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    Summary
    EudraCT Number:2009-016140-39
    Sponsor's Protocol Code Number:IDI-GAD-2009-01
    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:2009-10-28
    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 number2009-016140-39
    A.3Full title of the trial
    MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T

    Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple.
    A.4.1Sponsor's protocol code numberIDI-GAD-2009-01
    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 SponsorInstitut Diagnostic per la Imatge
    B.1.3.4CountrySpain
    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 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 GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado
    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 INNGADOBUTROL
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 typeMedio de contraste
    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
    Realce de contraste en resonancia magnética en
    pacientes con Síndrome Clínico Aislado o
    recaída de Esclerosis Múltiple con resonancia
    magnética anormal anterior después de la
    administración de dosis única y acumulada de
    GADOVIST®

    High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist®
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si se detectan mayor número de
    lesiones emergentes con dosis acumulada de
    GADOVIST 0.2 mmol/kg ( administrada como
    0.1 mmol/kg + 0.1 mmol/kg) en comparación
    con dosis única de GADOVIST 0.1 mmol/kg en
    pacientes con Síndrome Clínico Aislado o
    recaída de Esclerosis Múltiple.

    To determine whether a greater number of enhancing lesions is detected in patients with CIS or relapsing MS using a cumulative dose of GADOVIST 0.2 mmol/kg (administered as 0.1 + 0.1 mmol/kg), compared with a single dose of GADOVIST 0.1 mmol/kg
    E.2.2Secondary objectives of the trial
    - Si una gran proporción pacientes con CIS cumple el criterio para demostrar la diseminación a tiempo (criterio de McDonald)
    - Si una gran proporción de pacientes con recaída de EM demuestra actividad de la enfermedad – Grado de realce de contraste
    - Número de lesiones pequeñas aumentadas (<1 cm) detectadas
    - Número de lesiones aumentadas de localización específica (lesiones periventriculares y subcorticales)
    - Aparición de lesión (nodular, anillo)

    - Whether a greater proportion of CIS patients fulfill the criteria for demonstration dissemination in time (McDonald criteria)
    - Whether a greater proportion of relapsing MS patients demonstrate disease activity
    - Degree of contrast enhancement
    - The number of small enhancing lesions (<1 cm) detected;
    - The number of enhancing lesions specific to location (e.g. periventricular and subcortical lesions);
    - Lesion appearance (nodular, ring)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hombres o mujeres, de entre 18 y 50 años
    - Pacientes con Síndrome Clínico aislado sugestivo de desmielinización del sistema nervioso central implicando el nervio óptico, tallo cerebral, espina dorsal, u otra topografía, no atribuible a otras enfermedades con al menos 2 lesiones cerebrales T2 subclínicas (demostrado en RM previa).
    - Pacientes con recaída de esclerosis múltiple
    - Obtención del consentimiento informado por escrito y disposión para cumplir con los requerimientos del estudio.

    - Male or female subjects, aged between 18 and 50 years.
    - Patients with a clinically isolated syndrome (CIS) suggestive of central nervous system demyelination involving the optic nerve, brainstem, spinal cord, or other topography, not attributable to other diseases with at least two brain T2 subclinical lesions (demonstrated on a previous MR scan)
    - Relapsing MS patients
    - Given written Informed Consent and are willing to comply with protocol requirements.
    E.4Principal exclusion criteria
    - Mujeres embarazadas o en período de lactancia.
    - Excluir la posibilidad de embarazo: por test (suero u orina ßHCG) durante 24h antes de la administración del agente en estudio, o por esterilización quirúrgica, o post menopausia, con un mínimo de 1 año de historia sin menstruación.
    - Pacientes con marcapasos, material magnético como grapas quirúrgicas o cualquier otra condición que excluya proximidad a campos magnéticos fuertes.
    - Pacientes que sufren de claustrophobia severa
    - Pacientes con alergia conocida a uno o más ingredientes del agente de estudio.
    - Pacientes que han participado previamente en este studio o en un ensayo clínico del medicamento en investigación durante los 30 días previos al examen de RM.
    - Pacientes con cualquier condición o otras circunstancias las cuales significaran una disminución de la posibilidad de obtener datos fiables, o de lograr los objetivos del estudio (ejemplo: dependencia a las drogas, trastornos psiquiátricos, demencia, o otras razones para la baja expectativa de seguimiento con las instrucciones del investigador y/o el seguimiento post tratamiento.
    - Pacientes en tratamiento actual con corticoesteroides o que lo han recibido durante los últimos 30 días anteriores al MRI
    - Pacientes con diagnóstico establecido de microangiopatia.
    - Pacientes que han empezado tratamiento inmunosupresivo antes de MRI
    - Deterioro severo de la función renal conocido
    - Candidato a trasplante de hígado

    - Pregnant or nursing female.
    - Exclude the possibility of pregnancy:by testing (serum or urine ßHCG) within 24 hours before study agent administration, or by surgical sterilization, or post menopausal, with minimum 1 year history without menses.
    - Patients having a pacemaker, magnetic material such as surgical clips or any other condition that would preclude proximity to a strong magnetic field.
    - Patients who suffer from severe claustrophobia
    - Patients with known allergy to one or more of the ingredients of the study agent.
    - Patients having previously participated in this study or in a clinical trial of an investigational drug within the last 30 days prior to the MR examination.
    - Patients having any medical condition or other circumstances which will significantly decrease the chances of obtaining reliable data, or achieving the study objectives, i.e. drug dependence, psychiatric disorders, dementia, or other reasons for the expected poor compliance with the investigators instructions and/or post-dose follow-up
    - Patients currently on corticosteroid therapy or who had received it during the last 30 days before MRI scanning
    - Patients with established diagnosis of microangiopathy
    - Patients who have started immunomodulatory/immunosuppressive treatment before MRI scanning
    - Known severe renal function impairment
    - Candidate for liver transplantation
    E.5 End points
    E.5.1Primary end point(s)
    Número de lesiones aumentadas de gadolinium: número total de lesiones aumentadas y no aumentadas detectadas en cada uno de los 4 escaner que se contaran y grabarán.

    Number of gadolinium enhancing lesions: the total number of enhancing lesions and non enhancing lesions detected in each one of the four scans will be counted and recorded.
    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 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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    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 Information not present in EudraCT
    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
    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 months3
    E.8.9.1In the Member State concerned 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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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 Decision2010-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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