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    Summary
    EudraCT Number:2008-005606-39
    Sponsor's Protocol Code Number:BIA-2093-208
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-27
    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 ConcernedPoland - Office for Medicinal Products
    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, palcebo-controlled, parallel-group, multicenter clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberBIA-2093-208
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIAL - Portela & Cª, SA
    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 supportBial-Portela & Ca, SA
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIAL - Portela & Cª, SA
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. Siderurgia Nacional
    B.5.3.2Town/ cityS. Mamede do Coronado
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351 22 9866 100
    B.5.5Fax number+351 22 9866192
    B.5.6E-mailfernando.mota@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 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 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 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.3.9.2Current sponsor codeBIA 2-093
    D.3.9.3Other descriptive name(S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 to mg
    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 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 oncognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures over a 12-week double blind period.
    E.1.1.1Medical condition in easily understood language
    NA
    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 LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial 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
    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 over a 12-week double blind period.
    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 effect of ESL on global cognitive skills, social competence and quality of life in comparison with placebo over a 12-week double-blind period.
    •To evaluate the effects of long term treatment with ESL as adjunctive therapy on global cognitive skills, social competence and quality of life over a 1-year open label period.
    •To evaluate the safety, tolerability and sustainability of the therapeutic effect of ESL during a 1-year open label period, and (6) To evaluate the safety, tolerability, and sustainability of the therapeutic effect of ESL during a 2-year, open-label extension.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit1 (screening), patient must be / have:
    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.
    4.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.
    5.An IQ of at least 70 within the 1 year prior to screening.
    6.A parent or legal representative able to understand and willing to complete the CBCL and CHQ throughout the study.
    7.Current treatment with 1 to 2 AEDs (any except oxcarbazepine).
    8.Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
    9.In the opinion of the investigator, able to complete the CDR test battery.
    10.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:
    11.At least 2 partial-onset seizures during the 4-week baseline period prior to randomisation (documented in a diary).
    12.In case of a girl of childbearing potential, patient presents a urine ß-hCG test consistent with a non-gravid state.
    13.Stable dose regimen of concomitant AEDs during the 4 week baseline period.
    14.Diaries satisfactorily completed by the patient or his/her caregiver during the baseline period.
    15.Satisfactory compliance with the study requirements during the baseline period.
    At OL7, the patient will be evaluated for eligibility into the Part III additional 2-year open-label extension. Assessments at this visit will be considered baseline values for Part III
    E.4Principal exclusion criteria
    At Visit1 (screening), patients must not be / have:
    1. 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. Documented and established diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD) currently treated with stimulants or history of other diseases adversely affecting cognitive abilities (if stable ADHD and not treated with stimulants patients can be included).
    13. Currently treated with oxcarbazepine.
    14. Occasional use of benzodiazepines for any reason other than epilepsy.
    15. On ketogenic diet.
    16. Receiving VNS
    17. Known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine).
    18. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
    19. Second or third degree atrioventricular blockade.
    20. Relevant clinical laboratory abnormalities.
    21. Estimated creatinine clearance (CLCR) <60 mL/min.
    22. Pregnancy or nursing.
    23. Treatment with ESL in any previous study.
    24. Participation in other drug clinical trial within the last 2 months.
    25. Not ensured capability to perform the trial.
    26. 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:
    27. 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 ot the evaluation period in the composite power of attention measure in order to assess information processing speed and attention / psychomotor speed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of OL phase
    E.5.2Secondary end point(s)
    Global Cognitive Skills/Social Competence/Quality of Life:
    During Part I:
    Change from baseline to the end of the double blind period in scores derived from results of the UBC neurocognitive test battery that are related to evaluation of different aspects of attention and memory.
    In addition, change from baseline to the end of the double-blind period in 1) number of correct answers on the Raven’s SPM test; 2) competence summary score from the CBCL; 3) physical and psychosocial functioning summary scores from the CHQ.
    During Part II:
    Change from baseline to the end of the open-label period in scores derived from results of the UBC neurocognitive test battery that are related to evaluation of different aspects of attention and memory. Also, 1) number of correct answers on the Raven’s SPM test; 2) competence summary score from the CBCL; 3) physical and psychosocial functioning summary scores from the CHQ.
    Efficacy:
    Part I: Relative reduction from baseline in seizure frequency during the double blind period as compared with placebo; proportion of patients with a 50% or greater reduction in seizure frequency from the baseline period to the 8-week maintenance period (responders); proportion of seizure free patients (100% seizure reduction) over the 8 week maintenance period; proportion of patients with a 25% or greater exacerbation in seizure frequency versus baseline.
    Part II: Relative reduction from baseline in seizure frequency over the 1-year, open label period; proportion of patients with a 50% or greater reduction in seizure frequency from the baseline period (responders); proportion of seizure free patients (100% seizure reduction); proportion of patients with a 25% or greater exacerbation in seizure frequency versus baseline.
    Part III: Treatment retention time as actual time treated; CGI-S change from baseline.
    Safety: Part I and Part II: Treatment-emergent adverse events (TEAEs); change from baseline in clinical laboratory tests (haematology, biochemistry, thyroid function and urinalysis); vital signs, body weight, height and head circumference; ECG.
    Part III: TEAEs, vital signs, body weight, height and head circumference, and ECG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of OL phase
    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.8.2.4Number 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 concerned5
    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 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
    Ukraine
    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 patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 18
    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.1.1.3.1Number of subjects for this age range: 0
    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: 58
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 117
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-10-27. Yes
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    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 patients have completed the additional 2-year open-label extension, further extensions will be defined based on safety and efficacy data until marketing authorisation for ESL in the paediatric indication is granted (or until clinical development is discontinued) and if the parent(s)/legal representative(s)/patient and his/her physician all agree this is in the patient’s best interest. Further information is stated on page 40 of the protocol.
    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 Decision2010-01-06
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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