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    Summary
    EudraCT Number:2012-001965-34
    Sponsor's Protocol Code Number:oral-CORTEM
    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:2012-08-09
    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 number2012-001965-34
    A.3Full title of the trial
    Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.
    ENSAYO CLÍNICO, PILOTO, DE NO-INFERIORIDAD, MULTICÉNTRICO, CON ASIGNACIÓN ALEATORIA Y DOBLE CIEGO, PARA COMPARAR LA EFICACIA CLÍNICA, RADIOLÓGICA DE 2 DOSIS DE METILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL EN PACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.
    ESTUDIO PARA COMPARAR LA EFICACIA CLÍNICA, RADIOLÓGICA DE 2 DOSIS DE METILPREDNISOLONA ADMINISTRADAS POR VÍA ORAL EN PACIENTES EN BROTE DE ESCLEROSIS MÚLTIPLE
    A.4.1Sponsor's protocol code numberoral-CORTEM
    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 SponsorServicio de Neurología, HU. Germans Trias i Pujol
    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 supportMinisterio de Sanidad y Política Social, Convocatoria Investigación Independiente 2011
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Neurología, HU. Germans Trias i Pujol
    B.5.2Functional name of contact pointServicio de Neurología
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Canyet s/n
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493497 88 62
    B.5.5Fax number+3493497 87 82
    B.5.6E-mailcramot.germanstrias@gencat.cat
    D. IMP Identification
    D.IMP: 1
    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 Urbason 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis, S.A.
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    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 03/03/2375
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM HEMISUCCINATE
    D.3.9.4EV Substance CodeSUB26423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number625 to 1250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    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 15.0
    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 assess the non-inferiority of clinical and radiological efficacy of the treatment with lower-high dose of oMP (625mg/day for 3 days) vs high dose of oMP (1250mg/day for 3 days) in patients in relapse of MS, 28 days after the treatment.
    Evaluar la no inferioridad de la eficacia clínica y radiológica del tratamiento con una megadosis menos alta (625mg/24h) de MP administrada durante 3 días por vía oral versus megadosis más alta (1250mg/24) de MP administrada durante 3 días por vía oral en pacientes en brote de EM.
    E.2.2Secondary objectives of the trial
    To assess the safety, tolerability and quality of life of both doses.
    Evaluar la seguridad, tolerabilidad y calidad de vida de ambas pautas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment
    2. EDSS (previous to relapse) between 0 and 5
    3. MS relapse of moderate intensity (EDSS increase from 1 to 2.5 points) or severe intensity (EDSS increase > 3 points)
    - If EDSS previous relapse is available:
    • optic neuritis, myelitis or brainstem relapse: the EDSS should increase of 1 point in visual, pyramidal or brainstem system function
    • relapse in other location or uncertain location: the EDSS should increase at least 1 point
    - If EDSS previous relapse is not available:
    • optic neuritis, myelitis or brainstem relapse: the visual, pyramidal or brainstem system function should be > 2 points.
    • relapse in other location or uncertain location: EDSS should be > 2 points
    4. Recent clinical relapse onset (<15 days) without fever
    5. One month of clinical stability prior to relapse
    6. Signed informed consent
    7. Capacity to ingest the medication.
    1. Estar diagnosticado de EM Remitente Recurrente según los criterios de Mc Donald 2010
    2 . Tener un EDSS previo al brote entre 0 y 5
    3. Tener un brote de EM de intensidad moderada (aumento EDSS 1-2,5 puntos) o grave (aumento EDSS > 3 puntos):
    - en los casos en los que se disponga de un EDSS previo al brote actual:
    o si el brote consiste en una neuritis óptica, un síndrome de tronco o una mielitis, el EDSS ha debido de aumentar al menos 1 punto en el sistema funcional visual, de tronco o piramidal
    o si el brote es de otra localización o localización incierta, el EDSS debe aumentar al menos 1 punto
    - en los casos en los que no se disponga de un EDSS previo al brote actual:
    o si el brote consiste en una neuritis óptica, un síndrome de tronco o una mielitis, el EDSS debe de puntuar > 2 puntos en el sistema funcional visual, de tronco o piramidal
    o si el brote es de otra localización o localización incierta, el EDSS debe puntuar > 2 puntos en los brotes de otra topografía o topografía incierta
    4. Ausencia de fiebre
    5. Los síntomas han aparecido tras al menos un mes de estabilidad previa
    6. Firma del consentimiento informado a participar en el estudio antes de iniciar cualquier procedimiento propio del estudio
    7. Capacidad y voluntad para poder ingerir la medicación.
    E.4Principal exclusion criteria
    1. Doubts about the diagnosis of multiple sclerosis
    2. First episode of inflammatory neurological disease
    3. Secondary progressive MS or primary progressive MS
    4.Symptoms with lasted less than 24 hours of evolution
    5. Any degree of subjective or objective remission
    6. Treatment with corticosteroids during the previous 30 days
    7. Patients with immunosuppressive treatment (azathioprine, mitoxantrone, cyclophosphamide) or Natalizumab or Fingolimod
    8. Pregnancy or breastfeeding women or women of childbearing potential not using contraceptive measures
    9. Diseases with a contraindication of treatment with corticosteroids
    10. History of serious adverse reaction or hypersensitivity to drugs related to study medication
    11. Patients who could not be regular MRI, not collaborators or who requires anesthesia.
    12. Lactose intolerance
    13. Patients with allergies to contrast used in MRI
    14. Patients with renal impairement
    1. Existencia de dudas respecto al diagnóstico de esclerosis múltiple
    2. Primer episodio inflamatorio neurológico (brote)
    3.Esclerosis múltiple secundaria progresiva o primaria progresiva
    4.Síntomas que hayan durado menos de 24 horas
    5. Cualquier grado de remisión subjetiva u objetiva
    6. Estar en tratamiento o haber sido tratado con corticoides en los 30 días anteriores
    7. Pacientes en tratamiento con inmunosupresores (azatioprina, mitoxantrona, ciclofosfamida) o que hayan recibido Natalizumab o Fingolimod
    8. Embarazo o lactancia o mujeres en edad fértil que no utilicen medidas contraceptivas
    9. Enfermedades que contraindiquen el tratamiento con corticoides
    10. Antecedentes de reacción adversa grave o de hipersensibilidad a fármacos relacionados con la medicación a estudio
    11. Pacientes que no pudieran realizarse de forma periódica exploraciones de RM, pacientes no colaboradores o que requieran anestesia
    12. Pacientes intolerantes a la lactosa
    13. Pacientes con alergia al contraste utilizado en la RM
    14. Pacientes con insuficiencia renal conocida.
    E.5 End points
    E.5.1Primary end point(s)
    - To assess the non-inferiority in the improvement in relapse based on a margin of 1 on the EDSS disability scale of Kurtzke
    - and radiological: MRI improvement in the number of MRI lesions and gadolinium enhancement (Gd +)
    - Evaluación de la no-inferioridad en la mejoría del brote en base a un margen de no-inferioridad de 1 en la escala EDSS mediante la escala de valoración de discapacidad de Kurtzke
    - Mejoría del número de lesiones y en el realce de gadolinio (Gd+) en la RM cerebral
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, day 8 and day 29
    Basal, día 8 y día 29
    E.5.2Secondary end point(s)
    - Adverse events / tolerability
    - Questionnaires MSQOL-54 and MFIS
    - Acontecimientos adversos / Tolerabilidad
    - Cuestionarios MSQol-54 y MFIS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, day 8 and day 29
    Basal, día 8 y día 29
    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 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) 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 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 Yes
    E.8.2.3.1Comparator description
    Diferente dosis de metilprednisolona administrados por vía oral
    Different dossage of methylprednisolone administered orally
    E.8.2.4Number of treatment arms in the trial2
    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 concerned9
    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 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 48
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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)
    Normal treatment
    Práctica clínica habitual
    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 Decision2012-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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