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:2021-006511-29
    Sponsor's Protocol Code Number:PTC857-CNS-001-ALS
    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:2022-06-21
    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 number2021-006511-29
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY, PK, AND BIOMARKER EFFECTS OF PTC857 IN ADULT SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (CARDINALS)
    Studio di fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, volto a valutare l'efficacia, la sicurezza, la tollerabilità, la PK e gli effetti sui biomarcatori di PTC857 in soggetti adulti affetti da sclerosi laterale amiotrofica (CARDINALS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study of PTC857 in patients with Amyotrophic Lateral Sclerosis
    Studio di fase 2 su PTC857 in pazienti con sclerosi laterale amiotrofica
    A.3.2Name or abbreviated title of the trial where available
    CARDINALS
    CARDINALS
    A.4.1Sponsor's protocol code numberPTC857-CNS-001-ALS
    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 SponsorPTC THERAPEUTICS INC.
    B.1.3.4CountryUnited States
    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 supportPTC Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPTC Therapeutics, Inc.
    B.5.2Functional name of contact pointPatient Advocacy
    B.5.3 Address:
    B.5.3.1Street Address100 Corporate Court
    B.5.3.2Town/ citySouth Plainfield
    B.5.3.3Post codeNJ 07080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019082227000
    B.5.5Fax number00000000
    B.5.6E-mailmedinfo@ptcbio.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePTC857 oral solution
    D.3.2Product code [PTC857]
    D.3.4Pharmaceutical form 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 INNPTC857
    D.3.9.2Current sponsor codePTC857
    D.3.9.4EV Substance CodeSUB210688
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboOral solution
    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
    Amyotrophic Lateral Sclerosis is a type of Motor Neurone Disease. It is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control.
    La SLA è un tipo di malattia del motoneurone, progressiva del sistema nervoso che colpisce le cellule nervose del cervello e del midollo spinale, causando la perdita del controllo muscolare.
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PTC857 in reducing disease progression in subjects with ALS.
    Valutare l'efficacia di PTC857 nella riduzione della progressione della malattia in soggetti con sclerosi laterale amiotrofica (SLA).
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1. Safety and tolerability of PTC857 in subjects with ALS
    2. Respiratory function in subjects randomized to PTC857 versus placebo
    3. Motor/limb and bulbar function in subjects randomized to PTC857 versus placebo
    4. Neuropsychological function in subjects randomized to PTC857 versus placebo
    5. Survival in subjects randomized to PTC857 versus placebo
    6. Quality of life in subjects randomized to PTC857 versus placebo
    7. Pharmacokinetics of PTC857

    Exploratory Objective:
    Effects on biomarker activity in subjects randomized to PTC857 versus placebo

    Long-Term Extension Period Objectives:
    1. Disease progression, survival, neuropsychological function, respiratory function, motor/limb and bulbar function, and effects on biomarker activity upon long-term treatment with PTC857
    2. Safety and tolerability upon long-term treatment with PTC857
    3. Quality of life upon long-term treatment with PTC857
    4. PK of PTC857
    obiettivi secondari:
    1. Sicurezza e tollerabilità di PTC857
    2. Funzionalità respiratoria nei soggetti randomizzati a PTC857 vs a placebo
    3. Funzionalità motoria/degli arti e bulbare nei soggetti randomizzati a PTC857 vs a placebo
    4. Funzionalità neuropsicologica nei soggetti randomizzati a PTC857 vs a placebo
    5. Sopravvivenza nei soggetti randomizzati a PTC857 vs a placebo
    6. Qualità della vita nei soggetti randomizzati a PTC857 vs a placebo
    7. PK di PTC857

    Obiettivo esplorativo
    1. Effetti sull'attività dei biomarcatori nei soggetti randomizzati a PTC857 vs a placebo

    Obiettivi LTE:
    1. Progressione della malattia, sopravvivenza, funzionalità neuropsicologica, funzionalità respiratoria, funzionalità motoria/degli arti e bulbare ed effetti sull'attività dei biomarcatori post trattamento a lungo termine con PTC857
    2. Sicurezza e tollerabilità subito dopo il trattamento a lungo termine con PTC857
    3. QoL subito dopo il trattamento a lungo termine con PTC857
    4. PK di PTC857
    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: Pharmacokinetics

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: farmacocinetica
    E.3Principal inclusion criteria
    1. Males or females aged between 18 and 70 years with a body mass index (BMI) between 18 and 35 kg/m2

    2. ALS with preserved function, defined as:
    a. Onset of the first symptom leading to the diagnosis of ALS =7 and =18 months at the time of the initial Screening Visit
    b. Revised EL Escorial criteria of either:
    (i) Clinically definite ALS
    (ii) Clinically probable ALS

    3. A total ALSFRS-R score of at least 34 at the start of the Screening Period

    4. No significant respiratory compromise as evidenced by slow vital capacity =60%

    5. All concomitant medications (both prescription and over the counter [OTC]) and non pharmacologic therapy regimens should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study, with the exception of prohibited medications
    1. Maschi o femmine di età compresa tra 18 e 70 anni con un indice di massa corporea (BMI) compreso tra 18 e 35 kg/m2.
    2. SLA con funzione conservata, definita come:
    a. Insorgenza del primo sintomo che ha portato alla diagnosi di SLA =7 e =18 mesi al momento della visita di screening iniziale
    b. Criteri di EL Escorial rivisti di:
    (i) SLA clinicamente definita
    (ii) SLA clinicamente probabile
    3. Un punteggio totale ALSFRS-R di almeno 34 all'inizio del periodo di screening.
    4. Nessuna compromissione respiratoria significativa, evidenziata da una capacità vitale lenta =60%.
    5. Tutti i farmaci concomitanti (sia su prescrizione che da banco [OTC]) e i regimi di terapia non farmacologica devono essere stabili e
    invariati rispetto ai 30 giorni precedenti l'inizio del periodo di screening e devono rimanere stabili e invariati per tutta la durata dello studio, ad eccezione dei farmaci vietati
    E.4Principal exclusion criteria
    1. Females who are pregnant or nursing or plan to become pregnant during the study
    2. Subjects with clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular/ischemic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
    3. Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the investigator or the medical monitor, would interfere with the subject’s ability to participate in the study or increase the risk of participation for that subject
    4. Current participation in any other investigational study with an investigational product or participation within 30 days prior to the start of the Screening Period or 5 half-lives of the previously taken investigational drug, whichever is longer
    5. Subject has previously received PTC857
    6. Edaravone treatment, where applicable, within 30 days prior to the start of the Screening Period
    1. Le donne in gravidanza o in allattamento o che prevedono una gravidanza durante lo studio
    2. Soggetti con patologie gastrointestinali, renali, epatiche, neurologiche, ematologiche, endocrine, oncologiche, polmonari, immunologiche, psichiatriche o cardiovascolari/ischemiche o qualsiasi altra condizione che, a giudizio dello sperimentatore, possa
    mettere a repentaglio la sicurezza del del soggetto o influire sulla validità dei risultati dello studio.
    3. Qualsiasi condizione medica o psichiatrica clinicamente significativa o anamnesi medica che, a parere dello sperimentatore o del medical monitor, possa interferire con la capacità del soggetto di partecipare allo studio o che possa aumentare il rischio di partecipazione per quel soggetto
    4. Partecipazione attuale a qualsiasi altro studio in sperimentale con un prodotto in fase di sperimentazione o partecipazione nei 30 giorni precedenti l'inizio del periodo di screening o di 5 emivite del farmaco in sperimentazione precedentemente assunto, a seconda di quale sia il periodo più lungo
    5. Il soggetto ha ricevuto in precedenza PTC857
    6. Trattamento con edaravone, se applicabile, nei 30 giorni precedenti l'inizio del periodo di screening.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) in the modified Intent-to-Treat Analysis Set (mITT) after 24 weeks of treatment
    Cambiamento dal basale nella ALS Functional Rating Scale-Revised (ALSFRS-R) nel set di analisi Intent-to-Treat modificato (mITT) dopo 24 settimane di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 settimane
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    1. Change from baseline in ALSFRS-R in the Intent-to-Treat (ITT) Analysis Set after 24 weeks of treatment
    2. Safety and tolerability of PTC857 as measured by the severity and number of TEAEs and TESAEs, and change in clinical laboratory tests, physical examination, vital signs, Columbia-Suicide Severity Rating Scale (C-SSRS), and 12-lead electrocardiograms (ECGs) during the Treatment Period
    3. Change from baseline in respiratory function as assessed by pulmonary function tests (PFTs) after 24 weeks of treatment
    4. Change from baseline in motor/limb and bulbar function as assessed by the Modified Norris Scale after 24 weeks of treatment
    5. Change from baseline in neuropsychological function as assessed by the ALS Cognitive Behavioral Screen (ALS CBS) after 24 weeks of treatment
    6. Survival as assessed by rate of and length of time to needing respiratory support/intubation and/or death
    7. Survival and functional change as assessed by the Combined Assessment of Function and Survival (CAFS) after 24 weeks of treatment
    8. Quality of life as assessed by Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) after 24 weeks of treatment
    9. Plasma PK and cerebrospinal fluid (CSF) exposure of PTC857

    Exploratory Endpoint:
    Change from baseline in blood, urine, and CSF biomarker activity after 24 weeks of treatment

    Long-Term Extension Endpoints:
    1. Severity and number of TEAEs and TESAEs, change in clinical laboratory tests, physical examination, vital signs, and 12-lead ECGs during the long-term treatment
    2. Change from baseline in ALSFRS-R with long-term treatment
    3. Change from baseline in respiratory function as assessed by PFTs with long-term treatment
    4. Change from baseline in motor/limb and bulbar function as assessed by the Modified Norris Scale with long-term treatment
    5. Change from baseline in neuropsychological function as assessed by the ALS CBS with long-term treatment
    6. Survival and functional change as assessed by CAFS with long-term treatment
    7. Time to needing respiratory support/intubation and/or death with long-term treatment
    8. Quality of life as assessed by ALSAQ-40 with long-term treatment
    9. Change from baseline in blood and urine biomarker activity with long-term treatment
    10. PK of PTC857

    Long-Term Extension Endpoints:
    1. Severity and number of TEAEs and TESAEs, change in clinical laboratory tests, physical examination, vital signs, and 12-lead ECGs during the long-term treatment
    2. Change from baseline in ALSFRS-R with long-term treatment
    3. Change from baseline in respiratory function as assessed by PFTs with long-term treatment
    4. Change from baseline in motor/limb and bulbar function as assessed by the Modified Norris Scale with long-term treatment
    5. Change from baseline in neuropsychological function as assessed by the ALS CBS with long-term treatment
    6. Survival and functional change as assessed by CAFS with long-term treatment
    7. Time to needing respiratory support/intubation and/or death with long-term treatment
    8. Quality of life as assessed by ALSAQ-40 with long-term treatment
    9. Change from baseline in blood and urine biomarker activity with long-term treatment
    10. PK of PTC857
    Gli endpoint secondari dello studio sono i seguenti:
    1. Variazione rispetto al basale nella ALSFRS-R nel Gruppo di analisi Intent-To-Treat (ITT) dopo 24 settimane di trattamento
    2. Sicurezza e tollerabilità di PTC857, misurate in base alla gravità e al numero di eventi avversi emergenti dal trattamento (TEAE) e di eventi avversi seri emergenti dal trattamento (TESAE), e variazioni nei test clinici di laboratorio, nell'esame obiettivo, nei segni vitali, nella Scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS) e negli elettrocardiogrammi a 12 derivazioni (ECG) durante il Periodo di trattamento
    3. Variazione rispetto al basale nella funzionalità respiratoria valutata dai test di funzionalità polmonare (PFT) dopo 24 settimane di trattamento
    4. Variazione rispetto al basale nella funzionalità motoria/degli arti e bulbare valutata dalla Scala di Norris modificata dopo 24 settimane di trattamento
    5. Variazione rispetto al basale nella funzionalità neuropsicologica valutata dallo Screening cognitivo-comportamentale per la SLA (ALS CBS - Cognitive Behavioral Screen) dopo 24 settimane di trattamento
    6. Sopravvivenza valutata in base al tasso e alla durata della necessità di supporto respiratorio/intubazione e/o decesso
    7. Sopravvivenza e variazione funzionale valutate dalla Valutazione combinata di funzione e sopravvivenza (CAFS - Combined Assessment of Function and Survival) dopo 24 settimane di trattamento
    8. Qualità della vita valutata dal Questionario di valutazione della sclerosi laterale amiotrofica (ALSAQ-40) dopo 24 settimane di trattamento
    9. Parametri PK plasmatici ed esposizione del liquido cerebrospinale (CSF) di PTC857

    Endpoint esplorativo
    L’endpoint esplorativo di questo studio è il seguente:
    1. Variazione rispetto al basale dell'attività dei biomarcatori nel sangue, nelle urine e nel CSF dopo 24 settimane di trattamento

    Gli endpoint del Periodo LTE di questo studio sono i seguenti:
    1. Gravità e numero di TEAE e TESAE, variazione nei test clinici di laboratorio, esame obiettivo, segni vitali ed ECG a 12 derivazioni durante il Periodo LTE
    2. Variazione rispetto al basale nella ALSFRS-R con il trattamento a lungo termine
    3. Variazione rispetto al basale della funzionalità respiratoria valutata tramite PFT con il trattamento a lungo termine
    4. Variazione rispetto al basale della funzionalità motoria/degli arti e bulbare valutata dalla Scala di Norris modificata con il trattamento a lungo termine
    5. Variazione rispetto al basale della funzionalità neuropsicologica valutata tramite ALS CBS con il trattamento a lungo termine
    6. Sopravvivenza e variazione funzionale valutate da CAFS con il trattamento a lungo termine
    7. Periodo di tempo fino alla necessità di supporto respiratorio/intubazione e/o decesso con il trattamento a lungo termine
    8. Qualità della vita valutata da ALSAQ-40 con il trattamento a lungo termine
    9. Variazione rispetto al basale dell'attività dei biomarcatori nel sangue e nelle urine con il trattamento a lungo termine
    10. PK di PTC857
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary and Exploratory Endpoints: 24 weeks
    Long-Term Extension Period Endpoints: 52 weeks
    Endpoint secondari ed esplorativi: 24 settimane
    Endpoint del periodo di estensione a lungo termine: 52 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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Argentina
    Australia
    Brazil
    Japan
    Mexico
    United States
    France
    Poland
    Sweden
    Netherlands
    Spain
    Czechia
    Germany
    Italy
    Belgium
    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 - A subject is considered to have completed the study if she/he has completed all Part B study visits (or Part A if they are not participating in the optional LTE Period), including the follow-up telephone call.
    LVLS - Si considera che un soggetto abbia completato lo studio se ha completato tutte le visite della Parte B dello studio (o della Parte A se non partecipa al periodo LTE opzionale), compresa la telefonata di follow-up.
    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 months8
    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 months8
    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: 248
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 161
    F.4.2.2In the whole clinical trial 258
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    non applicabile
    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 Decision2022-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-12
    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-Wed May 15 00:16:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA