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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-020345-27
    Sponsor's Protocol Code Number:N01379
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-24
    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 number2010-020345-27
    A.3Full title of the trial
    Estudio de seguimineto abierto y multicéntrico para evaluar la eficacia y la seguridad a largo plazo de Brivaracetam utilizado como tratamiento complementario en sujetos de 16 años de edad o mayores con crisis de inicio parcial
    An open-label, multicenter, follow-up study to evaluate the long-term safety and efficacy of Brivaracetam used as adjunctive treatment in subjects aged 16 yeras or older with partial onset seizures
    A.4.1Sponsor's protocol code numberN01379
    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 SponsorSCHWARZ BIOSCIENCES, INC. A Member of the UCB Group of Companies
    B.1.3.4CountryUnited States
    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 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.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Film-coated 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 INNbrivaracetam
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(alpha1S, 4R)-alpha-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamida
    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) 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.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.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Film-coated 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 INNbrivaracetam
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(alpha1S, 4R)-alpha-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamida
    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) 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.IMP: 3
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/315
    D.3 Description of the IMP
    D.3.1Product namebrivaracetam
    D.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Film-coated 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 INNbrivaracetam
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(alpha1S, 4R)-alpha-ethyl-2-oxo-4-propyl- 1-pyrrolidineacetamida
    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) 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
    Crisis de inicio parcial
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10061334
    E.1.2Term Partial seizures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primario es evaluar la seguridad y la tolerabilidad a largo plazo del BRV a dosis individualizadas hasta un máximo de 200 mg/día en sujetos con epilepsia focal.
    E.2.2Secondary objectives of the trial
    Evaluar el mantenimiento de la eficacia del BRV en el tiempo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.
    El consentimiento informado por escrito aprobado por un Comité Ético de Investigación Clínica (CEIC) firmado y fechado por el sujeto o por su o sus padres o su representante legal. Los menores firmarán y fecharán el formulario de consentimiento o un formulario de asentimiento específico, en los casos en que se requiera.
    2.
    Sujeto de sexo masculino/femenino de 16 años de edad o más. El sujeto menor de 18 años solo podrá ser incluido en los casos permitidos por la ley y aceptados éticamente.
    3.
    Sujeto que completó el período de tratamiento del estudio N01358.
    4.
    Sujeto para quien el investigador cree que se puede esperar un beneficio razonable de la administración a largo plazo del BRV.
    5.
    Las participantes no fértiles (premenárquicas, con más de 2 años de menopausia, ovariectomía bilateral o ligadura de trompas, histerectomía completa) son elegibles. Las participantes en edad fértil son elegibles si utilizan un método anticonceptivo aceptado médicamente. El tratamiento anticonceptivo oral o de depósito implantable con al menos 30 &#956;g de etinilestradiol por ingesta [o 50 &#956;g de etinilestradiol por ingesta si está asociado con cualquier inductor enzimático potente (p. ej. carbamazepina, fenobarbital, primidona, fenitoína, oxcarbazepina, hierba de San Juan, rifampicina)], relación monógama con una pareja sometida a vasectomía o un método anticonceptivo de doble barrera son métodos aceptables. El sujeto debe entender las consecuencias y los riesgos potenciales de la actividad sexual sin protección adecuada, debe recibir instrucción y comprender el uso apropiado de los métodos anticonceptivos, y debe comprometerse a informar al investigador sobre cualquier cambio potencial de su estado. La abstinencia será considerada un método anticonceptivo aceptable si el investigador puede documentar que el sujeto acepta cumplirla.
    6.
    A criterio del investigador, el sujeto/representante legal es considerado fiable y capaz de cumplir el protocolo (p. ej., capaz de comprender y completar los diarios y los cuestionarios), el programa de visitas o la ingesta de medicamentos.
    E.4Principal exclusion criteria
    1.
    El sujeto desarrolló hipersensibilidad a algún componente del producto en investigación (PMI) o de los fármacos de comparación, según se establece en este protocolo, durante el transcurso del estudio principal.
    2.
    Presenta trastornos médicos, neurológicos o psiquiátricos, o valores de laboratorio que puedan afectar la seguridad del sujeto.
    3.
    Escaso cumplimiento del programa de visitas o de la ingesta de medicamentos en el estudio previo de BRV.
    4.
    Participación planificada en algún otro estudio clínico de otro fármaco o dispositivo en investigación durante este estudio.
    5.
    Mujer embarazada o en período de lactancia.
    6.
    Toda afección médica que, según la opinión del investigador, justifica la exclusión
    E.5 End points
    E.5.1Primary end point(s)
    Variables de eficacia
    1. Variables de eficacia primaria
    La variable de eficacia primaria es la frecuencia de CIP (tipo I) estandarizada a una duración de 28 días. La variable de eficacia primaria se resumirá en períodos de 3 meses durante el período de evaluación.
    2. Variables de eficacia secundaria
    La frecuencia de crisis cada 28 días para todos los tipos de crisis (I+II+III) por períodos de 3 meses durante el período de evaluación
    La proporción de días sin crisis para todos los tipos de crisis (I+II+III) por períodos de 3 meses durante el período de evaluación

    La proporción de sujetos sin crisis de forma constante para todos los tipos de crisis (I+II+III) por períodos de 3 meses durante el período de evaluación

    La tasa de sujetos que presentan respuesta en las CIP (tipo I) por períodos de 3 meses durante el período de evaluación Los sujetos que presentan respuesta son sujetos con una reducción del 50% en la frecuencia de crisis con respecto al período inicial en el estudio doble ciego N01358
    3. Otras variables de eficacia
    El cambio en las puntuaciones del cuestionario QOLIE-31-P desde el inicio del estudio N01358 hasta cada valoración durante los primeros 2 años y hasta la última valoración del período de evaluación durante los primeros 2 años
    El cambio en las puntuaciones de la escala HADS desde el inicio del estudio N01358 hasta cada valoración durante los primeros 2 años y hasta la última valoración del período de evaluación durante los primeros 2 años

    El uso de recursos médicos durante los primeros 2 años del período de evaluación

    El cambio de los datos socio-profesionales desde el inicio del estudio N01358 hasta cada valoración durante los primeros 2 años y hasta la última valoración del período de evaluación durante los primeros 2 años
    4. Variables de seguridad
    AA

    Análisis de laboratorio (incluidos hematología, química sanguínea, análisis de orina y prueba de embarazo)

    ECG

    Examen físico

    Examen neurológico

    Constantes vitales

    Peso corporal
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 fin del estudio se define como la fecha de la última visita del último sujeto del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Yes
    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.1.2Adults (18-64 years) Yes
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 274
    F.4.2.2In the whole clinical trial 720
    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)
    Planes de tratamiento o cuidados médicos después de que los sujetos hayan finalizado su participación en el ensayo están detallados en el Protocolo de estudio:
    - Sección 6.3 Criterios de retirada
    - Sección 8.6 Última visita del periodo de evaluación o visita de interrupción anticipada
    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 Decision2011-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-18
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