or severe renal impairment) that impair reliable participation in the study or
    necessitate the use of medication not allowed by protocol.
    18. Subject is suffering from severe cardiovascular disease or peripheral vascular disease.
    19. Subject has presence of a terminal illness.
    20. Subject has presence of a serious infection.
    21. Subject has impaired hepatic function: ALT/SGPT (alanine aminotransferase/serum glutamic pyruvate transaminase), AST/SGOT (aspartate aminotransferase/serum glutamic oxaloacetic transaminase), or alkaline phosphatase of more than 2 times the upper limit of the reference range.
    22. Subject has gamma-glutamyltransferase (GGT) values of more than 3 times the upper limit of the reference range. A result of GGT exceeding 3 times the upper limit can antiepileptic treatment and other hepatic enzymes are below 2 times the upper limit of the reference range.
    23. Subject has clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated <30mL/min, platelets <100,000/?L, or neutrophil cells <1,800/?L.
    24. Subject is pregnant or lactating.
    25. Subjects are Investigators, co-Investigators, their spouses or children, or any study collaborators.
    1. El paciente ha participado anteriormente en este estudio o ha sido asignado anteriormente al tratamiento en un estudio con la medicación que se está investigado en este estudio.
    2. El paciente ha participado en otro estudio con una medicación en investigación (o con un dispositivo médico) en los últimos 30 días o está participando en la actualidad en otro estudio con una medicación en investigación (o con un dispositivo médico).
    3. El paciente tiene antecedentes de abuso crónico del alcohol o las drogas en el último año.
    4. El paciente tiene algún trastorno médico o psiquiátrico que, según la opinión del Investigador, podría poner en peligro o comprometería la capacidad del paciente para participar en este estudio.
    5. El paciente tiene antecedentes en cualquier momento de su vida de intento de suicidio (incluyendo un intento activo, un intento interrumpido o un intento abortado) o presenta ideación suicida en los últimos 6 meses como indica una respuesta positiva (?Sí?) a la pregunta 4 o a la pregunta 5 de la Escala de Valoración de la Severidad del Suicidio de Columbia (C-SSRS) en la V1.
    6. El paciente tiene hipersensibilidad conocida a algún componente del medicamento en investigación (MI) o de los fármacos comparadores tal como se indica en este protocolo.
    7. El paciente tiene antecedentes de reacción hematológica adversa severa a algún fármaco.
    8. El paciente ha estado recibiendo LEV a cualquier dosis durante más de 12 semanas antes de la V1.
    9. Paciente que recibe algún fármaco que pueda influir de forma significativa en el metabolismo de BRV, como inductores potentes del citocromo P450, excepto si la dosis se ha mantenido estable desde al menos 1 mes antes de la V1 y se espera que se mantenga estable durante el Periodo de Tratamiento.
    10. Paciente que recibe felbamato con menos de 18 meses de exposición antes de la V1.
    11. El paciente no puede entender el formulario de Consentimiento Informado, el formulario de Conformidad o las instrucciones de la ficha de registro diario (FRD).
    12. El paciente tiene deterioro cognitivo obvio o retraso mental según la valoración del Investigador.
    13. Paciente cuyas crisis de manera regular no pueden contarse de forma fiable debido a que son rápidas o repetitivas (agrupadas o en ráfagas)
    14. El paciente tiene antecedentes o presencia de estatus epiléptico durante el año precedente a la V1 o durante el Periodo de Selección.
    15. El paciente tiene antecedentes o presencia de convulsiones no epilépticas psicógenas conocidas.
    16. El paciente presenta algún signo (clínico o radiológico) que sugiera un tumor cerebral o un trastorno cerebral de progresión rápida (o sea, que no se espera que el paciente esté estable durante su participación en el estudio). Pueden ser aceptables las malformaciones arteriovenosas, los meningionas u otros tumores benignos
    17. El paciente tiene algún trastorno médico (p. ej., depresión de la médula ósea, enfermedad hepática crónica y/o insuficiencia renal severo) que pueda hacer que su participación en el estudio no sea fiable o necesite utilizar medicación no permitida por el protocolo.
    18. El paciente padece enfermedad vascular periférica o enfermedad cardiovascular severa.
    19. El paciente presenta una enfermedad terminal.
    20. El paciente presenta una infección grave.
    21. El paciente presenta deterioro de la función hepática: ALT/SGPT (alanina aminotransferasa/glutámico piruvato transaminasa sérica), AST/SGOT (aspartato aminotransferasa/glutámico oxalacético transaminasa sérica) o fosfatasa alcalina de más de 2 veces el límite superior del rango de referencia.
    22. El paciente presenta valores de gamma-glutamiltransferasa (GGT) de más de 3 veces el límite superior del rango de referencia. Sólo puede aceptarse un resultado de GGT de más de 3 veces el límite superior del rango de referencia si es atribuible a inducción enzimática hepática causada por el tratamiento antiepiléptico concomitante y si las demás enzimas hepáticas están por debajo de 2 veces el límite superior del rango de referencia.
    23. El paciente presenta desviaciones clínicamente significativas respecto a los valores del rango de referencia en los parámetros analíticos: aclaramiento de creatinina calculado <30 ml/min, plaquetas <100.000/µl o neutrófilos <1.800/µl.
    24. La paciente está embarazada o dando lactancia materna.
    25. Pacientes que sean investigadores, coinvestigadores, sus cónyuges o sus hijos, o cualquier colaborador del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1)Percentage of subjects who have achieved a clinically meaningful
    reduction of nonpsychotic behavioral side effects from study entry to the end of the Treatment Period, based on the Investigator?s overall assessment.
    2) Entry into the Long-Term Follow Up extension study (N01372)
    1)Porcentaje de pacientes que han logrado una reducción clínicamente significativa de los efectos secundarios conductuales no psicóticos desde la inclusión en el estudio hasta el final del Periodo de Tratamiento, basándose en la evaluación global del Investigador.
    2)Inclusión en el ensayo de extensión a largo plazo (N01372)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Between V2 (Week 0) and Visit 6 (Week 12)
    2) Between V2 (Week 0) and Visit 6 (Week 12)
    1) Entre la V2 (semana 0) y la visita 6 (semana 12)
    2) Entre la V2 (semana 0) y la visita 6 (semana 12)
    E.5.2Secondary end point(s)
    The safety and efficacy of BRV will be assessed:

    - Safety variables include the emergence of a SAEs or TEAEs, withdrawal due to an AE, investigator global evaluation of nonpsychotic behavioural side effects, shift in maximum side effect intensity from baseline to end of treatment, freedom or abatement of nonpsycotice behavioural side effects, laboratory tests (blood chemistry, hematology, urinalysis), vital signs (systolic blood pressure, diastolic blood pressure, heart rate), electrocardiogram (ECG), physical and neurologicals examination.

    - Efficacy variables include the partial onset seizure (POS) frequency during the treatment period for subjects with focal epilepsy, generalized seizure days during the Treatment Period for subjects with idiopathic generalized epilepsy, investigator and patient global evaluations at the end of the study, and seizure freedom (for all seizure types).
    La seguridad y eficacia de BRV será evaluada:

    - Las variables de seguridad incluyen la aparición de AAGs o AAMTs, retirada debido a un AA, evaluación global del investigador de los efectos secundarios conductuales no psicóticos, cambio de la intensidad máxima de los efectos secundarios desde el momento basal hasta el final del Periodo de Tratamiento, ausencia de efectos secundarios conductuales no psicóticos,determinaciones analíticas (bioquímica en sangre, hematología, análisis de orina), constantes vitales (presión arterial sistólica, presión arterial diastólica, frecuencia cardiaca),Electrocardiograma (ECG),Exploración física y neurológica
    E.5.2.1Timepoint(s) of evaluation of this end point
    The safety and efficacy variables be assessed as specified in the protocol during the treatment period (V0 to V6).
    Las variables de seguridad y eficacia serán evaluadas según lo especificado en el protocolo durante el periodo de tratamiento (V0 a V6).
    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 Yes
    E.6.13.1Other scope of the trial description
    To evaluate the reduction of nonpsychotic behavioral side effects
    Evaluar la reducción de efectos secundarios conductuales no psicóticos
    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.8.2.4Number of treatment arms in the trial1
    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 EEA20
    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
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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 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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 110
    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)
    The treatment period for the N01395 protocol will last 12 weeks. after completion of the Treatment Period at V6 (Week 12), the subject will have the possibility to continue receiving BRV by entering the Long Term Follow Up (LFTU) study (Protocol N01372, EudraCT 2012-000827-42). In case of premature termination or in case the subject does not want to continue into LFTU, the subject will enter the Down-Titration Period. Refer protocol for further details.
    El periodo de trat.para el protocolo N01395 durará 12 sem.Después de completar el Periodo de Tratamiento en la V6 (semana 12), el paciente tendrá la posibilidad de continuar recibiendo BRV al entrar en el Ensayo de Seguimiento a Largo Plazo (LFTU) (Protocolo N01372, EudraCT 2012-000827-42).En caso de terminación prematura o en caso de que el paciente no quiera continuar en el LFTU,el paciente entrará en el Periodo de Ajuste Descendente de la Dosis. Referirse al protocolo para más detalles.
    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 Decision2012-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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