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    Summary
    EudraCT Number:2020-005947-22
    Sponsor's Protocol Code Number:SIPO20
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005947-22
    A.3Full title of the trial
    Effect of siponimod on relevant imaging and immunological hallmarks of progressive multiple sclerosis
    Effetto del siponimod su variabili di neuroimmagine e immunologiche in pazienti con sclerosi multipla secondaria progressiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of siponimod on progressive multiple sclerosis
    Effetto del siponimod in pazienti con sclerosi multipla progressiva
    A.3.2Name or abbreviated title of the trial where available
    Effect of siponimod on progressive multiple sclerosis
    Effetto del siponimod in pazienti con sclerosi multipla progressiva
    A.4.1Sponsor's protocol code numberSIPO20
    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 SponsorAZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    B.1.3.4CountryItaly
    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 supportNovartis Farma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Universitaria Integrata Verona
    B.5.2Functional name of contact pointUOC Neurologia B
    B.5.3 Address:
    B.5.3.1Street AddressPiazzale L.A. Scuro, 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37134
    B.5.3.4CountryItaly
    B.5.6E-mailmassimiliano.calabrese@univr.it
    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 nameSiponimod 2 mg
    D.3.2Product code [Siponimod]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1230487-00-9
    D.3.9.2Current sponsor codeSiponimod
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 nameSiponimod 0,25 mg
    D.3.2Product code [Siponimod]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1230487-00-9
    D.3.9.2Current sponsor codeSiponimod
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 3
    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 nameSiponimod 1 mg
    D.3.2Product code [Siponimod]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSiponimod
    D.3.9.1CAS number 1230487-00-9
    D.3.9.2Current sponsor codeSiponimod
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active progressive MS course after an initial relapse clinical course
    Forma progressiva di sclerosi multipla dopo un esordio di malattia con forma recidivante-remittente
    E.1.1.1Medical condition in easily understood language
    Active progressive MS
    Forma progressiva di sclerosi multipla
    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 10053395
    E.1.2Term Progressive 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 evaluate the effect of siponimod on paramagnetic rim lesions (as visualized by MRI) in secondary progressive MS patients.
    Valutare l'effetto di siponimod in pazienti con SM secondaria progressiva con riferimento a lesioni paramagnetiche visualizzate dalla risonanza magnetica.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of siponimod in modifying the CSF and serum levels of biomarkers of microglial/macrophage activity and the axonal/neuronal damage.
    - To evaluate the effect of siponimod on the clinical and cognitive worsening in progressive MS patients and its long-term safety
    Valutare l'effetto di siponimod in pazienti con SM secondaria progressiva con riferimento a:
    - livelli sierici e liquorali dei biomarcatori dell'attività microglia / macrofagica e del danno assonale / neuronale;
    - parametri clinici e cognitivi;
    - sicurezza a lungo termine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-65 years.
    • Active progressive MS course after an initial relapse clinical course defined as an EDSS progression of at least 1 point with a history of relapse and/or evidence of radiological activity defined as new/enlarging T2-FLAIR hyperintense or Gd-enhancing lesion on MRI acquired, in the previous 2 years before the enrolment.
    • Availability of a 3T MRI performed within the last 2 years. This MRI must include these sequences:
    - 3D T1 weighted Fast Field Echo (FFE)
    - 3D Fluid Attenuated Inversion Recovery (FLAIR)
    - 3D Echo Planar Imaging Susceptibility weighted (Magnitude and Phase)
    • Availability of a detailed clinical data on medical history with neurological evaluation performed at least twice in the past two years (or once in the past year).
    • EDSS between 3.0 and 6.0
    • Less than 5 years since entering the progressive phase of the disease.
    • Female subjects must not be pregnant or breast feeding at T0 nor during the study phase.
    • Età compresa tra i 18 e i 65 anni.
    • Forma progressiva di sclerosi multipla dopo un esordio di malattia con forma recidivante-remittente (cosiddetta forma secondariamente progressiva), con attività di malattia definita come aumento di almeno 1 punto di EDSS e/o evidenza di attività radiologica definita come nuove o aumentate lesioni (T2-FLAIR hyperintense or Gd-enhancing lesions) rilevabili in risonanza magnetica, nei 2 anni precedenti l’arruolamento.
    • EDSS compreso tra 3.0 e 6.0
    • Disponibilità di risonanza magnetica 3T nei 2 anni precedenti l’arruolamento. La risonanza deve includere le seguenti sequenze:
    - 3D T1 weighted Fast Field Echo (FFE)
    - 3D Fluid Attenuated Inversion Recovery (FLAIR)
    - 3D Echo Planar Imaging Susceptibility weighted (Magnitude and Phase)
    • Disponibilità di dettagliata cartella clinica con valutazioni neurologiche effettuate almeno due volte negli ultimi due anni (o una volta nell’ultimo anno).
    • Meno di 5 anni dall’ingresso in fase progressiva.
    • I soggetti di sesso femminile non devono essere in gravidanza o in allattamento
    E.4Principal exclusion criteria
    Medical conditions:
    • Patients homozygous for the CYP2C9 *3 *3 allele.
    • Immunodeficiency syndrome.
    • History of progressive multifocal leukoencephalopathy or cryptococcal meningitis.
    • Hematologic alterations (lymphocyte count not within normal limits)
    • Rheumatic disease under specific treatment (including chronic use of steroid)
    • Severe active infections (regard to positive result to HBV, HCV, HIV, Quantiferon)
    • Active malignities
    • Myocardial infarction, unstable angina, stroke (any time), TIA (in the last 6 months)
    • NYHA Class III or IV heart failure
    • Complete left bundle branch block
    • First- or second-degree [Mobitz type I] AV block,
    • Second grade AV block (Mobitz type II);
    • Third grade AV block (unless patient has a functioning pacemaker)
    • Sinus bradycardia (HR < 55 bpm) or symptomatic bradycardia (i.e. history of recurrent syncope)
    • QTc =500 msec
    • Severe liver dysfunction (i.e. transaminase and/or bilirubin levels > 3x ULN)
    • Negativity for varicella zoster IgG antibodies (in case of vaccination by live vaccine the beginning of therapy must be postponed of at least 30 days).
    • History of hypersensitivity to any metabolites or drugs of the same class as siponimod.
    • Hypersensitivity to the active substance or to peanuts, soy or to any of the excipients
    • Pregnancy or breast feeding.
    • Fertile women who do not use effective methods of contraception.

    Previous and ongoing therapies:
    ¿ Natalizumab (last dose less than 6 months prior to enrollment);
    ¿ Rituximab, Ocrelizumab, Cyclophosphamide (last dose less than 1-year prior enrollment);
    ¿ Fingolimod, Mitoxantrone therapy or evidence of cardiotoxicity or a cumulative dose greater than 60 mg/m2 (last dose less than 2-year prior enrollment)
    ¿ Alemtuzumab, cladribine, autologous stem cell transplantation and other immunosuppressive treatments with expected effect of over 6 months (any time)
    ¿ Intravenous corticosteroid cycle to treat MS clinical relapse (1-month before enrollment)
    ¿ Antiarrhythmics Class Ia (e.g. quinidine, procainamide), Class III (amiodarone, sotalolo) drugs and those that may decrease heart rate (e.g. beta-blockers, calcium channel blockers, ivabradine and digoxin)
    Condizioni mediche:
    • Allele CYP2C9 *3 *3.
    • Sindrome di immunodeficienza.
    • Storia di leucoencefalopatia multifocale progressiva o meningite criptococcica.
    • Alterazioni ematologiche (conta dei linfociti non entro i limiti di norma).
    • Malattia reumatica sotto trattamento specifico (compreso l'uso di steroidi).
    • Severe infezioni attivi (HBV, HCV, HIV, Quantiferon).
    • Tumori.
    • Infarto miocardico, angina instabile, ictus (in qualsiasi momento), TIA (negli ultimi 6 mesi).
    • Insufficienza cardiaca di classe NYHA III o IV.
    • Completo blocco di branca sinistro.
    • Blocco AV di primo o secondo grado (Mobitz tipo I).
    • Blocco AV di secondo grado (Mobitz tipo II).
    • Blocco AV di terzo grado (a meno che il paziente non abbia un pacemaker funzionante).
    • Bradicardia sinusale (FC < 55 bpm) o bradicardia sintomatica (cioè storia di sincope ricorrente).
    • QTc =500 msec.
    • Grave disfunzione epatica (cioè livelli di transaminasi e / o bilirubina> 3x ULN).
    • Negatività per gli anticorpi IgG contro la varicella zoster (in caso di vaccinazione con vaccino vivo l'inizio della terapia deve essere posticipato di almeno 30 giorni).
    • Storia di ipersensibilità a qualsiasi metabolita o farmaco della stessa classe el siponimod.
    • Ipersensibilità al principio attivo o alle arachidi, alla soia o ad uno qualsiasi degli eccipienti.
    • Gravidanza o allattamento.
    • Donne in età fertile che non usano metodi contraccettivi efficaci

    Terapie in corso o antecedenti:
    • Natalizumab (ultima dose meno di 6 mesi prima dell'arruolamento).
    • Rituximab, Ocrelizumab, Cyclophosphamide (ultima dose meno di 1 anno prima dell'arruolamento).
    • Terapia con Fingolimod o mitoxantrone con evidenza di cardiotossicità o dose cumulativa superiore a 60 mg / m2 (ultima dose meno di 2 anni prima dell'arruolamento).
    • Alemtuzumab, cladribina, trapianto autologo di cellule staminali e altri trattamenti immunosoppressivi con effetto previsto di oltre 6 mesi (in qualsiasi momento).
    • Ciclo endovenoso di corticosteroidi per il trattamento della ricaduta clinica della SM (1 mese prima dell'arruolamento)
    • Antiaritmici di classe Ia (ad es. Chinidina, procainamide), farmaci di classe III (amiodarone, sotalolo) e quelli che possono ridurre la frequenza cardiaca (ad es. Beta-bloccanti, calcio antagonisti, ivabradina e digossina)
    E.5 End points
    E.5.1Primary end point(s)
    The study endpoint is the change (assumed to be a reduction) of the susceptibility of the rim lesions after treatment with siponimod in comparison to the “natural” change of this parameter during a recent period-time preceding treatment (no later than two years before) with siponimod, so that for each patient an internal comparison will be available.
    Valutare il cambiamento (che si presume sia una riduzione) della suscettibilità delle lesioni dopo il trattamento con siponimod rispetto al cambiamento "naturale" di questo parametro durante un recente periodo di tempo precedente al trattamento con siponimod (non oltre due anni prima).
    E.5.1.1Timepoint(s) of evaluation of this end point
    T3-T24 vs T24-T0
    T3-T24 vs T24-T0
    E.5.2Secondary end point(s)
    To evaluate the effect of siponimod in reducing the number of SEL comparing to the period prior the treatment (retrospective phase) with the study phase (T3 vs T12 and T3 vs T24).; To describe the individual changes in CSF levels of specific makers of activated microglia/macrophages (sCD14, sCD163, TNF, sTNFR1, sTNFR2, Chitinase 3-1like) and of neuronal/axonal damage (neurofilament-light chains, parvalbumin) from baseline to T24; To evaluate the changes of sCD14, sCD163, TNF, sTNFR1, sTNFR2, Chitinase 3-1like, neurofilament-light chains, and parvalbumin in serum of patients at baseline and at T6, T12, T18, T24; To evaluate the EDSS change between the retrospective phase and the study phase (T0 vs T12 and T12 vs T24; To evaluate changes in cognitive functioning during the two-year study phase (T0-T24); Treatment emergent adverse effect (TEAE) and serious adverse event (SAE) at each follow-up visit
    Verificare l'effetto del siponimod nel ridurre il numero di SEL confrontando il periodo precedente il trattamento (fase retrospettiva) con la fase di studio (T3 vs T12 e T3 vs T24).; Descrivere i cambiamenti nel CSF di specifici biomarker di microglia / macrofagi attivati (sCD14, sCD163, TNF, sTNFR1, sTNFR2, chitinasi 3-1 simile) e del danno neuronale / assonale (catene leggere dei neurofilamenti, parvalbumina) dal basale a T24; Verificare i cambiamenti di sCD14, sCD163, TNF, sTNFR1, sTNFR2, chitinasi 3-1, catene leggere dei neurofilamenti e parvalbumina nel siero dei pazienti dal basale a T6, T12, T18 e T24.; Valutare la variazione di EDSS tra la fase retrospettiva e la fase di studio (T0 vs T12 e T12 vs T24).; Valutazione dei cambiamenti nel funzionamento cognitivo durante la fase di studio (T0-T24); Valutazione sicurezza del farmaco (TEAE e SAE) ad ogni time-point
    E.5.2.1Timepoint(s) of evaluation of this end point
    T3 vs T12 e T3 vs T24; Baseline vs T24; Baseline vs T6, T12, T18, T24; T0 vs T12 e T12 vs T24; T0-T24; at each follow-up visit
    T3 vs T12 and T3 vs T24; Baseline vs T24; Baseline vs T6, T12, T18, T24; T0 vs T12 e T12 vs T24; T0-T24; ad ogni time-point
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    best practice
    best practice
    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 Decision2021-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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