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

NCT05904717 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-11

No results posted yet for this study

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.

Conditions

  • REM Sleep Behavior Disorder

Interventions

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

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2024-09-30
Completion
2026-01-31

Countries

  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05904717 on ClinicalTrials.gov