Clinical Trial

An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

Name: An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome — clinical trial record (NCT07593391)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 3

View on ClinicalTrials.gov →

Summary

This Phase 3, open-label extension, multicenter study will evaluate long-term safety, tolerability and efficacy of NNZ-2591 in pediatric participants with Phelan- McDermid Syndrome.

Protocol Amendment History 2 changes

notable Trial sites expanded: 2 -> 6 locations 2026-08-13

critical Recruitment opened 2026-05-23

Trial Details

NCT Number	NCT07593391
Lead Sponsor	Neuren Pharmaceuticals Limited
Conditions	Phelan-McDermid Syndrome
Enrollment	180 participants
Start Date	2026-06-08
Primary Completion	2028-10-29 (estimated)
Study Completion	2028-11-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-12