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    Summary
    EudraCT Number:2010-019765-28
    Sponsor's Protocol Code Number:SP0993
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-019765-28
    A.3Full title of the trial
    ESTUDIO MULTICÉNTRICO, DOBLE CIEGO Y DOBLE SIMULACIÓN, ALEATORIZADO Y CONTROLADO CON PRINCIPIO ACTIVO, PARA COMPARAR LA EFICACIA Y LA SEGURIDAD DE LACOSAMIDA (200 A 600 MG/DÍA) FRENTE A CARBAMAZEPINA DE LIBERACIÓN CONTROLADA (400 A 1.200 MG/DÍA), ADMINISTRADA EN MONOTERAPIA EN SUJETOS (IGUAL O MAYOR DE 16 AÑOS) CON EPILEPSIA DE DIAGNÓSTICO NUEVO O RECIENTE Y AFECTOS DE CRISIS TÓNICO-CLÓNICAS DE COMIENZO PARCIAL O GENERALIZADAS. //

    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 (FROM 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 SponsorSCHWARZ 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 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 VIMPAT 50 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNLACOSAMIDA
    D.3.9.3Other descriptive nameLACOSAMIDA
    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 AuthorisationUnited Kingdom
    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 // Carmapazepina de liberación controlada
    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 number200
    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 100 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNLACOSAMIDA
    D.3.9.3Other descriptive nameLACOSAMIDA
    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 placeboOver encapsulated tablet
    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
    Epilepsia de diagnóstico nuevo o reciente y afectos de crisis tónico-clónicas de comienzo parcial o generalizadas. //

    Epilepsy, partial onset or generalised tonic-clonic seizures.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia y la seguridad de LCM (200 a 600 mg/día) con las CBZ-CR(400 a 1.200 mg/día)administrada en monoterapia, 1 año como mínimo, midiendo la eficacia como criterio de valoración principal mediante la ausencia de crisis durante 6 meses, en sujetos con epilepsia de diagnóstico nuevo o reciente. En este estudio se utilizará un diseño de no inferioridad, para demostrar que el equilibrio entre beneficio y riesgo de LCM es cuando menos similar al de CBZ-CR, utilizando la ausencia de crisis durante 6 meses como criterio de valoración principal. //
    To compare efficacy and safety of Lacosamide(200 to 600mg/day)to Carbamazepine Controlled release (400 to 1200mg/day)used as monotherapy for at least 1 year, efficacy as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZCR, using 6month seizure freedom as primary endpoint
    E.2.2Secondary objectives of the trial
    Por favor, ver secciones 4.1.2 y 4.2.2.del protocolo.//
    Please see 4.1.2 and 4.2.2 sections in the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.El sujeto, su progenitor o su representante han firmado y fechado un documento de consentimiento informado por escrito, aprobado por un CEIC. Los menores firmarán y fecharán el documento de consentimiento u otro de asentimiento específico, en su caso. /
    2.El sujeto está dispuesto a cumplir todos los requisitos del estudio y es capaz de hacerlo./
    3.El sujeto es un hombre o una mujer igual o mayor de 16 años./
    4.El sujeto ha recibido un diagnóstico nuevo o reciente de epilepsia y ha experimentado crisis tónico-clónicas POS no provocadas (IA, IB, IC con focalidad precisa) o generalizadas (sin focalidad precisa) que se pueden clasificar con arreglo a la Clasificación de las crisis epilépticas de la ILAE de 1981. No es preciso diferenciar los grados IC y IIE para la inclusión. /
    5.El sujeto ha experimentado al menos 2 crisis no provocadas (con 48 horas de diferencia, como mínimo) en el año previo a la aleatorización, una de las cuales tuvo lugar en los 3 meses previos a la aleatorización./
    6.El sujeto presenta un electroencefalograma (EEG) (normal o compatible con el diagnóstico de epilepsia de inicio parcial) y una TC o RM cerebral compatibles con el diagnóstico de crisis tónico-clónicas de inicio parcial o generalizadas (sin focalidad precisa), obtenidos en el año previo. Si no se han obtenido el EEG y la TC o RM cerebral antes de la visita 1, se obtendrán dichas pruebas, y sus resultados deberán estar disponibles antes de la aleatorización en la visita 2.//
    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 Consent form or a specific Assent form, where required, will be signed and dated by minors./
    2. Subject is willing and able to comply with all study requirements./
    3. Subject is male or female and from 16 years of age.
    4. Subject has newly or recently diagnosed epilepsy having experienced unprovoked POS (IA, IB, IC with clear focal origin) or generalized tonic-clonic seizures (without clear focal origin) that are classifiable according to the ILAE Classification of Epileptic
    Seizures, 1981. The discrimination between IC and IIE is not requested for inclusion./
    5. Subject has experienced at least 2 unprovoked seizures (separated by a minimum of 48 hours) in the year preceding randomization out of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization./
    6. Subject has had an electroencephalogram and a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) exam of the brain consistent with the diagnosis of partial-onset or generalized tonic-clonic seizures (without clear focal origin) within the past year. 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
    1. El sujeto ha participado antes en este estudio o ha sido asignado anteriormente al tratamiento en un estudio sobre los fármacos que se investigan en el presente estudio./
    2. El sujeto está participando actualmente o ha participado en los últimos 2 meses en algún estudio de un medicamento en investigación o producto sanitario (dispositivo) experimental./
    3. El sujeto tiene antecedentes de crisis de tipos distintos que las tónico-clónicas de inicio parcial (IA, IIB, IC con focalidad precisa) y generalizadas (sin focalidad precisa) (p. ej., mioclónicas, ausencia) o las presenta en la actualidad./
    4.El sujeto tiene antecedentes de crisis que se dan sólo agrupadas, lo que se define por crisis repetidas que se producen en un período corto de tiempo (es decir, <20 minutos) tanto si se recupera la función entre 2 episodios como si no se recupera, o presenta dichas crisis en la actualidad./
    5.El sujeto tiene antecedentes de hallazgos de la historia, clínicos o del EEG indicativos de epilepsia generalizada idiopática (IGE) en la aleatorización (de acuerdo con la Clasificación de las crisis epilépticas de la ILAE, 1989)./
    6.El sujeto presenta o ha presentado diagnóstico de pseudocrisis, trastornos de conversión u otros episodios ictales no epilépticos que pueden confundirse con crisis.
    Por favor, ver sección 6.2 del protocolo para más información. //
    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 study of an investigational drug or experimental device./
    3. Subject has a history or presence of seizures of other types than partial-onset (IA, IIB, 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 which could be confused with seizures.
    Please see section 6.2 of protocol for further information.
    E.5 End points
    E.5.1Primary end point(s)
    1.Variable de eficacia principal:
    Porcentaje de sujetos que no presenten crisis durante 6 meses consecutivos (26 semanas consecutivas) de tratamiento tras la estabilización con la última dosis evaluada en cada sujeto.
    2.Variables de seguridad principales:
    - AE notificados de manera espontánea por el sujeto y/o el cuidador, u observados por el investigador.
    - Retiradas de sujetos debido a AE.
    - AE graves (SAE).//
    1.Primary efficacy variable:
    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:
    -AEs reported spontaneously by the subject and/or caregiver or observed by the investigator.
    -Subject withdrawals due to AEs.
    -Serious AEs (SAEs).
    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 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) 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
    Doble simulación // 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 concerned8
    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
    El final del estudio se define como la fecha de la última visita del último sujeto en el estudio.//

    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 years3
    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 years3
    E.8.9.2In all countries concerned by the trial months3
    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 state70
    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 Decision2010-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
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