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    Summary
    EudraCT Number:2015-002756-27
    Sponsor's Protocol Code Number:N01349
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-29
    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 number2015-002756-27
    A.3Full title of the trial
    A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures
    Studio multicentrico, in aperto, a braccio singolo, volto a valutare la farmacocinetica,
    l'efficacia e la sicurezza di brivaracetam in neonati che manifestano crisi convulsive ripetute con alterazioni elettroencefalografiche.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the pharmacokinetics, efficacy, and safety of brivaracetam in newborns with repeated electroencephalographic seizures.
    Studio per valutare la farmacocinetica,
    l'efficacia e la sicurezza di brivaracetam in noenati che manifestano crisi convulsive ripetute con alterazioni
    A.3.2Name or abbreviated title of the trial where available
    PETITE
    PETITE
    A.4.1Sponsor's protocol code numberN01349
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/048/2017
    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 number004902173481515
    B.5.5Fax number004902173481572
    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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrivaracetam
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB20383
    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 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 Yes
    D.2.1.1.1Trade name Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Oral solution
    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 INNBrivaracetam
    D.3.9.2Current sponsor codeNon applicabile
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB25397
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Electroencephalographic neonatal seizures
    Crisi convulsive ripetute con alterazioni
    elettroencefalografiche nei neonati.
    E.1.1.1Medical condition in easily understood language
    Electroencephalographic neonatal seizures
    Crisi convulsive ripetute con alterazioni
    elettroencefalografiche nei neonati.
    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 22.0
    E.1.2Level LLT
    E.1.2Classification code 10010921
    E.1.2Term Convulsions neonatal
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with phenobarbital (PB) treatment and to identify the optimum BRV dose (Exploratory Cohort) for the treatment of subjects enrolled into the Confirmatory Cohorts of this study.
    Valutare la farmacocinetica (PK) di brivaracetam (BRV) in neonati che manifestano crisi convulsive non adeguatamente controllate mediante trattamento con fenobarbital (PB) ed identificare la dose ottimale di BRV (Coorte Esplorativa) per il trattamento dei pazienti arruolati nelle Coorti Confirmatorie di questo studio.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of brivaracetam (BRV) in severe and nonsevere seizure burden (defined as
    total minutes of electroencephalographic neonatal seizures [ENS] per hour) in neonates with seizures that are not adequately controlled with phenobarbital (PB) treatment;
    - To evaluate the short-term safety and tolerability of BRV in neonates.
    - Valutare l’efficacia di brivaracetam (BRV) in caso di carico delle crisi convulsive grave e non grave (definita come numero totale di crisi convulsive con alterazioni elettroencefalografiche [ENS] per ora) in noenati con crisi convulsive non adeguatamente controllate con il trattamento a base di fenobarbital;
    - Valutare la sicurezza e la tollerabilità di BRV a breve termine nei noenati.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmation on video-electroencephalography (VEEG) of >= 2 minutes of cumulative
    electroencephalographic neonatal seizures (ENS), or >=3 identifiable ENS within the 2 hours prior to
    entering the Evaluation Period, despite receiving phenobarbital (PB) for the treatment of repeated seizures.
    - Subject is male or female with an age at birth of at least 34 weeks of gestational age (GA) and up to 28
    days of postnatal age at the time of enrollment.
    - Subject weighs at least 2.3 kg at the time of enrollment.
    - Subjects with or without concomitant hypothermia treatment.
    - Conferma video-elettroencefalografica (VEEG) di crisi convulsive con alterazioni elettroencefalografiche (ENS) di >= 2 minuti, o >=3 ENS identificabili nelle 2 ore prima dell'ingresso nel Periodo di Valutazione, nonostante la somministrazione di fenobarbital (PB) per il trattamento di crisi ripetute.
    - Il soggetto è un maschio o una femmina con un’età gestazionale (GA) di almeno 34 settimane fino a meno di 42 settimane alla nascita e fino a 28 giorni di età postnatale al momento dell’arruolamento.
    - Il soggetto pesa almeno 2.3 kg al moento dell’arruolamento.
    - Soggetti con o senza trattamento concomitante con ipotermia.
    E.4Principal exclusion criteria
    - Subject received antiepileptic drug (AED) treatment (other than the required 1 or 2 doses of
    phenobarbital (PB) [total therapeutic administered dose of 20 to 40mg/kg] for the treatment of repeated
    seizures) prior to entering the Evaluation Period.
    - Subject with seizures responding to PB (total therapeutic administered dose of 20 to 40mg/kg),
    pyridoxine treatment, or correction of metabolic disturbances (hypoglycemia, hypomagnesemia or
    hypocalcemia).
    - Subject has a poor prognosis for survival, as judged by the Investigator.
    - Subject has 2x upper limit of normal (ULN) of any of the following: aspartate aminotransferase (AST),
    alanine aminotransferase (ALT), and alkaline phosphatase (ALP), according to the subject’s gestational age (GA) and the site’s normal range values for the respective GA.
    - Subject has conjugated bilirubin levels >2mg/dL.
    - Subject requires extra corporeal membrane oxygenation.
    - Subject has seizures related to prenatal maternal drug use or drug withdrawal.
    - Subject has known severe disturbance of hemostasis, as assessed by the Investigator.
    - Il soggetto ha ricevuto un trattamento con farmaco antiepilettico (AED) (oltre le 1 o 2 dosi richieste di 40mg/kg) per il trattmento delle crisi ripetute) prima di entrare nel Periodo di Valutazione.
    - Soggetto con crisi responsivo al PB (dose terapeutica totale somministrata di 20-40 mg/kg), trattamento con piridossina o correzione di disturbi metabolici (ipoglicemia, ipomagnesemia o ipocalcemia).
    - Il soggetto ha una diagnosi infausta per la sopravvivenza, a giudizio dello Sperimentatore
    - Il soggetto una un valore di due volte superiore al limite normale (ULN) per: aspartato aminotransferasi (AST), alanina aminostransferasi (ALT) e fostafatsi alcalina (ALP), in base all’età gestazionale (GA) ed ai valori normali di laboratorio del centro per la GA corrispondente.
    - Il soggetto ha livelli di bilirubina coniugata >2mg/dL.
    - Il soggetto richiede ossigenzaione a membrana extracorporea.
    - Il soggetto ha crisi correlate ad abuso od astinenza di/da droghe materno pre-natale.
    - Il soggetto è noto per disturbi di emostasi, come verificato dallo Sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    1. Plasma concentration of brivaracetam (BRV) 30-60 min after the BRV infusion on day 1.
    2. Plasma concentration of brivaracetam (BRV) 2-4 hours after the BRV infusion on day 1.
    3. Plasma concentration of brivaracetam (BRV) 8-12 hours after the BRV infusion on day 1.
    4. Plasma concentration of the BRV metabolite ucb-42145 (acid) 30-60 min after the BRV infusion on day 1.
    5. Plasma concentration of the BRV metabolite ucb-42145 (acid) 2-4 hours after the BRV infusion on day 1.
    6. Plasma concentration of the BRV metabolite ucb-42145 (acid) 8-12 hours after the BRV infusion on day 1.
    7. Plasma concentration of the BRV metabolite ucb-100406-1 (hydroxy) 30-60 min after the BRV
    infusion on day 1.
    8. Plasma concentration of the BRV metabolite ucb-100406-1 (hydroxy) 2-4 hours after the BRV
    infusion on day 1.
    9. Plasma concentration of the BRV metabolite ucb-100406-1 (hydroxy) 8-12 hours after the BRV
    infusion on day 1.
    10. Plasma concentration of the BRV metabolite ucb-107092-1 (hydroxyacid) 30-60 min after the BRV infusion on day 1.
    11. Plasma concentration of the BRV metabolite ucb-107092-1 (hydroxyacid) 2-4 hours after the BRV infusion on day 1.
    12. Plasma concentration of the BRV metabolite ucb-107092-1 (hydroxyacid) 8-12 hours after the BRV infusion on day 1.
    13. Area under the BRV plasma concentration time curve.
    14. Distribution volume of BRV.
    15. Plasma clearance of BRV.
    16. Plasma concentration of the concomitant antiepileptic drug phenobarbital (PB).
    17. Plasma concentration of the concomitant antiepileptic drug phenytoin (PHT).
    1. Concentrazione plasmatica di brivaracetam (BRV) 30-60 min dopo infusione con BRV al giorno 1.
    2. Concentrazione plasmatica di brivaracetam (BRV) 2-4 ore dopo infusione con BRV al giorno 1
    3. Concentrazione plasmatica di brivaracetam (BRV) 8-12 ore dopo infusione con BRV al giorno 1.
    4. Concentrazione plasmatica del metabolita di BRV ucb-42145 (acid 30-60 min dopo infusione con BRV al giorno 1.
    5. Concentrazione plasmatica del metabolita di BRV ucb-42145 (acido) 2-4 dopo infusione con BRV al giorno 1.
    6. Concentrazione plasmatica del metabilita di BRV ucb-42145 (acido) 8-12 ore dopo infusione con BRV al giorno 1.
    7. Concentrazione plasmatica del metabolita di BRV ucb-100406-1 (idrossi) 30-60 min dopo infusione con BRV al giorno 1.
    8. Concentrazione plasmatica del metabolita di BRV ucb-100406-1 (idrossi) 2-4 ore dopo infusione con BRV al giorno 1.
    9. Concentrazione plasmatica del metabolita di BRV ucb-100406-1 (idrossi) 8-12 ore dopo infusione con BRV al giorno 1.
    10. Concentrazione plasmatica del metabolita di BRV ucb-107092-1 (idrossiacido) 30-60 min dopo infusione con BRV al giorno 1.
    11. Concentrazione plasmatica del metabolita di BRV ucb-107092-1 (idrossiacido) 2-4 ore dopo infusione con BRV al giorno 1.
    12. Concentrazione plasmatica del metabolita di BRV ucb-107092-1 (idrossiacido) 8-12 ore dopo infusione con BRV al giorno 1.
    13. Area sotto la curva della concentrazione plasmatica di BRV.
    14. Volumem di distribuzione di BRV.
    15. Clearance plasmatica di BRV.
    16. Concentrazione plasmatica del farmaco anti-epilettico concomitante fenobarbital.
    17. Concentrazione plasmatica del farmaco anti-epilettico concomitante fenitoina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 4, 7, 10: 30-60 min after the BRV infusion on day 1.
    2, 5, 8, 11: 2-4 hours after the BRV infusion on day 1.
    3, 6, 9, 12: 8-12 hours after the BRV infusion on day 1.
    13, 14, 15: Samples will be collected 30-60 min, 2-4 hours, and 8-12 hours after the BRV infusion on day 1 and potentially on day 2 for the exploratory cohort and on day 1 and day 2, or on day 1 and day 3, or on day 1 and day 4 for the confirmatory cohorts.
    16, 17: Samples will be collected 3 hours after the initial dose of BRV.
    1, 4, 7, 10: 30-60 min dopo infusion con BRV al giorno 1.
    2, 5, 8, 11: 2-4 ore dopo infusion con BRV al giorno 1.
    3, 6, 9, 12: 8-12 ore dopo infusion con BRV al giorno 1.
    13, 14, 15: I campioni saranno raccolti 30-60 min, 2-4 ore e 8-12 ore dopo infusion con BRV al giorno 1 e potenzialmente al giorno 2 per la coorte esplorativa al giorno 1 e giorno 2, o al giorno 1 ed al giorno 3, o al giorno 1 e giorno 4 per le coorti di conferma.
    16, 17: I campioni saranno raccolti 3 ore dopo la dose iniziale di BRV.
    E.5.2Secondary end point(s)
    1. Percentage of responders to brivaracetam (BRV) treatment from Baseline to 3 hours after the initial BRV dose.
    2. Percentage of subjects with at least 80% reduction in nonsevere seizure burden from Baseline to 3 hours after the initial BRV treatment.
    3. Percentage of subjects with at least 50% reduction in severe seizure burden from Baseline to 3 hours after the initial BRV treatment.
    4. Absolute change in average seizure burden measured by continuous video-electroencephalography (VEEG) from Baseline to the end of the 96-hour Evaluation Period.
    5. Percentage change in average seizure burden measured by continuous VEEG from Baseline to the end of the 96-hour Evaluation Period
    6. Percentage of BRV responders at the end of the 96-hour Evaluation Period.
    7. Percentage of subjects who are seizure-free (100% reduction in seizure burden from Baseline) at 24 hours following the start of initial BRV treatment, categorized by subjects with nonsevere or severe seizure burden at Baseline.
    8. Time to reduction in seizure burden for BRV responders .
    9. Percentage of Subjects with Seizure Freedom at the end of Down-Titration Period.
    10. Percentage of Subjects with at least 50% reduction in electroencephalographic neonatal seizures (ENS) frequency per hour from Baseline to the end of the 96-hour Evaluation Period.
    11. Percentage of subjects who are seizure-free by time interval over the 96-hour evaluation period.
    12. Absolute change of clinical seizures correlated with continuous VEEG from Baseline to the end of the 96-hour Evaluation Period.
    13. Absolute change of clinical seizures correlated with continuous VEEG by time interval over the 96-hour evaluation period.
    14. Percentage of Subjects with clinical seizures correlated with continuous VEEG from Baseline to the end of the 96-hour Evaluation Period.
    15. Percentage of Subjects with clinical seizures correlated with continuous VEEG by time interval over the 96-hour evaluation period.
    16. Absolute change from Baseline in clinical seizure burden by time interval over the 96-hour evaluation period.
    17. Percentage change from Baseline in clinical seizure burden by time interval over the 96-hour evaluation period.
    18. Categorized percentage change from Baseline to the end of the 96-hour Evaluation Period in seizure burden.
    19. Percentage of responders to BRV treatment by time interval over the 96-hour evaluation period.
    20. Percentage of subjects who switch over from BRV to another antiepileptic drug (AED) during the 96-hour Evaluation Period.
    21. Percentage of responders to other treatment from Baseline to the end of the 96-hour Evaluation Period.
    22. Percentage of responders to other treatment by time interval over the 96-hour evaluation period.
    1. Percentuale di soggetti che rispondono al trattamento con brivaracetam (BRV) dal basale a 3 ore dopo la dose iniziale di BRV.
    2. Percentuale di soggetti con una riduzione di almeno l'80% del carico di crisi non gravi dal basale a 3 ore dopo il trattamento iniziale con BRV.
    3. Percentuale di soggetti con una riduzione di almeno il 50% del carico di crisi gravi dal basale a 3 ore dopo il trattamento iniziale con BRV.
    4. Variazione assoluta nel carico medio di crisi misurata tramite video-elettroencefalografia continua (VEEG) dal basale alla fine del periodo di valutazione di 96 ore.
    5. Variazione percentuale nel carico medio di crisi misurata tramite video-elettroencefalografia continua (VEEG) dal basale alla fine del periodo di valutazione di 96 ore.
    6. Percentuale di soggetti che rispondono a BRV alla fine del period di valutaizone di 96 ore.
    7. percentuale di soggetti liberi da crisi (riduzione del 100% del carico delle crisi rispetto al Basale) 24 ore dopo l'inizio del trattamento iniziale con BRV, per soggetti con carichi di crisi non gravi o gravi al basale.
    8. tempo di riduzione del carico delle crisi nei soggetti responsivi a BRV .
    9. Percentuale di soggetti liberi da crisi alla fine del period di riduzione del dosaggio.
    10. percentuale di soggetti con una riduzione di almeno il 50% della frequenza di ENS (ENS) all’ora dal basale fino alla fine del periodo di valutazione di 96 ore.
    11. Percentuale di soggetti liberi da crisi per intervallo di tempo al termine del periodo di valutazione di 96 ore.
    12. Variazione assoluta delle crisi cliniche correlate alla VEEG dal basale alla fine del periodo di valutazione di 96 ore.
    13. Variazione assoluta delle crisi cliniche correlate alla VEEG per intervallo di tempo al termine del periodo di valutazione di 96 ore.
    14. Percentuale di soggetti con crisi cliniche correlate alla VEEG dal basale alla fine del periodo di valutazione di 96 ore.
    15. Percentuale di soggetti con crisi cliniche correlate alla VEEG per intervallo di tempo al termine del periodo di valutazione di 96 ore
    16. Variazione assoluta nel carico di crisi cliniche dal basale per intervallo di tempo al termine del periodo di valutazione di 96 ore.
    17. Variazione percentuale nel carico di crisi cliniche dal basale per intervallo di tempo al termine del periodo di valutazione di 96 ore.
    18. Variazione percentuale categorizzata dal basale al termine del periodo di valutazione di 96 ore.
    19. Percentuale di soggetti che rispondono al trattamento con BRV per intervallo di tempo al termine del periodo di valutazione di 96 ore.
    20. Percentuale di soggetti che passano da BRV ad un altro farmaco anti-epilettico durante il period di valutazione di 96 ore.
    21. Percentuale di soggetti che rispondono ad altro trattamento dal basale al termine del periodo di valutazione di 96 ore.
    22. Percentuale di soggetti che rispondono ad altro trattamento per intervallo di tempo al termine del periodo di valutazione di 96 ore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3: From Baseline to 3 hours after the initial BRV dose.
    4, 5, 6, 10, 12, 14, 16, 17, 18, 19, 21, 22: From Baseline to the end of the 96-hour Evaluation Period.
    13, 15: At each 3-hour interval from Baseline to the end of the 96-hour Evaluation Period.
    8: From Baseline to the first timepoint when BRV responder criteria is met.
    7: From Baseline to 24 hours after the initial BRV treatment.
    9: From Baseline to the end of the end of the Down-Titration Period.
    11: From 3 hours following the start of the initial BRV treatment to the end of the 96-hour Evaluation Period.
    20: During the 96-hour Evaluation Period.
    1, 2, 3: dal basale a 3 ore dopo la dose iniziale di BRV.
    4, 5, 6, 10, 12, 14, 16, 17, 18, 19, 21, 22: dal basale alla fine del period di valutazione di 96 ore.
    13, 15: ad ogni intervallo di 3 ore dal basale alla fine del period di valutazione di 96 ore.
    8: dal basale al primo time point cui sono soddisfatti i criteri per i soggeti responsivi a BRV.
    7: dal basale a 24 ore dopo il trattamento iniziale con BRV.
    9: dal basale alla fine del period di riduzione della dose
    11: da 3 ore dopo l’inizio del trattamento iniziale con BRV alla fine del period di valutazione di 96 ore.
    20: durante il period di valutazione di 96 ore.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 paziente.
    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 months1
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 10
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 30
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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
    Neonates from at least 34 weeks to less than 42 weeks of gestational age (GA) to 28 days of postnatal age at the time of enrollment.
    Neonati da un’età gestazionale di almeno 34 settimane fino a meno di 42 settimane, fino a 28 giorni di età post natale al momento dell'arruolamento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    All subjects who participate in the Brivaracetam (BRV) Extension Period must be offered entry into a
    long-term follow-up study, if they meet the eligibility criteria.
    A tutti i soggetti che partecipano al Periodo di Estensione con Brivaracetam (BRV) deve essere offerta la possibilità di entrare in uno studio di follow-up a lungo termine, se sodisfano i criteri di eleggibilità.
    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 Decision2017-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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