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    Summary
    EudraCT Number:2011-002461-37
    Sponsor's Protocol Code Number:SP0980
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-002461-37
    A.3Full title of the trial
    A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN
    ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES
    A.3.2Name or abbreviated title of the trial where available
    Optimising Combination Therapy On Partial Onset Seizures (OCToPOS)
    A.4.1Sponsor's protocol code numberSP0980
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01484977
    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 SponsorUCB BIOSCIENCES 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 supportUCB BIOSCIENCES Inc
    B.4.2CountryUnited States
    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+49217348 1515
    B.5.5Fax number+49217348 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 SA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB25407
    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) 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 Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB25407
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy with partial onset seizures
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    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 14.1
    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 this study is to assess the overall effectiveness of LCM (optimized within the range of 200mg/day to 600mg/day) when added to a stable dose of LEV (in the label range of 1000mg/day to 3000mg/day) with withdrawal of the concomitant SCB-AED in
    subjects with partial-onset seizures not adequately controlled on their dual LEV and SCB-AED regimen.
    E.2.2Secondary objectives of the trial
    Other objectives of this study are to evaluate seizure reduction during the study versus Baseline and to evaluate the safety of LCM when LCM (optimized within the range of 200mg/day to 600mg/day) is added to LEV (in the label range of 1000mg/day to 3000mg/day) with withdrawal of the concomitant SCB-AED in subjects with partial-onset seizures not adequately controlled on their dual SCB-AED and LEV regimen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
    written Informed Consent form is signed and dated by the subject or legal representative.
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol
    (eg, able to understand and complete diaries), visit schedule, and medication intake
    according to the judgment of the investigator.
    3. Subject is male or female, at least 18 years of age.
    4. Subject has a diagnosis of epilepsy with partial-onset seizures according to the
    International Classification of Epileptic Seizures (1981).
    5. Subject is taking LEV in combination with 1 SCB-AED (defined as carbamazepine,
    lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for
    epilepsy.
    6. The minimum required seizure frequency during the 8-week Retrospective Seizure
    Baseline is on average ≥2 partial-onset seizures (IA, IB, or IC) per 28 days (based on
    investigator assessment of subject report) with at least 1 seizure per 4-week period within
    the 8-week Retrospective Seizure Baseline. Additionally, subjects must experience at
    least 1 seizure during the 4-week Prospective Seizure Baseline. In the case of simple
    partial seizures, only those with motor signs (IA1) will be counted towards meeting this
    inclusion criterion.
    7. Subject has been maintained on a stable dose of LEV and a SCB-AED for at least
    4-weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure
    Baseline, with or without additional concurrent stable VNS. The VNS must have been in
    place for at least 6 months prior to the Screening Visit (Visit 1) with constant settings for
    at least 4-weeks prior to the Screening Visit (Visit 1) and throughout the duration of the
    study.
    E.4Principal exclusion criteria
    1. Subject has previously participated in this study or subject has previously been exposed to
    LCM.
    2. Subject has participated in another study of an investigational medicinal product (IMP) or
    an experimental medical device within the last 2 months or is currently participating in
    another study of an IMP or a medical device.
    3. Female subject who is pregnant or nursing, and/or a woman of childbearing potential who
    is not surgically sterile, 2 years postmenopausal or does not practice 2 combined methods
    of contraception, unless sexually abstinent, for the duration of the study. Male subject
    who does not agree to practice 2 combined methods of contraception (eg, condom,
    spermicide), unless sexually abstinent, for the duration of the study.
    4. Subject has a history of chronic alcohol or drug abuse within the last 2 years.
    5. Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial
    seizures without observable motor signs).
    6. Subject has a history of primary generalized seizures.
    7. Subject has a history of status epilepticus within the 12-month period prior to Visit 1.
    8. Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than
    30 minutes in which several seizures occur with such frequency that the initiation and
    completion of each individual seizure cannot be distinguished) during the 8-week
    Retrospective Seizure Baseline and during the 4-week Prospective Seizure Baseline.
    9. Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or
    other nonepileptic ictal events which could be confused with seizures.
    10. Subject has any medical or psychiatric condition that, in the opinion of the investigator,
    could jeopardize the subject’s health or would compromise the subject’s ability to
    participate in this study.
    11. Subject has a lifetime history of suicide attempt (including an active 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.
    12. Subject has a known hypersensitivity to any components of LCM tablets.
    13. Subject has taken an AED other than the current SCB-AED and LEV during the 4-weeks
    prior to the Screening Visit (Visit 1), excepting 1-time use of benzodiazepines as rescue
    medication (less than or equal to 3 doses within 24 hours).
    14. Subject has a medical condition that could reasonably be expected to interfere with drug
    absorption, distribution, metabolism, or excretion.
    15. Subject has an acute or sub-acute progressive central nervous system disease.
    16. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
    17. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total
    bilirubin levels ≥2x the upper limit of normal (ULN) or has alkaline phosphatase levels
    ≥3xULN at Visit 1.
    18. 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) x weight in kg/(72 x serum creatinine in mg/dL)
    Adult females: CLcr = [(140-age) x weight in kg/(72 x serum creatinine in mg/dL)] x 0.85
    19. Subject has sick sinus syndrome without a pacemaker, or atrioventricular (AV) block, or
    subject has any other clinically significant ECG abnormalities.
    20. Subject has a known sodium channelopathy, such as Brugada syndrome.
    21. Subject has experienced a myocardial infarction in the last 3 months.
    22. Subject has New York Heart Association Class III or Class IV heart failure.
    23. Subject with concomitant felbamate treatment or previous felbamate therapy within the
    last 6 months prior to study Visit 1.
    24. Subject with previous or concomitant vigabatrin use.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the retention at the end of the 21-week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation is at end of the treatment period (21 weeks).
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Australia
    Austria
    Bulgaria
    Canada
    Denmark
    France
    Germany
    Netherlands
    Romania
    Spain
    Sweden
    Switzerland
    United States
    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
    LVLS
    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 months3
    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 months8
    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.1.2.1Number of subjects for this age range: 294
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects can either taper off from Lacosamide according to the protocol or continue with the commercial available Lacosamide.
    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 Decision2012-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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