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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2021-002093-34
    Sponsor's Protocol Code Number:NW-3509/020/III/2021
    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:2021-08-31
    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 number2021-002093-34
    A.3Full title of the trial
    A Phase II/III, multi-center, open-label, extension study to determine the long-term safety, tolerability, and efficacy of evenamide in patients with psychiatric disorders who participated in a previous trial with evenamide.
    Studio di estensione di fase II/III, multicentrico, in aperto, per determinare la sicurezza, la tollerabilità e l'efficacia a lungo termine di evenamide in pazienti con disturbi psichiatrici che hanno partecipato a una precedente sperimentazione con evenamide.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II / III, open-label, extension study designed to determine the long-term safety, tolerability and efficacy of evenamide (NW-3509) in patients with psychiatric disorders who participated in previous trials with evenamide.
    Studio di fase II/III, di estensione, in aperto, progettato per determinare la sicurezza a lungo termine, la tollerabilità e l'efficacia di evenamide (NW-3509) in pazienti con disturbi psichiatrici che hanno partecipato a precedenti studi con evenamide.
    A.3.2Name or abbreviated title of the trial where available
    Evenamide_020
    Evenamide_020
    A.4.1Sponsor's protocol code numberNW-3509/020/III/2021
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/215/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNEWRON PHARMACEUTICALS SPA
    B.1.3.4CountryItaly
    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 supportNewron Pharmaceuticals S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHippocrates Research Srl
    B.5.2Functional name of contact pointClinical Operations’ Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressVia XX Settembre 30/12
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16121
    B.5.3.4CountryItaly
    B.5.4Telephone number0105454820
    B.5.5Fax number0108936856
    B.5.6E-maile.besio@hippocrates-research.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 nameEvenamide
    D.3.2Product code [NW3509]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNW3509
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 nameEvenamide
    D.3.2Product code [NW3509]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNW3509
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Patients with psychiatric disorders who participated in a previous trial with evenamide.
    Pazienti con disturbi psichiatrici che hanno partecipato a una precedente sperimentazione con evenamide.
    E.1.1.1Medical condition in easily understood language
    Patients with psychiatric disorders who participated in a previous trial with evenamide.
    Pazienti con disturbi psichiatrici che hanno partecipato a una precedente sperimentazione con evenamide.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10037175
    E.1.2Term Psychiatric disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057667
    E.1.2Term Bipolar disorder
    E.1.2System Organ Class 10037175 - Psychiatric 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 long-term safety and tolerability of evenamide (15 and 30 mg bid) in patients with psychiatric disorders.
    Disease-Specific Efficacy Objectives:
    Schizophrenia:
    • Primary: To evaluate the long-term efficacy of evenamide (15 and 30 mg bid), based on improvement in symptoms of psychosis, as assessed by the change from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the total score on the Positive and Negative Syndrome Scale (PANSS).
    Bipolar Disorder:
    • Primary: To evaluate the long-term efficacy of evenamide (15 and 30 mg bid), based on improvement in symptoms of mania, as assessed by the change from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the total score on the Young Mania Rating Scale (YMRS).
    Valutare la sicurezza e la tollerabilità a lungo termine di evenamide (15 e 30 mg bid) in pazienti con disturbi psichiatrici.
    Obiettivi di efficacia specifici per la malattia:
    Schizofrenia:
    • Primario: valutare l’efficacia a lungo termine di evenamide (15 e 30 mg bid), in base al miglioramento dei sintomi di psicosi, valutato in base alla variazione dal basale (Studio 020) all’endpoint (Settimana 52 o interruzione anticipata) sul punteggio totale sulla Scala di sindrome positiva e negativa (Positive and Negative Syndrome Scale, PANSS).
    Disturbo bipolare:
    • Primario: valutare l’efficacia a lungo termine di evenamide (15 e 30 mg bid), in base al miglioramento dei sintomi di mania, valutato in base alla variazione dal basale (Studio 020) all’endpoint (Settimana 52 o interruzione anticipata) sul punteggio totale sulla Scala di classificazione della mania di Young (Young Mania Rating Scale, YMRS).
    E.2.2Secondary objectives of the trial
    Other Secondary Efficacy Objectives (all patients):
    • To determine the long-term effect of evenamide on general functioning, based on the change from baseline to endpoint (Week 52 or early discontinuation) on the Global Assessment of Functioning (GAF) scale.
    • To determine the long-term effect of evenamide on daily functioning, based on the change from baseline to endpoint (Week 52 or early discontinuation) on the Strauss-Carpenter Levels of Functioning (LOF) scale.
    • To evaluate the patients’ satisfaction with the study medication, compared to their previous treatment, using the Patient’s Medication Satisfaction Questionnaire (MSQ).
    Altri obiettivi di efficacia secondari (tutti i pazienti):
    • Determinare l’effetto a lungo termine di evenamide sul funzionamento generale, in base alla variazione dal basale all’endpoint (Settimana 52 o interruzione anticipata) sulla scala di valutazione globale del funzionamento (Global Assessment of Functioning, GAF).
    • Determinare l’effetto a lungo termine di evenamide sul funzionamento nella quotidianità, in base alla variazione dal basale all’endpoint (Settimana 52 o interruzione anticipata) sulla scala di valutazione dei livelli di funzionamento (Levels of Functioning, LOF) di Strauss-Carpenter.
    • Valutare la soddisfazione dei pazienti con il farmaco in studio, rispetto al loro precedente trattamento, utilizzando il Questionario sulla soddisfazione del farmaco per il paziente (Medication Satisfaction Questionnaire, MSQ).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient completed the specified treatment period in their prior evenamide study
    -Patient has provided informed consent for this extension study
    - If female, the patient must have a negative pregnancy test at baseline and must not be lactating (If of childbearing potential, the patient agrees to continue using a highly effective method of contraception, (i.e., a method that can achieve a failure rate of less than 1% per year when used consistently and correctly) during the trial until the final follow-up visit. A woman is considered to be of non-childbearing potential if she meets one of the following criteria: is post-menopausal has no uterus, ovaries or fallopian tubes. Women who are taking hormone replacement therapy (HRT) must use contraception (as described above) during the trial. Sexual abstinence is not an acceptable method of contraception.
    -Male patients who are not sterilized must agree to not have sex without using a condom, if their partner is a woman of childbearing potential, during the trial (from the first dose until the final follow-up visit). Male patients must also agree not to attempt to father a child and must not donate sperm from the first dose until the final follow-up visit.
    - Il paziente ha completato il periodo di trattamento specificato nel precedente studio con evenamide
    il paziente ha fornito il consenso a partecipare a questo studio di estensione
    Se in età fertile, la paziente accetta di continuare a utilizzare un metodo contraccettivo altamente efficace (ovvero, un metodo che possa raggiungere un tasso di insuccesso inferiore all’1% annuo se utilizzato in modo costante e corretto) durante la sperimentazione fino alla visita finale di follow-up. Una donna è considerata non in età fertile se soddisfa uno dei seguenti criteri:è in post-menopausa , non presenta utero, ovaie o tube di Falloppio.Le donne che assumono una terapia ormonale sostitutiva (hormone replacement therapy, HRT) devono utilizzare metodi contraccettivi (come descritto sopra) durante la sperimentazione.L’astinenza sessuale non è un metodo contraccettivo accettabile.
    -I pazienti di sesso maschile non sterilizzati devono accettare di non avere rapporti sessuali senza utilizzare il preservativo, se la loro compagna è una donna in età fertile, durante la sperimentazione (dalla prima dose fino alla visita finale di follow-up). I pazienti di sesso maschile devono inoltre accettare di non tentare di procreare e non devono donare sperma dalla prima dose fino alla visita finale di follow-up.
    E.4Principal exclusion criteria
    1. Patient demonstrated substantial non-compliance with any requirement of the protocol in the prior study, as judged by the Investigator, that would put him/her at risk for continuing treatment in Study 020;
    2. In the Investigator’s opinion, the patient had a significant worsening of risk for suicidality during the prior study;
    3. Patient is experiencing any moderate/severe neurological adverse events;
    4. Patient has shown significant worsening of symptoms of his/her psychiatric disorder between baseline and the final assessment during the treatment period in the prior study;
    5. Patient demonstrated substantial non-compliance with dosing of the study medication or the concomitant psychotropic medication in the prior study, as judged by the Investigator.
    1. Il paziente ha dimostrato una sostanziale non conformità a qualsiasi requisito del protocollo nello studio precedente, secondo il giudizio dello sperimentatore, che lo metterebbe a rischio di continuare il trattamento nello Studio 020;
    2. A giudizio dello sperimentatore, il paziente ha manifestato un significativo peggioramento del rischio di suicidio durante lo studio precedente;
    3. Il paziente sta manifestando un qualsiasi evento avverso neurologico moderato/grave;
    4. Il paziente ha mostrato un peggioramento significativo dei sintomi del suo disturbo psichiatrico tra il basale e la valutazione finale durante il periodo di trattamento nello studio precedente;
    5. Il paziente ha dimostrato una sostanziale non aderenza alla somministrazione del farmaco dello studio o del farmaco psicotropo concomitante nello studio precedente, secondo il giudizio dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint. Mean values and mean changes from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the PANSS total score (schizophrenia patients) or YMRS (bipolar disorder patients) will be presented.
    Endpoint primario di efficacia. Saranno presentati i valori medi e le variazioni medie dal basale (Studio 020) all’endpoint (Settimana 52 o interruzione anticipata) sul punteggio totale PANSS (pazienti con schizofrenia) o YMRS (pazienti con disturbo bipolare).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52 or early discontinuation. A similar assessment of safety data will be performed by the ISMB in each additional one-year segment of the study if treatment is to be extended for another year.
    Settimana 52 o interruzione anticipata. Un’analoga valutazione dei dati di sicurezza sarà eseguita dall’ISMB in ogni ulteriore segmento di un anno dello studio se il trattamento deve essere esteso per un altro anno.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints. For bipolar disorder patients, mean values and mean changes from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the PANSS total score and MADRS total score will be presented. The mean score at each visit and at endpoint for the CGI-C (schizophrenia patients) or CGI-BP-C (bipolar disorder patients) will be presented. The distribution of patients by each category of change and the proportion of patients with improvement, no change, or worsening from baseline to endpoint on the CGI-C or CGI-BP-C will be provided. Mean values and mean changes from baseline (Study 020) to endpoint (Week 52 or early discontinuation) on the CGI-S (schizophrenia patients), CGI-BP-S (bipolar disorder patients), GAF, LOF and MSQ will be presented.
    Endpoint secondari di efficacia. Per i pazienti con disturbo bipolare, saranno presentati i valori medi e le variazioni medie dal basale (Studio 020) all’endpoint (Settimana 52 o interruzione anticipata) sul punteggio totale PANSS e sul punteggio totale MADRS. Sarà presentato il punteggio medio ad ogni visita e all’endpoint sulla CGI-C (pazienti con schizofrenia) o la CGI-BP-C (pazienti con disturbo bipolare). Sarà fornita la distribuzione dei pazienti per ciascuna categoria di variazione e la percentuale di pazienti con miglioramento, nessuna variazione o peggioramento dal basale all’endpoint sulla CGI-C o CGI-BP-C. Saranno presentati i valori medi e le variazioni medie dal basale (Studio 020) all’endpoint (Settimana 52 o interruzione anticipata) sulla scala CGI-S (pazienti con schizofrenia), CGI-BP-S (pazienti con disturbo bipolare), GAF, LOF e MSQ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52 or early discontinuation. A similar assessment of safety data will be performed by the ISMB in each additional one-year segment of the study if treatment is to be extended for another year.
    Settimana 52 o interruzione anticipata. Un’analoga valutazione dei dati di sicurezza sarà eseguita dall’ISMB in ogni ulteriore segmento di un anno dello studio se il trattamento deve essere esteso per un altro anno.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Studio di estensione
    Extension trial
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    India
    Mexico
    Croatia
    Germany
    Hungary
    Poland
    Romania
    United Kingdom
    Argentina
    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
    The “end of trial” will be considered to be the date of completion of any follow-up monitoring and data collection after the last patient completes his/her last visit in the study.
    La "fine della sperimentazione" sarà considerata la data dell'ultima raccolta dati al termine di tutte le visite di monitoraggio di follow-up, dopo che l'ultimo paziente ha completato la sua ultima visita dello studio.
    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 months3
    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 months3
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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)
    An attempt should be made to perform all final (Week 52) assessments in the period on the subject, as well as the safety follow-up evaluation 7 days after the final dose of study medication, and to follow-up on any safety issues until resolution. Subjects who discontinue prematurely, as well as those subjects completing the study, should be followed up for 30 days after the last dose of study medication regarding the occurrence of any Serious Adverse Events.
    Follow up di valutazione della sicurezza 7 giorni dopo la dose finale del farmaco in studio e follow up per ogni problema di sicurezza fino alla risoluzione.
    Follow up fino a 30 giorni dall'ultima dose del farmaco nei i pazienti che hanno discontinuato prematuramente il farmaco per la comparsa di eventi avversi seri .
    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 Decision2021-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-10
    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 03 02:34:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA