Phase 3
Completed N=178
A Study of Paliperidone Palmitate 6-Month Formulation
Source: ClinicalTrials.gov NCT04072575 ↗Enrolled (actual)
178
Serious AEs
4.5%
Results posted
May 2023
Primary outcomePrimary: Number of Participants With Relapse — 7 Participants
◆ Published Evidence
Emerging
19citations · ~6 / year
Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia.
Summary
The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.
Linked Publications (3)
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Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia.
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Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas.
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Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-World Data for the 1-Month and 3-Month Formulations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse |
7 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
111 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score |
0.0 | — |
| SECONDARY Change From Baseline in Personal and Social Performance (PSP) Scale Score |
0.5 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score |
0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (PP6M)
- Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study
- A woman of childbearing potential: a) Must have a negative pregnancy test on Day 1; b) Use contraception consistent with local regulations. A man must agree that during the study and for a minimum 12 months after receiving the last dose of the study intervention: a) His female partner(s) will use highly effective method pf contraception
- Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (that is, consent cannot be provided by a legal representative of the participant)
- In the opinion of the investigator, the patient would be able to participate for the duration of this study
Exclusion Criteria
- Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
- 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
Data sourced from ClinicalTrials.gov (NCT04072575) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.