PXS-4728A
Research type
Research Study
Full title
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
IRAS ID
1008383
Contact name
Michele Hu
Contact email
Sponsor organisation
Syntara Ltd.
Clinicaltrials.gov Identifier
Research summary
The participant are diagnosed with Isolated Rapid Eye Movement Sleep Behavior Disorder (iRBD) in which the patients develop dream-enactment behaviours such as hand gestures, violent thrashing, punching, and kicking.
This study is to investigate the safety and efficacy of the PXS-4728A (study drug) as new therapy in participants with iRBD. Study drug acts by blocking a protein called Amine oxidase, copper containing 3 (AOC3). AOC3 combines with some specific immune system cells and encourages more immune cells to the area, these extra immune cells cause inflammation and disease. Study drug also inhibits another protein called monoamine oxidase B (MAO-B). Inhibition of MAO-B makes more dopamine (a feel-good chemical in the brain that helps nerve cells send messages to each other) available.
This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level. Up to 48 participants are planned to be screened and approximately 40 participants are planned to be enrolled in this study. Participants will be randomised 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 3 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. The total participation will be approximately 24 weeks (6 months) and will involve approximately 5 visits to the study clinic.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0256
Date of REC Opinion
7 Mar 2024
REC opinion
Further Information Favourable Opinion