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    Summary
    EudraCT Number:2010-019765-28
    Sponsor's Protocol Code Number:SP0993
    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:2011-03-23
    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 number2010-019765-28
    A.3Full title of the trial
    A MULTICENTER, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS (≥16 YEARS) NEWLY OR RECENTLY DIAGNOSED WITH EPILEPSY AND EXPERIENCING PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES
    A.4.1Sponsor's protocol code numberSP0993
    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 SponsorUCB BIOSCIENCES GmbH
    B.1.3.4CountryGermany
    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 organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClinical Trial Registries
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 1515
    B.5.5Fax number+49 2173 48 1572
    B.5.6E-mailclinicaltrials@ucb.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 Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma 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 nameLacosamide
    D.3.2Product code SPM927
    D.3.4Pharmaceutical form Film-coated 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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 RoleComparator
    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 Tegretol Retard
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK limited
    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 nameCarbamazepine controlled release
    D.3.4Pharmaceutical form
    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.3.9.1CAS number 298-46-4
    D.3.9.3Other descriptive nameCARBAMAZEPINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number 200
    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 Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma 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 nameLacosamide
    D.3.2Product code SPM927
    D.3.4Pharmaceutical form Film-coated 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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    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 placeboCapsule, hard
    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
    Epilepsy, partial onset or generalised tonic-clonic seizures.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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 objective of this study is to compare the efficacy and safety of Lacosamide (LCM) (200 to 600mg/day) to Carbamazepine Controlled release CBZ CR (400 to 1200mg/day) used as monotherapy for at least 1 year, efficacy being measured as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ a noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZ CR, using 6-month seizure freedom as primary endpoint.
    E.2.2Secondary objectives of the trial
    See protocol sections 4.1.2 and 4.2.2
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    N/A
    E.3Principal inclusion criteria
    Subjects must fulfill the following inclusion criteria to be eligible to participate in this study:
    1. Subject has previously been assigned to treatment in this study or in a
    study of the drugs under investigation in this study.
    2. Subject is currently participating or has participated within the last 2
    months in any study of an investigational drug or experimental device.
    3. Subject has a history or presence of seizures of other types than
    partial-onset (IA, IB, IC with clear focal origin) and generalized tonicclonic
    (without clear focal origin) seizures (eg, myoclonic, absence).
    4. Subject has a history or presence of seizures occurring in clustered
    patterns, defined as repeated seizures occurring over a short period of
    time (ie, <20 minutes) with or without function regained between 2 ictal
    events.
    5. Subject has experienced at least 2 unprovoked seizures (separated by a minimum of 48 hours) in the 12 months preceding randomization out of which at least 1 unprovoked seizure occurred in the 3 months preceding Visit 1.
    6. Subject has had an electroencephalogram (EEG) and a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) exam of the brain within the past 12 months. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2.
    E.4Principal exclusion criteria
    Subjects are not permitted to enroll in the study if any of the following criteria are met:
    1.Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the drugs under investigation in this study 2.Subject is currently participating or has participated within the last 2 months in any other study of an investigational drug or experimental device 3.Subject has a history or presence of seizures of other types than partial-onset(IA,IB,IC with clear focal origin) and generalized tonic-clonic(without clear focal origin) seizures (eg,myoclonic,absence) 4.Subject has a history or presence of seizures occurring only in clustered patterns,defined as repeated seizures occurring over a short period of time (ie,<20 minutes) with or without function regained between 2 ictal events 5.Subject has a history,clinical,or EEG finding suggestive of idiopathic generalized epilepsy(IGE) at randomization(according to the ILAE Classification of Epileptic Seizures,1989) 6.Subject has current or previous diagnosis of pseudoseizures,conversion disorders,or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or EEG evidence.7.Subject has any medical or psychiatric condition,which in the opinion of the investigator,could jeopardize the subject’s health or would compromise the subject’s ability to participate in this study 8.Deleted and no longer applicable with Protocol Amendment 2(see protocol amendment details in Section 17.6) 9.Subject has a known hypersensitivity to any components of the investigational product(s) 10.Subject has ever been treated(for any indication) with LCM or CBZ in the past 11.Subject has been treated for epilepsy with any AED(including benzodiazepines) in the last 6 months before Visit 1
    • However,acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization
    • Prior use of felbamate or vigabatrin is not allowed
    • Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week 12.Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
    13.Subject is taking benzodiazepines for a nonepilepsy indication 14.The use of monoamine oxidase inhibitors(MAOIs) is not allowed within 14 days of Visit 1 15.Subject has experienced seizure(s) while treated with any AED for an indication other than epilepsy 16.Subject is taking any drug or product(eg,grapefruit) that may influence CBZ metabolism(see Section 7.8.3) 17.Subject has a known history of severe anaphylactic reaction,serious blood dyscrasias,or hepatic porphyrias 18.Subject has an acute or sub-acutely progressive central nervous system disease 19.Subject has alanine aminotransferase (ALT),aspartate aminotransferase (AST), or total bilirubin levels≥2× the upper limit of normal (ULN) or has alkaline phosphatase levels≥3× the ULN
    20.Subject has a medical condition that could reasonably be expected to interfere with drug absorption,distribution,metabolism, or excretion. 21.Subject has a history of alcohol or drug abuse within the previous 2 years 22.Subject is of Asian ancestry and tests positive for human leukocyte antigen HLA-B*1502 allele
    23.Subject has impaired renal function, ie, creatinine clearance (CLcr) is lower than 30mL/min at Visit 1.Creatinine clearance will be estimated as follows:
    Adult males: CLcr=(140-age)×weight in kg/(72×serum creatinine in mg/dL)
    Adult females: CLcr=[(140-age)×weight in kg/(72×serum creatinine in mg/dL)]×0.85
    24.Subject has sick sinus syndrome without a pacemaker, or second- or third-degree atrioventricular (AV) block, or subject has any other clinically significant ECG abnormalities
    25.Subject has experienced a myocardial infarction in the last 3 months 26.Subject has New York Heart Association Class III or Class IV heart failure 27.Female subject who is pregnant or nursing and/or a woman of childbearing potential who is not surgically sterile, not at least 2 years postmenopausal, or does not practice 1 highly effective method of contraception according to the WHO recommendation with administration of enzyme-inducing AEDs or does not practice 2 combined
    methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study. 28.Subject has a history of status epilepticus 29.Subject has a known sodium channelopathy, such as Brugada syndrome 30.Deleted 32.Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening 33. Subject is of Asian ancestry and tests positive for HLA-A*3101 allele.
    E.5 End points
    E.5.1Primary end point(s)
    1. Primary efficacy variable
    The primary efficacy variable is as follows:
    •Proportion of subjects remaining seizure free for 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject

    2.The primary safety variables are as follows:
    • AEs reported spontaneously by the subject and/or caregiver or observed by the investigator
    • Subject withdrawals due to AEs
    • Serious AEs (SAEs)
    E.5.2Secondary end point(s)
    • Proportion of subjects remaining seizure free for 12 consecutive
    months (52 consecutive weeks) of treatment following stabilization at
    the last evaluated dose for each subject
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    • Time to first seizure or discontinuation due to AE or LOE during 12
    months of treatment following stabilization at the last evaluated dose for
    each subject
    • Time to first seizure or discontinuation during 12 months of treatment
    following stabilization at the last evaluated dose for each subject
    • Time to first seizure during 12 months of treatment from the first dose
    of study medication
    • Time to first seizure or discontinuation due to AE or LOE during 12
    months of treatment from the first dose of study medication
    • Time to first seizure or discontinuation during 12 months of treatment
    from the first dose of study medication
    • Time to discontinuation due to AE or LOE during 12 months of
    treatment from the first dose of study medication
    Safety variables are as follows:
    • Changes in hematology, chemistry, and urinalysis parameters
    Changes in 12-lead electrocardiograms (ECGs)
    • Changes in vital sign measurements (ie, blood pressure [BP] and pulse
    rate)
    • Changes in physical or neurological examination findings
    • Changes in body weight
    • Changes in fasting serum lipid levels, and thyroid and sex hormone
    concentrations
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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
    Double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    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 months0
    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 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 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 state144
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 825
    F.4.2.2In the whole clinical trial 1000
    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)
    See section 8.6 End of study phase 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 Decision2011-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-07
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