drugset / Trial / NCT07281079

A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

NCT07281079 ↗

Phase 3 Recruiting 160 enrolled Neuren Pharmaceuticals Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 3, randomized, double-blind, parallel-group (2-arm), placebo-controlled, multicenter study will evaluate the efficacy and safety of NNZ-2591 compared to placebo in pediatric participants with Phelan- McDermid Syndrome.

Timeline

Start
2025-11-12
Primary completion
2027-10-31
Completion
2027-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject NNZ-2591 Small molecule — Oral