Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2012-001091-11
    Sponsor's Protocol Code Number:BIA-2093-211
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-21
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2012-001091-11
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to investigate the bioavailability, safety and tolerability of Eslicarbazepine Acetate as additive therapy in babies aged from 1 month to <2 years with refractory epilepsy with partial-onset seizures
    A.4.1Sponsor's protocol code numberBIA-2093-211
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/015/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIAL - Portela & Ca, S.A.
    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 supportBIAL - Portela & Ca, S.A.
    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.5.4Telephone number+351229866100
    B.5.5Fax number+351229866198
    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.2.1.2Country 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 nameEslicarbazepine Acetate
    D.3.2Product code BIA 2-093
    D.3.4Pharmaceutical form Oral suspension
    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.3.9.1CAS 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/ml milligram(s)/millilitre
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    refractory epilepsy with partial-onset seizures in children aged from 1 month to < 2 years
    E.1.1.1Medical condition in easily understood language
    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 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 evaluate the steady state PK profile of ESL.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of ESL in the defined patient population at the doses used and to perform exploratory analyses of efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have an informed consent signed by their parent(s) or guardian(s) before undergoing any study-related activities.
    2. Male or female ≥1 month (i.e. at least 28 days) but <2 years of age.
    3. Weigh a minimum of 4 kg at Visit 1.
    4. Epilepsy refractory to treatment with 1 to 2 AEDs and with clinical or electroencephalogram (EEG) evidence of partial onset seizures for at least 1 month in infants ≥6 months of age, or for at least 2 weeks in infants <6 months of age, as defined by the International League Against Epilepsy. In case a child has a significant birth defect, hydrocephalus, or tetraparesis, EEG confirmation must be available.
    5. Current treatment with 1 to 2 AEDs (except OXC; vagus nerve stimulation if present and functioning will not be counted as an AED).
    6. Ability to come to the study site every day during the Titration/Evaluation Periods.
    E.4Principal exclusion criteria
    1. A neonate who is a preterm baby (i.e. born before 36 weeks of gestation).
    2. Diagnosis of treatable seizure aetiology such as metabolic, toxic, and infectious disorders.
    3. Primarily generalised seizures.
    4. Known rapidly progressive neurological disorders (e.g. rapidly progressive brain disease, epilepsy secondary to rapidly progressive cerebral lesion).
    5. History of status epilepticus or cluster seizures (i.e. 3 or more seizures within 30 minutes) within the month prior to screening.
    6. Seizures of non-epileptic origin.
    Ohtahara syndrome, West syndrome [current], Dravet’s syndrome, or Lennox-Gastaut syndrome).
    8. Difficult venous access.
    9. Ketogenic diet.
    10. Currently treated with OXC (at Screening or for at least 2 weeks before).
    11. Previous use of ESL.
    12. An AED that started or was discontinued in the 3 weeks before Visit 1.
    13. Diseases that can have an impact on drug absorption (e.g. any disease leading to diarrhoea or vomiting).
    14. Treatments that can have an impact on blood volume (e.g. transfusions or intravenous infusions).
    15. Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, OXC), or to any of the excipients, in particular methyl parahydroxybenzoate (E218) or sulphites.
    16. Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorders.
    17. Relevant clinical laboratory abnormalities (e.g. sodium <130 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (measured at Visit 1).
    18. Estimated glomerular filtration rate below the lower limit of the normal range (measured at Visit 1).
    19. Participation in other drug clinical trial within the last 2 months or having received an IMP within 5 half-lives of that IMP, whichever is longer.
    20. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    • Minimum (i.e. pre-dose) plasma concentration (Cmin).
    • Maximum observed plasma concentration (Cmax).
    • Time of occurrence of Cmax (tmax).
    • Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t), calculated by the linear trapezoidal rule.
    • AUC from time zero to 24 hours post-dose (AUC0-τ).
    • Apparent terminal rate constant (λz) calculated by log-linear regression of the terminal segment of the drug plasma concentration versus time curve.
    • Apparent half-life (t1/2), calculated from ln 2/λz.
    • Apparent plasma clearance (CL/F), calculated from Dose/AUC0-τ.
    Additional PK parameters may also be calculated if considered appropriate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • An interim analysis of the PK data will be performed after at least 8 subjects in Group 1 (4 in each age group) have completed their 24-hour PK profile.
    • At the end of the trial
    E.5.2Secondary end point(s)
    • Seizures (date, time, type, and duration) recorded by the investigator at each visit.

    • Treatment-emergent adverse events (TEAEs) defined as all AEs with onset or worsening after first intake of study treatment until 4 weeks after last intake of study treatment.
    • Clinical laboratory safety tests:
    - Biochemistry: sodium, potassium, calcium, creatinine, blood urea nitrogen, aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, albumin, total protein, total bilirubin, and glucose.
    - Haematology: haemoglobin, haematocrit, erythrocyte count, leucocyte count with differential, and platelet count.
    • Urinalysis: local dipstick test of pH, specific gravity, protein, blood, glucose, ketones, bilirubin, and urobilinogen. If dipstick results indicate a significant abnormality, microscopy and other appropriate tests (as needed) will be performed by the central laboratory.
    • Physical examination, vital signs, neurological examination, and electrocardiogram.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    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 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. 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Russian Federation
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 24
    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) Yes
    F. of subjects for this age range: 24
    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. of subjects incapable of giving consent
    infants with refractory epilepsy with partial-onset seizures aged from 1 month to < 2 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 24
    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 completion of this PK study, the parent(s) or guardian(s) may choose to allow their child to continue treatment in a subsequent extension study (BIA-2093-211/EXT), which is intended to last for approximately 1 year.
    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 Decision2017-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-03
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands