Clinical Trial Results:
Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
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Summary
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EudraCT number |
2018-004532-30 |
Trial protocol |
PL IT |
Global end of trial date |
03 May 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
19 May 2023
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First version publication date |
19 May 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
R092670PSY3016
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04072575 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
920 US Highway 202, Raritan, United States, 08869-1420
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Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 May 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 May 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Sep 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Argentina: 46
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Country: Number of subjects enrolled |
Hong Kong: 1
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Country: Number of subjects enrolled |
Italy: 6
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Country: Number of subjects enrolled |
Poland: 44
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Country: Number of subjects enrolled |
Russian Federation: 39
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Country: Number of subjects enrolled |
Ukraine: 42
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Worldwide total number of subjects |
178
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EEA total number of subjects |
50
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
176
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||
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Pre-assignment
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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. | ||||||||||||||||
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Period 1
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Period 1 title |
Open-label Extention (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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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
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Investigational medicinal product code |
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Other name |
R092670
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
PP6M 700 or 1000 mg eq. IM injections were administered on Days 1, 183, 365, and 547.
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Baseline characteristics reporting groups
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Reporting group title |
Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
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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. | ||
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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.
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End point type |
Primary
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End point timeframe |
Up to Day 730
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| 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. |
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| No statistical analyses for this end point | |||||||
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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.
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End point type |
Primary
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End point timeframe |
Up to Day 730
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| 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. |
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| No statistical analyses for this end point | |||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline up to Day 730
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| No statistical analyses for this end point | |||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline up to Day 730
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| No statistical analyses for this end point | |||||||||
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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.
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End point type |
Secondary
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End point timeframe |
Baseline up to Day 730
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to Day 730
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Adverse event reporting additional description |
The safety analysis population included all subjects who received at least 1 dose of study drug in this study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
Total Paliperidone Palmitate 6-month (PP6M) 700 or 1000 mg eq.
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| 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. | |||
