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An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 6 → 9 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 7 of 7 entries
  2. Trial sites expanded: 2 → 6 locationsv4
  3. Study sites: 1 to 2
    • Start date changed from estimate of May 20, 2026 to Jun 8, 2026
    v3
  4. Recruitment opened
    • Study sites: 0 to 1
    • Start date: May 6, 2026 to May 20, 2026
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07593391
Lead Sponsor Neuren Pharmaceuticals Limited
Conditions
(from sponsor)		 Phelan-McDermid Syndrome
Related terms Telomeric 22q13 Monosomy Syndrome
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov