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    Summary
    EudraCT Number:2007-001887-55
    Sponsor's Protocol Code Number:SCO/BIA-2093-305
    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:2007-08-13
    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 number2007-001887-55
    A.3Full title of the trial
    Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as adjunctive therapy for refractory partial seizures in children: a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eslicarbazepine Acetate (BIA 2-093) as Therapy for Refractory Partial Seizures in Children
    A.4.1Sponsor's protocol code numberSCO/BIA-2093-305
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00988156
    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 supportBIAL - Portela & Ca, S.A.
    B.4.2CountryPortugal
    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 pointDep. of Research and Development
    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 number00351229866100
    B.5.5Fax number00351229866192
    B.5.6E-mailteresa.nunes@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 Yes
    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.3.10 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) 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.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 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 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.3.8INN - Proposed INNEslicarbazepine acetate
    D.3.9.1CAS number 236395-14-5
    D.3.9.2Current sponsor codeBIA 2-093
    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.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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    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
    children and adolescents with refractory partial epileptic seizures
    E.1.1.1Medical condition in easily understood language
    Epilepsy / Partial onset seizures
    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 13.1
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term 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 objective of the study is to assess the efficacy of eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures.
    The primary analysis variables for the assessment of efficacy will be:
    1. the responder rate, defined as the proportion of patients with at least a 50% decrease in the standardised seizure frequency
    2. the relative reduction in the standardised seizure frequency
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • To assess the safety and tolerability of eslicarbazepine acetate as adjunctive therapy in children and adolescents with refractory partial seizures
    • To assess the proportion of seizure-free patients and of patients with more than 75% reduction in seizure frequency
    • To assess the frequency of patients with exacerbations
    • To assess the duration of seizures and severity of seizures (using the Hague seizure severity scale)
    • To assess the potential for rebound effects and withdrawal phenomena
    • To assess the potential for interactions between eslicarbazepine acetate and concomitant AED medication
    • To assess the seizure frequency by seizure type
    • To assess the maintenance of the therapeutic effect of eslicarbazepine acetate during long-term treatment in Part II, Part III, Part IV and Part V of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    • Children aged 2 to 18 years
    • Diagnosis of epilepsy for at least 6 months prior to enrolment
    • At least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
    • At least 4 partial-onset seizures during each 4 week interval of the 8 week baseline period
    • Previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
    • Current treatment with 1 or 2 AEDs (any AED except oxcarbazepine); if present, vagus stimulation is considered an AED
    • Stable dose regimen of AEDs during the 8 week baseline period
    • Cooperation and willingness to complete all aspects of the study, including hospitalisation if required
    • Written informed consent to participate in the study in accordance with local legislation

    Patients participating in the second extension period (Part III) must have/be:
    • An additional written informed consent form signed by patient or by patient’s parent(s)/guardian and an assent form signed by patients 7 years and older (as described in Section 12.3 of the protocol)
    • Ongoing treatment with Eslicarbazepine Acetate in the dose range from 10 mg/kg/day to 30 mg/kg/day (or 800 mg/day to maximum 1200 mg/day for patients with high body weight)

    Patients participating in the third extension period (Part IV) must have/be:
    • An additional written informed consent form signed by patient or by patient’s parent(s)/guardian and an assent form signed by patients 7 years and older (as described in Section 12.3 of the protocol)
    • Ongoing treatment with Eslicarbazepine Acetate in the dose range from 10 mg/kg/day to 30 mg/kg/day (or 800 mg/day to maximum 1200 mg/day for patients with high body weight)

    Patients participating in the 2-year extension period (Part V) must have/be:
    • An additional written informed consent form signed by patient or by patient’s parent(s)/guardian and an assent form signed by patients 7 years and older (as described in Section 12.3 of the protocol)
    • Ongoing treatment with Eslicarbazepine Acetate in the dose range from 10 mg/kg/day to 30 mg/kg/day (or 800 mg/day to maximum 1200 mg/day for patients with high body weight)
    E.4Principal exclusion criteria
    • Primarily generalised seizures
    • Baseline seizure frequency aubstantially different from usual aeizure frequency
    • Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion)
    • Known second or third degree atrioventricular (AV) block
    • History of status epilepticus within the 3 months prior to enrolment
    • Seizures of non-epileptic origin (e.g. metabolic or neoplastic, or related to active infection)
    • Lennox-Gastaut syndrome
    • West syndrome
    • Major psychiatric disorders
    • Previous treatment in any study with Eslicarbazepine Acetate
    • Pregnancy
    • Breast-feeding
    • History of hypersensitiviti to the investigational products or to drugs with similar chemical structures
    • Impaired renal function, as shown by creatinine clearance values <60mL/min at screening
    • Any other clinically significant abnormal laboratory finding at screening
    • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
    • Inadequate completion of the study diaries during the baseline period
    • Inadequate completation with study requirements during the baseline period
    • Participation in a clinical trial within the last 2 months
    E.5 End points
    E.5.1Primary end point(s)
    Two primary variables with the following hierarchical order are defined:
    1. Responder rate, defined as the proportion of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
    2. Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part I: • Baseline period (8 weeks scheduled): between Visit V1 (screening visit) and first intake of double-blind study medication at Visit V2
    • Titration period (6 weeks scheduled): between first intake of double-blind study medication at Visit V2 and Visit V4
    • Maintenance period (12 weeks scheduled): between intake of study medication at Visit V4 and Visit V7
    • Tapering-off /follow-up period (4 8 weeks scheduled): between Visit V7 and Visit FU1
    Part II to V: please refer to protocol and amendments.
    E.5.2Secondary end point(s)
    • To assess the safety and tolerability of Eslicarbazepine Acetate as adjunctive therapy in children and adolescents with refractory partial seizures
    • To assess the proportion of seizure-free patients and of patients with more than 75% reduction in seizure frequency
    • To assess the frequency of patients with exacerbations
    • To assess the duration of seizures and severity of seizures (using the Hague seizure severity scale)
    • To assess the potential for rebound effects and withdrawal phenomena
    • To assess the potential for interactions between Eslicarbazepine Acetate and concomitant AED medication
    • To assess the seizure frequency by seizure type
    • To assess the maintenance of the therapeutic effect of Eslicarbazepine Acetate during long-term treatment in Part II, Part III, Part IV and Part V of the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part I: • Baseline period (8 weeks scheduled): between Visit V1 (screening visit) and first intake of double-blind study medication at Visit V2
    • Titration period (6 weeks scheduled): between first intake of double-blind study medication at Visit V2 and Visit V4
    • Maintenance period (12 weeks scheduled): between intake of study medication at Visit V4 and Visit V7
    • Tapering-off /follow-up period (4 8 weeks scheduled): between Visit V7 and Visit FU1
    Part II to V: please refer to protocol and amendments.
    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.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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Austria
    Bosnia and Herzegovina
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    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 end of the study is defined as the date of the last visit for the last patient to complete the study (including 14 days for AE reporting).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 230
    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.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 2007-08-13. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 315
    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)
    the test substance will be tapered-off subsequently and will be replaced by a standard anti-epileptic medication, the investigator will remain the primary treating physician and the first contact person of the patients
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-24
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