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    Summary
    EudraCT Number:2018-004532-30
    Sponsor's Protocol Code Number:R092670PSY3016
    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:2021-06-17
    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 number2018-004532-30
    A.3Full title of the trial
    Single-arm, Open-label Extension to a Double-blind, Randomized, Activecontrolled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
    Un’estensione in aperto a braccio singolo di uno studio in doppio cieco, randomizzato, con controllo attivo, a gruppi paralleli sul paliperidone palmitato in formulazione semestrale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24 month Open-Label, international study of paliperidone 6 month formulation in patients with who have completed study R092670PSY3015
    Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hearing or seeing things that are not there and delusions (fixed, false beliefs)
    Uno studio internazionale in aperto della durata di 24 mesi sul paliperidone palmitato in formulazione semestrale in pazienti che hanno completato lo studio R092670PSY3015.
    La schizofrenia è una malattia mentale comprendente diversi sintomi, tra cui disorganizzazione del pensiero e della parola, sentire o vedere cose che non esistono e allucinazioni (ossessioni, false credenze)
    A.3.2Name or abbreviated title of the trial where available
    NAp
    NAp
    A.4.1Sponsor's protocol code numberR092670PSY3016
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag SpA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310715242166
    B.5.5Fax number310715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 name1092mg paliperidone palmitate extended release suspension for injection (eq. 700 mg paliperidone dai
    D.3.2Product code [R092670]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaliperidone Palmitato
    D.3.9.1CAS number 199739-10-1
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePaliperidone Palmitato
    D.3.9.4EV Substance CodeSUB31687
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 name1560 mg paliperidone palmitate extended release suspension for injection (eq. 1000 mg paliperidone d
    D.3.2Product code [R092670]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaliperidone Palmitato
    D.3.9.1CAS number 199739-10-1
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePaliperidone Palmitato
    D.3.9.4EV Substance CodeSUB31687
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Schizophrenia
    Schizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hearing or seeing things that are not there and delusions (fixed, false beliefs)
    La schizofrenia è una malattia mentale composta da molti sintomi, tra cui:disorganizzazione di pensiero e parole, sentire o vedere cose che non esistono e allucinazioni (ossessioni, false credenze)
    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 PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    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 assess the long-term safety and tolerability of PP6M (700 or 1000 mg eq.) and to provide access to PP6M in subjects with schizophrenia completing the R092670PSY3015 study without relapse
    Valutare la sicurezza e tollerabilità a lungo termine di PP6M (700 o 1000 mg eq.) e fornire accesso a PP6M a soggetti con schizofrenia che completano lo studio R092670PSY3015 senza sviluppare recidive
    E.2.2Secondary objectives of the trial
    • To assess the long-term efficacy of PP6M based on:
    - Overall symptom improvement and global severity of the illness
    - Personal and social functioning
    - Remission rates
    • To continually assess the long-term effectiveness of PP6M on the prevention of relapse by evaluating the data from R092670PSY3015 and R092670PSY3016
    • To evaluate the impact of PP6M on Medical Resource Utilization
    •Valutare l’efficacia a lungo termine di PP6M sulla base di:
    - Miglioramento generale dei sintomi e gravità complessiva della malattia
    - Funzionalità personali e sociali
    - Tassi di remissione
    •Valutare su base continua l’efficacia a lungo termine di PP6M sulla prevenzione della recidiva tramite analisi dei dati ottenuti da R092670PSY3015 e R092670PSY3016
    •Valutare l’impatto di PP6M sull’utilizzo delle risorse mediche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Completed the Double-blind Phase of StudyR092670PSY3015 without relapse and continue to be willing to be treated withPP6M. Note:There may be a small number of pt who complete PSY3015before the PSY3016 protocol is approved and implemented in that local country.These pt may be screened and can enter Study R092670PSY3016 later, provided that:Visit 1(Day1) of StudyR092670PSY3016 is scheduled to occur no later than 3m after the end visit ofPSY3015,that in the interim period the pt has been treated withPP1M(100or150mg eq) orPP3M(350or525mg eq)(PP3M is preferred) and has not experienced a relapse, and the pt meets other criteria for study entry
    2.Must,in the opinion of the PI, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of PSY3015at the time of screening for this study
    3.A woman of childbearing potential must have a negative urine pregnancy test on D1
    4.Use contraception consistent with local reg. for pt participating in clinical studies.Before receiving study intervention, a woman must be either:
    a.Not of childbearing potential, defined as being either postmenopausal or permanently sterile, as follows:
    Postmenopausal:A post. state is defined as no menses for12months without an alternative medical cause.A high FSH level(>40 IU/LormIU/mL)in the post. range may be used to confirm a post.state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of12months of amenorrhea,a single FSH measurement is insufficient.
    Permanently sterile:Permanent ster. methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.Of childbearing potential, but meeting the contraception requirements as follows:
    Practicing a highly effective method of contraception(failure rate of<1%per year when used consistently and correctly).Examples of highly effective contraceptives include the following:
    -User-independent methods:Implantable progestogen-only hormone contraception associated with inhibition of ovulation;intrauterine device (IUD);intrauterine hormone-releasing system;vasectomized partner;sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the subject)
    -User-dep. methods: combined(estrogen- and progestogencontaining)hormonal contraception associated with inhibition of ovulation:oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable.Typical use failure rates may differ from those when used consistently and correctly.Use should be consistent with local regulations regarding the use of contraceptive methods for pt participating in clinical studies
    Agree to remain on a highly effective method throughout the study and for at least12months after the last dose of study intervention.A woman using oral contraceptives should use an additional birth control method
    Note: If the childbearing potential changes after start of the study or the risk of pregnancy changes(eg, a woman who is not heterosexually active becomes active),a woman must begin a highly effective method of contraception, as described throughout this incl crit.If reproductive status is questionable,additional evaluation should be considered.A man must agree that during the study and for a minimum of12months after receiving the last dose of study intervention,his female partner(s) will use a highly effective method of contraception as described in the Italian part.
    6. See italian part.
    7.In the opinion of the PI, the pt. would be able to participate for the duration of the study
    1Completamento della fase in doppio cieco dello studioR092670PSY3015senza recidive e intenzione di proseguire il trattamento conPP6M
    Nota:1numero ridotto di pt potrebbe completare lo studioR092670PSY3015prima che il protR092670PSY3016venga approvato e implementato nel loro Paese.Questi pt potranno essere sottoposti a screening e poi iniziare lo studioR092670PSY3016in un secondo momento, a condizione che:la Visita 1(gg1)dello studioR092670PSY3016(cioè la prima dose diPP6M)sia in programma entro e non oltre3mesi dopo la visita di fine dello studioR092670PSY3015e nel periodo intermedio il pt sia stato trattato con PP1M(100 o 150 mg eq.)oPP3M(350 o 525 mg eq.),non abbia sviluppato recidive e soddisfi altri crit
    2Capacità di proseguire il trattamento allo stesso livello di dosaggio(moderato o alto)impiegato nella fase in doppio cieco dello studioR092670PSY3015in occasione dello screening per questo studio
    3Pt di sesso femm in età fertile con test di gravidanza sulle urine neg il gg1
    4Uso di1metodo contraccettivo conforme ai regolamenti locali relativi ai pt che partecipano agli studi clinici.Prima di ricevere l’intervento dello studio,le donne devono rientrare in1delle seguenti categorie:
    a.Donne non potenzialmente fertili,ovvero in postmenopausa o permanentemente sterili, secondo le definizioni:
    oDonne in postmenopausa:per postmenopausa si intende la mancanza di mestruazioni da12mesi in assenza di una causa medica alternativa.Nelle donne che non assumono contraccettivi ormonali o terapie ormonali sostitutive,lo stato post-menopausale può essere confermato da un livello elevato diFSH(>40 IU/L o mIU/mL nel range postmenopausale);tuttavia in assenza di12mesi di amenorrea non sarà sufficiente una sola misura dell’FSH
    oDonne permanentemente sterili
    b.Donne potenzialmente fertili che si attengono ai requisiti sulla contraccezione:
    oUtilizzano1metodo contraccettivo altamente efficace.Es di metodi contraccettivi altamente efficaci:
    ¿Metodi indipendenti dall’utilizzatore:contraccettivo ormonale impiantabile a base di solo progestinico associato all’inibizione dell’ovulazione;IUD;sistema intrauterino a rilascio di ormoni;vasectomia del partner;astinenza sessuale
    ¿Metodi dipendenti dall’utilizzatore:contraccettivo ormonale combinato associato all’inibizione dell’ovulazione:orale,intravaginale o transdermico;contraccettivo ormonale a base di solo progestinico associato all’inibizione dell’ovulazione:orale o iniettabile
    I tassi di fallimento associati all’uso tipico possono differire dai tassi di fallimento associati all’uso costante e corretto.L’uso deve essere conforme ai regolamenti locali relativi l’impiego di metodi contraccettivi per i pt che partecipano agli studi clinici
    OConsenso all’uso di1metodo contraccettivo altamente efficace per l'intera durata dello studio e per almeno12mesi dopo l'ultima dose dell’intervento sperimentale.Le donne che usano contraccettivi orali devono adottare anche1altro metodo contraccettivo supplementare
    Nota:in caso di variazione delle condizioni di fertilità o del rischio di gravidanza dopo l’inizio dello studio,la donna dovrà iniziare a usare1metodo contraccettivo altamente efficace
    5Gli uomini devono acconsentire a usare1metodo contraccettivo altamente efficace,durante lo studio e per almeno i12mesi successivi l’ultima dose di farmaco di studio;la partner di sesso femm userà un metodo altamente efficace.Inoltre:
    a)Se sessualmente attivi con1donna potenzialmente fertile,devono usare1metodo contraccettivo a barriera
    b)Se sessualmente attivi con1donna in stato di gravidanza,devono usare il profilattico
    c)Impegnarsi a non donare lo sperma
    6Firmare 1ICF indicante che comprendono lo scopo dello studio e le procedure richieste e che sono intenzionati a partecipare allo studio.Devono inoltre essere in grado di fornire il consenso personalmente
    7Essere in grado di partecipare allo studio per la sua intera durata
    E.4Principal exclusion criteria
    1. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    2. Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the patient.
    3. If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention.
    1.Qualsiasi condizione del soggetto per cui, secondo il giudizio dello sperimentatore, la partecipazione non sarebbe nel miglior interesse del soggetto (ad es. ne comprometterebbe il benessere) o potrebbe impedire, limitare o confondere le valutazioni specificate dal protocollo.
    2.Completamento dello studio R092670PSY3015 in presenza di eventi avversi che lo sperimentatore giudica clinicamente rilevanti e tali da interferire con la sicurezza e il benessere del paziente.
    3.Per gli uomini: intenzione di concepire un figlio durante l'arruolamento nello studio o nei 12 mesi successivi all'ultima dose di intervento dello studio. Per le donne: intenzione di concepire un figlio durante l’arruolamento nello studio o entro i 12 mesi successivi all’ultima dose di farmaco dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety: assessed through evaluation of adverse events, mental status examination, clinical laboratory values, vital signs, physical examinations, the Abnormal Involuntary Movement Scale (AIMS), and injection site evaluations. Mandatory assessments will occur at limited time points during the study with additional assessments to be added at the discretion of the investigator if considered necessary.
    • Proportion of subjects who receive 1, 2, 3, or 4 PP6M injections.
    •La sicurezza sarà valutata tramite analisi di eventi avversi, esame della condizione mentale, valori clinici di laboratorio, segni vitali, esami obiettivi, scala AIMS e valutazioni del punto di iniezione. Le valutazioni obbligatorie saranno effettuate in momenti temporali limitati durante lo studio, con l’integrazione di valutazioni aggiuntive a discrezione dello sperimentatore, se ritenute necessarie.
    •Proporzione di soggetti che ricevono 1, 2, 3 o 4 iniezioni di PP6M.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed: Every 6 months and at end of trial
    Valutazione: Ogni 6 mesi e alla fine dello studio
    E.5.2Secondary end point(s)
    Efficacy will be assessed based on the change from open-label extension baseline on:
    - The Clinical Global Impression-Severity (CGI-S) scale.
    - The Personal and Social Performance (PSP) scale.
    - The proportion of subjects in remission will be assessed based on the Positive and Negative Syndrome Scale (PANSS) assessment at openlabel extension baseline, Month 12, Month 24, and the End-of Study/Early Withdrawal visit.; Effectiveness will be assessed based on relapse, where relapse in the open-label extension is defined as one or more of the following:
    - Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject's schizophrenic symptoms);
    - Emergency Department/Room/Ward visit due to a worsening of the subject's symptoms of schizophrenia, but a psychiatric hospitalization does not occur;
    - The subject inflicts deliberate self-injury or exhibits violent behavior resulting in suicide, clinically significant injury to him/her self or another person, or significant property damage;
    - The subject has suicidal or homicidal ideation and aggressive behavior that is clinically significant (in frequency and severity) in the investigator's judgment.; Based on the Healthcare Resource Utilization Questionnaire (HRUQ).
    L’efficacia sarà valutata sulla base della variazione rispetto al valore baseline dell'estensione in aperto, relativamente a:
    -scala CGI-S;
    -scala PSP;
    -la proporzione di soggetti in remissione sarà valutata sulla base della scala PANSS alla baseline dell'estensione in aperto, al mese 12, al mese 24 e alla visita di fine dello studio/ritiro anticipato.; •L’efficacia sarà valutata sulla base delle recidive, dove per recidiva nell'estensione in aperto si intende una o più delle condizioni seguenti:
    -ospedalizzazione psichiatrica per schizofrenia (ricovero volontario o involontario in un ospedale psichiatrico per scompenso dei sintomi schizofrenici del soggetto);
    -visita al pronto soccorso a causa di un peggioramento dei sintomi schizofrenici del soggetto, ma senza ospedalizzazione psichiatrica;
    -il soggetto si infligge deliberatamente delle autolesioni oppure mostra un comportamento violento che sfocia nel suicidio, in lesioni clinicamente significative a carico del paziente stesso o di un’altra persona o in danni significativi a oggetti;
    -il soggetto presenta intenzioni suicide o omicide e comportamento aggressivo considerato clinicamente significativo (per frequenza e gravità) dallo sperimentatore.; •Sulla base del questionario HRUQ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed: Every 6 months and at end of trial; Assessed: Every 6 months and at end of trial; Assessed: Every 6 months and at end of trial
    Valutazione: Ogni 6 mesi e alla fine dello studio; Valutazione: Ogni 6 mesi e alla fine dello studio; Valutazione: Ogni 6 mesi e alla fine dello studio
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    NAp
    NAp
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Hong Kong
    Italy
    Poland
    Ukraine
    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 days4
    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 days4
    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: 97
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 100
    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)
    After Open-label Treatment: Poststudy PP1M, PP3M, or another LAI antipsychotic at an interval appropriate to the open-label identity of the last study dose, as described in the approved prescribing information. The poststudy treatment after openlabel treatment is at the discretion of the subject's physician.
    After Double-blind Treatment: Poststudy or Follow-up Phase. Another antipsychotic treatment at the discretion of the subject's physician; and is not a study subjects medication
    Dopo la fase di Trattamento in Aperto:PP1M,PP3M o un altro antipsicoticoLAI ad un intervallo appropriato rispetto all'ultima dose di farmaco di studio assunta in aperto,come descritto nelle informazioni di prescrizione approvate.Il trattamento post-studio dopo il trattamento in aperto è a discrezione del medico del pz;
    Dopo la fase in Doppio Cieco:Fase di post-studio o fase di Follow-up con un altro trattamento antipsicotico a discrezione del medico del pz; questo non è un trattamento di studio
    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 Decision2019-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-03
    P. End of Trial
    P.End of Trial StatusOngoing
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