Phase 3
N=178
A Study of Paliperidone Palmitate 6-Month Formulation
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT04072575 ↗Enrolled (actual)
178
Serious AEs
4.5%
Results posted
May 2023
Primary outcome: Primary: Number of Participants With Relapse — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PP6M injection Dose 1 (Drug); PP6M injection Dose 2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- May 2022
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 | — |
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.
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). 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.