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    Summary
    EudraCT Number:2011-000990-29
    Sponsor's Protocol Code Number:OMS/DES2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-14
    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 number2011-000990-29
    A.3Full title of the trial
    Multinational European Trial for Children with the
    Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome
    OMS/DES
    Ensayo Multinacional Europeo para niños con el
    Síndrome de Opsoclono Mioclono/ Síndrome del Ojo Danzante
    SOM/SOD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational European Trial for Children with the
    Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome
    OMS/DES
    Ensayo Multinacional Europeo para niños con el
    Síndrome de Opsoclono Mioclono/ Síndrome del Ojo Danzante
    SOM/SOD
    A.3.2Name or abbreviated title of the trial where available
    OMS/DES 2011
    SOM/SOD 2011
    A.4.1Sponsor's protocol code numberOMS/DES2011
    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 SponsorInstitut Curie
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIntitute Curie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Curie
    B.5.2Functional name of contact pointGudrun Schleiermacher
    B.5.3 Address:
    B.5.3.1Street Address26 rue d?Ulm
    B.5.3.2Town/ cityParis cedex
    B.5.3.3Post code75248
    B.5.3.4CountryFrance
    B.5.4Telephone number330156245500
    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 FORTECORTIN
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SL
    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 Injection
    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 INNDEXAMETHASONE
    D.3.9.2Current sponsor codeDEXAMETHASONE
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 GENOXAL
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology GMBH
    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 Concentrate and solvent 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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.2Current sponsor codeCYCLOPHOSPHAMIDE
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 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 RITUXIMAB
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRITUXIMAB
    D.3.9.3Other descriptive nameRITUXIMAB
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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
    Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome
    Síndrome de Opsoclono Mioclono/ Síndrome del Ojo Danzante
    E.1.1.1Medical condition in easily understood language
    Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome
    Síndrome de Opsoclono Mioclono/ Síndrome del Ojo Danzante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    the response to the treatment schedule as defined by the percentage of patients with disappearance of all symptoms
    La respuesta al esquema de tratamiento, definido por el porcentaje de pacientes con desaparición de todos los síntomas
    E.2.2Secondary objectives of the trial
    ?the response to the treatment schedule as defined by the percentage of patients with disappearance of all symptoms
    the response as estimated by the parents
    ?the response with respect to each treatment step
    ?to assess the number of OMS/DES relapses
    ?To determine the percentage of (OMS-NBpos) and (OMS-NBneg)
    ?To describe the patients with neuroblastoma with respect to INSS stage of disease and the need for chemotherapeutic intervention (for neuroblastoma)
    ?To compare OMS-NBpos and OMS-NBneg patients
    ?to prospectively address the neurological and neuropsychological outcome of patients with OMS/DES
    ?to prospectively address the quality of life of the patients with OMS/DES with standardized quality of life measurements
    ?To correlate long term outcome and quality of life with age at diagnosis,
    ?To compare the neurological and cognitive outcome of patients treated within the clinical trial
    ?To evaluate Event Free Survival and Overall Survival for patients with neurobl
    ? La respuesta al esquema de tratamiento definida por el porcentaje de pacientes con la desaparición de todas los síntomas
    ? La respuesta estimada por los padres
    ? La respuesta con respecto al cada escalón de tratamiento
    ? Evaluar el número de recurrencias de SOM/SOD
    ? Establecer el porcentaje de SOM/SOD asociados a neuroblastoma
    ? Describir los pacientes con neuroblastoma en según estadíos INSS y la necesidad de tratamiento quimioterapico (para los neuroblastomas)
    ? Evaluar la carga administrada a los los pacientes como:
    ? Comparar los pacientes SOM-NBpos y SOM-NBneg
    ? Estudiar prospectivamente el resultado neurológico y neuropsicológico de los pacientes con SOM/DES
    ? Estudiar la calidad de la vida de los pacientes
    ? Correlacionar el resultado a largo plazo y la calidad de vida con edad al diagnóstico,
    ? Comparar resultados neurológicos y congnitivos
    ? Evaluar la Supervivencia Libre de Eventos y Supervivencia Global de pacientes con neuroblastoma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Children with newly diagnosed OMS/DES either NB-pos or NB-neg.
    Three out of the following four components are necessary for the diagnosis of OMS/DES:
    - Opsoclonus or ocular flutter (but not nystagmus)
    - Ataxia and/or myoclonus
    - Behavioural change and/or sleep disturbance
    - Neuroblastoma
    ?Age 6 months or over up to less than 8 years (< 8th birthday)
    ?Treatment start with the standard corticosteroid treatment with dexamethasone pulses as proposed by the guidelines given in this trial protocol
    ?In patients with presumed NB-neg OMS/DES, neuroblastoma must be excluded according the guidelines of this trial
    ?Documented informed consent for treatment and enrolment in the trial by parents / legal representatives .
    ?Niños con SOM/SOD de nuevo diagnóstico bien NB-pos or NB-neg
    ?Edad mayor de 6 meses hasta 8 años (< 8º cumpleaños)
    ?Comienzo del tratamiento con el tratamiento corticoideo estandar con pulsos de dexametasona como se propone en las recomendaciones de este ensayo clínico
    ?En los pacientes con sospecha de SOM/SOD NB-neg, debe excluírse Neuroblastoma de acuerdo las recomendaciones de este ensayo clínico
    ?Documentación de Consentimiento informado para el tratamiento e inclusión en el ensayo clínico por los padres o representantes legales
    E.4Principal exclusion criteria
    ? Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).
    An identified viral precursor is not an exclusion criterion.
    ? prior or parallel use of chemotherapy (other than required for treatment of the neuroblastoma)
    ? Corticoid steroid for OMS/DES or other reasons lasting 14 days or more immediately before treatment start according the standard treatment proposed (treatment with corticosteroids for less than 14 days will be allowed)
    ? contre-indication of use of one of the experimental study drug (cf Summary of Product Characteristics used in this study)
    ? Los pacientes con opsoclono, mioclonias o ataxia causada por otra enfermedad (p.ej. una infección activa del SNC, trastornos neurometabólicos o desmielinización). Una determinación de una infección viral no es un criterio de exclusión.
    ? Uso de quimioterapia previo o en paralelo (distinta de la requerida para el tratamiento del Neuroblastoma)
    ? Tratamiento corticoideo para SOM/SOD o por otras razones durante 14 o más días inmediatamente antes del comienzo del tratamiento estándardizado propuesto (se permitirá el uso de corticoides durante menos de 14 días)
    E.5 End points
    E.5.1Primary end point(s)
    ? response to treatment at 48 weeks after treatment start
    ? respuesta al tratamiento a las 48 semanas desde el inicio
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 semanas
    E.5.2Secondary end point(s)
    ? response at 3 months, 6 months, 12 months, and 2 years after treatment start
    ? number of OMS/DES relapses
    ? percentage of OMS-NBpos
    ? need for chemotherapy in OMS-NBpos
    ? evaluation of treatment burden
    (neurological and oncological treatment)
    ? comparison of OMS-NBpos and OMS-NBneg in terms of presentation, severity and treatment response
    ? neuropsychological longterm outcome
    ? long term quality of life
    ? evaluation of factors influencing long term outcome and quality of life
    ? comparison of long term outcome to other OMS cohorts
    ? Event free Survival and Overall survival in OMS-NBpos
    Further objectives:
    ? to develop a European multidisciplinary network of specialists in the treatment of patients with OMS/DES
    ? to develop a Europe-wide collaboration of scientist interested in OMS/DES
    ? to investigate the biology of OMS/DES
    ? respuesta a los 3 meses, 6 meses, 12 meses y 2 años tras inicio del tratamiento
    ? número de recaídas de SOM/SOD
    ? porcentaje de SOM-NBpos
    ? necesidad de quimioterapia en SOM-NBpos
    ? evaluación de cantidad de tratamiento
    (neurológico y oncológico)
    ? comparación de SOM-NBpos y SOM-NBneg en terminos de presentación, severidad y respuesta al tratamiento
    ? pronóstico a largo plazo neuropsicológico
    ? calidad de vida a largo plazo
    ? evaluación de factores que influyen en el pronóstico a largo plazo y calidad de vida
    ? comparación de pronóstico a largo plazo con otras cohortes SOM
    ? Supervivencia libre de acontecimientos y supervivencia global en SOM-NBpos

    Otros Objetivos
    ? desarrollo de una red multidisciplinar Europea de especialistas en el tratamiento de pacientes con SOM/SOD
    ? desarrollo de una colaboración intereuropea de científicos interesados en SOM/SOD
    ? investigar la biología de SOM/SOD
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 No
    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 EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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
    children 6 months-8 years, parents consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 0
    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
    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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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