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    Summary
    EudraCT Number:2021-001702-30
    Sponsor's Protocol Code Number:200175
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-001702-30
    A.3Full title of the trial
    « Use of Levosimendan as treatment of aneurysmal SubArachnoid Hemorrhage »
    Etude pilote comparant l’efficacité de l’ajout d’un traitement par Levosimendan à la prise en charge habituelle pour la prise en charge de la phase aiguë des hémorragies sous-arachnoïdiennes anévrysmales»
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Levosimendan as treatment of aneurysmal Hemorrhage
    Utilisation du Levosimendan dans la prise en charge des hémorragies anévrysmales»
    A.3.2Name or abbreviated title of the trial where available
    LEVOSAH
    LEVOSAH
    A.4.1Sponsor's protocol code number200175
    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 SponsorAPHP
    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 supportLaboratoire ORION corporation
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointDRCI; Hopital Saint-Louis
    B.5.3 Address:
    B.5.3.1Street Address1 Av Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailfadila.amerali@aphp.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 Yes
    D.2.1.1.1Trade name ZIMINO 2,5 mg/ml (Levosimendan)
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire ORION Corporation
    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 nameZIMINO 12,5 mg
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 placeboSolution 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
    subarachnoid hemorrhages of aneurysmal origin (HSAa)
    hémorragies sous-arachnoïdiennes d’origine anévrysmales (HSAa)
    E.1.1.1Medical condition in easily understood language
    subarachnoid hemorrhages of aneurysmal origin (HSAa)
    hémorragies sous-arachnoïdiennes d’origine anévrysmales (HSAa)
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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
    To assess the efficacy of levosimendan in patients admitted to intensive care for HSAa at high risk of ASV (WFNS Grade I to IV and Fisher score 3 or 4) on the occurrence of ASV.
    Evaluer l’efficacité du levosimendan chez des patients admis en réanimation pour HSAa à haut risque de VSA (Grade WFNS I à IV et score de Fisher 3 ou 4) sur la survenue du VSA.
    E.2.2Secondary objectives of the trial
    1.evaluate the effects of treatment with Levosimendan on: mortality on D14, D28 and D90; the occurrence of ICD within 14 days of the bleeding.
    2.Assess the effects of levosimendan treatment on mRS at 3 months
    3.assessment of the effects of levosimendan treatment on cardiac dysfunction
    4.evaluation of the effects of levosimendan treatment on cerebral perfusion
    5.assessment of the effects of treatment with levosimendan on the length of stay in intensive care
    1. évaluer les effets du traitement par Levosimendan sur : la mortalité à J14, J28 et J90 ; la survenue d’un DCI dans les 14 jours suivant le saignement.
    2. évaluer les effets du traitement par levosimendan sur le mRS à 3 mois
    3. évaluation des effets du traitement par levosimendan sur la dysfonction cardiaque
    4. évaluation des effets du traitement par levosimendan sur la perfusion cérébrale
    5. évaluation des effets du traitement par levosimendan sur la durée de séjour en réanimation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - All adult patients ( 18 to 75),
    - hospitalized in surgical intensive care at Lariboisière for subarachnoid hemorrhage of aneurysm origin
    - (HSAa) clinical score WFNS I to IV and Fisher score 3 or 4.
    - Tous les patients majeurs ( 18 ans à 75 ans),
    - hospitalisés en réanimation chirurgicale à Lariboisière pour hémorragie sous-arachnoïdienne d’origine anévrysmale
    - (HSAa) de score clinique WFNS I à IV et score Fisher 3 ou 4.
    E.4Principal exclusion criteria
    pregnant women
    - contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension, tachycardia, cardiac mechanical obstructions)
    - severe renal impairment (creatinine clearance <30 ml / min)
    - severe hepatic insufficiency (signs of hepatic encephalopathy);
    - history of torsades de pointes
    - severe pre-existing neuro-vascular pathologies.
    - Moribund patients.
    - les femmes enceintes
    - les contre-indications au levosimendan (comprenant l’hypersensibilité au levosimendan, l’hypotension sévère, la tachycardie, les obstructions mécaniques cardiaques)
    - insuffisance rénale sévère (clairance de la créatinine < 30 ml/min)
    - insuffisance hépatique sévère (signes d’encéphalopathie hépatique);
    - antécédents de torsades de pointes
    - pathologies neuro-vasculaire sévères préexistantes.
    - Patients moribonds.
    E.5 End points
    E.5.1Primary end point(s)
    the occurrence of cerebral arterial vasospasm within 14 days of the bleeding
    la survenue d’un vasospasme artériel cérébral dans les 14 jours suivants le saignement
    E.5.1.1Timepoint(s) of evaluation of this end point
    June 2024
    Juin 2024
    E.5.2Secondary end point(s)
    1.the cumulative incidence of death rate, ICDs and vasospasms
    2. The mRS score at 3 months
    3. The impact of Levosimendan treatment on cardiac dysfunction will be assessed by:
    - Peak value of serum catecholamines (noradrenaline, adrenaline) within 5 days of admission
    - Number of days alive on D14 without catecholamines and maximum dose (noradrenaline, dobutamine, dopamine, adrenaline, isoprenaline) if used.
    - The time to onset of the troponin and BNP peak and their values
    - Systolic and diastolic heart function assessed by echocardiography

    4. The effect of treatment with Levosimendan on cerebral perfusion will be assessed by:
    - Daily clinical course with Glasgow score reading
    - Evolution of transcranial Doppler performed on a daily basis
    - Occurrence and extent of secondary cerebral ischemia diagnosed by systematic MRI at 3 months.
    1. l’incidence cumulée du taux de mortalité, des DCI et des vasospasmes
    2. Le score mRS à 3 mois
    3. La répercussion du traitement par Levosimendan sur la dysfonction cardiaque sera évaluée par :
    - Valeur du pic de catécholamines (noradrénaline, adrénaline) sériques dans les 5 jours suivant l’admission
    - Nombres de jours vivants à J14 sans catécholamines et dose maximum (noradrénaline, dobutamine, dopamine, adrénaline, isoprénaline) si utilisées.
    - Le délai de survenu du pic de troponine et BNP et leurs valeurs
    - Fonction cardiaque systolique et diastolique évaluée par échocardiographie
    4. La répercussion du traitement par Levosimendan sur la perfusion cérébrale sera évalué par :
    - L’évolution clinique quotidienne avec relevé du score de Glasgow
    - Evolution des doppler transcrâniens réalisés de façon quotidienne
    - Survenue et étendue des ischémies cérébrales secondaires diagnostiquées par une IRM systématique à 3 mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    June 2021
    Juin 2021
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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
    LVLS
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    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.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient in a medical emergency
    Patient en état d'urgence médicale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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
    Non
    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 Decision2021-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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