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    Summary
    EudraCT Number:2018-002303-33
    Sponsor's Protocol Code Number:EP0092
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-05-21
    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 number2018-002303-33
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y la seguridad de padsevonil como tratamiento adyuvante de crisis focales en sujetos adultos con epilepsia fármacorresistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of padsevonil as treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy
    Un estudio para probar la eficacia y la seguridad de padsevonil como tratamiento de crisis focales en sujetos adultos con epilepsia fármacorresistente
    A.4.1Sponsor's protocol code numberEP0092
    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 pointClin Trial Reg & 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.5.6E-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 namePadsevonil
    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 INNPadsevonil
    D.3.9.1CAS number 1294000-61-5
    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 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: 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 namePadsevonil
    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 INNPadsevonil
    D.3.9.1CAS number 1294000-61-5
    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.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 namePadsevonil
    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 INNPadsevonil
    D.3.9.1CAS number 1294000-61-5
    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.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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Focal-Onset Seizures
    Crisis focales
    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 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
    The primary objective is to evaluate the efficacy of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
    El objetivo principal es evaluar la eficacia de las 3 pautas posológicas seleccionadas de padsevonil (PSL) administrado de manera concomitante con un máximo de 3 fármacos antiepilépticos (FAE) en comparación con placebo para el tratamiento de crisis focales observables en sujetos con epilepsia fármacorresistente.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety and tolerability of padsevonil (PSL) in relation to placebo.
    El objetivo secundario es evaluar la seguridad y la tolerabilidad de PSL en relación con el placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
    - Subject has failed to achieve seizure control with >=4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. 'Prior AED' is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1)
    - Average of >= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month
    - Current treatment with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve Stimulation (VNS) or other neurostimulation treatments
    - Diagnóstico de epilepsia focal de acuerdo con la Clasificación de crisis epilépticas de la Liga internacional contra la epilepsia [International League Against Epilepsy, ILAE], 1989 durante al menos 3 años en el momento de la inscripción
    - El sujeto no ha logrado el control de las crisis con >=4 FAE que se han tolerado y elegido adecuadamente, incluidos los tratamientos anteriores y en curso optimizados de manera individual para una dosis y duración suficientes. El investigador tendrá que evaluar el tratamiento anterior con FAE que se ha interrumpido teniendo en cuenta la historia clínica del paciente y la entrevista con el paciente o el cuidador. “FAE anterior” se define como todos los tratamientos con FAE anteriores y en curso con fecha de inicio anterior a la visita de selección (visita 1).
    - Media >= 4 crisis focales observables y espontáneas (tipo IA1 (p.ej. conciencia focal), IB (ej. conciencia de deficiencia focal), IC (es decir, focal a bilateral tónico-clónico)) por mes.
    - Actual tratamiento con una dosis estable e individualmente optimizada de entre 1 y 3 FAE desde las 8 semanas anteriores a la visita de selección con o sin estimulación del nervio vago (ENV) complementaria concurrente o tratamientos de neuroestimulación de otro tipo
    E.4Principal exclusion criteria
    - Subject has a history of or signs of generalized or combined generalized and focal epilepsy
    - Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline
    - Current treatment with carbamazepine, phenytoin, primidone, phenobarbital
    - Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
    - Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit
    - Subject has been taking vigabatrin less than 2 years at study entry
    - Subject has been taking felbamate for less than 12 months
    - Subject taking retigabine for less than 4 years
    - Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) <3 times per week for emergencies
    - Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study
    - Sujeto con antecedentes o signos de epilepsia generalizada o generalizada y focal combinadas.
    - Crisis regulares que no se pueden contar, durante las 8 semanas previas a la visita de selección y el periodo inicial de 4 semanas
    - Tratamiento actual con carbamazepina, fenitoína, primidona o fenobarbital
    - Tratamiento actual/ uso de productos con receta, sin receta, alimenticios (p. ej., pomelo o fruta de la pasión) o a base de plantas medicinales que son inductores o inhibidores potentes de la via CYP3A4 o 2C19 durante las 2 semanas (o 5 semividas, el periodo que sea más largo) anteriores a la visita inicial.
    - Sujeto que tome substratos sensibles del CYP2C19 durante 2 semanas (o 5 semividas, el periodo que sea más largo) anteriores a la visita inicial.
    - Sujeto que ha estado tomando vigabatrina durante menos de 2 años en el momento de la inclusión en el estudio.
    - Sujeto que ha estado tomando felbamato durante menos de 12 meses
    - Sujeto que ha estado tomando retigabina durante menos de 4 años.
    - Tratamiento actual con benzodiacepinas (p. ej. fármacos GABA-A-érgicos como zolpiden, zaleplon o zoplicone, excepto FAE GABA-A-érgicos) <3 veces a la semana para emergencias.
    - El sujeto presenta una enfermedad actual acaecida en los 12 meses anteriores que, a juicio del investigador, pueda poner en peligro o alterar la capacidad del sujeto para participar en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. 75% responder rate from Baseline over the 12-week Maintenance Period
    2. Incidence of Treatment-Emergent Adverse Events (TEAEs)
    3. Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to study withdrawal
    4. Incidence of treatment-emergent serious adverse events (SAEs)
    1. La tasa de sujetos con una respuesta del 75 %, desde la basal durante el periodo de mantenimiendo de 12 semanas
    2. Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST)
    3. Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST) que provocan la retirada del estudio.
    4. Incidencia de acontecimientos adversos grave surgidos durante el tratamiento (SAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: From Baseline over the 12 Week Maintenance Period (up to Week 16)
    2-4: From Baseline until Safety Follow-Up (up to Week 23)
    1: De la visita basal durante el período de mantenimiento de 12 semanas (hasta la semana 16)
    2-4: Desde la visita basal hasta la visita de seguimiento de seguimiento de seguridad (hasta la semana 23)
    E.5.2Secondary end point(s)
    1. Change in log-transformed observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
    2. 50% responder rate status, from Baseline, over the 12-week Maintenance Period
    3. Percent reduction in observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period
    1. Variación con respecto al valor inicial en la frecuencia con transformación logarítmica de las crisis focales observables durante el periodo de mantenimiento de 12 semanas
    2. Tasa de respuesta del 50 %, desde la basal, durante el periodo de mantenimiento de 12 semanas
    3. Porcentaje de reducción en la frecuencia de las crisis focales observables desde la basal, durante el periodo de mantenimiento de 12 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 3: From Baseline until Safety Follow-Up (up to Week 23)
    1-3: Desde la visita basal hasta la visita de seguimiento de seguridad (hasta la semana 23)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Austria
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    Greece
    Hungary
    Italy
    Mexico
    Netherlands
    Poland
    Serbia
    Spain
    Switzerland
    Turkey
    United Kingdom
    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 subject last visit (LSLV)
    Ultima visita del ultimo sujeto (LPLV)
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 555
    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 qualify will be allowed to participate in the open label extension study EP0093.
    Los sujetos elegibles podrán participar en el estudio de extensión abierto EP0093
    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 Decision2019-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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