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    Summary
    EudraCT Number:2014-003330-12
    Sponsor's Protocol Code Number:EP0069
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-30
    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 number2014-003330-12
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy
    Estudio aleatorizado, con doble enmascaramiento y control con placebo sobre la eficacia, la seguridad/tolerabilidad y el perfil farmacocinético de UCB0942 en pacientes adultos con Epilepsia focal altamente resistente a los medicamentos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of UCB0942 in adult patients with highly drug-resistant focal epilepsy
    Un estudio de UCB0942 en pacientes adultos con epilepsia focal altamente resistente a los medicamentos.
    A.4.1Sponsor's protocol code numberEP0069
    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-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+492173481515
    B.5.5Fax number+492173481572
    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 nameUCB0942
    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 INNNot yet available
    D.3.9.2Current sponsor codeUCB0942
    D.3.9.3Other descriptive nameUCB0942
    D.3.9.4EV Substance CodeSUB33843
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 nameUCB0942
    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 INNNot yet available
    D.3.9.2Current sponsor codeUCB0942
    D.3.9.3Other descriptive nameUCB0942
    D.3.9.4EV Substance CodeSUB33843
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    highly drug-resistant focal epilepsy
    Epilepsia focal altamente resistente a los medicamentos
    E.1.1.1Medical condition in easily understood language
    highly drug-resistant focal epilepsy
    Epilepsia focal altamente resistente a los medicamentos
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10065337
    E.1.2Term Focal epilepsy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of UCB0942 administered concomitantly with each subject´ss current, stable AED regimen in subjects who have 4 or more focal seizures with or without secondary generalization per week and who have failed to achieve seizure control with >=4 AED regimens of adequate dose and duration.
    Evaluar la eficacia de UCB0942 administrado en combinación con el tratamiento con un FAE estable actual de cada paciente en el caso de los pacientes que sufren 4 o más crisis focales con o sin generalización secundaria a la semana y que no han conseguido controlar las crisis con >=4 tratamientos con FAE con la dosis y la duración adecuadas.
    E.2.2Secondary objectives of the trial
    Evaluate the safety and tolerability of UCB0942
    Evaluate the PK of UCB0942 and its metabolites
    Evaluar la seguridad y la tolerabilidad de UCB0942.
    Evaluar la FC de UCB0942 y sus metabolitos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is an adult (18 years of age or more).
    Subjects with known mental retardation (defined as IQ below 70) are not eligible to participate.
    Subject and/or caregiver is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and take the medication as instructed according to the judgment of the Investigator.
    Subject is of normal weight as determined by a body mass index (BMI) between 18.0 and 35.0kg/m2 (exclusive), with a body weight of at least 50kg (males) or 45kg (females).
    ?Subject fulfills ILAE (1989) criteria for focal epilepsy.
    Subject has failed to achieve seizure control with >=4 appropriately-chosen AED regimens of adequate dose and duration, including the current treatment, as documented in medical records and per Investigator assessment of patient report.
    Subject is currently treated with a stable dose of at least 1 AED for the 4 weeks prior to the Screening Visit (Visit 1) and throughout the duration of the Treatment Period with or without additional concurrent VNS or other neurostimulation treatments. The VNS must have been in place for at least 12 months with constant settings for at least 3 months.
    During the 4 weeks prior to Screening, subject must have reported to have had an average of at least 4 spontaneous and observable focal seizures per week, and cannot have had any seizure-free period longer than 3 days. The cut-off seizure frequency (4 seizures per week) and maximum seizure-free interval (3 days) must be maintained during the 2-week prospective Baseline Period.
    Subject has clinical laboratory test results within the reference ranges of the laboratory or isolated test results that are outside the specified ranges and that are deemed as not clinically significant by the Investigator.
    Subject has blood pressure and heart rate within normal range in the supine position after 5 minutes rest, or the subject has hypertension that is under partial control with a stable antihypertensive medication regimen but that the Investigator deems as clinically not significant.
    El paciente es adulto (18 años de edad como mínimo).
    Las personas con un retraso mental conocido (definido como un cociente intelectual inferior a 70) no son aptas para la participación.
    El paciente o el cuidador se considera fiable y capaz de cumplir el protocolo (por ejemplo, tiene capacidad para entender y rellenar los diarios), el programa de visitas y el programa de toma de medicamentos de acuerdo con las instrucciones.
    El paciente tiene un peso normal según un índice de masa corporal (IMC) entre 18,0 y 35,0 kg/m2 (exclusive), con un peso corporal de como mínimo 50 kg (hombres) o 45 kg (mujeres).
    El paciente debe cumplir los requisitos de ILAE (1989) para la epilepsia focal
    El paciente no ha logrado controlar las crisis con >=4 tratamientos con FAE elegidos de la forma apropiada con la dosis y la duración adecuadas, incluido el tratamiento actual, como se documenta en la historia clínica y según la evaluación del informe del paciente por parte del investigador.
    El paciente recibe una dosis estable de como mínimo 1 FAE durante las 4 semanas antes de la visita de selección (visita 1) y durante todo el período de tratamiento con o sin estimulación del nervio vago (ENV) u otros tratamientos de neuroestimulación simultáneos. El sistema de ENV se debe haber usado durante 12 meses como mínimo con un ajuste constante durante 3 meses como mínimo y se debe haber previsto la duración de la batería de la unidad antes de la visita de selección y durante todo el estudio.
    Durante las 4 semanas anteriores a la selección (período de valoración inicial histórico), el paciente debe indicar que ha sufrido una media de 4 crisis focales espontáneas y observables como mínimo a la semana («crisis focales» hace referencia a las crisis de inicio parcial de tipo IA1, IB e IC, pero no incluye las crisis de tipo IA2, IA3 o IA4). No puede haber tenido un período sin crisis superior a 3 días. El valor de corte de la frecuencia de las crisis (4 crisis por semana) y el intervalo sin crisis máximo (3 días) se deben mantener durante el período de valoración inicial ambulatoria prospectiva de 2 semanas
    Los resultados de los análisis clínicos del paciente están comprendidos en los intervalos de referencia del laboratorio o los resultados de análisis aislados fuera de los intervalos especificados no se consideran clínicamente relevantes según el criterio del investigador.
    El paciente tiene una tensión arterial y una frecuencia cardíaca dentro del intervalo normal en la posición decúbito supino tras 5 minutos de reposo o el paciente padece hipertensión controlada parcialmente con un tratamiento antihipertensivo estable, pero el investigador considera que esto no es clínicamente relevante.
    E.4Principal exclusion criteria
    Subject has participated in another study of an investigational medication (or medical device) within the last 30 days or is currently participating
    Subject has a history of liver disease, including but not limited to, stable (on repeat testing) elevation of liver enzymes ([ALT] or [AST], >1.5 times ULN or [ALP] >2 times ULN).
    Subject has a known hypersensitivity to any components of UCB0942 formulation or to similar drugs (LEV, BRV, or benzodiazepines), or a history of drug or other allergy that, in the opinion of the Investigator or UCB Study Physician, contraindicates her/his participation.
    Subject has had significant blood loss or has donated or received 1 or more units (450mL) of blood within 30 days prior to UCB0942 administration, or has donated plasma or platelets within 14 days prior to UCB0942 administration for this study.
    Subject tests positive for human immunodeficiency virus-1/2 antibody (HIV-1/2Ab), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab).
    Subject has a medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject?s safety or his/her ability to participate in this study.
    Subject has current or past psychiatric condition that, in the opinion of the Investigator, could compromise his/her safety or ability to participate in this study including a history of schizophrenia, schizoaffective disorder, bipolar disorder, or severe unipolar depression.
    The presence of potential psychiatric exclusion criteria will be determined based on screening with the BPRS and MINI.
    Subject has a history of status epilepticus or has been hospitalized for status epilepticus within the 6-month period prior to Screening Visit.
    Subject has had EEGs showing a pattern not consistent with a diagnosis of focal epilepsy (eg, generalized spike-wave).
    ?Subject only has seizures that are uncountable due to clustering.
    Subject has had pseudoseizures, conversion disorder, or other nonepileptic ictal events that in the opinion of the Investigator could be confused with seizures.
    Subject had epilepsy surgery <1 year or an epilepsy dietary therapy initiated < 3 months prior to Screening.
    Subject has taken other (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 pathway for 2 weeks (or 5 half-lives whichever is longer) prior to the Baseline Visit.
    Subject is currently treated with carbamazepine, phenytoin, primidone, or phenobarbital or any other drug known to induce CYP3A4 liver enzymes.
    Subject is taking tiagabine, felbamate, or vigabatrin.
    Subject is taking benzodiazepines, zolpidem, zaleplon, or zopiclone >3 times per week for any indication.
    Subject had intolerable or serious psychiatric side effects with a previous exposure to LEV or BRV.
    Subject has a history in the last 5 years of drug or alcohol dependency or tests positive for drugs of abuse or alcohol during screening.
    Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening.
    Subject has a clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study.
    QT corrected for heart rate using Bazett?s formula (QTcB) or QT corrected for heart rate using Fridericia´s formula (QTcF) interval >450ms
    Bundle branch blocks and other conduction abnormalities that are clinically significant according to the Investigator and/or with a PR interval >=220ms
    Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
    In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
    Subject has a history of syncope or a family history of sudden death due to long QT syndrome.
    Subject has a clinically-significant abnormality on echocardiography at screening or a history of rheumatic heart disease or other known valvular abnormalities.
    Subjects with a history of hypersensitivity reactions or autoimmune disease.
    Female subject who is pregnant or breastfeeding.
    El paciente ha participado en otro estudio de un medicamento (o dispositivo médico) en investigación en los últimos 30 días o está participando actualmente
    El paciente tiene antecedentes de hepatopatía, lo que incluye sin carácter limitativo, elevación estable (tras análisis repetidos) de las enzimas hepáticas ([ALT] o [AST] >1,5 veces el LSN o [FA] >2 veces el LSN).
    El paciente tiene hipersensibilidad conocida a cualquiera de los componentes de la formulación de UCB0942 o a fármacos similares (LEV, BRV o benzodiacepinas), o antecedentes de alergia a fármacos u otro tipo de alergia que, en opinión del investigador o el médico del estudio de UCB, suponen una contraindicación para la participación.
    El paciente ha perdido mucha sangre o ha donado o recibido 1 o varias unidades de sangre (450 ml) 30 días antes de la administración de UCB0942 o ha donado plasma o plaquetas 14 días antes de la administración de UCB0942 para este estudio.
    El paciente ha dado positivo en la pruebas de anticuerpos frente al virus de la inmunodeficiencia humana 1/2 (Ac-VIH-1/2), antígeno de superficie del virus de la hepatitis B (AgHBs) o anticuerpos frente a la hepatitis C (Ac-VHC).
    El paciente padece una afección que, en opinión del investigador, puede poner en peligro o alterar la seguridad del paciente y su capacidad para participar en este estudio
    El paciente padece o ha padecido un trastorno psiquiátrico que, en opinión del investigador, puede afectar a su seguridad o capacidad para participar en este estudio, como antecedentes de esquizofrenia, trastorno esquizoafectivo, trastorno bipolar o depresión unipolar grave. La presencia de posibles criterios de exclusión psiquiátricos se determinará durante la selección mediante la escala BPRS y la mini-entrevista neuropsiquiátrica internacional (MINI).
    El paciente tiene antecedentes de estado epiléptico o ha sido hospitalizado por estado epiléptico 6 meses antes de la visita de selección.
    Los EEG del paciente muestran un patrón no indicativo de un diagnóstico de epilepsia focal (por ejemplo, actividad de puntas y ondas generalizada).
    El paciente solo tiene crisis en brotes no numerables.
    El paciente ha padecido pseudocrisis, trastorno de conversión u otros episodios convulsivos no epilépticos que, en opinión del investigador, se pueden confundir con crisis epilépticas
    El paciente se ha sometido a una intervención quirúrgica para la epilepsia en <1 año o a un tratamiento dietético para la epilepsia iniciado <3 meses antes de la selección
    El paciente ha tomado otros productos (distintos de los FAE) con receta o sin receta, alimenticios (por ejemplo, pomelo o fruta de la pasión) o de fitoterapia que son potentes inductores o inhibidores de la vía del CYP3A4 durante 2 semanas (o 5 semividas [el valor superior]) antes de la visita de valoración inicial.
    El paciente está siendo tratado con carbamacepina, fenitoína, primidona, fenobarbital o cualquier otro fármaco inductor de las enzimas hepáticas CYP3A4.
    El paciente está tomando tiagabina, felbamato o vigabatrina.
    El paciente está tomando benzodiacepinas, zolpidem, zaleplón o zopiclona >3 veces por semana para cualquier indicación.
    El paciente ha padecido efectos secundarios psiquiátricos graves o intolerables tras una exposición previa a LEV o BRV.
    El paciente tiene antecedentes en los últimos 5 años de drogodependencia o alcoholismo o ha dado positivo en las pruebas de detección de consumo de drogas o alcohol durante la selección.
    El paciente tiene antecedentes de intento de suicidio (intento real, intento interrumpido o intento fracasado) o ha tenido ideas de suicidio en los últimos 6 meses, lo que concuerda con una respuesta positiva (Sí) a la pregunta 4 o la pregunta 5 de la escala C-SSRS en la selección.
    El paciente presenta una anomalía clínicamente significativa en el ECG que, en opinión del investigador, aumenta los riesgos asociados a la participación en el estudio
    QT corregido para la frecuencia cardíaca mediante la fórmula de Bazett (QTcB) o QT corregido para la frecuencia cardíaca mediante el intervalo de >450 ms de la fórmula de Fridericia (QTcF).
    Bloqueos de rama y otras anomalías de la conducción clínicamente significativas según el investigador o con un intervalo PR >=220 ms.
    Ritmos irregulares distintos de la arritmia sinusal o extrasístole supraventricular ocasional o infrecuente o extrasístole ventricular infrecuente.
    Según el criterio del investigador, las ondas T no tienen la calidad suficiente para evaluar la duración del intervalo QT.
    El paciente tiene antecedentes de sincope o antecedentes familiares de muerte súbita debido al síndrome de QT largo.
    El paciente presenta una anomalía clínicamente significativa en la ecocardiografía en la selección o tiene antecedentes de cardiopatía reumática u otras anomalías valvulares conocidas
    Pacientes con antecedentes de reacciones alérgicas o enfermedad autoinmunitaria
    Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    75 % responder rate (75 % RR, proportion of subjects who achieve ?75 % reduction in focal seizure frequency)
    índice de mejora del 75 % (IM 75 %, proporción de pacientes que logran una reducción del ?75 % de la frecuencia de las crisis focales
    E.5.1.1Timepoint(s) of evaluation of this end point
    During 2 weeks of the Inpatient Period
    Durante las dos semanas del Período de Ingreso Hospitalario.
    E.5.2Secondary end point(s)
    Median percent reduction in weekly focal seizure frequency , during 2-weeks of the Inpatient Period
    Median percent reduction in weekly focal seizure frequency , during the UCB0942 overall period (approximately 11 weeks)
    >=75 % responder rate (75 % RR, proportion of subjects who achieve >=75 % reduction in focal seizure frequency) during the last 4 weeks of the Outpatient Maintenance Period
    Seizure-free rate during the 2-week Inpatient Period
    Seizure-free rate during the last 4 weeks of the Outpatient Maintenance Period
    Seizure-free rate during the UCB0942 Overall period (approximately 11 weeks)
    Percentage of seizure free days during the 2-week Inpatient Period
    Percentage of seizure free days during the Outpatient Maintenance Period (approximately 8 weeks)
    Number of patients reporting at least one Adverse Event (AE) during the course of the study, all study duration (approximately 19 to 20 weeks)
    Number of patients reporting at least one at least one Serious Adverse Event (SAE) during the course of the study, all study duration (approximately 19 to 20 weeks)
    Number of subject withdrawals due to Adverse Events (AEs) during the course of the study, all study duration (approximately 19 to 20 weeks)
    Reducción porcentual de la mediana en el caso de la frecuencia semanal de las crisis focales durante las dos semanas del período de ingreso hospitalario.
    Reducción porcentual de la mediana en el caso de la frecuencia semanal de las crisis focales durante el período general de UCB0942(aproximadamente 11 semanas)
    índice de mejora del 75 %(75%RR) proporción de pacientes que han alcanzado un >=75% reducción en la frecuencia de crisis focales durante las 4 últimas semanas del período de mantenimiento ambulatorio.
    Índice de ausencia de crisis durante las dos semanas del período de ingreso hospitalario,
    Índice de ausencia de crisis durante las últimas 4 semanas del período de mantenimiento ambulatorio
    Índice de ausencia de crisis durante el periodo general de UCB0942 (aproximadammente 11 semanas)
    Porcentaje de ausencia de crisis durante las dos semanas del período de ingreso hospitalario,
    Porcentaje de ausencia de crisis durante el período de mantenimiento ambulatorio (aproximadamente 8 semanas)
    Número de pacientes reportando al menos un acontecimiento adverso(AA) durante el curso del estudio.
    Número de pacientes reportando al menos un acontecimiento adverso grave (AAG) durante el curso del estudio, la duración de todo el estudio (aproximadamente 19 a 20 semanas).
    Número de retiradas de pacientes debido a acontecimientos adversos (AAs) durante el curso del estudio, la duración de todo el estudio (aproximadamente 19 a 20 semanas).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the complete study at different time points as defined in field Secondary End Point.
    Durante el estudio completo, se han definido diversos puntos como el campo de Objetivo Secundario.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    UVUP
    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 months9
    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 months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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)
    Subjects who experience substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator may have the opportunity to continue taking UCB0942 in an open-label extension (OLE) study. Subjects who enter the OLE study will not have a Tapering Period at the end of the Outpatient Period. The OLE study is described in a separate protocol with number EP0073.
    Los pacientes que experimenten un beneficio sustancial de UCB0942, con tolerabilidad aceptable de acuerdo con el paciente y el investigador pueden tener la oportunidad de continuar tomando UCB0942 en un estudio de extensión abierto (EA). Los pacientes que entren en el estudio EA no tendrán un período de escalada de dosis el final de Periodo ambulatorio. El estudio EA se describe en un estudio separado con número EP0073.
    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 Decision2016-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-18
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