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

NCT07281079 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Phelan-McDermid Syndrome

Interventions

DRUG

NNZ-2591

The study drug will be administered twice daily orally.

DRUG

Placebo

The study drug will be administered twice daily orally.

Sponsors & Collaborators

  • Neuren Pharmaceuticals Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2027-10-31
Completion
2027-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281079 on ClinicalTrials.gov