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    Summary
    EudraCT Number:2006-006536-22
    Sponsor's Protocol Code Number:N01263
    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:2011-06-17
    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 number2006-006536-22
    A.3Full title of the trial
    ESTUDIO MULTICÉNTRICO, ABIERTO, DE UN SOLO BRAZO DE TRATAMIENTO, PARA EVALUAR LA FARMACOCINÉTICA, SEGURIDAD Y EFICACIA DE LA ADMINISTRACIÓN DE BRIVARACETAM COMO TRATAMIENTO ADYUVANTE EN PACIENTES DE 1 MES O MÁS HASTA 16 AÑOS DE EDAD CON EPILEPSIA OPEN-LABEL, SINGLE-ARM, MULTICENTER, PHARMACOKINETIC, SAFETY, AND EFFICACY STUDY OF ADJUNCTIVE ADMINISTRATION OF BRIVARACETAM IN SUBJECTS FROM 1 MONTH OR MORE UNTIL 16 YEARS OLD WITH EPILEPSY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio de la administración de Brivaracetam como tratamiento adyuvante en pacientes de 1 mes o más hasta 16 años con epilepsia
    A.4.1Sponsor's protocol code numberN01263
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/195/2010
    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 organisationn/a
    B.5.2Functional name of contact pointn/a
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountryBelgium
    B.5.4Telephone numbern/a
    B.5.5Fax numbern/a
    B.5.6E-mailna@na.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.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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-propilpirrolidin-1-il] butanamida
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Oral solution
    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-propilpirrolidin-1-il] butanamida
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Localization-related, generalized or undetermined whether focal or
    generalized epileptic syndrome, according to ILAE classification
    Síndrome epiléptico relacionado con localización, generalizado o indeterminado, ya sea focal o generalizado, según la clasificación ILAE.
    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 13.1
    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
    Caracterizar la FC estacionaria de BRV y sus metabolitos en pacientes de 1 mes o más hasta 16 años de edad, evaluar su relación con variables de desarrollo fisiológico y desarrollar adaptaciones posológicas.
    E.2.2Secondary objectives of the trial
    Documentar la seguridad y tolerabilidad a corto plazo de BRV
    Obtener información preliminar sobre la eficacia de BRV en niños con diversos síndromes epilépticos
    Evaluar el cumplimiento del tratamiento con la solución oral del fármaco del estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. El(los) padre(s)/representante(s) legal(es) firman y fechan un documento de consentimiento informado aprobado por el comité ético de investigación clínica (CEIC). Además, los menores firmarán y fecharán un formulario de consentimiento o un formulario específico de asentimiento, si es necesario.
    2. Se considera al paciente o al(a los) padres(s)/representante(s) legal(es) fiables y capaces de cumplir el protocolo (p. ej., capaces de entender y rellenar los diarios), el calendario de visitas o la toma de medicación según el criterio del investigador.
    3. Síndrome epiléptico relacionado con localización, generalizado o indeterminado, ya sea focal o generalizado, según la clasificación ILAE.
    4. Presencia de un EEG compatible con el diagnóstico clínico de epilepsia.
    5. Paciente con al menos 1 crisis (de cualquier tipo) durante las 3 semanas antes de la V1.
    6. Paciente que toma al menos 1 pero no más de 3 FAE concomitantes. Todos los FAE deben estar a una dosis estable durante al menos 7 días antes de la V1 y no se permitirán adiciones o eliminaciones de FAE. Las dosis de cualquier FAE concomitante deberá permanecer estable desde la V1 hasta la recogida de muestras para FC. Se permite el uso de un estimulador del nervio vago de manera estable durante al menos 2 semanas antes de la V1 y se contabilizará como FAE concomitante. Las benzodiacepinas recibidas más de una vez por semana (para cualquier indicación) se considerarán FAE concomitantes.
    7. El paciente es hombre o mujer y tiene desde 1 mes hasta 16 años de edad en la V1.
    8. El peso corporal en la V1 es de al menos 3 kg en los lactantes.
    9. Son elegibles las pacientes mujeres sin capacidad fértil (premenárquicas o esterilizadas quirúrgicamente).
    10. Son elegibles las pacientes mujeres potencialmente fértiles que no sean sexualmente activas. Los pacientes deben informar el investigador si hay un cambio esperado en su estado.
    11. Las pacientes mujeres adolescentes potencialmente fértiles que sean sexualmente activas 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 etinilestradiol 50 µg por toma si se asocia a cualquier inductor potente [p. ej., carbamazepina, fenobarbital, primidona, fenitoína, oxcarbazepina, hipérico, 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.
    12. Las mujeres potencialmente fértiles deben tener una prueba de embarazo negativa en la V1.
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en la lactancia.
    2. Uso concomitante de LEV en la V1. Además, está prohibido el uso de LEV durante al menos 4 semanas antes de la V1.
    3. Epilepsia secundaria a una enfermedad cerebral o tumor cerebral o cualquier otra enfermedad neurodegenerativa progresiva. Podrían ser aceptables malformaciones arteriovenosas estables, meningiomas u otros tumores benignos según la opinión del investigador.
    4. Antecedentes del estado epiléptico en el último mes previo a la V1 o durante el momento basal del estudio.
    5. Antecedentes o presencia de pseudocrisis.
    6. Paciente que padece sólo crisis febriles.
    7. Paciente que recibe felbamato con menos de 18 meses de exposición continua. Paciente que ha tomado felbamato en una duración combinada del tratamiento y periodo de lavado de menos de 18 meses antes de la V1.
    8. Pacientes tratados con vigabatrina que tengan defectos del campo visual.
    9. Paciente con alergia a derivados de la pirrolidona, los excipientes del producto en investigación o antecedentes de alergias medicamentosas múltiples.
    10. El paciente presenta cualquier enfermedad clínicamente significativa aguda o crónica (determinada durante la exploración física o a partir de otra información disponible para el investigador: p. ej., depresión de la médula ósea, hepatopatía crónica, insuficiencia renal grave, trastorno psiquiátrico).
    11. El paciente tiene una enfermedad subyacente o está recibiendo un tratamiento que podría interferir con la absorción, distribución, metabolismo y eliminación del fármaco del estudio.
    12. El paciente tiene cualquier afección médica que pueda interferir con su participación en el estudio, p. ej., una infección grave, cirugía electiva programada, etc.
    13. El paciente tiene antecedentes de intento de suicidio o ideación y/o conducta suicida actual.
    14. Enfermedad terminal.
    15. El paciente presenta cualquier anomalía clínicamente significativa respecto a los valores del intervalo de referencia del laboratorio en parámetros analíticos, según el investigador.
    16. Anomalías clínicamente relevantes del ECG de acuerdo con el investigador.
    17. El paciente se ha sometido a cirugía mayor en los 6 meses previos a la V1.
    18. El paciente ha recibido cualquier fármaco o dispositivo en investigación dentro de los 30 días anteriores a la V1. El uso de FAE comercializados para adultos, pero no aprobados para uso pediátrico no se considera experimental a efectos de este estudio.
    19. Los hijos de los investigadores y los coinvestigadores no pueden incluirse como pacientes en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Las variables principales son las concentraciones plasmáticas de BRV y sus metabolitos ucb 42145 (ácido), ucb 100406-1 (hidroxilo), y ucb 107092-1 (hidroxiácido) y las concentraciones plasmáticas de los FAE concomitantes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Día 7 (v3), Día 14 (v4), Día 21 (v5)
    E.5.2Secondary end point(s)
    SEGURIDAD
    ? Acontecimientos adversos
    ? Determinaciones analíticas de seguridad (hematología, bioquímica, endocrinología y análisis de orina en pacientes ? 4 años de edad)
    ? ECG
    ? Constantes vitales (presión arterial, frecuencia cardiaca y temperatura corporal)
    ? Exploración física (escala de Tanner) y neurológica
    ? Estado psiquiátrico y mental
    ? Peso corporal y estatura
    ? CBCL de Achenbach en el momento basal en niños de 18 meses o más (CBCL/1½ - 5 y CBCL/6 - 18) para evaluar el comportamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Todas o algunas de las variables secundarias son evaluadas en: Día -7 (v1), Día 1 (v2), Día 7 (v3), Día 14 (v4), Día 21 (v5), Día 35 (v6), Día 49 (v7)
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    Belgium
    Czech Republic
    Mexico
    Poland
    Spain
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Última visita del paciente
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    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)
    5.1.1 Duración del estudio por sujeto
    6.3 Criterios de retirada de sujetos
    8.5 Visita 5 (Dia 21)/Visita de discontinuidad temprana
    8.6 Visita 6 (Dia 49, visita de segurdad para sujetos que no entraron en el estudio de seguimiento a largo plazo)
    10.2.24 Finalización del estudio
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation n/a
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-13
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