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    Summary
    EudraCT Number:2016-002452-25
    Sponsor's Protocol Code Number:EP0065
    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:2018-01-17
    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 number2016-002452-25
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF INTRAVENOUS BRIVARACETAM IN SUBJECTS ≥1 MONTH TO <16 YEARS OF AGE WITH EPILEPSY
    ESTUDIO ABIERTO Y MULTICÉNTRICO PARA EVALUAR LA FARMACOCINÉTICA, SEGURIDAD Y TOLERABILIDAD DE BRIVARACETAM INTRAVENOSO EN PACIENTES DE ≥1 MES A <16 AÑOS DE EDAD CON EPILEPSIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the pharmacokinetics, safety, and tolerability of intravenous brivaracetam in subjects >= 1 month to < 16 years of age with epilepsy
    Un estudio para evaluar la farmacocinética, seguridad y tolerabilidad de brivaracetam intravenoso en sujetos de entre un mes y 16 años de edad con epilepsia.
    A.4.1Sponsor's protocol code numberEP0065
    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 BIOPHARMA SPRL
    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 Biopharma SPRL
    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 pointCT Registries & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Str. 10
    B.5.3.2Town/ cityMonheim am Rhein
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number00492173481515
    B.5.5Fax number00492173481572
    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 Yes
    D.2.1.1.1Trade name Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 codeBRV
    D.3.9.3Other descriptive nameBriviact
    D.3.9.4EV Substance CodeSUB25397
    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.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 Yes
    D.2.1.1.1Trade name Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB25397
    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.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 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 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-propylpyrrolidin-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: 4
    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 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-propylpyrrolidin-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.IMP: 5
    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 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-propylpyrrolidin-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 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) 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: 6
    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 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-propylpyrrolidin-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 number75
    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: 7
    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 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-propylpyrrolidin-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 number100
    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
    De acuerdo con la clasificación ILAE , síndrome epiléptico focal, local, generalizado o indeterminado.
    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 20.0
    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 PK, safety, and tolerability of BRV administered intravenously in subjects >= 1 month to < 16 years of age with epilepsy
    Evaluar la FC, seguridad y tolerabilidad de BRV administrado de forma intravenosa en sujetos de entre un mes o mayores y menos de 16 años.
    E.2.2Secondary objectives of the trial
    N/A
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and
    who were preterm infants, the corrected gestational age should be used for this entry requirement
    - Weight >= 3 kg (6.6 lbs)
    - Diagnosis of epilepsy
    - Acceptable candidate for venipuncture and intravenous (iv) infusion
    - Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at
    least 7 days prior to Screening
    - No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the
    settings have been constant for >=7 days prior to Screening
    - For female subjects: not of childbearing potential, OR of childbearing potential and not sexually
    active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy
    test/uses medically acceptable contraceptive methods
    1. Formulario de consentimiento informado por escrito aprobado por un comité ético de investigación clínica (CEIC) firmado y fechado por el paciente, sus padres o representantes legales. Los menores firmarán y fecharán el formulario de consentimiento informado o un formulario de asentimiento específico, en los casos en que se requiera.
    2. El investigador considera que el paciente o representante legal es de confianza y capaz de cumplir con todos los requisitos del estudio.
    3. El paciente es varón o hembra, de ≥1 mes a <16 años de edad. En el caso de los pacientes prematuros de <1 año de edad desde su nacimiento, se utilizará la edad gestacional corregida como requisito de entrada. La edad gestacional corregida se calcula restando el número de semanas nacido antes de las 37 semanas de gestación de la edad cronológica.
    4. Peso del paciente ≥3 kg (6,6 lb).
    5. El paciente tiene un diagnóstico de epilepsia.
    6. El paciente es un candidato apto para la venopunción y la infusión i.v.
    7. El paciente recibe un tratamiento con ≥1 fármaco antiepiléptico (FAE), incluido BRV, sin cambios en la pauta posológica durante al menos 7 días antes de la selección.
    8. El paciente no recibe ningún tratamiento de estimulación del nervio vago (ENV) O el paciente recibe tratamiento de ENV y la configuración ha sido constante durante ≥7 días antes de la selección.
    9. Para las pacientes de sexo femenino, la paciente
    • No está en edad fértil
    O
    • Está en edad fértil y
    - No tiene actividad sexual
    - Presenta una prueba de embarazo negativa
    O
    • Está en edad fértil y
    - Tiene actividad sexual
    - Presenta una prueba de embarazo negativa
    - Comprende las consecuencias y los riesgos de mantener actividad sexual sin la protección adecuada, comprende y utiliza adecuadamente los métodos anticonceptivos y está dispuesta a informar al investigador de cualquier cambio en los métodos anticonceptivos. Se consideran métodos anticonceptivos aceptables desde el punto de vista médico para el estudio, entre otros:
    - Tratamiento anticonceptivo oral o de liberación prolongada como mínimo con 30 μg de etinilestradiol por toma o 50 μg de etinilestradiol por toma si también se toma uno de los siguientes: carbamacepina, fenobarbital, primidona, fenitoína, oxcarbacepina, hierba de san Juan o rifampicina.
    - Método anticonceptivo de barrera: dispositivo intrauterino, diafragma con espermicida o preservativo masculino o femenino con espermicida
    - Abstinencia de relaciones sexuales
    E.4Principal exclusion criteria
    - Subject has previously received iv Brivaracetam (BRV) in this study.
    - Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with
    body weights >40kg.
    - Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of
    concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv)
    pharmacokinetic (PK) Period.
    - Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating
    Oral BRV (IOB) Treatment or iv PK Periods.
    - Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or
    during the Screening Period.
    1. El paciente ha recibido BRV i.v. anteriormente en este estudio.
    2. La paciente está embarazada o en periodo de lactancia.
    3. El paciente tiene alguna afección médica, neurológica o psiquiátrica que, en opinión del investigador, podría hacer peligrar la salud del paciente o comprometer su capacidad para participar.
    4. El paciente recibe tratamiento con BRV en una dosis de >5 mg/kg/día (redondeado) o >200 mg/día en el caso de pacientes con un peso corporal >40 kg.
    5. El paciente necesita, o puede necesitar, un cambio en los FAE concomitantes, la dosis de FAE concomitantes o la formulación de FAE durante los 7 días previos al periodo de FC i.v.
    6. Es probable que el paciente, según la opinión del investigador, necesite medicamentos de rescate durante los periodos de tratamiento de IBO o de FC i.v.
    7. El paciente tiene ≥6 años y antecedentes de intento de suicidio (incluidos un intento real, un intento interrumpido o un intento fracasado), o ha tenido pensamientos suicidas en los últimos 6 meses como lo indicaría una respuesta positiva (“Sí”) a la pregunta 4 o a la pregunta 5 de la escala de Columbia para evaluar la gravedad de las conductas suicidas (C-SSRS) en la selección.
    8. El paciente participa en un estudio abierto de BRV a largo plazo y cumple cualquiera de los criterios de retirada obligatorios de ese estudio.
    9. El paciente padece cualquier afección médica que es de esperar de modo razonable que interfiera con la absorción, la distribución, el metabolismo o la excreción de BRV.
    10. El paciente presenta alguna alteración clínicamente significativa en el ECG, según la opinión del investigador.
    11. El paciente ha sufrido un episodio de estado epiléptico convulsivo en los 28 días previos a la selección o durante el periodo de selección.
    12. El paciente padece una hipersensibilidad conocida a derivados de la pirrolidona o a cualquiera de los componentes de la formulación oral o i.v. de BRV.
    13. El paciente tiene antecedentes de reacción hematológica adversa grave a cualquier fármaco.
    14. El paciente tiene un valor >1,5 x límite superior de la normalidad (LSN) en cualquiera de los siguientes: alanina aminotransferasa (ALT), aspartato aminotransferasa (AST), fosfatasa alcalina (FA) o bilirrubina total >LSN (bilirrubina total ≥1,5 x LSN en caso de síndrome de Gilbert conocido). Si el paciente tiene solo elevaciones de la bilirrubina total >LSN y <1,5 x LSN, se debe analizar la bilirrubina fraccionada para identificar un posible síndrome de Gilbert no diagnosticado (es decir, bilirrubina directa <35 %).
    En los pacientes aleatorizados con un resultado inicial de ALT, AST, FA o bilirrubina total >LSN, se debe conocer el diagnóstico inicial o la causa de cualquier elevación de importancia clínica y documentarla en el CRD.
    Si el paciente tiene ALT, AST o FA >LSN que no cumple con el límite de exclusión en la selección, se deben repetir las pruebas antes de la administración, si es posible, para garantizar la ausencia de un incremento clínicamente relevante en curso. En caso de un aumento clínicamente relevante, la inclusión del paciente se debe consultar con el supervisor médico.
    Los análisis que resulten en ALT, AST o FA hasta un 25 % por encima del límite de exclusión pueden repetirse una vez con fines de confirmación. Se incluye también la repetición de la selección.
    15. El paciente tiene hepatopatía crónica.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of adverse events throughout the study
    - Number of subject withdrawals due to AEs
    - Plasma concentration of brivaracetam (BRV)
    _Incidencia de acontecimientos adversos a lo largo del ensayo.
    _Número de abandono de sujetos por acontecimientos adversos.
    _Concentración de brivaracetam (BRV) en plasma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1+2: From Screening (Day -20 to -1) until last visit (up to day 68)
    3: Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min
    and 3 hours post-initiation of iv BRV infusion
    1+2: desde la selección (día -20 a día -1) hasta la última visita (hasta el día 68)
    3: las muestras de sangre se recogerán durante la hora anterior a la infusión intravenosa (IV) y 15 minutos y 3 horas tras el inicio de la infusión intravenosa de BRV.
    E.5.2Secondary end point(s)
    N/A
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 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.8.2.4Number 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Czech Republic
    Hungary
    Italy
    Mexico
    Spain
    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
    Last Patient Last Visit
    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 months11
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days19
    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: 50
    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: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects younger than 18 years are included. Parent(s) or legal representative of the subject will sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF)
    Se incluyen sujetos menores de 18 años. Los padres o representantes legales del sujeto firmarán y fecharán un consentimiento informado aprobado por el Comité Ético.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 50
    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)
    Patient will be offered to participate in the open label extension study N01266
    A los pacientes se les ofrecerá la posibilidad de participar en el estudio de extensión en abierto N01266
    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 Decision2018-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-04
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