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    Summary
    EudraCT Number:2017-001941-28
    Sponsor's Protocol Code Number:R092670PSY3015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial results View 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 number2017-001941-28
    A.3Full title of the trial
    A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6 Month Formulation.
    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
    Study of Paliperidone Palmitate 6 Month formulation for the Treatment of Patients with subjects schizophrenia (a type of mental disorder or illness characterized by abnormal social behavior and failure to understand what is real).
    Uno studio sul paliperidone palmitato in formulazione semestrale per il trattamento di pazienti con schizofrenia (un tipo di disordine mentale o malattia caratterizzata da un comportamento sociale anomalo e dalla incapacit¿ di comprendere la realt¿).
    A.3.2Name or abbreviated title of the trial where available
    Study of Paliperidone Palmitate 6 Month formulation for the Treatment of Patients with subjects sch
    Uno studio sul paliperidone palmitato in formulazione semestrale per il trattamento di pazienti con
    A.4.1Sponsor's protocol code numberR092670PSY3015
    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 N.V.
    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 number00310715242166
    B.5.5Fax number00310715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 TREVICTA 350 mg prolonged release suspensioni for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name546mg paliperidone palmitate extended release suspension for injection (eq. 350mg paliperidone)
    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 Palmitate
    D.3.9.1CAS number 199739-10-1
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePaliperidone Palmitate
    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 number350
    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 RoleComparator
    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 TREVICTA 525 mg prolonged release suspension for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name819mg paliperidone palmitate extended release suspension for injection (eq. 525 mg paliperidone)
    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 Palmitate
    D.3.9.1CAS number 199739-10-1
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePaliperidone Palmitate
    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 number525
    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: 3
    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)
    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 Palmitate
    D.3.9.1CAS number 199739-10-1
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePaliperidone Palmitate
    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: 4
    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.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 Palmitate
    D.3.9.1CAS number 199739-10-1
    D.3.9.2Current sponsor codeR092670
    D.3.9.3Other descriptive namePaliperidone Palmitate
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEmulsion for infusion
    D.8.4Route of administration of the placeboIntramuscular use
    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, suspiciousness and delusions (false beliefs)
    Schizofrenia, una malattia mentale con diversi sintomi, inclusi disorganizzazione in pensiero e linguaggio, percezione visiva o uditiva di cose non esistenti, sospetti e delusioni (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.1.2 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective is to demonstrate that injection cycles consisting of a single administration of PP6M (700 or 1000 mg eq.) are not less effective than 2 sequentially administered injections of PP3M (350 or 525 mg eq.) for the prevention of relapse in subjects with schizophrenia previously stabilized on corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.)
    L'obiettivo di efficacia primario consiste nel dimostrare che i cicli di iniezione costituiti da una singola somministrazione di PP6M (700 o 1000 mg eq.) non sono meno efficaci di 2 iniezioni di PP3M (350 o 525 mg eq.) somministrate in sequenza per la prevenzione della recidiva in soggetti con schizofrenia precedentemente stabilizzati su dosi corrispondenti di PP1M (100 o 150 mg eq.) o PP3M (350 o 525 mg eq.)
    E.2.2Secondary objectives of the trial
    To evaluate the:
    - safety & tolerability of PP6M (700 or 1000 mg eq.) in subjects with schizophrenia who have switched from corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.)
    - PK profile of PP6M (700 or 1000 mg eq.) administered in the gluteal muscle in subjects with schizophrenia who have switched from corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.)
    - clinically assessed efficacy of PP6M (700 or 1000 mg eq.) v.PP3M (350 or 525 mg eq.) in maintaining symptom control, functioning personally and socially, and achieving or sustaining remission in subjects with schizophrenia who were previously stabilized on corresponding doses of PP1M (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.)
    - subject-reported efficacy outcomes of PP6M (700 or 1000 mg eq.) or PP3M (350 or 525 mg eq.) compared with treatment with previous oral antipsychotics in terms of satisfaction with medication & with participation in social roles.
    - Valutare sicurezza e tollerabilità di PP6M (700 o 1000 mg eq.) in pz con schizofrenia che prima assumevano dosi corrispondenti di PP1M (100 o 150 mg eq.) o PP3M (350 o 525 mg eq.)
    - Valutare il profilo farmacocinetico (PK) di PP6M (700 o 1000 mg eq.) somministrato nel gluteo in pz con schizofrenia che prima assumevano dosi corrispondenti di PP1M (100 o 150 mg eq.) o PP3M (350 o 525 mg eq.)
    - Valutare l'efficacia clinicamente valutata di PP6M (700 o 1000 mg eq.) vs PP3M (350 o 525 mg eq.) in termini di mantenimento del controllo dei sintomi, funzionamento personale e sociale e ottenimento o prosecuzione della remissione in pz con schizofrenia precedentemente stabilizzati su dosi corrispondenti di PP1M (100 o 150 mg eq.) o PP3M (350 o 525 mg eq.)
    - Valutare gli esiti di efficacia riferiti dal pz di PP6M (700 o 1000 mg eq.) o PP3M (350 o 525 mg eq.) vs trattamento con precedenti antipsicotici orali in termini di soddisfazione verso il trattamento e la partecipazione a ruoli sociali.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must satisfy all of the following criteria to be enrolled in the study:
    1.Male or female subjects
    2.Must be 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) to 70 years of age, inclusive, at the time of informed consent
    3.Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
    4.Must be receiving treatment with paliperidone palmitate (as either the PP1M or PP3M formulation), or injectable risperidone, or any oral antipsychotic.
    a.If the treatment is paliperidone palmitate, then:
    1) The dose strength must be PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq
    2) The dose timing must fit the study schedule. The next injection must be due within 28 days of the first screening (or first rescreening) visit
    b.If the treatment is injectable risperidone, then the dose strength must be 50 mg, the dosing cycle must be every 2 weeks, the efficacy and tolerability must have been established as adequate with the same strength and frequency for at least 3 injection cycles before screening, and the subject must have a preference for a longer-acting injectable medication
    c.If the treatment is an oral antipsychotic, then the subject must have a valid reason to discontinue the previous treatment, such as problems with efficacy, safety, or tolerability, or preference for a long-acting injectable medication
    5.Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M or PP3M during the Screening Phase
    6.Must have a full PANSS score of <70 points at screening.
    Please refer to protocol for additional inclusion criteria.
    1.Pz di sesso maschile o femminile
    2.Pz devono avere tra i 18 anni (o maggiore età legale secondo la giurisdizione del Paese in cui si svolge lo studio) e 70 anni, inclusi, al momento di firma dell'ICF
    3.I pz devono soddisfare i criteri diagnostici della schizofrenia descritti nel manuale DSM-5 (Diagnostic and Statstical Manual of Mental Disorders, 5th Ed) da almeno 6 mesi prima dello screening
    4.I pz devono essere in terapia con paliperidone palmitato (formulazione PP1M o PP3M) o con risperidone iniettabile o con un altro antipsicotico orale
    a.Se il trattamento è paliperidone palmitato:
    1)La dose deve corrispondere a PP1M (100 o 150mg eq) o a PP3M (350 o 525mg eq)
    2)La tempistica di somministrazione della dose deve adattarsi al programma di studio. L'iniezione successiva deve essere prevista entro 28gg dalla prima visita di screening (o rescreening)
    b.Se il trattamento è risperidone iniettabile, la dose deve corrispondere a 50mg, la somministrazione avvenire ogni 2 sett, efficacia e tollerabilità devono risultare adeguate con la stessa dose e frequenza per almeno 3 cicli di iniezione prima dello screening e il pz deve avere una preferenza per un trattamento iniettabile a più lunga durata d'azione
    c.Se il trattamento è un antipsicotico orale, il pz deve avere un valido motivo per l'interruzione,ad es problemi di efficacia, sicurezza o tollerabilità o preferenza per trattamento iniettabile a lunga durata d'azione
    5.I pz devono essere in grado, secondo il giudizio dello sperimentatore, di interrompere eventuali terapie antipsicotiche diverse da PP1M e PP3M durante lo screening
    6.I pz devono avere un punteggio PANSS tot <70 punti allo screening.

    Vedasi il Protocollo per criteri di inclusione aggiuntivi.
    E.4Principal exclusion criteria
    1.Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
    2.Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
    3.Must not have a DSM-5 diagnosis of moderate to severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
    4.Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
    5Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe
    6. Must not have been treated with injectable formulations of neuroleptic drugs based on active ingredients other than risperidone or paliperidone (eg, haloperidol decanoate, fluphenazine decanoate, etc) during the 6 months before screening

    Please refer to protocol for additional exclusion criteria
    1.I pz non devono ricevere alcuna forma di trattamento involontario, come un ricovero involontario in istituto psichiatrico o un trattamento imposto dal tribunale o ai fini della libertà condizionale.
    2.I pz non devono aver tentato il suicidio entro i 12 mesi precedenti allo screening e non devono essere a rischio imminente di suicidio o comportamento violento, secondo la valutazione clinica effettuata dallo sperimentatore al momento dello screening.
    3.I pz non devono presentare una diagnosi di grave disturbo da uso di sostanze (ad eccezione di nicotina e caffeina) secondo il manuale DSM-5 entro i 6 mesi precedenti allo screening. L’utilizzo di sostanze acuto o intermittente prima dello screening non costituisce tuttavia un criterio di esclusione ed è soggetto al giudizio clinico dello sperimentatore.
    4.I pz non devono avere una storia di sindrome neurolettica maligna o discinesia tardiva.
    5.I pz non devono avere un storia di intollerabilità o gravi reazioni a dosi moderate o elevate di farmaci antipsicotici e non devono presentare altri fattori che, secondo il giudizio dello sperimentatore, indicherebbero che il trattamento con dosi moderate o elevate di paliperidone palmitato sarebbe intollerabile o non sicuro.
    6.I pz non devono essere stati trattati con formulazioni iniettabili di farmaci neurolettici a base di principi attivi diversi dal risperidone e dal paliperidone (ad es., aloperidolo decanoato, flufenazina decanoato, ecc.) durante i 6 mesi precedenti allo screening.
    E.5 End points
    E.5.1Primary end point(s)
    1. Time to relapse during the Double-blind Phase.
    This noninferiority primary endpoint will be based on the difference in Kaplan-Meier 12-month estimate of survival (ie, percentage of subjects remaining relapse-free) between PP6M and PP3M.
    1. Tempo alla recidiva durante la fase in doppio cieco.
    L’endpoint primario di non inferiorità si baserà sulla differenza tra PP6M e PP3M relativa alla stima della sopravvivenza a 12 mesi di Kaplan-Meier (percentuale di soggetti che continuano a essere liberi da recidiva).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time between participant randomization into the Double-Blind phase and the first documentation of a relapse event
    Tempo tra la randomizzazione del partecipante nella fase in doppio-cieco e il primo episodio di recidiva documentato
    E.5.2Secondary end point(s)
    (1) the PANSS total score and subscale scores, (2) the Clinical Global Impression - Severity (CGI-S), and (3) the Personal and Social Performance (PSP) scale. (4) Additionally, the proportion of subjects during the Double Blind Phase who meet criteria for symptomatic remission. (5) The secondary PK endopoint is paliperidone exposure. (6) The secondary endopoints for satisfaction with medication and with participation in social roles are abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and Satisfaction with Partecipation in Social Roles (SPSR), respectively. (7) The secondary endpoints that measure safety and tolerability include physical examinations, vital signs, adverse events, electrocardiograms (ECGs), the Columbia Suicide Severity Rating Scale (C-SSRS Baseline/Screening and C-SSRS Since Last Visit), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Rating Scale (BARS), the Simpson Angus Scale (SAS), clinical laboratory assessments (in full [including prolactin] at some time points, or for prolactin only at other time points), and injection site evaluations
    Gli endpoint secondari di efficacia includono le variazioni rispetto al basale durante i =12 mesi della fase in doppio cieco delle seguenti scale: (1) il punteggio totale della scala PANSS e i punteggi delle relative sottoscale, (2) la scala CGI-S (Clinical Global Impression - Severity) e (3) la scala PSP (Personal and Social Performance). (4) Sarà inoltre sintetizzata la percentuale di soggetti che durante la fase in doppio cieco soddisferanno i criteri di remissione sintomatica dalla prima scadenza semestrale al termine della fase; la definizione di remissione è indicata nella versione integrale del protocollo. (5) L'endpoint secondario di PK è l'esposizione a paliperidone. (6) Gli endopints secondari relativi alla soddisfazione al trattamento e alla partecipazione nei ruoli sociali sono misurati rispettivamente con il questionario TSQM-9 (in inglese Treatment Satisfaction Questionnaire for Medication) e il questionario SPSR (in inglese Satisfaction with Participation in Social Roles). (7) Gli endpoints secondari che misurano la sicurezza e la tollerabilità includono l'esame obiettivo fisico, i segni vitali, gli eventi avversi, l'elettrocardiogramma (ECGs), i punteggi delle scale C-SSRS (in inglese Columbia Suicide Severity Rating Scale) Basale/Screening e dall'ultima visita, AIMS (in inglese Abnormal Involuntary Movement Scale), BARS (in inglese Barnes Akathisia Rating Scale), SAS (in inglese Simpson Angus Scale), gli esiti degli esami di laboratorio (per intero [inclusa la prolattina] in specifici momenti, oppure per la prolattina solo in certi altri momenti) e le valutazioni al sito di iniezione
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1), (2) and (3): changes from baseline during the =12 months of the Double-blind Phase (4): from the first 3 month time point to the end of the double blind phase (5),(6) e (7): Please refer to Clinical Protocol, section 11.3.2. 11.4. e 11.5.
    (1), (2) e (3): cambiamenti dal Basale durante =12 mesi della fase di Doppio Cieco (4): dai primi 3 mesi alla fine della fase di Doppio Cieco (5),(6) e (7): Si faccia riferimento al Protocollo Clinico sezione 11.3.2. 11.4. e 11.5.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Bulgaria
    Czechia
    France
    Germany
    Hong Kong
    Hungary
    India
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Turkey
    Ukraine
    United States
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 825
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 224
    F.4.2.2In the whole clinical trial 841
    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(OL)Treatment: Poststudy (PS) PP1M/PP3M/another LAI antipsychotic may be used at interval appropriate to OL identity of the last study dose, as per approved prescribing information.
    After Double-blind(DB)Treatment: PS/Follow-up Phase treatment: antipsychotic treatment is at the discretion of PI&/or subject's treating physician.Given DB conditions&durations of activity expected from PP6M&PP3M, recommendations (not requirements) for PS/Follow-up treatment are given in the Prot.
    Dopo la fase di Trattamento in Aperto(OL):Trattamento post-studio (PS) con PP1M/PP3M/altro antipsicotico LAI ad intervallo appropriato rispetto all'ultima dose di farmaco di studio assunta in OL,come descritto nelle informazioni di prescrizione approvate.
    Dopo la fase Doppio Cieco(DB):PS/fase di Follow-up:Trattamento antipsicotico a discrezione del PI e/o medico del pz.Date le condizioni/durata di attività attesa per PP6MePP3M,nel Prot vengono fornite raccomandazioni per la fase PS/FUP.
    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 Decision2018-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
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