RecruitingPhase 3NCT07593391

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

A Phase 3 Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Orally Administered NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome


Sponsor

Neuren Pharmaceuticals Limited

Enrollment

180 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NNZ-2591 for people with phelan-mcdermid syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Years to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNNZ-2591

The study drug will be administered twice daily orally.


Locations(2)

Neuren PMS-302 Site#111

San Rafael, California, United States

Neuren PMS-302 Site#109

Chevy Chase, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT07593391


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