Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44266   clinical trials with a EudraCT protocol, of which   7347   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-003100-30
    Sponsor's Protocol Code Number:EFC13429
    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:2017-02-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-003100-30
    A.3Full title of the trial
    A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)
    Estudio multicéntrico, abierto, de un solo brazo, antes y después del cambio para evaluar la eficacia, la seguridad y la tolerabilidad de alemtuzumab en pacientes pediátricos con esclerosis múltiple recurrente remitente (EMRR) con actividad de la enfermedad en la terapia previa modificadora de la enfermedad (TME)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT
    Estudio para evaluar la eficacia, la seguridad y la tolerabilidad de alemtuzumab en pacientes pediátricos con esclerosis múltiple recurrente remitente (EMRR) con actividad de la enfermedad en la terapia previa modificadora de la enfermedad (TME)
    A.4.1Sponsor's protocol code numberEFC13429
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/170/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenzyme Corporation
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 Lemtrada
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme therapeutics Ltd.
    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 nameLemtrada
    D.3.2Product code GZ402673
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalemtuzumab
    D.3.9.1CAS number 216503-57-0
    D.3.9.2Current sponsor codeGZ402673
    D.3.9.4EV Substance CodeSUB12459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanised Monoclonal Antibody
    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
    Multiple Sclerosis
    Esclerosis Múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Esclerosis Múltiple
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    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 evaluate the efficacy, safety, and tolerability of alemtuzumab (IV) in pediatric patients from 10 to <18 years of age with RRMS who have disease activity on prior DMT.
    Evaluar la eficacia, seguridad y tolerabilidad del alemtuzumab por vía intravenosa (i. v.) en pacientes pediátricos de entre 10 y <18 años de edad con EMRR que presentan actividad de la enfermedad en la TME previa.
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).
    Evaluar la farmacocinética (FC), la farmacodinámica (FD), la formación de anticuerpos antifármaco (AAF) y los posibles efectos del alemtuzumab en otros aspectos de la esclerosis múltiple (EM) como las funciones cognitivas o la calidad de vida (CdV).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with RRMS aged from 10 years to less than 18 years at study entry are eligible. Patients should meet the criteria of diagnosis of MS as defined by the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on McDonald criteria 2010.
    -Signed informed consent/assent obtained from patient and patient’s legal representative (parent or guardian) according to local regulations.
    -Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening.
    -At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a interferon-beta (IFNB) or glatiramer acetate (GA) after having been on that therapy for at least 6 months
    -At least 1 of the following:
    -≥1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion* while on that same prior therapy (IFNB or GA), OR
    -Two or more relapses in the prior year, OR
    -Tried at least 2 MS DMTs.
    • Son aptos para su participación en el estudio los pacientes con EMRR de entre 10 y menos de 18 años de edad en el momento del inicio del estudio. Los pacientes deben cumplir los criterios de diagnóstico de EM establecidos por el International Pediatric Multiple Sclerosis Study Group [Grupo de Estudio Internacional de la Esclerosis Múltiple Pediátrica] así como los criterios de EM basados en los criterios de McDonald de 2010.
    • Obtención del consentimiento/asentimiento informado firmado del paciente y de su representante legal (padres o tutores) según la normativa local.
    • Puntuación en la Escala ampliada del estado de discapacidad (EDSS) de 0,0 a 5,0 (ambos incluidos) en la selección.
    • Al menos dos brotes de EM registrados y al menos un brote de EM (recaída) en el último año durante el tratamiento con interferón β (IFNB) o acetato de glatirámero (AG) tras haber recibido este tratamiento durante al menos 6 meses.
    • Al menos uno de los siguientes:
    - ≥1 lesión nueva o aumentada de tamaño hiperintensa en T2 o una lesión captante de gadolinio durante este mismo tratamiento previo (IFNB o AG), O
    - 2 o más recaídas en el año anterior, O
    - haber probado al menos 2 TME para la EM.
    E.4Principal exclusion criteria
    -Any progressive or non-relapsing forms of MS.
    -Conditions/situations such as:
    -Impossibility to meet specific protocol requirements.
    -Current participation in another interventional clinical study.
    -Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    -Uncooperative patient or any condition that could make the patient potentially non-compliant tothe study procedures in the opinion of the Investigator.
    -Mental condition rendering the patient or parent/guardian unable to understand the nature, scope, and possible consequences of the study.
    -Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study in the opinion of the Investigator.
    -History of drug or alcohol abuse.
    -History of known human immunodeficiency virus (HIV) positivity.
    -Pregnant or breast-feeding female patients or those who plan to become pregnant during the study.
    -Unwilling to agree to use a reliable and effective contraceptive method as defined for contraception in the Informed Consent form (ICF) when receiving a course of alemtuzumab treatment and for 4 months following that course of treatmenty (fertile patients only).
    -Female patients who have commenced menstruating (ie, are of childbearing potential) and are unwilling or unable to be tested for pregnancy.
    -Previous treatment with alemtuzumab
    -Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or as determined by the treating physician to have residual immune suppression from these or other MS treatments.
    - Treatment with teriflunomide in the last 12 months except if the patient underwent the recommended elimination procedure as per SmPC.
    -Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy.
    -Previous treatment with any investigational medication (drug that has not been approved at any dose or for any indication). Use of an investigational medication that was subsequently licensed and nonstandard use of a licensed medication (eg, using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) is not exclusionary. Prior treatment with herbal medications or nutritional supplements is also permitted.
    -Intolerance of pulsed corticosteroids, especially a history of steroid psychosis.
    -History of malignancy
    -Prior documented history of thrombocytopenia, or platelet count at screening < lower limits of normal (LLN).
    -Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS.
    -Patients with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent
    -Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, eg, current peptic ulcer disease, or other conditions that may predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis.
    -Medical, psychiatric, cognitive, or other conditions that, in the Investigator’s opinion, compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
    -Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator.
    -Epileptic seizures that are not adequately controlled by treatment.
    -Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc.).
    -Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand’s disease, disseminated intravascular coagulation [DIC], fibrinogen deficiency, clotting factor deficiency).
    -Prior history of invasive fungal infections
    -Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation.
    -In the Investigator’s opinion, patient is at high risk for infection (eg, indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection).
    • Cualquier exposición previa al alemtuzumab.
    • Cualquier forma progresiva o sin recaídas de EM.
    • Tratamiento con natalizumab, daclizumab, fingolimod, metotrexato, azatioprina, ciclosporina o micofenolato de mofetilo en los 6 últimos meses o padecimiento de inmunodepresión residual diagnosticada por el médico del paciente derivada de estos u otros tratamientos para la EM.
    • Tratamiento con teriflunomida en los últimos 12 meses excepto en los casos en los que el paciente se haya sometido a un proceso de eliminación acelerada según la ficha técnica local de la teriflunomida.
    • Tratamiento previo con mitoxantrona, ciclofosfamida, cladribina, rituximab, ocrelizumab, leflunomida o cualquier tratamiento citotóxico.
    • Recuento absoluto de células CD4+, CD8+, o CD19+ en sangre por debajo del límite inferior de la normalidad (LIN) en el momento de la selección.
    • Antecedentes previos registrados de trombocitopenia o cifra de trombocitos <LIN en el momento de la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Number of new or enlarging T2 lesions during continuation of
    prior DMT (Period 1) compared to an equal period after the first
    course of alemtuzumab treatment (Period 2)
    El número de lesiones nuevas o aumentadas de tamaño en T2 en las RM cerebrales durante la administración de la TME previa (periodo 1) en comparación con un periodo equivalente tras el primer ciclo del tratamiento con alemtuzumab (periodo 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    1) Number of patients with new or enlarging T2 lesions during
    continuation of prior DMT (Period 1) compared to an equal period
    after the first course of alemtuzumab treatment (Period 2)
    2) Annualized relapse rate (ARR)
    3) Assessment of cognition test scores throught Brief Visuospatial
    Memory Test
    4) Assesment of generic pediatric QoL measures
    5) Assessment of PK parameter: maximum concentration (Cmax)
    6) Assessment of PK parameter: time to Cmax (Tmax)
    7) Assessment of PK parameter: area under plasma concentration
    (AUC)
    8) Assessment of PD parameter: lymphocite phenotyping
    9) Number of patients with adverse events
    10) Assessment of development of anti-alemtuzumab antibodies
    1) El número de pacientes con lesiones nuevas o aumentadas de tamaño en T2 durante la administración de la TME previa (periodo 1) en comparación con un periodo equivalente tras el primer ciclo del tratamiento con alemtuzumab (periodo 2).
    2) Tasa anual de brotes (TAB) en el año 2
    3) Evaluación de las puntuaciones de la prueba cognitiva: prueba breve de memoria visuoespacial revisada
    4) Evaluación de las medidas genéricas de calidad de vida pediátrica
    5) Evaluación del parámetro PK: concentración máxima (Cmax)
    6) Evaluación del parámetro PK: tiempo hasta Cmax (Tmax)
    7) Evaluación del parámetro PK: área bajo concentración plasmática
    (ABC)
    8) Evaluación del parámetro PD: fenotipificación linfocítica
    9) Número de pacientes con acontecimientos adversos
    10) Evaluación del desarrollo de anticuerpos anti-alemtuzumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 12 months
    2) at year 2
    3) and 4) every 6 months over 2 years
    5) to 7) 2 years
    8) until month 60
    9) 4 years after last dose of alemtuzumab
    10) at Baseline, month 1, month 3, month 12, month 13, month 15, month 24
    1) 12 meses
    2) en el año 2
    3) y 4) cada 6 meses durante 2 años
    5) a 7) 2 años
    8) hasta el mes 60
    9) 4 años después de la última dosis de alemtuzumab
    10) en la basal, mes 1, mes 3, mes 12, mes 13, mes 15, mes 24
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cognition and Quality of Life
    Cognitiva y de Calidad de Vida
    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.8.3 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 concerned4
    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
    Austria
    Belgium
    Bulgaria
    Czech Republic
    France
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    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: 65
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 55
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Population : <18
    Población por debajo de 18 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 65
    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)
    none
    Ninguno
    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 Decision2017-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-27
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA