A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome (NCT07281079)
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Orally Administered NNZ-2591 Compared With Placebo in Pediatric Participants With Phelan-McDermid Syndrome
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Neuren PMS-301 Site #116 — Birmingham, Alabama
Age range: 3 Years to 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Neuren PMS-301 Site #116 — Birmingham, Alabama
- Neuren PMS-301 Site#122 — Glendale, California
- Neuren PMS-301 Site #112 — Palo Alto, California
- Neuren PMS-301 Site#103 — San Diego, California
- Neuren PMS-301 Site#111 — San Rafael, California
- Neuren PMS-301 Site#102 — Chicago, Illinois
- Neuren PMS-301 Site#109 — Chevy Chase, Maryland
- Neuren PMS-301 Site#106 — Brookline, Massachusetts
- Neuren PMS-301 Site#104 — Lexington, Massachusetts
- Neuren PMS-301 Site #117 — Ann Arbor, Michigan
- Neuren PMS-301 Site#101 — New York, New York
- Neuren PMS-301 Site#108 — Cincinnati, Ohio
- Neuren PMS-301 Site#115 — Houston, Texas
- Neuren PMS-301 Site #113 — Charlottesville, Virginia
- Neuren PMS-301 Site#201 — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (231) 203-8050
Email: medicalinformation@neurenpharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Phelan-McDermid Syndrome
- Mapping the Genotype, Phenotype, and Natural History of Phelan-McDermid Syndrome — Stanford, California
- An Open-label Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome — Glendale, California
Explore by condition: All Phelan-McDermid Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.