An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
Public ClinicalTrials.gov record NCT07593391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Enrollment
- 180 participants
Conditions and interventions
Conditions
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 7, 2026
- Primary completion
- Oct 28, 2028
- Completion
- Nov 11, 2028
- Last update posted
- Sep 20, 2026
2026 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| 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#111 | San Rafael | California | 94903 | 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 |
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 Sep 20, 2026 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07593391 live on ClinicalTrials.gov.