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    The EU Clinical Trials Register currently displays   37217   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000483-27
    Sponsor's Protocol Code Number:PRA/BIA-2093-302
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-000483-27
    A.3Full title of the trial
    Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.
    A.3.2Name or abbreviated title of the trial where available
    None
    A.4.1Sponsor's protocol code numberPRA/BIA-2093-302
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNone available
    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 & 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 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 Information not present in EudraCT
    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 nameNot applicable
    D.3.2Product code BIA 2-093
    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.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Refractory partial epilepsy
    MedDRA Classification
    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 this trial is to evaluate the efficacy of BIA 2-093 once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.
    E.2.2Secondary objectives of the trial
    (1) To evaluate the safety and tolerability of BIA 2-093 at once-daily doses of 400 mg, 800 mg and 1200 mg in comparison to placebo, over a 12-week maintenance period preceded by a 2-week titration period.
    (2) To evaluate the safety and tolerability of BIA 2-093 at doses titrated to an efficacy or safety endpoint over a 1-year open-label period.
    (3) To assess the maintenance of therapeutic effects of BIA 2-093 over a 12-week maintenance period preceded by a 2-week titration period, and over a 1-year open-label period.
    (4) To assess the drug-drug pharmacokinetic interactions between BIA 2-093 and concomitant anti-epileptic drugs over the double-blind and open-label parts of the study.
    (5) To assess the health-related quality-of-life and depressive symptoms over the double-blind and open-label parts of the study.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At visit 1 (screening), patient must be/have :
    1. Written informed consent signed by patient.
    2. Aged 18 years or more.
    3. A documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening.
    4. At least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening.
    5. Currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening. Patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified (a confirmatory test should be available within 1 month before study entry). Vagus nerve stimulation (VNS) is considered an AED (i.e., only one concomitant anti-epileptic drug is allowed in patients with VNS).
    6. Excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests.
    7. Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method) beginning at screening and continuing at least to the post-study visit (PSV).

    At visit 2 (randomisation), patient must have:
    8. At least 4 partial seizures in each 4 weeks during the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 21 consecutive days.
    9. In case of woman of childbearing potential, patient must present a urine beta-hCG test consistent with a non-gravid state.
    10. Diaries satisfactorily completed by the patient or his/her caregiver.
    11. Satisfactorily complied with the study requirements during the baseline period.
    E.4Principal exclusion criteria
    At visit 1 (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 [Appendix C]) that are not video-EEG documented.
    2. Primarily generalised epilepsy.
    3. Known rapid progressive neurological disorder.
    4. History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
    5. Seizures of psychogenic origin within the last 2 years.
    6. History of schizophrenia or suicide attempt.
    7. Currently on or with exposure to felbamate or oxcarbazepine within one month of screening.
    8. Using benzodiazepines on more than an occasional basis (except when used chronically as AED).
    9. Previous use of BIA 2-093 or participation in a clinical study with BIA 2-093.
    10. Known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances.
    11. History of abuse of alcohol, drugs or medications within the last 2 years.
    12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
    13. Second or third-degree atrioventricular blockade not corrected with a pacemaker.
    14. Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <3,000 cells/mm3).
    15. Estimated creatinine clearance <50 mL/min [men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL].
    16. Pregnancy or nursing.
    17. Participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whatever is longer.
    18. Not ensured capability to perform the trial.
    19. 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:
    20. Inadequate compliance to concomitant AEDs during the 8-week baseline period.
    21. Inadequate completion of the study diary.
    22. Any other 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)
    Seizure frequency over the 12 week maintenance period. Seizure frequency will be standardised to a “frequency per 4 weeks” period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Provided in Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 400
    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)
    There may be further extensions to the trial until the product is marketed. Otherwise subjects will revert to treatment with standard drugs for epilepsy.
    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 Decision2004-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
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