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

Part of paid clinical trials in San Rafael, California.

Sponsor
Neuren Pharmaceuticals Limited
Study ID
NCT07593391
Phase
PHASE3
Status
Recruiting
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Conditions

  • Phelan-McDermid Syndrome

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • NNZ-2591 — DRUG
    The study drug will be administered twice daily orally.

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Oct 29, 2028
Completion
Nov 12, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NNZ-2591 Arm
    The total duration of this study for each participant will be up to up to 56 weeks.

Primary Outcome Measure

Long-term safety and tolerability of NNZ-2591 as assessed by the incidence of adverse events across participants [ Time Frame: Baseline through Safety Follow-Up (Month 12) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Neuren PMS-302 Site#111San RafaelCalifornia94903

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Neuren PMS-302· San Rafael, CA

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