NCT05904717 is a Phase 2 clinical trial of PXS-4728 (A) in REM Sleep Behavior Disorder, sponsored by Syntara.

Who is sponsoring NCT05904717?

NCT05904717 is sponsored by Syntara.

What drugs are being tested in NCT05904717?

Interventions in NCT05904717: PXS-4728 (A), Matching Placebo (B).

What condition does NCT05904717 study?

NCT05904717 studies REM Sleep Behavior Disorder.

Is NCT05904717 still recruiting?

NCT05904717 is currently active, enrolled. Last updated 11 April 2025.

Last reviewed 2025-04-11 · How we verify

NCT05904717

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 11 April 2025

What this trial tests

Phase 2 trial testing PXS-4728 (A) in REM Sleep Behavior Disorder in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 November 2023

Primary endpoint
30 September 2024

31 January 2026

Quick facts

Lead sponsor	Syntara
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	8 November 2023
Primary completion	30 September 2024
Estimated completion	31 January 2026
Sites	3 locations across United Kingdom, Australia

Drugs / interventions tested

PXS-4728 (A) — full drug profile →
Matching Placebo (B) — full drug profile →

Conditions studied

REM Sleep Behavior Disorder — all drugs for REM Sleep Behavior Disorder →

Sponsor

Syntara — full company profile →

Who can join

Adults 50 to 80, any sex, with REM Sleep Behavior Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Imaging Biomarkers in Prodromal and Earliest Phases of Parkinson's Disease.
Theis H, Pavese N, Rektorová I, van Eimeren T. · · 2024 · cited 9× · PMID 38339941 · DOI 10.3233/jpd-230385
Targeting vascular adhesion protein-1 and myeloperoxidase with a dual inhibitor SNT-8370 in preclinical models of inflammatory disease.
Glaros E, Foot J, Rayner B, Schilter H, et al · · 2025 · cited 3× · PMID 40210617 · DOI 10.1038/s41467-025-58454-6
Implications and opportunities regarding biological frameworks in overt and prodromal dementia with Lewy bodies.
Goldman JG, Boeve BF, Galasko D, Taylor JP, et al · · 2025 · cited 2× · PMID 40684248 · DOI 10.1002/alz.70470
REM Sleep Behavior Disorder as a Prodromal Synucleinopathy: Updates on Clinical and Laboratory Biomarkers, and Implications for Neuroprotective Trials.
Neilson LE, Khattab YI, Lim MM. · · 2025 · cited 1× · PMID 41134495 · DOI 10.1007/s11910-025-01452-4
Future is now: an Australasian perspective on disease-modifying trials in Parkinson's and prodromal disease.
Lewis SJ, Sue CM, Cooper A, Halliday GM. · · 2025 · PMID 40129903 · DOI 10.1136/bmjno-2025-001070

Verify or expand the search:

Other recruiting trials for REM Sleep Behavior Disorder

Currently open trials in the same condition.

NCT06797284 — The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders · NA · recruiting
NCT07443293 — IMPACT 360 for Parkinson's Disease · Phase 2 · recruiting
NCT06629207 — Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder · NA · recruiting
NCT06441864 — Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder · NA · recruiting
NCT06270290 — The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls · recruiting

Other Syntara trials

Trials by the same sponsor.

NCT04676529 — Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patient · Phase 1, PHASE2 · completed
NCT04183517 — A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05904717 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Syntara
Last refreshed: 11 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05904717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing