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    Summary
    EudraCT Number:2017-003200-48
    Sponsor's Protocol Code Number:EP0091
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-08
    Trial 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 number2017-003200-48
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects with Drug- Resistant Epilepsy
    Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis 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
    Study to test the efficacy and safety of Padsevonil as adjunctive treatment of focal-onset seizures in adults with drug-resistant epilepsy
    Estudio para probar la eficacia y la seguridad de padsevonil como tratamiento adyuvante de crisis focales en adultos con epilepsia fármacorresistente.
    A.3.2Name or abbreviated title of the trial where available
    ARISE
    ARISE
    A.4.1Sponsor's protocol code numberEP0091
    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 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 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: 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 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: 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 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 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 of this study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 antiepileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
    Describir la relación entre dosis y respuesta con respecto a la eficacia de padsevonil (PSL) administrado de manera concomitante con un máximo de 3 fármacos antiepilépticos (FAE) para el tratamiento de crisis focales observables en sujetos con epilepsia fármacorresistente.
    E.2.2Secondary objectives of the trial
    - Assess the safety and tolerability of Padsevonil
    - Evaluate the efficacy of the 4 selected dose regimens of Padsevonil compared with placebo
    - Assess the safety and tolerability of all doses of Padsevonil in relation to placebo
    • Evaluar la seguridad y la tolerabilidad de PSL.
    • Evaluar la eficacia de las 4 pautas posológicas seleccionadas de PSL en comparación con el placebo.
    • Evaluar la seguridad y la tolerabilidad de todas las dosis de PSL en relación con el placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    During this study, subjects will have the option of providing additional informed consent for exploratory genetic (DNA) analyses and nonhereditary pharmacogenomics (ribonucleic acid, proteins, lipids, and metabolites biomarkers). Participation in this additional portion of the study is optional and does not preclude participation in the main study. The additional pharmacogenetic sample must not be collected if the subject has not consented to participate in this exploratory genomic substudy.
    Durante este estudio, los sujetos tendrán la oportunidad de otorgar un consentimiento informado adicional para realizar análisis genéticos exploratorios (ADN) y análisis de variables farmacogenómicas no hereditarias exploratorias (biomarcadores en el ácido ribonucleico (ARN), proteínas, lípidos y metabolitos). La participación en esta parte adicional del studio es opcional y no excluye de la participación en el studio principal. La muestra farmacogenética adicional no debe ser recogida si el sujeto no ha consentido participar en este subestudio genómico exploratorio.
    E.3Principal inclusion criteria
    - Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) criteria at least 3 years before study entry
    - Inadequate seizure control with >= 4 appropriately chosen anti-epileptic drug (AED) regimens including the current treatment
    - 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 a 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
    - El sujeto cumple los criterios diagnósticos de epilepsia y presenta crisis focales observables (1A1, 1B y 1C) como mínimo durante 3 años antes de la inclusion
    - El sujeto no ha logrado el control de las crisis con ≥4 pautas anteriores con FAE que se han tolerado y elegido adecuadamente y con dosis y duración suficientes, incluidos los tratamientos anteriores y en curso
    - Sujetos con una media ≥4 crisis focales observables y espontáneas cada 28 días (según la evaluación por parte del investigador del relato del sujeto) con al menos 1 crisis durante cada intervalo de 4 semanas del periodo inicial retrospectivo de 8 semanas anterior a la inclusión. Además, los sujetos deben presentar ≥4 crisis focales observables y espontáneas cada 28 días (según la evaluación por parte del investigador del relato del sujeto) durante el periodo inicial de 4 semanas
    - El sujeto actualmente recibe tratamiento con una dosis estable 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 for idiopathic generalized (genetic) epilepsy
    - History of status epilepticus or hospitalization for status epilepticus in the previous 6 months before study entry
    - 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) >2 times per week
    - 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
    - Antecedentes o signos de epilepsia generalizada idiopática (genética).
    - Antecedentes de estado epiléptico u hospitalización por estado epiléptico en los 6 meses anteriores a la visita de selección.
    - Crisis regulares que no se pueden contar, durante el periodo inicial retrospectivo de 8 semanas y el periodo inicial de 4 semanas.
    - El sujeto actualmente recibe tratamiento con carbamazepina, fenitoína, primidona, fenobarbital
    - El sujeto está tomando productos con receta, sin receta, alimenticios (p. ej., pomelo o fruta de la pasión) o a base de plantas medicinales (p. ej., hipérico) que son inductores o inhibidores potentes de la vía del CYP3A4 o 2C19 durante las 2 semanas (o 5 semividas, el periodo que sea más largo) anteriores a la visita inicial.
    - El sujeto está tomando productos que son inductores o inhibidores potentes de la vía del CYP2C19 durante las 2 semanas (o 5 semividas, el periodo que sea más largo) anteriores a la visita inicial.
    - El sujeto ha estado tomando vigabatrina durante menos de 2 años en el momento de la inclusión en el estudio.
    - El sujeto ha estado tomando felbamato durante menos de 12 meses
    - El sujeto ha estado tomando retigabina durante menos de 4 años.
    - El sujeto ha estado tomando fármacos GABA-A-érgicos (agonistas, [es decir, barbitúricos] o moduladores alostéricos positivos para el receptor [es decir, benzodiacepinas (BZD) o no-BZD], excepto FAE GABA-A-érgicos >2 veces a la semana para cualquier indicación.
    - El sujeto padece un trastorno actual acaecido en los 12 meses anteriores que a juicio del investigador, pueda poner en peligro o alterar la seguridad o capacidad del sujeto para participar en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change in log-transformed observable focal onset seizure frequency
    from Baseline over the 12 week Maintenance Period
    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
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline over the 12 week Maintenance Period
    Durante el periodo de mantenimiento de 12 semanas con respecto al valor inicial
    E.5.2Secondary end point(s)
    1. 75 % responder rate over the 12 week Maintenance Period
    2. 50 % responder rate over the 12 week Maintenance Period
    3. Percent change in observable focal-onset seizure frequency from Baseline over the 12 week Maintenance Period
    4. Incidence of Treatment-Emergent Adverse Events (TEAEs) reported by the subject and/or caregiver or observed by the Investigator during the entire study
    5. Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to study withdrawal
    6. Incidence of Treatment-Emergent Serious Adverse Events (SAEs) during the entire study
    1. El estado de la tasa de sujetos con una respuesta del 75 %, definido por la reducción con respecto al valor inicial ≥75 % en la frecuencia de crisis focales observables durante el periodo de mantenimiento de 12 semanas
    2. El estado de la tasa de sujetos con una respuesta del 50 %, definido por la reducción con respecto al valor inicial ≥50 % en la frecuencia de crisis focales observables durante el periodo de mantenimiento de 12 semanas
    3. Porcentaje de reducción con respecto al valor inicial en la frecuencia de las crisis focales observables durante el periodo de mantenimiento de 12 semanas.
    4. Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST) notificados por el sujeto o el cuidador u observados por el investigador durante todo el studio
    5. Incidencia de AAST que provoquen la retirada del studio
    6. Incidencia de AAG surgidos durante el tratamiento durante todo el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3: End of Maintenance Period (Week 16)
    4-6: From Baseline until Safety Follow-Up (up to Week 23)
    1-3: Fin del periodo de mantenimiento de 12 semanas (semana 16)
    4-6: Desde el valor inicial hasta el seguimiento de la 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA96
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Mexico
    Poland
    Spain
    Sweden
    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)
    Última visita último sujeto
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 could have potential cognitive impairment or could face other situations, which might make them unable to comprehend the ICF. Then one or more legally acceptable representatives will be required to sign the ICF as required by national law
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 157
    F.4.2.2In the whole clinical trial 250
    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)
    Patients will have the opportunity to move on to the open-label extension study, EudraCT 2017-003241-26.
    AN OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY.
    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 Decision2018-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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