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    Summary
    EudraCT Number:2008-005606-39
    Sponsor's Protocol Code Number:BIA-2093-208
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-07
    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 number2008-005606-39
    A.3Full title of the trial
    EFFECTS OF ESLICARBAZEPINE ACETATE (BIA 2-093) ON COGNITIVE FUNCTION IN CHILDREN WITH PARTIAL ONSET SEIZURES: AN ADD-ON, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE CLINICAL TRIAL
    A.3.2Name or abbreviated title of the trial where available
    BIA-2093-208
    A.4.1Sponsor's protocol code numberBIA-2093-208
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIAL - PORTELA &amp; C�, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Zebinix
    D.2.1.1.2Name of the Marketing Authorisation holderBial - Portela &Ca, SA
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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
    D.3.9.2Current sponsor codeBIA 2-093
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTablet
    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
    Evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective is to evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures (double blind 12 weeks)
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ESL in comparison with placebo, over an 8-week maintenance period preceded by a 4 week titration period and followed by a tapering-off period. To evaluate the efficacy of ESL compared with placebo as adjunctive therapy in children with refractory partial epilepsy over an 8 week maintenance period. To evaluate the safety, tolerability and sustainability of the therapeutic effect of ESL during a 1-year open label treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent signed by parent or legal representative and, where applicable, the patient. 2. Aged 6 to 16 years, inclusive. 3. A documented diagnosis of epilepsy for at least 12 months prior to screening. At least 2 partial onset seizures during the 4 weeks prior to screening despite treatment with 1 to 2 AEDs in a stable dose regimen. 4. An IQ of at least 70. 5. Current treatment with 1 to 2 AEDs (any except oxcarbazepine, benzodiazepines other than clobazam and VNS). 6. Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests. 7. In the opinion of the investigator, able to complete the CDR test battery. 8. In case of a girl of childbearing potential, patient presents a serum ß-hCG test consistent with a non gravid state and agrees to remain abstinent or use reliable contraception (if used, hormonal contraception must be combined with a barrier method) starting at screening and continuing until at least the PSV. At Visit 2 (randomisation), patient must have: 9. At least 2 partial-onset seizures during the 4-week baseline period prior to randomisation (documented in a diary). 10. In case of a girl of childbearing potential, patient presents a urine ß-hCG test consistent with a non-gravid state. 11. Stable dose regimen of concomitant AEDs during the 4 week baseline period. 12. Diaries satisfactorily completed by the patient or his/her caregiver during the baseline period. 13. Satisfactory compliance with the study requirements during the baseline period
    E.4Principal exclusion criteria
    . Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures). 2. Primarily generalised seizures. 3. Known rapidly progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion). 4. Occurrence of seizures too close together to count accurately. 5. History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening. 6. Seizures of non-epileptic origin. 7. Lennox-Gastaut syndrome. 8. West syndrome. 9. Major psychiatric disorders. 10. Seizures of psychogenic origin within the last 2 years. 11. History of schizophrenia or suicide attempt. 12. History of attention deficit disorder or other diseases adversely affecting cognitive abilities. 13. Currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a routine or chronic basis) and/or VNS. 14. Known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine). 15. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder. 16. Second or third degree atrioventricular blockade. 17. Relevant clinical laboratory abnormalities. 18. Estimated creatinine clearance (CLCR) <60 mL/min. 19. Pregnancy or nursing. 20. Treatment with ESL in any previous study. 21. Participation in other drug clinical trial within the last 2 months. 22. Not ensured capability to perform the trial. 23. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient s ability to comply with the study protocol. At Visit 2 (randomisation), patients must not be / have: 24. Any condition or circumstance that, in the opinion of the investigator, may compromise the patient s ability to comply with the study protocol
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to the end of the evaluation period in the composite power of attention measure in order to assess information processing speed and attention / psychomotor speed
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 117
    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 end of the study, no particular treatment of the patients is intended. The patietns are treated during and after the study with the best care available
    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 Decision2010-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-06
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