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    Summary
    EudraCT Number:2017-003200-48
    Sponsor's Protocol Code Number:EP0091
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio sulla determinazione del dosaggio, randomizzato, in doppio cieco, controllato con placebo per valutare l¿efficacia e la sicurezza di padsevonil come trattamento aggiuntivo di crisi convulsive a esordio focale in soggetti adulti con epilessia farmaco-resistente
    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
    Studio per testare l'efficacia e la sicurezza di padsevonil come trattamento aggiuntivo di crisi convulsive a esordio focale in soggetti adulti con epilessia farmaco-resistente.
    A.3.2Name or abbreviated title of the trial where available
    ARISE
    ARISE
    A.4.1Sponsor's protocol code numberEP0091
    A.5.4Other Identifiers
    Name:-Number:-
    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 SRL
    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.5.4Telephone number000000
    B.5.5Fax number000000
    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.3.2Product code -
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 -
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.3.2Product code -
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Crisi convulsive a esordio focale
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilessia
    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 21.1
    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
    The primary objective of this study is to characterize the dose-response relationship with respect to efficacy of Padsevonil (PSL) administered concomitantly with up to 3 antiepileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy and to evaluate the efficacy of the 4 selected dose regimens of PSL compared with placebo.
    L'obiettivo principale di questo studio ¿ quello di caratterizzare il rapporto dose-risposta relativamente all¿efficacia di padsevonil (PSL)somministrato in concomitanza con un massimo di 3 farmaci antiepilettici (AED) per il trattamento di crisi convulsive a esordio focale osservabili in soggetti con epilessia farmaco-resistente e per valutare l¿efficacia dei 4 regimi di dosaggio di PSL selezionati rispetto al placebo
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety and tolerability of all doses of Padsevonil (PSL) in relation to placebo.
    L'obiettivo secondario ¿ quello di valutare la sicurezza e la tollerabilit¿ di tutti i dosaggi di Padsevonil (PSL) rispetto al 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

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: During this study, subjects will have the option of providing additional informed consent for exploratory deoxyribonucleic acid (DNA) ribonucleic acid (RNA), and lipidomics/proteomics/additional blood biomarker analyses. 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 genetic substudy. A volume of 6 mL of whole blood samples will be collected at Baseline (Visit 2).

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Durante questo studio, i soggetti hanno la possibilit¿ di dare un consenso informato aggiuntivo per le analisi genetiche esplorative dell'acido desossiribonucleico (DNA), l'acido ribonucleico (RNA) e di lipidomica/proteomica/dei biomarcatori aggiuntivi nel sangue. La partecipazione a questa parte aggiuntiva dello studio ¿ facoltativa e non preclude la partecipazione allo studio principale. I campioni aggiuntivi per la farmacogenetica non possono essere raccolti qualore il soggetto non abbia dato il consenso alla partecipazione a questo sottostudio esplorativo di genomica. Per tutti I campioni di sangue sar¿ raccolto un volume pari a 6 ml al Baseline (Visita 2).
    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
    - Diagnosi di epilessia focale secondo i criteri della Lega Internazionale contro l’epilessia (ILAE) del 1989 almeno 3 anni prima dell’ingesso nello studio
    - Il soggetto non è riuscito a controllare le crisi convulsive con 4 AED precedenti tollerati e correttamente scelti , compresi i trattamenti precedenti e quello in corso, che sono stati individualmente ottimizzati per dose e durata adeguate. Il trattamento AED precedente interrotto deve essere valutato dallo sperimentatore tenendo in considerazione le cartelle cliniche del paziente e il colloquio con il paziente e/o con la persona che lo assiste. Per “AED precedente” si intendono tutti i trattamenti AED precedenti e in corso con una data di inizio precedente alla visita di screening (Visita 1).
    - Media di =4 crisi convulsive a esordio focale spontanee e osservabili (tipo IA1 (es. focal aware), IB (es. focal impaired awareness), IC (es. focal to bilateral tonic-clonic))
    - Trattamento corrente con dose individualmente ottimizzata e stabile di almeno 1 e fino a 3 AEDs per 8 settimane prima della visita di screening con o senza stimolazione del nervo vago (VNS) o altri trattamenti neurostimolanti.
    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) <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
    - Anamnesi o segni di epilessia (genetica) idiopatica generalizzata.
    - Anamnesi di stato epilettico o ospedalizzazione per lo stato epilettico nei 6 mesi precedenti l’ingresso nello studio
    - Crisi convulsive cluster non numerabili nelle 8 settimane precedenti l’ingresso nello studio e durante il periodo basale prospettico di 4 settimane
    - Trattamento corrente con carbamazepina, fenitoina, pirimidone, fenobarbital
    - Ha assunto o sta assumendo prodotti (non AED) su prescrizione, da banco, dietetici (es. pompelmo o frutto della passione)o erboristici che sono potenti induttori o inibitori del pathway CYP3A4 o 2C19 per 2 settimane (o 5 emivite, a seconda di quale periodo è più lungo) prima della visita basale
    - Soggetti che hanno assunto vigabatrin per meno di due anni al momento dell’ingresso nello studio
    - Soggetti che hanno assunto felbamato per meno di 12 mesi
    - Soggetti che hanno assunto retigabina per meno di 4 anni
    - Soggetti che stanno assumendo benzodiazepine (es. farmaci GABA(A)ergici come zolpidem, zaleplon o zopiclone, ad esclusione di AEDs GABA(A)ergici) meno di tre volte a settimana per le emergenze
    - Soggetti con condizione medica verificatasi negli ultimi 12 mesi che, secondo il parere dello sperimentatore, potrebbe compromettere la sua sicurezza o la capacità di partecipare a questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    75 % responder rate over the 12 week Maintenance Period
    Percentuale di responder del 75% per il periodo di mantenimento di 12 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Maintenance Period (Week 16) following 3 weeks of titration and 1 week stabilization
    Fine del Periodo di Mantenimento (Settimana 16) dopo 3 settimane di aggiustamento posologico e 1 settimana di stabilizzazione
    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 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. Variazione rispetto al basale della frequenza trasformata in logaritmo delle crisi convulsive a esordio focale per il periodo di mantenimento di 12 settimane.
    2. Stato della percentuale di responder del 50% per il periodo di mantenimento di 12 settimane.
    3. Variazione percentuale rispetto al basale della frequenza delle crisi convulsive a esordio focale osservabili per il periodo di mantenimento di 12 settimane.
    4. Incidenza degli eventi avversi successivi al trattamento (treatment-emergent adverse event, TEAE) segnalati dal soggetto e/o dalla persona che lo assiste o osservati dallo sperimentatore durante l¿intero studio.
    5. Incidenza dei TEAE che portano a interruzione dello studio.
    6. Incidenza dei SAE successivi al trattamento durante l¿intero studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: From Baseline over the 12 week Maintenance Period
    2-3: End of Maintenance Period (Week 16) following 3 weeks of titration and 1 week stabilization
    4-6: From Baseline until Safety Follow-Up (up to Week 23)
    1. Dal basale per le 12 settimane del periodo di mantenimento
    2-3. Fine del periodo di mantenimento (settimana 16) dopo 3 settimane aggiustamento della dose e una settimana di stabilizzazione
    4-6. Dal basale fino al follow-up di sicurezza (fino alla Settimana 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
    Tollerabilit¿
    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 concerned5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Bulgaria
    Canada
    Czechia
    France
    Germany
    Hungary
    Italy
    Japan
    Lithuania
    Mexico
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    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 dell'ultimo soggetto (LPLV)
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    I soggetti potrebbero presentare una compromissione delle facolt¿ cognitive o potrebbero dover fronteggiare altre situazioni con la possibilit¿ di essere incapaci di comprendere i contenuti dell'ICF. Di conseguenza uno o pi¿ rappresentanti legali sar
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 400
    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.
    I pazienti avranno l'opportunit¿ di essere trasferiti allo studio di estensione in aperto EudraCT 2017-003241-26.
    Studio di estensione in aperto, multicentrico per valutare l¿efficacia e la sicurezza di padsevonil come trattamento aggiuntivo di crisi convulsive a esordio focale in soggetti adulti con epilessia farmaco-resistente
    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 Decision2018-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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