An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome
NCT07593391 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2026-05-22
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.
Conditions
- Phelan-McDermid Syndrome
Interventions
- DRUG
-
NNZ-2591
The study drug will be administered twice daily orally.
Sponsors & Collaborators
-
Neuren Pharmaceuticals Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-20
- Primary Completion
- 2028-10-29
- Completion
- 2028-11-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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