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    Summary
    EudraCT Number:2022-000680-49
    Sponsor's Protocol Code Number:MATRIx1.0
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-18
    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 number2022-000680-49
    A.3Full title of the trial
    Mesenchymal stromal cells for traumatic brain injury. A multicenter, double blind, randomized, placebo-controlled phase II trial
    Cellule mesenchimali stromali per il trattamento del trauma cranico. Studio clinico di fase II multicentrico, in doppio cieco, randomizzato, controllato con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of stem cells for the treatment of traumatic brain injury. Multicenter, double-blind, randomized with placebo phase II clinical trial.
    Utilizzo di cellule staminali per il trattamento del trauma cranico. Studio clinico di fase II multicentrico, in doppio cieco, randomizzato, con utilizzo di placebo.
    A.3.2Name or abbreviated title of the trial where available
    MATRIx
    MATRIx
    A.4.1Sponsor's protocol code numberMATRIx1.0
    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 SOCIO SANITARIA TERRITORIALE MONZA (ASST-MONZA)
    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 supportRegione Lombardia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Socio Sanitaria Territoriale di Monza (ASST-MONZA)
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street Addressvia Pergolesi 33
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+390392334316
    B.5.5Fax number+390392334316
    B.5.6E-mailgiuseppe.citerio@unimib.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 nameBONE MARROW DERIVED MESENCHYMAL STROMAL CELLS
    D.3.2Product code [BM-MSC]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMesenchymal stromal cells (MSC)
    D.3.9.2Current sponsor codeBM-MSC
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number160000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Severe traumatic brain injury
    Trauma cranico severo
    E.1.1.1Medical condition in easily understood language
    Patients affected by traumatic brain injury and admitted to the intensive care unit
    Pazienti affetti da trauma cranico ricoverati in terapia intensiva
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032349
    E.1.2Term Other open skull fracture with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032350
    E.1.2Term Other open skull fracture with intracranial injury of other and unspecified nature
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009630
    E.1.2Term Closed fracture of vault of skull with intercranial injury of other and unspecified nature
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009631
    E.1.2Term Closed fracture of vault of skull with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009648
    E.1.2Term Closed skull fracture with intracranial injury of other and unspecified nature
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009512
    E.1.2Term Closed fracture of base of skull with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031756
    E.1.2Term Other closed skull fracture with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10030657
    E.1.2Term Open fracture of vault of skull with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10030658
    E.1.2Term Open fracture of vault of skull with intracranial injury of other and unspecified nature
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10030666
    E.1.2Term Open fractures involving skull or face with other bones, with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017263
    E.1.2Term Fracture of vault of skull, closed with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031757
    E.1.2Term Other closed skull fracture with intracranial injury of other and unspecified nature
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009636
    E.1.2Term Closed fractures involving skull or face with other bones, with intracranial injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042327
    E.1.2Term Subarachnoid, subdural, and extradural haemorrhage, following injury
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031590
    E.1.2Term Other and unspecified intracranial hemorrhage following injury
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031587
    E.1.2Term Other and unspecified intracranial haemorrhage following injury
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy and safety of the allogeneic bone marrow derived mesenchymal stromal cells (BM-MSCs) intravenously administered in traumatic brain injured (TBI) patients within 48 h from injury.
    The study is meant:
    i) to define if BM-MSCs, administered at dosage of 80 or 160 x 10^6 cells are safe in patients with severe TBI;
    ii) to define if BM-MSCs, administered at the dosage found to be safe and more promising in terms of activity as revealed by the interim analysis, decrease the plasmatic NFL biomarker of brain damage at 14 days.
    Verificare efficacia e sicurezza dell'infusione endovenosa di cellule mesenchimali stromali derivate da midollo osseo (BM-MSCs) allogeniche in pazienti affetti da trauma cranico (TC) grave entro 48 ore dal trauma.
    Lo studio è destinato a:
    i) definire se le BM-MSC, somministrate al dosaggio di 80 o 160 x 10^6 cellule sono sicure in pazienti con TBI grave;
    ii) definire se le BM-MSC, somministrate al dosaggio trovato sicuro e più promettente in termini di attività come rivelato dall'analisi ad interim, diminuiscono il biomarcatore plasmatico NFL del danno cerebrale a 14 giorni.
    E.2.2Secondary objectives of the trial
    To assess:
    i) brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days, 14 days and 6 months)
    ii) brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation
    iii) clinical outcome by a structured clinical and neuropsychological assessments at both 6 and 12 months
    Valutare:
    i) l'evoluzione del danno cerebrale e della materia bianca tramite neuroimaging longitudinale (a 4 giorni, 14 giorni e 6 mesi);
    ii) i cambiamenti immunomodulatori cerebrali attraverso il profilo temporale dei biomarcatori circolanti del danno cerebrale e della neuroinfiammazione;
    iii) l'esito clinico attraverso una valutazione clinica e neuropsicologica strutturata sia a 6 che a 12 mesi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: 18-70 years
    - Clinical frailty index (CFI) < 5
    - Evidence of TBI confirmed by abnormalities consistent with trauma on computed tomography scan upon admission (Marshall’s CT Classification >1)
    - Feasibility of study drug (MSC/placebo) administration within 48 hours from TBI
    - GCS < = 8 at recruitment and at least one pupil reactive to light
    - ICP monitoring, already inserted or planned for clinical indications
    - Weight < 100 Kg and > 40 kg
    - Età: 18-70 anni
    - Indice di fragilità clinica (CFI) < 5
    - Evidenza di TBI confermata da anomalie coerenti con il trauma sulla tomografia computerizzata all'ammissione (Classificazione TAC di Marshall >1)
    - Fattibilità della somministrazione del farmaco in studio (BM-MSC/placebo) entro 48 ore dal TBI
    - GCS <= 8 al reclutamento e almeno una pupilla reattiva alla luce
    - Monitoraggio ICP, già inserito o pianificato per indicazioni cliniche
    - Peso < 100 Kg e > 40 kg
    E.4Principal exclusion criteria
    - Motor GCS > 5 at recruitment
    - High likelihood (>85%) of death in the first 48 h calculated by IMPACT calculator on early admission data
    - Bilateral mydriasis
    - Opening ICP > 40 mmHg
    - Known history of prior brain injury, psychiatric disorder, neurological impairment and/or deficit
    - Brain penetrating injury
    - Spinal cord injury
    - Previous epilepsy requiring anti-convulsant therapy
    - Severe organ failure (including PaO2/FiO2<200 and shock)
    - Recent serious infectious process
    - Cancer
    - Immunosuppression
    - Human immunodeficiency virus (HIV)
    - Positive urine pregnancy test or nursing
    - Participation in a concurrent interventional study
    - GCS motorio > 5 al reclutamento
    - Alta probabilità (>85%) di morte nelle prime 48 ore calcolata dal calcolatore IMPACT sui primi dati del ricovero
    - Midriasi bilaterale
    - ICP iniziale > 40 mmHg
    - Storia nota di precedente lesione cerebrale, disturbo psichiatrico, compromissione e/o deficit neurologico
    - Lesione cerebrale penetrante
    - Lesione al midollo spinale
    - Precedente epilessia che richiede una terapia anti-convulsivante
    - Grave insufficienza d'organo (inclusi PaO2/FiO2<200 e shock)
    - Recente processo infettivo grave
    - Cancro
    - Immunosoppressione
    - Virus dell'immunodeficienza umana (HIV)
    - Test di gravidanza positivo o allattamento
    - Partecipazione a uno studio interventistico concomitante
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety: The number of patients experiencing at least one serious adverse drug reaction (SADR)
    2. Biological activity:
    a) The number of responder patients, defined as patients who reaches a percentage NFL increase at 14 days equal or lower than 20% compared to baseline
    b) The quantitative blood NFL at Day 14 as measured by SIMOA
    1. Sicurezza: Il numero di pazienti che sperimentano almeno una reazione avversa grave al farmaco (SADR)
    2. Attività biologica:
    a) Il numero di pazienti responder, definiti come pazienti che raggiungono un aumento percentuale di NFL a 14 giorni uguale o inferiore al 20% rispetto al basale
    b) Il quantitativo di NFL nel sangue al giorno 14, misurato dal SIMOA
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    14 giorni
    E.5.2Secondary end point(s)
    Assessment of biological activity of intravenous infusions of allogeneic BM-MSCs in terms of modification of the following clinical variable:

    1. brain injury evolution and white matter damage by longitudinal advanced MRI (with morphological sequences as T1, T2 as well as FLAIR, SWI, DWI and DTI for quantification of traumatic axonal injury) acutely (4 days) subacutely (14 days) and at 6 months post-TBI to provide a detailed description in atrophy, diffusion and myelin integrity; Assessment of biological activity of intravenous infusions of allogeneic BM-MSCs in terms of modification of the following biological parameters:

    1. brain immunomodulatory changes by temporal profiling (daily for 3 days after TBI, at day 7 and 14 and at 1, 6 and 12 months) of circulating biomarkers of:
    a. structural damage: NFL, GFAP
    b. neuroinflammation: IL-6, IL-10, TNFalpha
    c. vascular integrity: MMP9; Assessment of biological activity of intravenous infusions of allogeneic BM-MSCs in terms of modification of the following clinical variable:
    3. Clinical outcome by a structured clinical and neuropsychological outcome assessment at both 6 and 12 months, by:
    a. extended Glasgow Outcome Scale (eGOS)
    b. quality of life after brain injury test (QOLIBRI, www.qolibrinet.com)
    Valutazione dell'attività biologica delle infusioni endovenosa di BM-MSC allogeniche in termini di modifica della seguente variabile clinica:

    1. evoluzione della lesione cerebrale e danno della materia bianca tramite risonanza magnetica avanzata longitudinale (con sequenze morfologiche come T1, T2 e FLAIR, SWI, DWI e DTI per la quantificazione della lesione assonale traumatica) in modo acuto (4 giorni), subacuto (14 giorni) e a 6 mesi post-TBI per fornire una descrizione dettagliata di atrofia, diffusione e integrità della mielina; Valutazione dell'attività biologica delle infusioni endovenosa di BM-MSC allogeniche in termini di modifica dei seguenti parametri biologici:

    1. cambiamenti immunomodulatori del cervello attraverso il profilo temporale (giornalmente per 3 giorni dopo il TC, al giorno 7 e 14 e a 1, 6 e 12 mesi) dei biomarcatori circolanti di:
    a. danno strutturale: NFL, GFAP
    b. neuroinfiammazione: IL-6, IL-10, TNFalpha
    c. integrità vascolare: MMP9; Valutazione dell'attività biologica delle infusioni endovenosa di BM-MSC allogeniche in termini di modifica della seguente variabile clinica:
    3. Esito clinico mediante una valutazione strutturata di esito clinico e neuropsicologico sia a 6 che a 12 mesi, mediante:
    a. Glasgow Outcome Scale estesa (eGOS)
    b. test sulla qualità della vita dopo una lesione cerebrale (QOLIBRI, www.qolibrinet.com)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 4 days, 14 days and 6 months after TBI; At baseline, day 3, 7 and 14 and at 1, 6 and 12 months after TBI; At 6 and 12 months after TBI
    4 giorni, 14 giorni e 6 mesi in seguito al TC; baseline, 3 giorni, 7 giorni, 14 giorni, 1 mese, 6 mesi e 12 mesi dopo il TC; A 6 e 12 mesi in seguito al TC
    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 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 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 trial3
    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 concerned3
    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 months0
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-11-18. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Comatose patients. Consent taken according to CE-approved procedures for clinical trials in an emergency situation with patients temporarily unable to express consent.
    Pazienti in stato di coma. Consenso rilevato secondo procedure approvate da CE per sperimentazione clinica in situazione di emergenza con pazienti temporaneamente non in grado di esprimere consenso.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 78
    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)
    I pazienti al termine dello studio verranno seguiti come da normale pratica clinica.
    I pazienti al termine dello studio verranno seguiti come da normale pratica clinica.
    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 Decision2022-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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