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    Summary
    EudraCT Number:2010-019100-23
    Sponsor's Protocol Code Number:BIA-2093-307
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-019100-23
    A.3Full title of the trial
    A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Clinical Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain
    A.4.1Sponsor's protocol code numberBIA-2093-307
    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 Yes
    D.2.1.1.1Trade name Zebinix 400 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBIAL - Portela & Cª , 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 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.3.8 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.3.9.3Other descriptive nameESL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.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 Yes
    D.2.1.1.1Trade name Zebinix 600 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBIAL - Portela & Cª , 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 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEslicarbazepine Acetate
    D.3.9.1CAS number 236396-14-5
    D.3.9.2Current sponsor codeBIA 2-093
    D.3.9.3Other descriptive nameESL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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.IMP: 3
    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 800 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBIAL - Portela & Cª , 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 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.3.8 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.3.9.3Other descriptive nameESL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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
    Diabetic Neuropathic Pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067547
    E.1.2Term Diabetic peripheral neuropathic pain
    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 study is to assess the efficacy of ESL as therapy in subjects with DNP over a 15 week treatment phase.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics of ESL in subjects with DNP over a 19-week treatment phase. It is also to evaluate the safety and tolerability of ESL at doses titrated to an efficacy or safety endpoint over a 36-week OL phase and the maintenance of therapeutic effect of ESL over 31 weeks of OL ESL treatment at flexible doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female outpatients aged 18 years or older. Female subjects are of nonchildbearing potential, defined as surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or at least 2 years postmenopausal (spontaneous amenorrhea for at least 24 months before Visit 1), or if of childbearing potential, subjects agree to use a medically acceptable nonhormonal method of contraception (Section ‎3.8.7).
    2. Diagnosis of Type 1 or Type 2 diabetes mellitus.
    3. Pain due to bilateral peripheral polyneuropathy caused by Type 1 or Type 2 diabetes mellitus. Daily pain should be present for at least 6 months and should have begun in the feet with relatively symmetrical onset. The diagnosis of DNP must be confirmed by a score of at least 3 on the investigator rated Part B of the Michigan Neuropathy Screening Instrument at Visit 1 (Screening).
    4. Have stable glycemic control, as assessed by the investigator, and have glycosylated hemoglobin proportion of less than or equal to 11% before randomization.
    5. A mean score between 4.0 and 9.0, inclusive, on the 24 hour average pain intensity assessment; the mean is determined by averaging all available daily scores from the 24 hour average pain assessment in the subject eDiary from the last 7 days before Visit 3. The period between Visit 2 and Visit 3 can vary between 7 to 10 days. To be randomly assigned, a subject must have at least 5 assessments of 24 hour average pain from the last 7 days prior to randomization.
    6. A subject rated score at Visit 3 of 40 mm or more on a 100 mm VAS for DNP during the previous 24 hours.
    7. Daily eDiaries must be completed for at least 70% of the 7 to 10 days between Visit 2 and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9 days, or 7 of 10 days).
    8. If not used to treat DNP, subjects are permitted to take nonsteroidal anti inflammatory drugs and selective serotonin reuptake inhibitors if they were kept on a stable dose for 1 month prior to Screening and are foreseen to remain stable throughout the study.
    9. Competent and able to freely give own informed consent.
    10. A degree of education and understanding sufficient to communicate intelligibly with the investigator and other study center staff.
    11. Considered reliable and agree to keep all appointments for protocol required study visits, tests, and procedures.
    12. Female subjects of childbearing potential, who are not currently breastfeeding, must have a negative serum pregnancy test at Visit 1.
    E.4Principal exclusion criteria
    1. Historical exposure to drugs known to cause neuropathy, such as vincristine, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have caused neuropathy.
    2. Other chronic pain conditions not associated with DNP. However, subjects will not be excluded if all the following criteria apply:
    •Pain is located in a different region of the body,
    •Pain intensity is not greater than the pain intensity of DNP, and
    •Subject can assess DNP pain independently of the other pain condition.
    3. Significant skin lesions (active infection, ulcer, etc) that could interfere with pain assessment.
    4. Peripheral vascular disease with a history of amputation, except amputation of toes.
    5. Known intolerance to ESL or to other carboxamide derivatives (eg, carbamazepine or oxcarbazepine) or frequent or severe allergic reactions with multiple medications.
    6. Subjects who previously participated in a clinical study with ESL.
    7. Current or previous (within the past year) axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol abuse, history of suicide attempt, or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM IV) American Psychiatric Association, 2000 criteria, as determined by the investigator.
    8. Serious or unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic, gastrointestinal or hematologic illness, symptomatic peripheral vascular disease, or other medical condition that the investigator considers would compromise participation or likely cause hospitalization during the study.
    9. Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead ECG as determined by the investigator.
    10. Subjects taking the following drug classes and individual drugs are excluded: benzodiazepines (except short half life sleep agents), skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletine, centrally acting analgesics (dextromethorphan, tramadol), opiates, topical lidocaine, anticonvulsants, tricyclic antidepressants, and serotonin norepinephrine reuptake inhibitors. These drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide.
    11. Taking excluded medications that cannot be stopped prior to Visit 2.
    12. Plasma sodium less than 130 mmol/L, alanine or aspartate aminotransferases greater than 2.0 times above the upper limit of the normal range, white blood cell count less than 3000 cells/mm3, or any other relevant clinical laboratory abnormality that, in the investigator’s opinion, can compromise the subject’s safety.
    13. Prior renal transplant or current renal dialysis.
    14. History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.
    15. Subjects with a positive Visit 1 drugs of abuse screen test will be excluded from the study, except for medications used to treat a medical condition (including DNP) and reported as such by the subject at Visit 1 (screening visit). These subjects can wash out the medication and be retested at Visit 3. All subjects must have a negative result at Visit 3.
    16. An estimated creatinine clearance of less than 50 mL/min calculated using the 4 variable Modification of Diet in Renal Disease method.
    17. Unwilling or unable to comply with the use of an eDiary to directly record subject data.
    18. Study center personnel directly affiliated with the study or their immediate families, defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    19. Employees of BIAL or PPD.
    20. Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry.
    21. History of recurrent epileptic seizures except febrile seizures.
    22. History of severe gastroparesis or gastric bypass surgery.
    23. Neurolytic treatment for DNP.
    24. Injected anesthetics or steroid use within 30 days of Visit 1.
    25. Malignancy within past 2 years, except basal cell carcinoma that has been treated.
    26. History of chronic hepatitis B or C within the past 3 months or human immunodeficiency virus infection.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the change from Baseline to endpoint in mean pain, ie, the difference between endpoint mean pain and baseline mean pain, which are defined as follows:
    • Endpoint mean pain is defined as the mean of all available pain scores in the last 7 days of the treatment maintenance phase (while on study drug).
    • Baseline mean pain is defined as the mean of all available pain scores in the last 7 days prior to Randomization.
    The primary efficacy variable will be based on the morning response to the 11 point NRPS question relating to average pain intensity over the last 24 hours (1 of the 2 morning pain related questions).
    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 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 Yes
    E.8.1.7.1Other trial design description
    The trial has an open label phase
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 visit of the last subject undergoing the trial.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    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 No
    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) No
    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 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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 468
    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 Decision2010-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-24
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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