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    Clinical Trial Results:
    Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

    Summary
    EudraCT number
    2018-004532-30
    Trial protocol
    PL   IT  
    Global end of trial date
    03 May 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    19 May 2023
    First version publication date
    19 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R092670PSY3016
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04072575
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Highway 202, Raritan, United States, 08869-1420
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to assess (in a limited number of countries) the long-term safety and tolerability of paliperidone palmitate 6-month (PP6M; 700 or 1000 milligrams equivalent [mg eq.]) and to provide access to PP6M in subjects with schizophrenia who completed study R092670PSY3015 (2017-001941-28) without relapse.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Sep 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 46
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Poland: 44
    Country: Number of subjects enrolled
    Russian Federation: 39
    Country: Number of subjects enrolled
    Ukraine: 42
    Worldwide total number of subjects
    178
    EEA total number of subjects
    50
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    176
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 178 subjects who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (2017-001941-28) without a relapse, were enrolled in this open-label extension (OLE) study. Out of 178 subjects, 154 completed this OLE study.

    Period 1
    Period 1 title
    Open-label Extention (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Arm description
    Subjects who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (2017-001941-28) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.
    Arm type
    Experimental

    Investigational medicinal product name
    PP6M
    Investigational medicinal product code
    Other name
    R092670
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    PP6M 700 or 1000 mg eq. IM injections were administered on Days 1, 183, 365, and 547.

    Number of subjects in period 1
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Started
    178
    Completed
    154
    Not completed
    24
         Physician decision
    1
         Consent withdrawn by subject
    14
         Adverse event, non-fatal
    7
         Unspecified
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Reporting group description
    Subjects who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (2017-001941-28) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.

    Reporting group values
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq. Total
    Number of subjects
    178 178
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    176 176
        From 65 to 84 years
    2 2
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    40.4 ± 10.76 -
    Title for Gender
    Units: subjects
        Female
    52 52
        Male
    126 126

    End points

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    End points reporting groups
    Reporting group title
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Reporting group description
    Subjects who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (2017-001941-28) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.

    Primary: Number of Subjects With Relapse

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    End point title
    Number of Subjects With Relapse [1]
    End point description
    Number of subjects with relapse were reported. Relapse is defined as one or more of the following: a) Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the subject’s schizophrenic symptoms); b) Emergency Department/Room/Ward visit due to a worsening of the subject’s symptoms of schizophrenia, but a psychiatric hospitalization does not occur; c) The subject inflicts deliberate self-injury or exhibits violent behaviour resulting in suicide, clinically significant injury to him/herself or another person, or significant property damage; d) The subject has suicidal or homicidal ideation and aggressive behaviour that is clinically significant (in frequency and severity) in the investigator’s judgment. The intent-to-treat (ITT) analysis population included all subjects who received at least 1 dose of study drug in this study.
    End point type
    Primary
    End point timeframe
    Up to Day 730
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were planned. No inferential statistics were planned.
    End point values
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Number of subjects analysed
    178
    Units: Subjects
    7
    No statistical analyses for this end point

    Primary: Number of Subjects with Treatment-emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects with Treatment-emergent Adverse Events (TEAEs) [2]
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events if they started after administration of the first dose and until 183 days after the last dose of study medication. The safety analysis population included all subjects who received at least 1 dose of study drug in this study.
    End point type
    Primary
    End point timeframe
    Up to Day 730
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were planned. No inferential statistics were planned.
    End point values
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Number of subjects analysed
    178
    Units: Subjects
    111
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score

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    End point title
    Change from Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score
    End point description
    Change from baseline in CGI-S scale score was reported. CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a subject was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill subjects. A higher score implies a more severe condition. The ITT analysis population included all subjects who received at least 1 dose of study drug in this study. Here, 'N' (number of subjects analysed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 730
    End point values
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Number of subjects analysed
    176
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.0 ± 0.51
    No statistical analyses for this end point

    Secondary: Change from Baseline in Personal and Social Performance (PSP) Scale Score

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    End point title
    Change from Baseline in Personal and Social Performance (PSP) Scale Score
    End point description
    Change from baseline in PSP scale score was reported. The PSP scale assesses degree of a subject's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Subjects with score of 71 to 100 had mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance. The ITT analysis population included all subjects who received at least 1 dose of study drug in this study. Here, 'N' (number of subjects analysed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 730
    End point values
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Number of subjects analysed
    173
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.5 ± 7.47
    No statistical analyses for this end point

    Secondary: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

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    End point title
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
    End point description
    Change from baseline in PANSS total score were reported. The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale of 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia). The ITT analysis population included all subjects who received at least 1 dose of study drug in this study. Here, 'N' (number of subjects analysed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 730
    End point values
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Number of subjects analysed
    173
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.7 ± 8.22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 730
    Adverse event reporting additional description
    The safety analysis population included all subjects who received at least 1 dose of study drug in this study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Reporting group description
    Subjects who completed the 12-month double-blind (DB) phase of study R092670PSY3015 (2017-001941-28) without a relapse, were enrolled in this open-label extension (OLE) study and received intramuscular (IM) injections of PP6M 700 (if received moderate dose previously) or 1000 milligrams equivalent (mg eq.) (if received higher dose previously) on Day 1. On Days 183, 365, and 547, flexible dosings were permitted to increase PP6M 700 mg eq. to 1000 mg eq. or decrease 1000 mg eq. to 700 mg eq. as per investigator's judgement.

    Serious adverse events
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 178 (4.49%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon Cancer
         subjects affected / exposed
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases to Peritoneum
         subjects affected / exposed
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrotic Syndrome
         subjects affected / exposed
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Psychiatric Symptom
         subjects affected / exposed
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
         subjects affected / exposed
    4 / 178 (2.25%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hallucination, Auditory
         subjects affected / exposed
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 178 (38.20%)
    Investigations
    Weight Increased
         subjects affected / exposed
    9 / 178 (5.06%)
         occurrences all number
    9
    Blood Prolactin Increased
         subjects affected / exposed
    19 / 178 (10.67%)
         occurrences all number
    19
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 178 (13.48%)
         occurrences all number
    30
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 178 (6.18%)
         occurrences all number
    12
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    13 / 178 (7.30%)
         occurrences all number
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 178 (5.06%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2020
    The overall rational of this amendment was to remove text related to anticipated events which do not apply in single arm open-label extension study and to increase the estimated number of subjects to be enrolled in the study for multiple reasons relating to preceding double-blind study.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The sponsor identified that the study did not include a control arm reference group. The coronavirus disease-2019 (COVID-19) pandemic placed some restrictions on study face-to-face visits.
    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.

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