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    Summary
    EudraCT Number:2017-002754-36
    Sponsor's Protocol Code Number:3119002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002754-36
    A.3Full title of the trial
    Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS
    Effetti di levosimendan orale (ODM-109) sulla funzionalità respiratoria nei pazienti con sclerosi laterale amiotrofica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS)
    Effetti di levosimendan orale sulla funzionalità respiratoria nei pazienti affetti da sclerosi laterale amiotrofica (SLA)
    A.3.2Name or abbreviated title of the trial where available
    REFALS
    REFALS
    A.4.1Sponsor's protocol code number3119002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03505021
    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 SponsorORION CORPORATION ORION PHARMA
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOrion Corporation
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Corporation
    B.5.2Functional name of contact pointSenior Regulatory Affairs Manager
    B.5.3 Address:
    B.5.3.1Street AddressOrionintie 1A
    B.5.3.2Town/ cityEspoo
    B.5.3.3Post codeFI-02200
    B.5.3.4CountryFinland
    B.5.4Telephone number00358104263059
    B.5.5Fax number0000000
    B.5.6E-mailclinicaltrials@orionpharma.com
    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 Yes
    D.2.5.1Orphan drug designation numberapplication pending
    D.3 Description of the IMP
    D.3.1Product nameOral LEVOSIMENDAN
    D.3.2Product code [ODM-109]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLEVOSIMENDAN
    D.3.9.1CAS number 141505-33-1
    D.3.9.2Current sponsor codeODM-109
    D.3.9.4EV Substance CodeSUB08493MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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, hard
    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
    Amyotrophic lateral sclerosis (ALS)
    Sclerosi laterale amiotrofica (SLA)
    E.1.1.1Medical condition in easily understood language
    ALS is a disorder that affects the function of nerves and muscles, eventually taking away the ability to walk, dress, write, speak, swallow, and breathe and shortening the life span.
    SLA è un disordine che impatta sulla funzione dei nervi e dei muscoli, togliendo progressivamente la capacità di camminare, vestire, scrivere, parlare, deglutire, respirare e accorciando la vita.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to confirm that levosimendan can significantly improve respiratory function measured by supine slow vital capacity (SVC) in amyotrophic lateral sclerosis (ALS) patients.
    l'obiettivo primario di questo studio è confermare che levosimendan può migliorare significativamente la funzionalità respiratoria misurata dalla capacità vitale lenta (slow vital capacity, SVC) in posizione supina nei pazienti affetti da sclerosi laterale amiotrofica (SLA).
    E.2.2Secondary objectives of the trial
    The secondary objective is to confirm that levosimendan improves the functionality of subjects, measured by Revised ALS Functional Rating
    Scale (ALSFRS-R), Clinical Global Impression (CGI), Borg Category Ratio 10 (CR10) scale on dyspnea (shortness of breath), Epworth Sleepiness scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). The latter two
    are sleep scales assessing daytime somnolence and sleep quality, respectively. In addition, the long-term tolerability and safety of levosimendan in ALS patients will be evaluated, assessing up to 48 weeks of exposure.
    L'obiettivo secondario è confermare che levosimendan migliora la funzionalità dei soggetti, misurata con la Scala rivista di valutazione funzionale SLA (Revised ALS Functional Rating Scale, ALSFRS-R), l'Impressione clinica globale (Clinical Global Impression, CGI), la scala del rapporto di categoria (CR10) di Borg modificata per la dispnea (respiro affannoso), la Scala della sonnolenza di Epworth (Epworth Sleepiness Scale, ESS) e con l'Indice della qualità del sonno di Pittsburgh (Pittsburgh Sleep Quality Index, PSQI). Le ultime due sono scale del sonno che valutano, rispettivamente, la sonnolenza durante il giorno e la qualità del sonno. Inoltre, saranno valutate la tollerabilità e la sicurezza a lungo termine di levosimendan nei pazienti affetti da SLA, esaminando un periodo di esposizione di 48 settimane al massimo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Optional Future Genetic Research, as part of the main protocol. The DNA of subjects who have given a separate Pharmaco Genetic Informed Consent will be stored to allow possible exploratory PG research to assess whether genetic polymorphisms relate to the absorption, distribution, metabolism, excretion, pharmacodynamics or safety of levosimendan.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Ricerca Genetica Futura facoltativa, come parte del protocollo principale. il DNA di quei soggetti che hanno firmato un consenso informato di farmacogenetica separato sarà conservato per permettere possibili ricerche FG esplorative per stabilire se i polimorfismi genetici sono correlati all'assorbimento, distribuzione, metabolismo, escrezione, farmacodinamiica o sicurezza di levosimendan
    E.3Principal inclusion criteria
    1. Written or verbal informed consent (IC) for participation in the study
    will be obtained from the subject. In case that the study subject
    him/herself cannot sign the IC due to severe muscle weakness, a
    witness may sign the consent form to indicate that the subject has given
    verbal consent.
    2. Age at least 18 years.
    3. Male or female subjects with diagnosis of laboratory supported probable, probable or definite ALS according to El Escorial revised
    criteria (Brooks BR et al., 2000). Full electromyogram (EMG) report
    available consistent with ALS (but not necessarily fulfilling the
    electrodiagnostic criteria for ALS) from an experienced
    neurophysiologist.
    4. Able to swallow study treatment capsules, and in the opinion of the
    investigator, is expected to continue to do so during the study.
    5. Sitting SVC between 60-90% of the predicted value for age, height
    and sex at screening visit.
    6. Disease duration from symptom onset (defined by first muscle
    weakness or dysarthria) 12- 48 months at the time of visit 1 (baseline).
    7. Able to perform supine SVC in an adequate and reliable way at
    screening and baseline visits as judged by the investigator.
    8. Subjects with or without riluzole and/or edavarone. If using riluzole (any daily dose up to 100 mg), the dose must have been stable for at least 4 weeks before the screening visit and should not be changed during the study. If using edavarone, the treatment should have been started at least 4 weeks before the screening visit (at least one 28-day treatment cycle as indicated) and should not be changed during the study. If not on riluzole and/or edavarone, the respective tretments should not be started during the study.
    1. consenso informato scritto o orale ottenuto dal soggetto. Nel caso in cui il soggetto non possa firmare di persona il consenso per debolezza muscolare severa, un testimone può firmare il consenso indicando che il soggetto ha dato consenso verbale.
    2. età superiore ai 18 anni
    3. soggetti di sesso maschile o femminile con diagnosi di SLA probabile o definita, supportata da esami di laboratorio e in accordo con i criteri El Escorial rivisti (Brooks BR et al.,2000). Disponibilità di un referto di elettromiografia completa (EMG) effettuta da un neurofisiologo esperto e compatibile con la SLA (non deve necessariamente soddisfare i criteri elettrodiagnostici per la SLA).
    4. capacità di deglutire le capsule di trattamento dello studio che, nel parere dello sperimentatore, verrà prevedibilmente conservata intatta durante lo studio.
    5. SVC in posizione seduta tra il 60-90% del valore atteso per età, altezza e sesso alla visita di screening.
    6. durata della malattia dall'insorgenza dei sintomi (definiti dalla prima debolezza muscolare o disartria) di 12-48 mesi al momento della visita 1 (basale).
    7. capacità di eseguire la SVC in posizione supina alla visita di screening e a quella basale, secondo giudizio dello sperimentatore.
    8. soggetti con o senza riluzolo e/o edaravone. In caso di utilizzo di riluzolo (qualunque dose giornaliera fino a 100 mg), la dose deve essere rimasta stabile per almeno 4 settimane prima della visita di screening e deve rimanere inalterata durante lo studio. In caso di utilizzo di edaravone, il trattamento deve essere avviato almeno 4 settimane prima della visita di screening (almeno un ciclo di trattamento di 28 giorni, come da indicazioni) e deve rimanere inalterato durante lo studio. In assenza di trattamento con riluzolo e/o edaravone, i rispettivi trattamenti non devono essere avviati durante lo studio.
    E.4Principal exclusion criteria
    1. Subject in whom other causes of neuromuscular weakness have not
    been excluded.
    2. Subject with a diagnosis of another neurodegenerative disease (e.g.
    Parkinson's or Alzheimer's disease).
    3. Assisted ventilation of any type within 3 months before the screening
    visit or at screening.
    4. Any use of a diaphragm pacing system (DPS) within 3 months before
    the screening visit.
    5. Any form of stem cell or gene therapy for the treatment of ALS.
    6. Known hypersensitivity to levosimendan.
    7. Administration of levosimendan within 3 months before the screening
    visit or previous participation in the present phase III study or earlier
    study with oral levosimendan in ALS patients (LEVALS).
    8. Any use of tirasemtiv or reldesemtiv within 1 month before the screening visit.
    9. Participation in a clinical trial with any experimental treatment within
    30 days or within 5 half-lives of that treatment (whichever is longer)
    before the screening visit.
    10. Any botulinum toxin use within 3 months before the screening visit.
    11. Recorded diagnosis or evidence of major psychiatric diagnosis,
    significant cognitive impairment or clinically evident dementia that may
    interfere with the patient's ability to comply with study procedures.
    12. Pulmonary illness (e.g. asthma or COPD) requiring regular
    treatment.
    13. Haemodynamically significant uncorrected valve disease or
    hypertrophic cardiomyopathy or restrictive cardiomyopathy.
    14. Any cardiovascular event (e.g. myocardial infarction, HF, arrhythmia
    or stroke) requiring hospitalisation within 3 months before the screening
    visit.
    15. History of Torsades de Pointes (TdP) or diagnosed long QTsyndrome.
    16. History of life-threatening ventricular arrhythmia, unless treated
    with reliable measures to prevent recurrence (e.g. with placement of
    implantable cardioverter defibrillator [ICD] or catheter ablation).
    17. History of second or third degree atrioventricular (AV) block or sinus
    node disease at screening, if not treated with pacemaker.
    18. HR repeatedly > 100 bpm in the 12-lead ECG after a 5-minute rest at
    screening. If the HR is > 100 bpm in the first recording, then the second
    recording must be done after another 5 min rest to confirm HR > 100 pbm.
    19. Systolic blood pressure (SBP) < 90 mmHg at screening.
    20. Potassium < 3.7 mmol/l or > 5.5 mmol/l at screening.
    21. Severe renal impairment (cretinine clearance <30 ml/min at screening), creatinine >170 µmol/l at screening or on dialysis.
    22. Blood haemoglobin < 10 g/dl at screening or blood donation or loss
    of significant amount of blood within 60 days before the screening visit.
    23. Clinically significant hepatic impairment at the discretion of the
    investigator.
    24. Body mass index (BMI) = 18.5kg/m2 (BMI = weight/height2).
    25. Women who are lactating or of reproductive age without a negative pregnancy test and
    without a commitment to using a highly effective method of contraception (e.g. oral hormonal contraceptives associates with inhibition of ovulation, intrauterine devices and long acting progestin agents), if sexually active during the study, and for 1 month after last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included.
    26. Patient judged to be actively suicidal by the investigator during 3
    months before the screening visit.
    27. Patients with known history of human immunodeficiency virus (HIV)
    infection.
    28. Any other clinically significant cardiovascular, gastrointestinal,
    hepatic, renal, neurological or psychiatric disorder or any other major
    concurrent illness that in the opinion of the investigator could interfere
    with the interpretation of the study results or constitute a health risk for
    the subject if he/she took part in the study.
    1. Soggetto in cui non sono state escluse altre cause di debolezza neuromuscolare.
    2. Soggetto con una diagnosi di altra malattia neurodegenerativa (per es. morbo di Parkinson o malattia di Alzheimer).
    3. Ventilazione assistita di qualsiasi tipo nei 3 mesi precedenti alla visita di screening o allo screening.
    4. Qualsiasi uso di un sistema di stimolazione del diaframmatica (DPS) nei 3 mesi precedenti alla visita di screening.
    5. Qualsiasi forma di terapia con cellule staminali o genica per il trattamento della SLA.
    6. Ipersensibilità nota a levosimendan.
    7. Somministrazione di levosimendan nei 3 mesi precedenti alla visita di screening o precedente partecipazione all’attuale studio di fase III o a uno studio precedente con levosimendan per via orale in pazienti affetti da SLA (LEVALS).
    8. Qualsiasi utilizzo di tirasemtiv o reldesemtiv entro 1 mese prima della visita di screening.
    9. Partecipazione a una sperimentazione clinica con qualsiasi trattamento sperimentale nei 30 giorni o nelle 5 emivite di quel trattamento (a seconda di quale sia più lungo) prima della visita di screening.
    10. Utilizzo di qualsiasi tossina botulinica nei 3 mesi precedenti alla visita di screening.
    11. Diagnosi registrata o evidenza di diagnosi psichiatrica maggiore, insufficienza cognitiva significativa o demenza clinicamente evidente che possa interferire con la capacità del paziente di conformarsi alle procedure dello studio.
    12. Malattia polmonare (per es. asma o BPCO) che richiede un trattamento regolare.
    13. Valvulopatia emodinamicamente significativa non corretta o cardiomiopatia ipertrofica o cardiomiopatia restrittiva.
    14. Qualsiasi evento cardiovascolare (per es. infarto dei miocardio, insufficienza cardiaca [HF], aritmia o ictus) che richiede ricovero ospedaliero nei 3 mesi precedenti alla visita di screening.
    15. Anamnesi di Torsade de Pointes (TdP) o diagnosi di sindrome del QT lungo.
    16. Anamnesi di aritmia ventricolare pericolosa potenzialmente letale, salvo se trattata con misure affidabili per prevenire la recidiva (per es. con inserimento di defibrillatore cardioverter impiantabile [ICD] o ablazione transcatetere).
    17. Anamnesi di blocco atrioventicolare (AV) di secondo o terzo grado o disfunzione del nodo del seno allo screening, se non trattati con pacemaker.
    18. Ritmo cardiaco (HR) ripetutamente >100 bpm all’ECG a 12 derivazioni dopo un riposo di 5 minuti allo screening. Se il ritmo cardiaco (HR) è >100 bpm alla prima registrazione, la seconda registrazione deve essere effettuata dopo un altro riposo di 5 minuti per confermare che HR >100 bpm.
    19. Pressione sanguigna sistolica (PSS) <90 mmHg allo screening.
    20. Potassio <3,7 mmol/l o >5,5 mmol/l allo screening.
    21. Grave insufficienza renale (clearance della creatinina <30 ml/min allo screening), creatinina >170 µmol/l allo screening o in dialisi.
    22. Emoglobina del sangue <10 g/dl allo screening o donazione di sangue o perdita di una quantità significativa di sangue nei 60 giorni precedenti la visita di screening.
    23. Insufficienza epatica clinicamente significativa a discrezione dello sperimentatore.
    24. Indice di massa corporea (IMC) =18,5 kg/m2 (IMC = peso/altezza2).
    25. Donne che allattano al seno o in età fertile senza un test di gravidanza con esito negativo e senza l’impegno di utilizzare un metodo contraccettivo altamente efficace (ad es. contraccettivi ormonali orali associati ad agenti inibenti l’ovulazione, dispositivi intrauterini e agenti progestinici ad azione prolungata), se sessualmente attive, durante lo studio e per 1 mese dopo l’ultima dose di trattamento dello studio. Le donne in post menopausa (1 anno dall’ultimo ciclo mestruale), sottoposte a un intervento di sterilizzazione o isterectomia, non sono da considerarsi in età fertile e possono essere incluse.
    [etc...non c'è spazio sufficiente]
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable SVC % measured in supine position.
    Variabile di efficacia primaria nella % della capacità vitale lenta (SVC) in posizione supina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary evaluation will be performed at 12 weeks and contrasts will be used to obtain estimates for each of the visit from the primary model including all SVC measurements prior to 12 weeks.
    Additional evaluations will be performed including all data through 48 weeks.
    La valutazione primaria verrà effettuata a 12 settimane e saranno utilizzati contrasti per ottenere delle stime per ognuna delle visite dal modello primario, includendo tutte le misure della SVC prima di 12 settimane. Verranno effettuate delle valutazioni supplementari includendo tutti i dati nel corso di 48 settimane.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints will be tested in following hierarchy to preserve the overall alpha level:
    1. Combined assessment of ALSFRS-R function and survival through 48 weeks
    2. Time to respiratory event trough 48 weeks
    3. CGI through 48 weeks
    4. Supine Borg CR 10 scale at 12 weeks
    5. Slope of decline in respiratory function of ALSFRS-R through 48 weeks
    The efficacy variables time to respiratory event, time to NIV or death, time to SVC (supine) decline of 20%, time to SVC (supine) = 50% of predicted, time to ALSFRS-R total score decline of 20% and time to decline in ALSFRS-R respiratory domain will be evaluated.
    Gli endpoint di efficacia secondari saranno testati secondo la seguente gerarchia per preservare il livello alfa globale: 1. Valutazione combinata della scala di valutazione funzionale rivista della SLA (ALSFRS-R) e sopravvivenza nel corso delledi 48 settimane
    2. Tempo all'evento respiratorio nel corso delledi 48 settimane
    3. Impressione clinica globale (CGI) nel corso delle 48 settimane
    4. Scala di Borg CR10 in posizione supina a 12 settimane
    5. Peggioramento della funzionalità respiratoria secondo la ALSFRS-R nel corso delle 48 settimane
    Saranno valutate il tempo delle variabili di efficacia all¿evento respiratorio, il tempo alla ventilazione non invasiva (NIV) o al decesso, il tempo a una diminuzione del 20% della SVC (in posizione supina), tempo alla SVC (in posizione supina) =50 % del valore atteso, il tempo a una diminuzione del 20% del punteggio totale della ALSFRS-R e il tempo alla diminuzione nel dominio respiratorio della ALSFRS-R
    E.5.2.1Timepoint(s) of evaluation of this end point
    The total duration for double-blind comparison will be 48 weeks. Interim/futility analyses will be done when approximately 50% and 100% of the subjects have been treated for 12 weeks.
    La durata totale del confronto in doppio cieco sarà di 48 settimane. Le analisi ad interim/di futilità saranno effettuate quando circa il 50% e il 100% dei soggetti sar¿ stato trattato per 12 settimane.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    United States
    Austria
    Belgium
    Finland
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    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
    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 months6
    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: 440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 450
    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)
    There is an option to continue levosimendan treatment once the study subject has completed 48 weeks of treatment and the end-of-study visit of the current study in the form of an open-label extension study. Details will be included in a future protocol amendment before the first patient reaches end of study visit.
    Esiste la possibilità di continuare il trattamento con levosimendan quando il soggetto dello studio abbia completato le 48 settimane di trattamento e la visita di fine studio dello studio attuale, nella forma di uno studio di estensione in aperto. I dettagli verranno inclusi in un futuro emendamento al protocollo prima che il primo paziente giunga alla visita di fine studio.
    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 Decision2018-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-26
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