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    Summary
    EudraCT Number:2010-020319-34
    Sponsor's Protocol Code Number:DGD-44-050
    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:2010-08-13
    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 number2010-020319-34
    A.3Full title of the trial
    Evaluación de la seguridad y la eficacia de Dotarem en resonancia magnética (RM) en pacientes con lesiones del sistema nervioso central (SNC)
    SAFETY AND EFFICACY EVALUATION OF DOTAREM® IN MAGNETIC RESONANCE IMAGING (MRI) IN PATIENTS WITH CENTRAL NERVOUS SYSTEM (CNS) LESIONS
    A.3.2Name or abbreviated title of the trial where available
    SENTIO
    A.4.1Sponsor's protocol code numberDGD-44-050
    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 SponsorGUERBET
    B.1.3.4CountryFrance
    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 DOTAREM 0,5 mmol/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderGUERBET
    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 injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGADOTERICO ACIDO
    D.3.9.3Other descriptive nameGADOTERIC ACID
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/g millimole(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente de contraste paramagnético
    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 MAGNEVIST 0,5 mmol/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderQUIMICA FARMACEUTICA BAYER, S.L.
    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 injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGADOPENTETATO DIMEGLUMINA
    D.3.9.3Other descriptive nameDIMEGLUMINE GADOPENTETATE
    D.3.10 Strength
    D.3.10.1Concentration unit mmol millimole(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 Yes
    D.3.11.13.1Other medicinal product typeparamagnetic contrast agent
    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
    Pacientes con lesiones del sistema nervioso central
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term 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
    Demostrar la superioridad de RM realzada con Dotarem con respecto a la RM sin contraste en las lesiones del sistema nervioso central (intracraneal y columna) en cuanto visualización (delimitación de bordes de las lesiónes, visualización de la morfología y grado de realce con contraste). Para determinar los criterios principales del estudio,los tres neurorradiólogos independientes ajenos al centro del estudio realizarán las evaluaciones de las RM sin conocer las asignaciones del estudio. Se considerará que el estudio ha tenido éxito si dos de los tres evaluadores coinciden en que se han alcanzado los objetivos principales.
    E.2.2Secondary objectives of the trial
    · Evaluación de la eficacia en cuanto a la visualización de las lesiónes ( Evaluación en el centro).
    · La localización número de las lesiones.
    · Determinación de la intensidad de la señal.
    · Calidad de imágenes.
    · Grado de confianza diagnóstica.
    · Seguridad y eficacia de Dotarem® en población pediátrica
    · Evaluación mediante comparación de las RM realzadas con Dotarem® y con Magnevist en terminos de visualización de las lesiónes, calidad de las imágenes,nivel de confianza diagnóstica, intensidad de la señal, número y localización de las lesiónes
    · Seguridad clínica y evaluación biológica mediante comparación entre Dotarem® y Magnevist® en términos de acontecimientos adversos, tolerancia en el punto de inyección, cambios en las constantes vitales y registro de ECG(en el subgrupo de pacientes del estudio) y datos de laboratorio (plazo: hasta 24 horas después de la administración).·
    Concordancia Inter- e intraevaluadores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Adultos ( que hayan cumplido la mayoría de edad) y pacientes pediátricos ( de ³2 anos de edad) estos últimos sólo en América Latina y estados Unidos.
    · Los pacientes presentarán certeza o sospecha fundada de presentar al menos una lesión con alteración de la barrera hematoencefálica (BHE) y/o vascularización anómala (incluidas enfermedades neoplásicas, vasculares, inflamatorias o infeccionsas) en el SNC (intracraneales y de columna), citados para someterse a una RM con contraste del SNC como parte de la asitencia habitual. Estas lesiones deberán haberse detectado mediante una evaluacvión por la imagen realziada anteriormente. El paciente ( o su progenitos o tutor legal, si es menor de 18 años) deberá entender y firmar el consentimiento
    E.4Principal exclusion criteria
    · Tener una insuficiencia renal aguda o crónica Grado IV or V, definida por un GFRestimado <30 mL/min/1.73m² en los 7 días antes del estudio RM.
    · Paro cardiaco congestivo Clase III/IV según la clasificación de Asociación de Corazón de Nueva York;
    · Sufriendo de síndrome largo QT.
    · La salud inestable o circunstancias (p.ej. sufrir claustrofobia
    · El teniendo cualquier contraindicación a RM como un marcapasos, el material magnético o cualquier otra condición que excluiría la proximidad a un campo fuente magnético.
    · Alergia sabida a quelatos de Gadolinio.
    · Haber recibido cualquier agente de contraste en los 3 días antes de la administración de contraste de estudio, o estar programado para recibir cualquier agente de contraste en las 24 horas después de la administración de contraste de estudio.
    · Embarazado, lactancia, o planificación de quedarse embarazada durante el estudio.
    · Antes participó en este estudio.
    ·
    · Haber participado dentro de 30 días en otro estudio clínico que implique un medicamento en investigación.
    · Cualquier condición que, basado en el juicio clínico del investigador, impediría al paciente completar todas las evaluaciones de estudio y visitas (por ejemplo: ¿incapacidad mental o física, comprensión de lengua, localización geográfica, etc.?).
    · Inhabilidad o desgana de cooperar con las exigencias de este estudio
    E.5 End points
    E.5.1Primary end point(s)
    Visualización de las lesiones: delineación de lso bordes, visualización del a morfología interna y grado de realce del contraste, evaluados fuera del centro.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    The end of the trial is the follow-up visit performed 24h after the MRI.
    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 months1
    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 months1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 396
    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)
    exactly from the expected normal treatment
    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 Decision2010-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-16
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    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
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