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    Summary
    EudraCT Number:2015-001268-20
    Sponsor's Protocol Code Number:EP0073
    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 number2015-001268-20
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF UCB0942 WHEN USED AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES IN ADULT SUBJECTS WITH HIGHLY DRUG-RESISTANT FOCAL EPILEPSY
    ESTUDIO ABIERTO, MULTICÉNTRICO Y DE EXTENSIÓN PARA EVALUAR LA SEGURIDAD A LARGO PLAZO, LA TOLERABILIDAD Y LA EFICACIA DE UCB0942 CUANDO SE UTILIZA COMO TRATAMIENTO COMPLEMENTARIO PARA CRISIS DE INICIO PARCIAL 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
    An open-label extension study of UCB0942 in adult patients with highly drug-resistant focal epilepsy.
    Estudio abierto de extensión de UCB0942 en pacientes adultos con epilepsia focal altamente resistente a los medicamentos.
    A.4.1Sponsor's protocol code numberEP0073
    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+34900 811 335
    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.3.2Product code UCB0942
    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 available yet
    D.3.9.1CAS number 1294000-61-5
    D.3.9.2Current sponsor codeUCB0942
    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.3.2Product code UCB0942
    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.3.9.1CAS number 1294000-61-5
    D.3.9.2Current sponsor codeUCB0942
    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
    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 long-term safety and tolerability of UCB0942 at individualized doses between 200mg/day to a maximum of 800mg/day in subjects with highly drug-resistant focal epilepsy.
    Evaluar la seguridad y la tolerabilidad a largo plazo de UCB0942 en dosis individualizadas de 200 mg/día hasta un máximo de 800 mg/día en pacientes con epilepsia focal altamente resistente a los medicamentos.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of UCB0942
    To evaluate the effects of UCB0942 on the subject?s quality of life.
    Evaluar la eficacia a largo plazo de UCB0942.
    Evaluar los efectos de UCB0942 en la calidad de vida de los pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A written Informed Consent form approved by the Independent Ethics Committee is signed and dated by the subject, after the Investigator assesses whether the subject is able to understand the potential risks and benefits of participating in the study
    Subject must have completed V13 of the Outpatient Maintenance Period of EP0069 to be eligible for enrollment into EP0073
    In EP0069, the subject demonstrated a reduction in frequency and/or severity of seizures as compared to baseline that is considered clinically significant by the Investigator and significant by the subject
    In EP0069, the subject experiences substantial benefit from UCB0942 with acceptable tolerability according to the subject and Investigator
    No tolerability issues that can outweigh attained benefits, in the opinion of the Investigator
    ? Female subjects of nonchildbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, and complete hysterectomy) are eligible. Female subjects of childbearing potential are eligible if they use medically accepted contraceptive methods.
    Male subject confirms that, during the study period and for a period of 3 months after the final dose, when having sexual intercourse with a woman of childbearing potential, he will use a barrier contraceptive (eg, condom) AND that the respective partner will use an additional contraceptive method
    El participante firma y fecha un consentimiento informado por escrito aprobado por el CEI una vez que el investigador determina si el participante puede comprender los riesgos y beneficios de la participación en el estudio.
    El paciente debe haber completado la V13 del período de mantenimiento ambulatorio de EP0069 para ser apto para la inscripción en EP0073.
    En EP0069, el paciente presenta una reducción de la frecuencia o la gravedad de las crisis en comparación con la situación inicial clínicamente significativa según el investigador y el paciente.
    En EP0069, el paciente se beneficia considerablemente de UCB0942 con una tolerabilidad aceptable según el paciente y el investigador.
    No se producen problemas de tolerabilidad de mayor importancia que los beneficios obtenidos en opinión del investigador.
    Las mujeres sin posibilidad de quedarse embarazadas (premenárquicas, posmenopáusicas durante 2 años como mínimo o sometidas a una ooforectomía bilateral, una ligadura de trompas o una histerectomía total) son aptas. Las mujeres con posibilidad de quedarse embarazadas son aptas si usan métodos anticonceptivos aceptados desde el punto de vista médico.
    Los hombres deben confirmar que, durante el período del estudio y durante un período de 3 meses después de la dosis final, en caso de tener relaciones sexuales con una mujer con posibilidad de quedarse embarazada, usarán un anticonceptivo de barrera (por ejemplo, preservativos) Y que su pareja usará un método anticonceptivo adicional.
    E.4Principal exclusion criteria
    Subject has active suicidal ideation as indicated by a positive response (?Yes?) to either Question 4 or Question 5 of the ?Since Last Visit? version of the Columbia Suicide Severity Rating Scale. The subject should be referred immediately to a Mental Healthcare Professional and must be withdrawn from the study
    Subject has taken other (non-Anti-Epileptic Drug) prescription, non-prescription, 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 study entry
    ? Subject has an abnormality in the 12-lead electrocardiography that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition, any subject with any of the following findings will be excluded:
    - Prolonged QTc (Bazett?s, machine-read) interval defined as > 450 ms for males and > 470 ms for females
    - Bundle branch blocks and other conduction abnormalities other than mild first degree atrioventricular block (defined as PR interval >= 220 ms)
    - 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 clinically significant abnormality on echocardiography at the Entry Visit (V2) of EP0073
    El paciente tiene ideas de suicidio actualmente de acuerdo con una respuesta positiva («sí») a la pregunta 4 o la pregunta 5 de la versión «desde la última visita» de C-SSRS. El paciente debe ser derivado de inmediato a un profesional de salud mental y retirado del estudio.
    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 CYP3A4 durante 2 semanas (o 5 semividas [el valor superior]) antes de la inclusión en el estudio.
    El paciente presenta una anomalía en el ECG de 12 derivaciones que, en opinión del investigador, aumenta los riesgos asociados a la participación en el estudio. Además, se excluirá a los pacientes con cualquiera de los siguientes hallazgos:
    Intervalo QTc prolongado (fórmula de Bazett, detección con aparato) definido como >450 ms en hombres y >470 ms en mujeres.
    Bloqueos de rama y otras anomalías de la conducción distintas del bloqueo auriculoventricular de primer grado leve (definidos como un intervalo PR >=220ms)
    Ritmos irregulares distintos de la arritmia sinusal o supraventricular ocasional o infrecuente, o la 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 presenta una anomalía clínicamente significativa en la ecocardiografía en la VI (V2) de EP0073.
    E.5 End points
    E.5.1Primary end point(s)
    The 75% Responder Rate at the end of the Evaluation Period
    Number of subjects with at least one treatment-emergent Adverse Events during the EP0073 study
    Number of subjects with at least one Serious Adverse Event during the EP0073 study
    Number of subjects discontinued due to treatment-emergent Adverse Events during the EP0073 study
    Índice de mejora del 75 % al final del Período de Evaluación
    Número de pacientes con por lo menos un acontecimiento adverso emergente durante el tratamiento, durante el estudio EP0073.
    Número de pacientes con al menos un Acontecimiento Adverso Grave durante el estudio EP0073.
    Número de pacientes que han discontinuado durante el estudio EP0073 debido a Acontecimientos Adversos Graves debidos al tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 months
    60 meses
    E.5.2Secondary end point(s)
    Median partial-onset seizure frequency per 28 days over the Evaluation Period of the EP0073 study
    Median partial-onset seizure frequency per 28 days by seizure type over the Evaluation Period of the EP0073 study
    Percent reduction in partial-onset seizure frequency relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069 over the Evaluation Period of the EP0073 study
    The 50 % responder rate over the Evaluation Period of the EP0073 study
    Percentage of seizure-free days over the Evaluation Period
    Seizure-free rate over the Evaluation Period
    Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) total scores from Visit 3 (Week 2) of EP0069 through the assessment of the Evaluation Period
    Frecuencia media de CPI por 28 días en intervalos de tres meses durante el período de evaluación del estudio EP0073.
    Frecuencia media de CPI por 28 días por tipo de crisis durante el período de evaluación del estudio EP0073.
    Porcentaje de reducción de la frecuencia de CIP en relación con el período inicial ambulatorio prospectivo de 2 semanas establecido en EP0069 durante el período de evaluación del estudio EP0073.
    Tasa de respuesta del 50% durante el Período de Evaluación del estudio EP0073
    Porcentaje de días sin crisis durante el Período de Evaluación.
    ïndice de ausencia de crisis durante el Período de Evaluación.
    Cambios en las puntuaciones de QOLIE-31-P desde la V3 de EP0069 durante el período de evaluación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months
    60 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 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) 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 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 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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 30
    F.4.2.2In the whole clinical trial 30
    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)
    None.
    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 Opinion2015-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-24
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