NCT03345342

A Study of Paliperidone Palmitate 6-Month Formulation

A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 841 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

Detailed description

The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12 months \[neither the researchers nor the participants know what treatment the participant is receiving\]). Additional/conditional phases include a transition phase (before maintenance phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety. The study duration will vary from approximately 13 months to 19 months.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	PP6M	Participants will receive intramuscular injection of PP6M.
DRUG	PP3M 350 mg eq.	Participants will receive intramuscular injection of PP3M 350 mg eq.
DRUG	PP3M 525 mg eq.	Participants will receive intramuscular injection of PP3M 525 mg eq.
DRUG	PP1M	Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
OTHER	Placebo	Participants will receive matching placebo.

Timeline

• Start date: 2017-11-20
• Primary completion: 2020-05-08
• Completion: 2020-05-08
• First posted: 2017-11-17
• Last updated: 2025-04-29
• Results posted: 2021-12-09

Locations

138 sites across 21 countries: United States, Argentina, Australia, Brazil, Bulgaria, Czechia, France, Hong Kong, Hungary, India, Italy, Malaysia, Mexico, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study