A Study of CSTI-500 in Patients With Prader-Willi Syndrome (NCT07348601)
A Proof-of-Concept Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of CSTI-500 in Participants With Prader-Willi Syndrome
🩺 Plain-English Summary (8th-Grade Level)
This is a proof-of-concept, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CSTI-500 in participants with genetically confirmed Prader-Willi Syndrome (PWS) who are 13 to 50 years of age. Participants will receive increasing doses of CSTI-500, and blood levels will be measured to guide individualized dosing.
Who can join: Review the eligibility criteria below.
Location: Vanderbilt University Medical Center — Nashville, Tennessee
Age range: 13 Years to 50 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 (1 Sites)
- Vanderbilt University Medical Center — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (859) 426-5035
Email: bethmack@lbr-regulatory.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 Prader-Willi Syndrome
- A Study of Setmelanotide in Patients With Prader-Willi Syndrome — Gainesville, Florida
- A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS — Palo Alto, California
- Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome — Orange, California
- A Study of Pitolisant in Patients With Prader-Willi Syndrome — Los Angeles, California
- Tirzepatide in PWS, HO and GNSO — Saint Paul, Minnesota
- Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation — Kansas City, Missouri
Explore by condition: All Prader-Willi 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.