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    The EU Clinical Trials Register currently displays   37211   clinical trials with a EudraCT protocol, of which   6120   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-001549-96
    Sponsor's Protocol Code Number:SP1042
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-15
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001549-96
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM USE OF LACOSAMIDE (FLEXIBLE DOSE FROM 200 TO 600 MG/DAY) USED AS MONOTHERAPY IN SUBJECTS WHO COMPLETED SP0994 AND RECEIVED LACOSAMIDE MONOTHERAPY TREATMENT
    ÉTUDE DE SUIVI MULTICENTRIQUE, EN OUVERT, VISANT A EVALUER UN TRAITEMENT A LONG TERME PAR LE LACOSAMIDE EN MONOTHERAPIE (DOSE FLEXIBLE DE 200 A 600 MG/JOUR) CHEZ DES PATIENTS AYANT TERMINE L’ETUDE SP0994 ET AYANT REÇU UN TRAITEMENT PAR LE LACOSAMIDE EN MONOTHERAPIE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the long-term use of Lacosamide as monotherapy in subjects who completed SP0994.
    Etude évaluant l'utilisation à long terme du lacosamide, en monothérapie chez des patients ayant terminé l'étude SP0994.
    A.4.1Sponsor's protocol code numberSP1042
    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 BioPharma SPRL
    B.1.3.4CountryBelgium
    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 Biopharma SPRL
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportEdev S.à.r.l.
    B.4.2CountryLuxembourg
    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 pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Str. 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+492173481515
    B.5.5Fax number+492173481572
    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 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.3.4Pharmaceutical 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.3.9.2Current sponsor codeSPM927
    D.3.9.3Other descriptive nameLCM
    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.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 or generalized tonic-clonic seizures
    Epilepsie avec crises épileptiques à début partiel ou tonico-cloniques généralisées
    E.1.1.1Medical condition in easily understood language
    Epilepsy with partial-onset seizures
    Epilepsie avec crises épileptiques à début partiel
    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 18.1
    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
    To assess the long-term safety and tolerability of Lacosamide dosed at 200mg/day to 600mg/day when used as monotherapy in subjects, with partial-onset seizures or generalized tonic-clonic seizures (without clear focal origin), who completed SP0994.
    Evaluer la tolérance et la sécurité d'emploi à long terme du Lacosamide administré à une dose de 200 à 600 mg/jour en monothérapie chez des patients atteints de crises épileptiques à début partiel ou tonico-cloniques généralisées (sans origine focale claire), ayant terminé l'étude SP0994 .
    E.2.2Secondary objectives of the trial
    Not applicable
    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 by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator.
    3. Subject has completed the Termination Visit of SP0994 and has been treated with Lacosamide monotherapy.
    1.Signature et datage par le patient ou se(s) parent(s) ou son(ses) représentant(s) légal(ux) du formulaire de consentement éclairé écrit approuvé par le Comité de protection des personnes. Le formulaire de consentement éclairé ou un formulaire spécifique pour les mineurs, le cas échéant, sera signé et daté par les mineurs.
    2.Patient/représentant légal considéré fiable et capable de respecter le protocole, le calendrier des visites, et la prise de médicaments, d'après le jugement de l'investigateur.
    3.Patient ayant effectué la Visite de fin de l'étude SP0994 et ayant été traité par Lacosamide en monothérapie.
    E.4Principal exclusion criteria
    1. Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide.
    2. Subject experienced a seizure at the third target dose (ie, Lacosamide 600 mg/day) during SP0994.
    3. Subject requires another antiepileptic drug for the treatment of seizures.
    4. Subject meets a “must” withdrawal criterion for the previous study, SP0994.
    5. Subject is experiencing an ongoing serious adverse event from the previous study, SP0994.
    6. Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study.
    1.Administration d'un autre médicament à l'étude ou utilisation d'un dispositif à l'étude, en plus du traitement par Lacosamide.
    2.Survenue d'une crise d'épilepsie à la troisième dose ciblée (c'est-à-dire, Lacosamide 600 mg/jour) pendant l'étude SP0994.
    3.Nécessité d'un autre médicament anti-épileptique pour le traitement des crises d'épilepsie.
    4.Présence d'un critère de retrait « obligatoire » lors de la précédente étude, SP0994.
    5.Persistance d'un évènement indésirable grave depuis la précédente étude, SP0994.
    6.Patiente en cours de grossesse ou d'allaitement et/ou femme en âge de procréer n'ayant pas été stérilisée chirurgicalement, non ménopausée depuis 2 ans ou n'utilisant pas de méthode de contraception hautement efficace (définie par les directives ICH (conférence internationale d'harmonisation) comme toute méthode ayant un taux d'échec inférieur à 1 % par an lors d'une utilisation constante et conforme), sauf en cas d'abstinence sexuelle complète, pendant toute la durée de l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator
    2. Percentage of withdrawals due to adverse events
    3. Number of serious adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator
    1. Nombre d'évènements indésirables décrits spontanément par le patient et/ou le soignant ou observés par l'investigateur
    2. Pourcentage d'abandons dus aux évènements indésirables
    3. Nombre d'évènements indésirables graves décrits spontanément par le patient et/ou le soignant ou observés par l'investigateur
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Visit 1 (Week 0) to Final Visit (up to week 158)
    De la Visite 1 (semaine 0) à la dernière visite (jusqu'à la semaine 158)
    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 No
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Bulgaria
    Finland
    France
    Germany
    Japan
    Korea, Republic of
    Latvia
    Mexico
    Philippines
    Poland
    Russian Federation
    Sweden
    Switzerland
    Ukraine
    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
    Dernière visite du dernier patient
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number of subjects for this age range: 1
    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.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 150
    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 will revert to commercially 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 Decision2015-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
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