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    Summary
    EudraCT Number:2015-000927-96
    Sponsor's Protocol Code Number:SUCRE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-000927-96
    A.3Full title of the trial
    Treatment of chronic subdural hematoma by corticosteroids : a prospective randomized study
    Traitement par corticoïdes des hématomes sous-duraux chroniques : une étude prospective randomisée
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of chronic subdural hematoma by corticosteroids : a prospective randomized study
    Traitement par corticoïdes des hématomes sous-duraux chroniques : une étude prospective randomisée
    A.3.2Name or abbreviated title of the trial where available
    Morandi SUCRE
    Morandi SUCRE
    A.4.1Sponsor's protocol code numberSUCRE
    A.5.4Other Identifiers
    Name:SUCRENumber:Morandi SUCRE
    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 SponsorCHU of Rennes
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU of Rennes
    B.5.2Functional name of contact pointGanivet
    B.5.3 Address:
    B.5.3.1Street Address2 rue Henri Le Guilloux
    B.5.3.2Town/ cityRennes cedex 9
    B.5.3.3Post code35033
    B.5.3.4CountryFrance
    B.5.4Telephone number33299282555
    B.5.5Fax number33299283722
    B.5.6E-mailanne.ganivet@chu-rennes.fr
    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 No
    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 namemethylprednisolne
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    chronic subdural hematoma
    hématome sous-dural chronique
    E.1.1.1Medical condition in easily understood language
    chronic subdural hematoma
    hématome sous-dural chronique
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10049163
    E.1.2Term Chronic subdural hematoma
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    show that a treatment with methylprednisolone can decrease the need for surgical treatment in patients with chronic subdural hematoma without clinical or radiological signs of severity
    évaluer l’efficacité du traitement par corticoïdes chez des patients ayant un hématome sous-dural chronique sans facteurs de gravité cliniques ou radiologiques
    E.2.2Secondary objectives of the trial
    assess the effect of methylprednisolone on :
    -quality of life evolution
    -morbidity and mortality
    -radiological evolution of the lesions
    évaluer l’effet du traitement par corticoïdes sur :
    -la qualité de vie
    -la morbi-mortalité
    -l’efficacité radiologique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 18 years old
    -With chronic or subacute, uni- or bilateral subdural hematoma
    -Confirmed by cerebral CT scan without contrast enhancement
    -Without clinical and radiological signs of severity
    -Written informed consent from patients or thier next of kin
    -Age > 18 ans
    -Avec un hématome sous-dural chronique ou subaigu, uni ou bilatéral
    -Confirmé par un scanner cérébral sans prise de contraste
    -Sans signes cliniques et radiologiques de gravité
    -Consentement libre et éclairé par écrit par le patient ou par un membre de la famille / une personne de confiance
    E.4Principal exclusion criteria
    -Contraindication for methylprednisolone
    -Previous surgery for chronic subdural hematoma during the past 6 months
    -Pre-existing severe dementia
    -Existing neurological pathology that can be associated with dementia
    -Patients treated with corticosteroids
    -Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty
    -Contre-indication à la méthylprednisolone
    -Chirurgie pour un hématome sous-dural chronique au cours des 6 derniers mois
    -Démence sévère
    -Pathologie neurologique existante pouvant être associée à la démence
    -Traitement par corticoïdes
    -Personne majeure faisant l’objet d’une protection légale (sauvegarde de justice, curatelle, tutelle), personne privée de liberté
    E.5 End points
    E.5.1Primary end point(s)
    rate of surgical treatment of the chronic subdural hematoma
    taux de recours à la chirurgie de l’hématome sous-dural chronique
    E.5.1.1Timepoint(s) of evaluation of this end point
    at one month
    à 1 mois
    E.5.2Secondary end point(s)
    -Quality of life assessed by the SF 12 scale
    -Time to surgical treatment
    -Functional scales : daily living, cognitive and modified Rankin Scale
    -Plasma sodium, potassium and fasting glucose
    -Occurrence of adverse events potentially related to methylprednisolone
    -Survival
    -Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated
    -Qualité de vie évaluée par l'échelle SF 12
    -Temps de traitement chirurgical
    -Échelles fonctionnelles : vie quotidienne (AIJD), cognitives (MMSE) et échelle de Rankin modifiée
    -Sodium, potassium et glycémie à jeun
    -Survenue d'événements indésirables potentiellement liés à la méthylprednisolone
    -Survie
    -Amélioration radiologique définie par la réduction de l'épaisseur maximale de l'hématome et la réduction de la ligne médiane
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Quality of life assessed by the SF 12 scale at 1, 3 and 6 months
    -Time to surgical treatment at 6 months
    -Functional scales at 1, 3 and 6 months
    -Plasma sodium, potassium and fasting glucose at day 0, 7, 14, and 21 and at 1 month
    -Occurrence of adverse events potentially related to methylprednisolone at 6 months
    -Survival at 6 months
    -Radiological improvement at 1, 3 and 6 months
    -Qualité de vie évaluée par l'échelle SF 12 à 1, 3 et 6 mois
    -Temps pour recourir à un traitement chirurgical au cours des 6 premiers mois
    -Échelles fonctionnelles : vie quotidienne (AIJD), cognitives (MMSE) et échelle de Rankin modifiée à 1, 3 et 6 mois
    -Sodium, potassium et glycémie à jeun aux jours 0, 7, 14, et 21 et à 1 mois
    -Survenue d'événements indésirables potentiellement liés à la méthylprednisolone à 6 mois
    -Survie à 6 mois
    -Amélioration radiologique à 1, 3 et 6 mois
    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 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 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 concerned19
    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 Yes
    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
    dernière visite du dernier patient
    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
    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.1.3Elderly (>=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 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
    -Written informed consent from thier next of kin according to the patients cognitive status
    -Consentement libre et éclairé par écrit par un membre de la famille / une personne de confiance si l’état cognitif du patient ne le permet pas
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state226
    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
    aucun
    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 Decision2015-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-20
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