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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006301-10
    Sponsor's Protocol Code Number:MAGNA
    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:2012-04-02
    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 number2011-006301-10
    A.3Full title of the trial
    Perioperative Magnesium Sulphate as a cerebral protector in neurosurgical patients
    Sulfato de Magnesio perioperatorio como factor de protección cerebral en pacientes neuroquirúrgicos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    N/A
    A.4.1Sponsor's protocol code numberMAGNA
    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 SponsorFundació Clinic per a la Recerca Biomèdica
    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
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Unit
    B.5.2Functional name of contact pointCTU
    B.5.3 Address:
    B.5.3.1Street Addressvillarroel 170
    B.5.3.2Town/ citybarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754003343
    B.5.5Fax number34932279877
    B.5.6E-mailsvarea@clinic.ub.es
    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 Magnesio (sulfato de) Lavoisier 15%
    D.2.1.1.2Name of the Marketing Authorisation holderCDM Lavoisier
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMagnesium sulfate
    D.3.4Pharmaceutical form Solution for 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.3.9.1CAS number 7487-88-9
    D.3.9.3Other descriptive nameMAGNESIUM SULFATE
    D.3.9.4EV Substance CodeSUB14448MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    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 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 placeboSolvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient who are going to be under cerebral parenchyma resection, due to epilepsy or tumor
    pacientes sometidos a resección de parénquima cerebral debido a tumor o epilepsia
    E.1.1.1Medical condition in easily understood language
    Patient who are going to be under cerebral parenchyma resection, due to epilepsy or tumor
    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 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10039911
    E.1.2Term Seizures (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006153
    E.1.2Term Brain tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the relationship between Magnesium Sulphate administration and levels of S100B protein in serum of patiens undergoing supratentorial brain parenquimal resection
    Determinar la relación entre la administración de sulfato de magnesio y los niveles de proteína S100, subunidad B, en suero, en pacientes sometidos a cirugía de resección de parénquima cerebral supratentorial.
    E.2.2Secondary objectives of the trial
    Determine the relationship between Magnesium Sulphate administration and levels of S100B protein and Specific Neuronal Enolase (SNE) at different points of the postoperative course.
    Determine the relationship between Magnesium Sulphate administration and improvement on Magnetic Resonance Imaging at early postoperative moment and 6 months after surgery, related to preoperative imaging.
    Determine the relationship between Magnesium Sulphate administration and improvement on Neuropsychological Assessment at early postoperative moment and 1, 6 and 12 months after surgery.
    Determine the relationship between Magnesium Sulphate administration and Glasgow Outcome Scale (GOS) and Mortality at 6 and 12 months after surgery.
    Determine how Apolipoprotein E genotype affects neurological outcome
    Determinar la relación entre la administración de sulfato de magnesio y los niveles de proteína S100, subunidad B, y Enolasa Neuronal Específica en suero en diferentes momentos del postoperatorio.
    Determinar la relación entre la administración de sulfato de magnesio y la mejoría en algunos parámetros de la resonancia magnética comparando preoperatoria, con una adquisición postoperatoria precoz, y otra a los 6 meses.
    Determinar la relación entre la administración de sulfato de magnesio y la mejoría en una batería de test neuropsicológicos, preoperatoria, al mes, 6 y 12 meses de la cirugía.
    Determinar la relación entre la administración de sulfato de magnesio y el GOS y la mortalidad a los 6 y 12 meses.
    Determinar como el genotipo de la Apolipoproteína E afecta al pronóstico neurológico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and females older than 18 years.
    -Undergoing supratentorial parenchyma resection surgery.
    -Capable of collaborate on probes and explorations included in the study.
    -Signature the written informed consent form.
    - Pacientes de ambos sexos mayores de 18 años.
    - Intervenido en el hospital Clínic para cirugía de resección de parénquima cerebral
    - Capaz de someterse a las pruebas y exploraciones que requiere el estudio.
    -Otorga su Consentimiento Informado por escrito tras ser informado.
    E.4Principal exclusion criteria
    - Life expectancy less than 12 months due to the suspected histological type of tumour.
    - Hypothalamic-pituitary axis illness.
    - Presence of Melanoma previously.
    - Glomerular filtration rate less than 60 mL/min.
    - Thyroid or parathyroid glands pathology.
    - Myasthenia gravis.
    - Respiratory depression.
    - Pregnancy or breastfeeding.
    - Pacientes con una esperanza de vida inferior a 12 meses debido al tipo histológico sospechado del tumor.
    - Pacientes con enfermedades del eje hipotálamo-hipofisario.
    - Pacientes con antecedentes de melanoma.
    - Pacientes con un filtrado glomerular por debajo de 60 mL/min.
    - Paciente con patología de tiroides o paratiroides.
    - Miastenia gravis.
    - Insuficiencia respiratoria.
    - Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Serum S100B protein level?s of patients undergoing supratentorial brain parenquimal resection
    Niveles de proteína S100, subunidad B, en suero, en pacientes sometidos a cirugía de resección de parénquima cerebral supratentorial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours after the end of the surgery
    A las 2 horas de finalizar la cirugía.
    E.5.2Secondary end point(s)
    Levels of S100B protein and Specific Neuronal Enolase (SNE).
    Improvement on Magnetic Resonance Imaging.
    improvement on Neuropsychological Assessment.
    Glasgow Outcome Scale (GOS) and Mortality.
    Apolipoprotein E genotype.
    Niveles de proteína S100, subunidad B, y Enolasa Neuronal Específica en suero.
    Determinados parámetros de la resonancia magnética.
    Batería de test neuropsicológicos.
    GOS y la mortalidad.
    Genotipo de la Apolipoproteína E.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It depends on the type of end point:
    S100B protein: pre-surgery; daily postoperative until day 10.
    SNE: pre-surgery; 2 hours after end of surgery; every 48 hours until day 10.
    RMI: pre-surgery; early postoperative; 6 months postoperative.
    Neuropsichologycal assessment: pre-surgery; early postoperative; 1, 6 and 12 months postoperative.
    GOS: 6 and 12 month postoperative.
    Mortality: 6 and 12 month postoperative.
    Apolipoprotein E genotype: pre-surgery.
    Depende del end point:
    S100B: preoperatoria; diariamente tras la cirugía hasta completar 10 días.
    SNE: preoperatoria; a las 2 horas de finalizar la cirugía; cada 48 horas hasta completar 10 días.
    RMI: preoperatoria; postoperatoria precoz (antes del día 5); a los 6 meses de las cirugía.
    Test neuropsicológicos: preoperatorio; postoperatorio precoz; a mes, 6 y 12 mese de la cirugía
    GOS: a los 6 y 12 meses de la cirugía.
    Mortalidad: a los 6 y 12 meses de la cirugía.
    Genotipo de la Apolipoproteína E: preoperatorio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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
    Last visit of las pacient included
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state80
    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)
    N/A
    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 Decision2012-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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