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    Summary
    EudraCT Number:2012-004996-38
    Sponsor's Protocol Code Number:SP0969
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-09-02
    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 number2012-004996-38
    A.3Full title of the trial
    A MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥4 YEARS TO <17 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
    STUDIO MULTICENTRICO, IN DOPPIO CIECO, RANDOMIZZATO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI PER VALUTARE L’EFFICACIA E LA SICUREZZA DI LACOSAMIDE COME TERAPIA AGGIUNTIVA IN SOGGETTI CON EPILESSIA DI ETÀ COMPRESA TRA 4 E 17 ANNI CON CRISI A INSORGENZA PARZIALE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety and efficacy of lacosamide in children with epilepsy who are already taking anti-epileptic medications. Children aged 4 years and older but less than 17 year can participate in the study
    Uno studio per verificare la sicurezza e l'efficacia di lacosamide in bambini con epilessia che stanno già assumendo farmaci antiepilettici. I bambini dai 4 anni di età ma meno di 17 anni possono partecipare allo studio
    A.4.1Sponsor's protocol code numberSP0969
    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 BIOSCIENCES, Inc.
    B.1.3.4CountryUnited States
    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 BIOSCIENCES, Inc
    B.4.2CountryUnited States
    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 number+492173 48 1515
    B.5.5Fax number+492173 48 1572
    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 Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLacosamide
    D.3.4Pharmaceutical form Syrup
    D.3.4.1Specific paediatric formulation Yes
    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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLacosamide
    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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLacosamide
    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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    D.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSyrup
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy
    Epilessia
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of LCM administered concomitantly with 1 to ≤3 AEDs in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.
    Valutare l'efficacia, la sicurezza e la tollerabilità di LCM somministrato in concomitanza con 1-3 AED in soggetti epilettici di età ≥4 e <17 anni attualmente afflitti da crisi convulsive parziali incontrollate.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of LCM in subjects ≥4 years to <17 years of age.
    Valutare la sicurezza e la tollerabilità di LCM in soggetti di età ≥4 e <17 anni.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1).An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
    2). Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator.
    3). Subject is male or female from ≥4 years to <17 years of age.
    4). Subject has a diagnosis of epilepsy with partial-onset seizures. The results of ≥1 prior electroencephalogram (EEG) and 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis.
    5). Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with ≥2 AEDs (concurrently or sequentially).
    6). Subject must have been observed to have on average ≥2 partial onset seizures per 28 days with seizure free phase no longer than 21 days in the 8 week period prior to entry into the Baseline Period. During this study, subjects must have reported ≥2 partial onset seizures during the 8 week prospective Baseline Period to be eligible for randomization at Visit 2. (Note: In the case of simple partial onset seizures, only those seizures with motor signs will be counted towards meeting the inclusion criterion).
    7). Subject is on a stable dosage regimen of 1 to ≤3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of ≥4 weeks prior to the Baseline Period.
    8). Vagal nerve stimulation is allowed and will not be counted as a concomitant AED. The VNS device must be implanted for ≥6 months before Visit 1, and the device settings must be stable for ≥4 weeks before Visit 1 and be kept stable during the Baseline Period. Use of the VNS device magnet is allowed.
    1). I genitori o il rappresentante legale devono firmare e datare un modulo di consenso informato scritto approvato dalla Commissione di Revisione dell’Istituzione (IRB) o dal Comitato Etico Indipendente (IEC). I minori devono firmare e datare il modulo di consenso informato o un modulo di assenso specifico, ove richiesto.
    2). Il soggetto/rappresentante legale è ritenuto affidabile e capace di conformarsi al protocollo (ad es. è in grado di comprendere e compilare i diari), al programma delle visite e al piano di somministrazione del farmaco secondo il giudizio dello sperimentatore.
    3). Soggetto maschio o femmina di età ≥ 4 e < 17 anni.
    4). Il soggetto ha una diagnosi di epilessia con crisi convulsive parziali. I risultati di ≥1 EEG precedente e di 1 risonanza magnetica/tomografia computerizzata devono confermare tale diagnosi.
    5). Il soggetto ha mostrato crisi convulsive parziali incontrollate dopo un adeguato regime di trattamento (a parere dello sperimentatore) con ≥2 AED (concomitanti o in sequenza).
    6). Il soggetto deve aver mostrato di avere in media ≥2 crisi parziali nell'arco di 28 giorni, con una fase libera da crisi non superiore a 21 giorni nel periodo di 8 settimane precedenti l'ingresso nel Periodo basale. Durante questo studio, i soggetti devono aver riferito ≥2 crisi parziali durante il Periodo basale prospettico di 8 settimane per essere idonei alla randomizzazione alla Visita 2. (Nota: in caso di crisi parziali semplici, solo le crisi con segni motori saranno conteggiate ai fini del criterio di inclusione.)
    7). Il soggetto riceve un regime di dosaggio stabile con 1-3 AED. Il regime di dosaggio giornaliero della terapia AED concomitante deve rimanere costante per ≥4 settimane prima del Periodo basale.
    8). La neurostimolazione vagale (VNS) è consentita e non sarà conteggiata come AED concomitante. Il dispositivo VNS deve essere impiantato da ≥6 mesi prima della Visita 1, e le sue impostazioni devono essere stabili da ≥4 settimane prima della Visita 1 e rimanere stabili durante il Periodo basale. L’uso del magnete di attivazione del dispositivo VNS è consentito.
    E.4Principal exclusion criteria
    Subjects are not permitted to enroll in the study if any of the following criteria is met:
    1). Subject has previously participated in this study or subject has been assigned to LCM in a previous LCM study.
    2). Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within ≤2 months of Visit 1 or is currently participating in another study of an IMP or a medical device.
    3). Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
    4). Subject ≥6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.
    5). Subject has a known hypersensitivity to any component of the IMP or has ever received LCM.
    6). Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception (according to International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the WHO recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study.
    7). Subject has a medical condition that could be expected in the opinion of the investigator to interfere with drug absorption, distribution, metabolism, or excretion.
    8). Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary.
    9). Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for ≥2 months prior to the Baseline Period.
    10). Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level ≥2 times the upper limit of normal (ULN), or creatinine clearance less than 50mL/min.
    11). Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] greater than 450ms).
    12). Subject has hemodynamically significant congenital heart disease.
    13). Subject has an arrhythmic heart condition requiring medical therapy.
    14). Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
    15). Subject has nonepileptic events that could be confused with seizures.
    16). Subject has a current diagnosis of Lennox-Gastaut syndrome, primary generalized epilepsy, mixed seizure disorder (partial and primarily generalized seizures), or purely nocturnal seizures.
    17). Subject has a history of convulsive status epilepticus ≤2 months prior to the Baseline Period.
    18). Subject has been treated with vigabatrin and experienced any vision loss. Subjects who have received vigabatrin in the past must have documentation of an assessment for vision loss prior to study entry or documentation of why visual field testing cannot be performed.
    19). Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for <12 months are excluded. Note: any subject who has been treated with felbamate for ≥12 months and has not experienced serious toxicity issues is eligible.
    20). Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen syndrome.
    21). Subject has a medically documented history of alcohol or drug abuse.
    22). Subject has a known sodium channelopathy, such as Brugada syndrome.
    23). Subject has an acute or sub acutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome).
    Un soggetto non può essere arruolato nello studio se rientra in qualsiasi dei seguenti criteri:
    1) Il soggetto ha partecipato in precedenza a questo studio o è stato assegnato al trattamento con LCM in uno studio precedente.
    2) Il soggetto ha partecipato a un altro studio su un medicinale sperimentale (IMP) o un dispositivo medico sperimentale nei 2 mesi precedenti la Visita 1 o sta attualmente partecipando a un altro studio su un IMP o un dispositivo medico sperimentale.
    3) Il soggetto ha una patologia medica o psichiatrica che, a giudizio dello sperimentatore, potrebbe mettere a rischio o comprometterebbe la capacità del soggetto di partecipare a questo studio.
    4) Il soggetto di età ≥6 anni è sempre stato caratterizzato da tentativi di suicidio (compreso un tentativo attivo, un tentativo interrotto o un tentativo fallito) o ha avuto idee suicide negli ultimi 6 mesi, come indicato da una risposta positiva (“Sì”) alla Domanda 4 o alla Domanda 5 della Columbia Suicide Severity Rating Scale (C SSRS) allo Screening.
    5) Il soggetto ha un’ipersensibilità nota a qualsiasi componente dell’IMP o ha ricevuto LCM in passato.
    6) Il soggetto di sesso femminile è in gravidanza o allattamento e/o un soggetto di sesso femminile potenzialmente fertile non è chirurgicamente sterile o non pratica 1 metodo contraccettivo altamente efficace (definito, secondo le linee guida della Conferenza internazionale per l’armonizzazione [ICH], come un metodo con tasso di fallimento inferiore all’1% l’anno se usato correttamente e con costanza), a meno che si astenga dai rapporti sessuali per l'intero studio. Soggetto di sesso femminile potenzialmente fertile che assume farmaci antiepilettici a induzione enzimatica (EI AED: carbamazepina, fenitoina, barbiturici, primidone, topiramato, oxcarbazepina), non è chirurgicamente sterile o non pratica 1 metodo contraccettivo altamente efficace secondo le raccomandazioni dell'OMS (ovvero, deposito di medrossiprogesterone acetato, noretisterone enantato, dispositivi intrauterini, iniezioni combinate e impianti progestinici) con la somministrazione di EI AED OPPURE non pratica 2 metodi contraccettivi combinati (ovvero contraccezione ormonale combinata più metodo a barriera con agente spermicida), a meno che si astenga dai rapporti sessuali per l'intero studio.
    7) Il soggetto ha una patologia medica che, a giudizio dello sperimentatore, potrebbe interferire con assorbimento, distribuzione, metabolismo o escrezione del farmaco.
    8) Il soggetto ha mostrato esclusivamente crisi convulsive febbrili. Il verificarsi di crisi febbrili oltre alle altre crisi non provocate non esclude il soggetto.
    9) Il soggetto è sottoposto a una dieta chetogena o un’altra dieta specialistica. Se il soggetto ha assunto una dieta specialistica in passato, deve averla conclusa da almeno 2 mesi prima del Periodo basale.
    10) Il soggetto presenta alanina aminotransferasi (ALT), aspartato aminotransferasi (AST) o bilirubina totale ≥ 2 volte il limite superiore di normalità (ULN) o clearance della creatinina inferiore a 50 ml/min.
    11) Il soggetto presenta un’anomalia clinicamente rilevante all’ECG secondo il parere dello sperimentatore (ad es. blocco cardiaco di secondo o terzo grado a riposo o intervallo QT corretto [QTc] superiore a 450 ms).
    12) Il soggetto ha una patologia cardiaca congenita significativa a livello emodinamico.
    13) Il soggetto ha una patologia cardiaca aritmica che richiede terapia medica.
    14) Il soggetto ha una storia nota di reazione anafilattica grave o discrasie ematiche serie.
    15) Il soggetto presenta eventi non epilettici che possono essere confusi con le crisi.
    16) Il soggetto ha una diagnosi in corso di sindrome di Lennox-Gastaut, epilessia primaria generalizzata, disturbo da crisi convulsive miste (crisi parziali e primariamente generalizzate) o crisi puramente notturne.
    17) Il soggetto ha una storia di stato epilettico convulsivo nei 2 mesi precedenti il Periodo basale.
    18) Il soggetto è stato trattato con vigabatrin e ha presentato perdita della vista. I soggetti che hanno assunto vigabatrin in passato devono documentare una valutazione della vista prima dell’ingresso nello studio o il motivo per cui il test del campo visivo non può essere eseguito.
    19) Soggetti che sono stati trattati con felbamato e hanno mostrato problemi di tossicità gravi (definiti come insufficienza epatica, anemia aplastica) con questo trattamento. I soggetti trattati con felbamato per <12 mesi sono esclusi. Nota: un soggetto trattato con felbamato per ≥12 senza problemi di tossicità gravi è idoneo.
    20) Il soggetto soffre di epilessia secondaria a una malattia cerebrale progressiva o ad altre malattie neurodegenerative progressive, come la sindrome di Rasmussen.
    21) Il soggetto ha una storia documentata di abuso di alcool o droghe.
    22) Il soggetto ha una canalopatia del sodio nota, come la sindrome di Brugada.
    23) Il soggetto ha una malattia del sistema nervoso centrale acuta o progressiva sub-acuta.
    E.5 End points
    E.5.1Primary end point(s)
    1).The change in partial onset seizure-frequency per 28 days from Baseline to the Maintenance Period.
    2).Adverse events reported spontaneously by the subject and/or caregiver (including parent/legal guardian) or observed by the investigator
    3).Subject withdrawals due to AEs
    1). a variazione della frequenza delle crisi convulsive parziali su 28 giorni dal basale al Periodo di mantenimento.
    2). Gli eventi avversi riportati spontaneamente dal soggetto e/o dalla persona che lo assiste (incluso il genitore/ tutore legale) oppure osservate dallo sperimentatore.
    3). Ritiro del soggetto a causa di eventi avversi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1).From Baseline to the Maintenance Period (16 weeks)
    2).From Baseline to End of the Treatment (24 weeks)
    3).From Baseline to End of the Treatment (24 weeks)
    1). Dal basale al periodo di mantenimento (16 settimane)
    2). Dal basale alla fine del trattamento (24 settimane)
    3). Dal basale alla fine del trattamento (24 settimane)
    E.5.2Secondary end point(s)
    1). Proportion of responders, where a responder is a subject experiencing a 50% or greater reduction in partial onset seizure frequency from Baseline to the Maintenance Period.
    2).Proportion of subjects experiencing a ≥25% to <50%, 50% to 75%, or >75% reduction in partial onset seizure frequency from Baseline to the Maintenance Period.
    3). Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)
    4). Proportion of subjects experiencing a ≥25% to <50%, 50% to 75%, or >75% reduction in partial onset seizure frequency from Baseline through the entire treatment period.
    5).Proportion of subjects experiencing no change in partial onset seizure frequency (between <25% reduction and <25% increase) from Baseline through the entire treatment period.
    6).Proportion of subjects experiencing an increase in partial onset seizure frequency of ≥25% from Baseline through the entire treatment period.
    7).Change in partial onset seizure frequency per 28 days by seizure type from Baseline through the entire treatment period.
    8).Proportion of seizure free days during the Maintenance Period for subjects who entered the Maintenance Period.
    9).Proportion of subjects who achieved “seizure free” status (yes/no) for subjects who completed the Maintenance Period.
    1). Proporzione di responders, dove un responder è un soggetto che ha dimostrato una riduzione del 50% o maggiore in frequenza delle crisi parziali dal basale al periodo di mantenimento.
    2). Proporzione di soggetti che hanno dimostrato una riduzione ≥25% al <50%, 50% al 75%, >75% in frequenza delle crisi parziali dal Linea dal basale al periodo di mantenimento.
    3). Variazione della frequenza delle crisi parziali per 28 giorni dal basale per l'intero trattamento (ad es., Titolazione + periodi di mantenimento)
    4). Proporzione di soggetti che hanno dimostrato una riduzione ≥25% al <50%, 50% al 75%, >75% in frequenza delle crisi parziali dal basale attraverso l'intero periodo di trattamento.
    5). Proporzione di soggetti che hanno dimostrato nessun cambiamento nella frequenza delle crisi parziali (tra il <25% di riduzione e il <25% di aumento) dal basale attraverso l'intero periodo di trattamento.
    6). Proporzione di soggetti che hanno dimostrato un aumento nel frequenza delle crisi parziali del ≥ 25% dal basale attraverso l'intero periodo di trattamento.
    7). Variazione delle frequenza delle crisi parziali per 28 giorni per il tipo di crisi dal basale attraverso l'intero periodo di trattamento.
    8). Proporzione di giorni con crisi libere durante il periodo di mantenimento per i soggetti che sono entrati nel periodo di mantenimento.
    9). Proporzione di soggetti che hanno raggiunto lo status "libero da crisi convulsive" (sì/no) per i soggetti che hanno completato il periodo mantenimento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1).From Baseline to the Maintenance Period
    2).From Baseline to the Maintenance Period
    3).From Baseline through the entire treatment (ie, Titration+Maintenance Periods).
    4).From Baseline through the entire treatment (ie, Titration+Maintenance Periods).
    5).From Baseline through the entire treatment (ie, Titration+Maintenance Periods).
    6).From Baseline through the entire treatment (ie, Titration+Maintenance Periods).
    7).From Baseline through the entire treatment (ie, Titration+Maintenance Periods).
    8).From week 8 of the study (visit n° 6) to week 16 of the study (visit n°8).
    9).At the end of Maintenance Period (wk 16).
    1). Dal basale al periodo di mantenimento
    2). Dal basale al periodo di mantenimento
    3). Dal basale attraverso l'intero trattamento (ad es., Titolazione + periodi di mantenimento).
    4). Dal basale attraverso l'intero trattamento (ad es., Titolazione + periodi di mantenimento).
    5). Dal basale attraverso l'intero trattamento (ad es., Titolazione + periodi di mantenimento).
    6). Dal basale attraverso l'intero trattamento (ad es., Titolazione + periodi di mantenimento).
    7). Dal basale attraverso l'intero trattamento (ad es., Titolazione + periodi di mantenimento).
    8). Dalla settimana 8 dello studio (visita n ° 6) alla settimana 16 dello studio (visita n ° 8).
    9). Alla fine del Periodo di mantenimento (settimana 16).
    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 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) 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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    European Union
    Israel
    Korea, Republic of
    Russian Federation
    Switzerland
    Taiwan
    Thailand
    Turkey
    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
    LVLS
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.1.1Number of subjects for this age range: 300
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 125
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 175
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Children
    Bambini
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    See protocol section 7.2.3, 7.2.4, 8.4, 85 and 86
    Vedere la sezione 7.2.3, 7.2.4, 8.4, 85 e 86 del protocollo
    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 Decision2013-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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