NCT05904717

Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder

A Phase 2a, Multi Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of 12 Weeks Treatment With Oral PXS-4728A on Microglia Activation, as Measured by Positron Emission Tomography, in Participants With Isolated Rapid Eye Movement Sleep Behavior Disorder

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Syntara · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the safety and efficacy of PXS-4728A as an intervention therapy in participants with iRBD. This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level.

Detailed description

Up to 48 participants are planned to be screened and approximately 40 participants are planned to be enrolled in this study. Participants will be randomized to receive either active IP or matching placebo in a ratio of 3:1 (30 active and 10 placebo). Study participation will consist of a Screening period of up to 2 weeks to confirm participant eligibility. Once confirmed as eligible, participants will be able to enroll in the study and will be required to attend the clinical site on Day 1 for treatment assignment, initial dosing, and Baseline assessments. Oversight of the study will be provided by a Data Safety Monitoring Committee (DSMC) comprising the Principal Investigator (PI), the local Medical Monitor (MM), and a representative of the Sponsor, at a minimum.

Conditions

• REM Sleep Behavior Disorder

Interventions

Type	Name	Description
DRUG	PXS-4728 (A)	Participants will receive once daily (QD) for period of 12 weeks
DRUG	Matching Placebo (B)	Participants will receive once daily (QD) for period of 12 weeks

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-09-30
• Completion: 2026-01-31
• First posted: 2023-06-15
• Last updated: 2025-04-11

Locations

3 sites across 2 countries: Australia, United Kingdom