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

ClinicalTrials.gov ID: NCT07593391

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07593391
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Neuren Pharmaceuticals Limited; Industry
Enrollment: 180 participants

Conditions and interventions

Conditions

Phelan-McDermid Syndrome

Interventions

NNZ-2591 Drug

Drug

Eligibility (public fields only)

Age range: 3 Years to 12 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 8, 2026 (Actual)
Primary completion: Oct 29, 2028 (Estimated)
Completion: Nov 12, 2028 (Estimated)
Last update posted: Nov 9, 2026

2026 – 2028

United States locations

U.S. sites: 12
U.S. states: 9
U.S. cities: 12

Facility	City	State	ZIP	Site status
Neuren PMS-302 Site #116	Birmingham	Alabama	35233	Recruiting
Neuren PMS-302 Site#122	Glendale	California	91203	Recruiting
Neuren PMS-302 Site#103	San Diego	California	92123	Recruiting
Neuren PMS-302 Site#111	San Rafael	California	94903	Recruiting
Neuren PMS-302 Site#102	Chicago	Illinois	60612	Recruiting
Neuren PMS-302 Site#109	Chevy Chase	Maryland	20815	Recruiting
Neuren PMS-302 Site#106	Brookline	Massachusetts	02445	Recruiting
Neuren PMS-302 Site#104	Lexington	Massachusetts	02421	Recruiting
Neuren PMS-302 Site#101	New York	New York	10029	Recruiting
Neuren PMS-302 Site#108	Cincinnati	Ohio	02421	Recruiting
Neuren PMS-302 Site#115	Houston	Texas	77030	Recruiting
Neuren PMS-302 Site#113	Charlottesville	Virginia	22903	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07593391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 9, 2026 · Synced Nov 15, 2026