Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-003028-19
    Sponsor's Protocol Code Number:PS_KSS_001_2019
    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:2021-05-24
    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 number2019-003028-19
    A.3Full title of the trial
    Clinical-instrumental definition of the phenotypic spectrum, response to treatment and natural history in Pearson and Kearns-Sayre syndrome
    Definizione clinico-strumentale dello spettro fenotipico, della risposta al trattamento e della storia naturale delle sindromi di Peason e Kearns-Sayre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Definition of the clinicla manifestation variability, response to treatment and natural history in Pearson and Kearns-Sayre syndrome
    Definizione della variabilità della manifestazione clinica, della risposta al trattamento e della storia naturale delle sindromi di Peason e Kearns-Sayre
    A.3.2Name or abbreviated title of the trial where available
    PS_KSS
    PS_KSS
    A.4.1Sponsor's protocol code numberPS_KSS_001_2019
    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 SponsorIRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    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 supportMinistero dell'Istruzione dell'Università e della Ricerca
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiego Martinelli
    B.5.2Functional name of contact pointU.O.C. Patologia Metabolica
    B.5.3 Address:
    B.5.3.1Street AddressPiazza Santo'Onofrio 4
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00165
    B.5.3.4CountryItaly
    B.5.6E-maildiego.martinelli@opbg.net
    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 Lederfolin
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameLederfolin
    D.3.2Product code [Lederfolin]
    D.3.4Pharmaceutical form Granules for oral solution
    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 INNCALCIO LEVOFOLINATO
    D.3.9.1CAS number 58-05-9
    D.3.9.2Current sponsor codeLderfolin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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.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
    Pearson and Kearns-Sayre syndrome.
    Sindrome di Pearson e Sindrome di Kearns-Sayre.
    E.1.1.1Medical condition in easily understood language
    Pearson and Kearns-Sayre syndrome.
    Sindrome di Pearson e Sindrome di Kearns-Sayre.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10058799
    E.1.2Term Mitochondrial encephalomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10058799
    E.1.2Term Mitochondrial encephalomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10051403
    E.1.2Term Mitochondrial DNA deletion
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10051403
    E.1.2Term Mitochondrial DNA deletion
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10074070
    E.1.2Term Mitochondrial encephalopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical effects of folinic acid in patients with PS/KSS syndromes on: disease severity as assessed by the Newcastle Pediatric/Adult Mitochondrial Disease Scale (NPMDS) Sections 1-3
    Valutare gli effetti clinici dell’acido folinico, in pazienti affetti da sindrome PS/KSS, su: gravità della malattia stabilita tramite il punteggio del questionario Newcastle Pediatric/Adult Mitochondrial Disease Scale (NPMDS/NAMDS) per le sezioni 1-3
    E.2.2Secondary objectives of the trial
    To evaluate the effects of folinic acid in patients with PS/KSS syndromes on:
    1. Neuromuscular function as assessed by:
    a. 6-minute walk test;
    b. 30 sec sit to stand test;
    c. Caregiver burden scale
    d. New muscle endurance test
    e. Int Adult Mitoch Disease Sc
    f. Timed test

    2. Quality of life as assessed by:
    a. PedsQL child-self report
    b. PedsQL parent-proxy report
    c. SF-36 for patients> 18 years
    d. WHO-QOL bref for parents
    e. Sec. 4 of NPMDS

    3. Electrophysio test (VEP/ERG)

    4. Disease morbidity and mortality as assessed by:
    a. Mortality
    b. Total num of medical encounters
    c. Total hospitalizations and hospital days
    d. Weight

    5. Metabolomics analysis in blood and urine
    6. Glutathione cycle biomarkers in blood
    7. Reduced Glutathione (GSH) in the brain
    8. Interferon Signature in blood and CSF immunophenotyping

    To examine the safety of folinic acid in children with PS/KSS syndromes by examining drug-related adverse and serious adverse events
    Valutare effetti acido folinico in pazienti affetti da sindrome PS/KSS
    1.Funz neurouscolare valutata dai seguenti tests:
    a.Test del cammino di 6 minuti;
    b.Il sit to stand test di 30 secondi;
    c.Quest sul grado di impegno del caregiver:
    d.Nuovo test di resist musc;
    e.Int Adult Mitochondrial Disease Scale
    f.Test a tempo.

    2. Qual della vita valutata da:
    a.Quest PedsQL bamb
    b.Quest PedsQL genit
    c.Quest SF-36 per il paz maggiore
    d.Quest breve WHO-QOL per i genitori
    e.Sez 4 sulla QoL del questionario NPMDS

    3. Test elettrofisiologici (VEP/ERG)

    4. Morbilità e Mortalità valutate da:
    a.Mortalità
    b.N. tot di visite mediche
    c.N. tot delle ospedalizzazioni e giorni di ospedale
    d.Peso

    5. An. di metabolomica del sangue
    6. Biomarker del glutatione nel sangue
    7. Gutatione ridotto (GSH) nel cervello
    8. Val fima interferonica nel sangue e analisi immunofenotipica nel CSF

    Valutare la sicurezza dell’ac folinico attraverso la raccolta e l’analisi delle reazioni avverse, serie e non serie, correlate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of PS/KSS syndromes with confirmed genetic mutations associated PS/KSS syndromes. Diagnosis will be performed on review of muscle/skin biopsies, presence of mtDNa deletion on mtDNA samples from peripheral blood lymphocytes, urinary tract cells in urine, or muscle (Southern blot, Long PCR, MLPA), quantification of mtDNA deletions by Quantitative PCR. If genetic confirmation and quantification of mtDNA deletion is not available, it will performed at screening
    • Newcastle Pediatric Mitochondrial Disease Scale score of =15 and = 60 on sections 1-3
    • Evidence of disease progression within 12 months preceeding the screening either by NPMDS score or documented evidence of neurologic deterioration
    • Availability of pre-enrollment brain MRI that confirms the characteristic basal ganglia damage or leukoencephalopathy of PS/KSS syndromes performed within 6 months prior to screening (if brain MRI/MRS is not available, it will performed at screening)
    • Male or female age 1 to 25 years
    • Patient or patient’s guardian able to consent and comply with protocol requirements
    a. Diagnosi, geneticamente confermata, delle sindromi PS/KSS. La diagnosi sarà confermata dalla presenza di delezione del mtDNA su campioni di DNA mitocondriale estratto da linfociti del sangue periferico, cellule di sfaldamento del tratto urinario nelle urine, cellule muscolari/fibroblasti da biopsia muscolo-cutanea attraverso tecniche di Southern blot, Long PCR, MLPA e dalla determinazione quantitativa tramite PCR delle delezioni del mtDNA. Se la conferma genetica e la determinazione quantitativa delle delezioni a carico del mtDNA non saranno gia’ disponibili, verranno eseguite alla visita di screening
    b. Punteggio del questionario NPMDS/NAMDS compreso tra 15 e 60 (inclusi) per le sezioni 1-3
    c. Evidenza di progressione delle malattia entro 12 mesi precedenti lo screening, attraverso il punteggio del questionario NPMDS/NAMDS o documentata evidenza di deterioramento neurologico.
    d. Disponibilità di una risonanza magnetica cerebrale pre-arruolamento che confermi le caratteristiche di danno ai gangli della base o la leucoencefalopatia caratteristica delle sindromi PS/KSS eseguita nei 6 mesi precedenti lo screening (se la risonanza magnetica al cervello non è disponibile, sarà eseguita alla visita di screening)
    e. Maschio o Femmina di età compresa tra 1 e 25 anni
    f. Paziente o Genitori del paziente in grado di fornire il proprio consenso scritto e rispettare le procedure previste dal protocollo
    E.4Principal exclusion criteria
    • Allergy to folinic acid
    • Clinical history of bleeding or abnormal baseline PT, PTT (or aPTT) or INR
    • Pernicious Anemia,
    • Hereditary fructose intolerance, glucose / galactose malabsorption syndrome or sucrase-isomaltase deficiency,
    • Not-mitochondrial Diabetes
    • Concomitant use of methotrexate
    • Clinically significant disease, such as, but not limited to, hepatitis C virus (HCV) / human Immunodeficiency virus (HIV) / hepatitis B virus (HBV) / Cancer, that precludes study participation
    • Diagnosis of any other concurrent inborn error of metabolism
    • Previous tracheostomy
    • Ventilator dependent or use of noninvasive ventilatory support within one month of enrollment
    • Hepatic insufficiency with ALT, AST, Alkaline phosphatase, Total bilirubin grater than two times upper limit of normal
    • Renal insufficiency requiring dialysis
    • End stage cardiac failure
    • Use of anticoagulant medications
    • Severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis
    • Pregnancy and breastfeeding women.
    a. Allergia all’acido folinico;
    b. Storia clinica di sanguinamento o valori basali di PT, PTT (o aPTT) o INR anormali;
    c. Anemia perniciosa;
    d. Intolleranza ereditaria al fruttosio, sindrome da malassorbimento del glucosio/galattosio o deficit dell’enzima sucrasi-isomaltasi;
    e. Diabete non mitocondirale;
    f. Uso concomitante di Metotrexato;
    g. Disturbi clinicamente significativi, come, ad esempio (e non limitati a) infezione da virus dell’Epatite C (HCV), virus dell’immunodeficienza umana (HIV) o virus dell’ Epatite B (HBV) o Cancro, che precludano la partecipazione allo studio; diagnosi di qualsiasi altro errore congenito del metabolismo;
    h. Precedente tracheostomia;
    i. Sviluppo di dipendenza da ventilazione meccanica o utilizzo di supporti ventilatori non invasivi entro un mese dall’arruolamento;
    j. Insufficienza epatica con valori dei valori di AST, ALT, Fosfatasi Alcalina e Bilirubina Totale maggiori di due volte il limite superiore di normalità
    k. Insufficienza renale che richieda dialisi;
    l. Insufficienza cardiaca allo stadio terminale;
    m. Uso di farmaci anticoagulanti;
    n. Grave sindrome da ipo-perfusione multiorgano secondaria a insufficienza cardiaca con acidosi lattica;
    o. Gravidanza e allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Newcastle Pediatric Mitochondrial Disease Scale Sections 1-3
    Sezioni 1-3 del questionario Newcastle Pediatric Mitochondrial Disease Scale/Newcastle Adult Mitochondrial Disease Scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    • Weight
    • Neuromuscular Functional scales (6-minute walk test; 30 seconds sit to stand test; Caregiver burden scale; Grip strength; New muscle endurance test: International Paediatric/Adult Mitochondrial Disease Scale; Timed test)
    • Newcastle Pediatric/Adult Mitochondrial Disease Scale Section 4
    • Glutathione cycle components
    • Metabolomics analysis in blood and urine
    • Brain and spinal MRI/MRS
    • Electrophysiological test (VEP/ERG)
    • Total hospitalizations and total hospital days
    • Total number of medical encounters
    • Mortality
    • Physical examination with vital signs
    • Neurological assessment
    • Routine assessments of AEs and SAEs
    • Routine serum chemistries with liver function tests, electrolytes, lactate, lipids and blood gas analysis
    • Routine hematology tests with coagulation tests
    • Adrenal gland hormone studie
    • 12-lead ECG, Holter ECG, Ecocardiography
    - Peso
    - Scala della funzione neuromuscolare (test del cammino di 6 minuti; sit to stand test di 30 secondi; questionario sul grado di impegno del caregiver; forza nella presa; Nuovo test di resistenza muscolare; questionario International Paediatric Mitochondrial Disease Scale; Test a tempo)
    - Sezione 4 del Newcastle Pediatric/Adult Mitochondrial Disease Scale
    - Metaboliti del ciclo del glutatione
    - Analisi metabolomica nel sangue e nelle urine
    - MRI/MRS cerebrale e spinale
    - Test elettrofisiologici (VEP/ERG)
    - Numero totale di ospedalizzazioni e numero di giorni in ospedale
    - Numero totale di visite mediche
    - Mortalità
    - Esame fisico e segni vitali
    - Valutazione neurologica
    - Valutazione routinaria di Eventi Avversi seri e non
    - Chimica clinica nel siero con LFTs, elettroliti, lattato, lipidi e emogas
    - Studio ormoni delle ghiandole surrenali
    - Valutazione cardiologica, ECG a 12 derivazioni, Holter ECG, Ecocardiogramma
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 9
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients
    Pazienti pediatrici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 27
    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)
    Although a specific therapy for Pearson or Kearns-Sayre Syndromes are not established, patients could assume antioxidants supplements (e.g. Coenzyme Q10, Idebenone, etc) as suggested by scientific literature for mitochondrial metabolic disease category which Pearson and Kearns-Sayre Syndromes belong to. These supplements can be assumed also during the trial. Furthermore, adopted follow up clinical programs (cardiological, neurological and endocrinological), shall be continued every six months.
    Sebbene non esistano al momento terapie specifiche per le Sindromi di Pearson o di Kearns-Sayre, i pazienti potranno assumere integratori antiossidanti (Coenzima Q10, Idebenone, etc) suggeriti in letteratura per malattie del metabolismo mitocondriale, categoria in cui rientrano le due Sindromi. Inoltre verranno proseguiti i percorsi di follow up cardiologico, neurologico e endocrinologico, semestralmente, già adottati come da buona pratica clinica nel nostro Ospedale previsti per la patologia.
    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 Decision2019-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-30
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 17 10:37:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA