A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
Public ClinicalTrials.gov record NCT07281079. 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 Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Orally Administered NNZ-2591 Compared With Placebo in Pediatric Participants With Phelan-McDermid Syndrome
Study identification
- NCT ID
- NCT07281079
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Neuren Pharmaceuticals Limited
- Industry
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Interventions
- NNZ-2591 Drug
- Placebo 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
- Nov 11, 2025
- Primary completion
- Oct 30, 2027
- Completion
- Nov 14, 2027
- Last update posted
- Jul 6, 2026
2025 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuren PMS-301 Site#122 | Glendale | California | 91203 | Recruiting |
| Neuren PMS-301 Site #112 | Palo Alto | California | 94305 | Recruiting |
| Neuren PMS-301 Site#103 | San Diego | California | 92123 | Recruiting |
| Neuren PMS-301 Site#111 | San Rafael | California | 94903 | Recruiting |
| Neuren PMS-301 Site#102 | Chicago | Illinois | 60612 | Recruiting |
| Neuren PMS-301 Site#109 | Chevy Chase | Maryland | 20815 | Recruiting |
| Neuren PMS-301 Site#106 | Brookline | Massachusetts | 02445 | Recruiting |
| Neuren PMS-301 Site#104 | Lexington | Massachusetts | 02421 | Recruiting |
| Neuren PMS-301 Site#101 | New York | New York | 10029 | Recruiting |
| Neuren PMS-301 Site#108 | Cincinnati | Ohio | 45229 | Recruiting |
| Neuren PMS-301 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07281079, 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 Jul 6, 2026 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07281079 live on ClinicalTrials.gov.