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    Summary
    EudraCT Number:2015-001243-36
    Sponsor's Protocol Code Number:BIA-2093-311/EXT
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-001243-36
    A.3Full title of the trial
    EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES: A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY

    — OPEN-LABEL ESL EXTENSION —
    Az eslicarbazepine acetát (BIA 2-093) monoterápia hatásosságának és biztonságosságának kettős vak, randomizált, aktív-kontrollált, párhuzamos csoportú, multicentrikus klinikai vizsgálata újonnan diagnosztizált parciális epilepsziás betegeken

    — ESL nyílt kiterjesztés —
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES - OPEN LABEL EXTENSION STUDY WITH ESLICARBAZEPINE ACETATE
    Az eslicarbazepine acetát (BIA 2-093) monoterápia hatásossága és biztonságossága újonnan diagnosztizált parciális epilepsziás betegeken - nyílt, kiterjesztett vizsgálat eslicarbazepine acetáttal
    A.3.2Name or abbreviated title of the trial where available
    not applicable
    A.4.1Sponsor's protocol code numberBIA-2093-311/EXT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02484001
    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 SponsorBIAL - Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    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 supportEuropean Investment Bank
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIAL - Portela & Ca, S.A.
    B.5.2Functional name of contact pointsponsor
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number00351229866100
    B.5.5Fax number00351229866192
    B.5.6E-mailjose.rocha@bial.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 nameEslicarbazepine Acetate
    D.3.2Product code BIA 2-093
    D.3.4Pharmaceutical form 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 INNESLICARBAZEPINE ACETATE
    D.3.9.1CAS number 236395-14-5
    D.3.9.2Current sponsor codeBIA 2-093
    D.3.9.3Other descriptive nameESLICARBAZEPINE ACETATE
    D.3.9.4EV Substance CodeSUB30424
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with recently diagnosed partial-onset seizures
    Felnőtt betegek nemrég diagnosztizált parciális rohamokkal
    E.1.1.1Medical condition in easily understood language
    Adult patients with recently diagnosed partial epilepsy
    Felnőtt betegek nemrég diagnosztizált parciális epilepsziával
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial 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
    To confirm maintenance of efficacy of eslicarbazepine acetate (ESL, 800 mg to 1600 mg once daily [QD]) monotherapy during long-term treatment in adults (≥18 years) with recently diagnosed epilepsy experiencing partial-onset seizures.
    Megerősíteni az eszlikarbazepin-acetát (~ESL, 800 mg és 1600 mg közötti, napi egyszeri dózis [QD - naponta]) tartós hatásosságát, ha azt monoterápiaként alkalmazzák parciális epilepsziával nemrég diagnosztizált felnőttek (≥18 évesek) hosszú távú kezelésében.
    E.2.2Secondary objectives of the trial
    1. To further demonstrate the efficacy of ESL in subjects switching from carbamazepine controlled-release (CBZ-CR) treatment.
    2. To demonstrate the safety of ESL in subjects switching from CBZ-CR treatment and in subjects already treated with ESL monotherapy for at least one year (i.e. during long-term treatment).
    1. Kimutatni továbbá az ESL hatásosságát azoknál a vizsgálati alanyoknál, akik a módosított hatóanyagleadású karbamazepin (~CBZ-CR) kezelésről állnak át.
    2. Kimutatni az ESL biztonságosságát azoknál a vizsgálati alanyoknál, akik CBZ-CR kezelésről állnak át és azoknál a vizsgálati alanyoknál, akiket már kezeltek legalább egy évig (azaz a hosszú távú kezelés tartama alatt) ESL monoterápiával.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study):
    1. Participated in the preceding double-blind study and were still ongoing at the time of unblinding.
    2. Have signed informed consent before undergoing any activities related to the open-label extension study.
    3. Demonstrated cooperation and willingness to complete all aspects of the study.
    4. Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV).
    A kiterjesztett vizsgálatba történő beválasztás céljából a vizsgálati alanyoknak az alábbiaknak kell megfelelniük a Vizit 1-en (1. nap, a nyílt kiterjesztett vizsgálat kezdete):
    1. Részt vett az előző kettős vak vizsgálatban, még akkor is, amikor annak kódfeltörésére sor került.
    2. Aláírta a beleegyező nyilatkozatot, még mielőtt a nyílt kiterjesztett vizsgálat bármely tevékenységére sor került volna.
    3. Együttműködésről és hajlandóságról tett tanúbizonyságot, hogy a vizsgálat minden szempontját teljesítse.
    4. A nem fogamzásképes női alanyok (2 év posztmenopauzális állapot, kétoldali petefészek-eltávolítás vagy petevezeték-elkötés, illetve teljes méheltávolítás) megfelelnek. A fogamzásképes női alanyok nem lehetnek terhesek, és ezt negatív szérum ß-humán chorion gonadotropin (hCG) tesztnek kell alátámasztania, illetve a szexuálisan aktív nőknek orvosilag elfogadható, hatásos, nem-hormonális fogamzásgátló módszert kell használniuk a vizsgálat ideje alatt, egészen a Vizsgálat Utáni Vizitig (~PSV).
    E.4Principal exclusion criteria
    Subjects having any of the following at Visit 1 are to be excluded from the study:
    1. Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double-blind study.
    2. Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study.
    3. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS).
    4. Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study.
    5. Events of alcohol, drug, or medication abuse during the preceding double-blind study.
    6. Relevant clinical laboratory abnormalities (e.g. sodium <125 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (as reported at Visit 1).
    7. Pregnancy or lactating.
    8. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the extension-study protocol.
    Azok a vizsgálati alanyok, akiknél a Vizit 1 alkalmával az alábbiak bármelyike fennáll, kizárásra kerülnek a vizsgálatból:
    1. Kizárták a kettős vak vizsgálatból roham miatt a Fenntartási, vagy Kiterjesztési Fázisban, vagy a C dózis szinten (akár CBZ-CR-nél vagy ESL-nél), vagy idő előtt szüntette be részvételét bármely más okból a kettős vak vizsgálatban.
    2. Bármely jelentős protokollsértés előfordulása a kettős vak vizsgálat tartama alatt, ami kihathat az együttműködési készségre ebben a kiterjesztett vizsgálatban.
    3. Klinikailag megítélt öngyilkossági kockázat a vizsgáló véleménye szerint a klinikai interjúra és a Columbia Súlyosságértékelő Skála Öngyilkosság kockázatára (C-SSRS) alapozva.
    4. Olyan nemkívánatos esemény (AE) következik be, mely (másodfokú és afeletti) atrioventricularis blokk gyanított jelenlétére utal, vagy bármely egyéb AE a kettős vak vizsgálat alatt, melyet a vizsgáló úgy ítél meg, hogy a nyílt kiterjesztett vizsgálatban való további részvételt ellenjavallja.
    5. Alkohol, drog vagy gyógyszer abúzus az előző kettős vak vizsgálat folyamán.
    6. Releváns klinikai laboratóriumi rendellenességek (pl. nátrium <125 mmol/l, alanin- vagy aszpartát-transzamináz értéke magasabb a normál érték felső határának 2-szeresénél, fehérvérsejtszám <3000 sejt/mm3) (a Vizit 1 jelentése szerint).
    7. Terhesség vagy szoptatás.
    8. Bármilyen olyan állapot vagy körülmény, ami a vizsgáló megítélése szerint az alany részéről kérdésessé teheti a kiterjesztett vizsgálati protokoll teljesítését.
    E.5 End points
    E.5.1Primary end point(s)
    Time to treatment failure, defined as time from start of open-label ESL treatment at Visit 1 until withdrawal due to AE or due to lack of efficacy (i.e. inadequate seizure control).
    A kezelés sikertelenségéig eltelt idő, meghatározásszerűen a nyílt ESL kezelés kezdetétől számított idő a Vizit 1-től egészen visszavonásig AE miatt, vagy a hatásosság hiánya (azaz elégtelen roham kontroll) miatt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 1 year
    legalább 1 év
    E.5.2Secondary end point(s)
    • Treatment retention time (overall, i.e. including previously CBZ-CR treated subjects, and by reason) at the last evaluated dose during open-label treatment, where treatment retention time is defined as the time from start of the extension study until withdrawal of ESL due to AEs or due to lack of efficacy (i.e. inadequate seizure control).
    • Time to withdrawal for any reason at the last evaluated dose.
    • Changes in quality of life assessed using the QOLIE-31.
    • Changes in overall treatment satisfaction as assessed on a 4-point scale.
    • A kezelés visszatartásának tartama (teljes, azaz ideértve az előzőleg CBZ-CR-rel kezelt betegeket, és ok szerinti) a nyílt kezelés folyamán az utolsónak megállapított dózison, ahol a kezelés visszatartásának tartama meghatározásszerűen a kiterjesztett vizsgálat kezdetétől számított idő, egészen az ESL visszavonásáig AE-k miatt, vagy hatásosság hiánya (azaz elégtelen roham kontroll) miatt.
    • Kivonásig eltelt idő, bármely okból történjen is a kiléptetés, az utolsónak megállapított dózison.
    • Változások a QOLIE-31 segítségével felmért életminőség tekintetében.
    • Változások a kezeléssel való általános megelégedés tekintetében, melyet 4-pontos skálán mérnek fel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at least 1 year
    legalább 1 év
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Chile
    Croatia
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Latvia
    Lithuania
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    The complete study duration including treatment with ESL under open-label conditions and follow-up is expected to last approximately 2 years (105 weeks).
    In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
    A vizsgálat teljes tartama, ideértve a nyílt fázis feltételei melletti ESL kezelést és az utánkövetést, várhatóan mintegy 2 év (105 hét).
    Ha az MA-t az ESL monoterápiaként történő használatára a 2017. év vége előtt megkapják, akkor a vizsgálatot idő előtt be lehet fejezni 42 napon belül az MA megszerzése után.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 279
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    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)
    After the Trial subjects will be treated according to local standard medical practice.
    A vizsgálatot követően az alanyok a helyi szokásos orvosi gyakorlatnak megfelelő kezelésben részesülnek.
    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 Decision2015-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-11
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