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    Summary
    EudraCT Number:2010-019000-22
    Sponsor's Protocol Code Number:093-050
    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:2010-09-30
    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 number2010-019000-22
    A.3Full title of the trial
    Long-Term Eslicarbazepine Acetate Extension Study
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code number093-050
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern/a
    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 SponsorSepracor Inc.
    B.1.3.4CountryUnited States
    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 & C., S.A.
    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 eslicarbazepine acetate
    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 acetate
    D.3.9.2Current sponsor codeSEP-0002093
    D.3.9.3Other descriptive nameeslicarbazepine acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 2400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Partial epilepsy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial epilepsy
    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 one-year safety and tolerability of eslicarbazepine acetate flexible dosing within the range of 800 mg to 2400 mg in subjects with partial epilepsy who have participated in an 18-week double-blind eslicarbazepine acetate monotherapy study (Protocols 093-045 or 093-046).
    E.2.2Secondary objectives of the trial
    To evaluate the maintenance of the therapeutic effects of eslicarbazepine acetate over a one-year open-label period.
    To evaluate the health-related quality of life, suicidality, and depressive symptoms over a one-year open label period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
    2.Subject must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject’s parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the “Women of Childbearing Potential” Addendum.
    3.Subject must continue to meet the inclusion and not meet the exclusion criteria defined in Protocols 093-045 or 093-046 and not present with any safety concerns (as determined by the Investigator).
    4.If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well.
    E.4Principal exclusion criteria
    1.Subject with serum sodium level ≤125 mmol/L.
    2.Subject with any kind of hypersensitivity (especially manifested as rash) suspected to be induced by eslicarbazepine, carbamazepine, oxcarbazepine, or chemically-related substances.
    3.Subject who needs to initiate prohibited concomitant medications.
    4.Subject who needs to reduce eslicarbazepine acetate dose to <800 mg QD or increase dose to >2400 mg QD.
    5.Subject who needs to use >2 additional AEDs. If applicable, provide sufficient study drug to taper subject off of study drug (taper schedule is at the Investigator’s discretion). Schedule a follow-up (unscheduled) visit, if applicable, to assess AEs and to collect all remaining study drug in the original container (including any empty containers).
    Please also refer to Section 12, Discontinuation and Replacement of Subjects.
    E.5 End points
    E.5.1Primary end point(s)
    1.Clinical evaluations (adverse events, vital signs, orthostatic effects, physical and full neurological examination, body weight, and 12-lead ECGs).
    2.Clinical laboratory evaluations (serum chemistry, hematology and urinalysis), high-density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol, and triglycerides), coagulation testing (PT/INR, and PTT), bone turnover markers (serum 25-hydroxyvitamin D [25-OHD], parathyroid hormone [PTH], osteocalcin, bone-specific alkaline phosphatase, and urinary N-telopeptides of type I collagen cross-links [NTx]).
    3.Proportion (%) of subjects with increase of body weight ≥7%.
    4.Proportion (%) of subjects with normal baseline blood sodium reaching levels of ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.
    5.Columbia Suicidality Severity Rating Scale (C-SSRS).
    6.Time on eslicarbazepine acetate monotherapy.
    7.Seizure frequency reduction from baseline period (Visit 1 to 2) of Protocols 093-045 or 093-046.
    8.Responder rate (proportion [%] of subjects with a ≥50% reduction of seizure frequency from baseline period [Visit 1 to 2] of Protocols 093-045 or 093-046).
    9.Proportion (%) of subjects seizure-free during study (determined in 12-week intervals).
    10.Seizure frequency by seizure type.
    11.Completion rate (proportion [%] of subjects completing the one-year treatment).
    12.Treatment retention time (time to withdrawal due to lack of efficacy or adverse events).
    13.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in 31-Item Quality of Life in Epilepsy (QOLIE-31).
    14.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in Montgomery-Asberg Depression Rating Scale (MADRS).
    15.Change in total score from Visit 2 (Day 0) of Protocols 093-045 or 093-046 to end of study treatment (Visit 7, Month 12) in MADRS in those subjects with a MADRS score of ≥14 at screening visit of the present study.
    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 Yes
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Described in the protocol
    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 months0
    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 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 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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 2010-09-30. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents 16 - 17 years patients: parent or legal guardian must sign informed consent and minor subjects must give written informed assent.
    Asian ancestry are required to give written informed consent for genotyping.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 348
    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)
    Not different from the expected normal treatment.
    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 Decision2011-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-25
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