PWS clinical trials are taking place around the world to help us understand Prader-Willi syndrome and investigate new treatments; please see the list below for active and pending clinical trials. Click on the link at the left of each column for additional information about each of the clinical trials that are active or are about to start. We encourage you to learn more about these clinical trials, talk with your physician about potential risks and benefits, and ask questions to help you decide if enrolling in a clinical trial is right for you or your loved one with PWS.
You can learn more about the drug development process on our blog: Stages of PWS Drug Development Overview. To learn more about clinical trials and the questions you might want to ask as a potential participant, check out this page on the NIH website.
Your participation is key to moving potential therapies forward. If you or someone you care for has PWS, learn about clinical trials by subscribing to FPWR's Clinical Trial Alerts — just fill out the form below!
| Drug / link | Phase | Sponsor | Status | Primary Target | Ages | Length | Site Locations |
| Phase 3 | FPWR | Enrolling | Behavior Outbursts | 10-40 | 12 mo |
CA, GA, NY, MO, TX |
|
| Phase 3 | Harmony Biosciences | Enrolling | Excessive Daytime Sleepiness | 6 - 65 |
CA, CO, DE, GA, OH, NY, TX |
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| Phase 3 | Acadia | Enrolling | Hyperphagia | 5-30 | 19 w |
AL, AZ, CA, CO, IA, IL, KY, MA, MO, NY, OH, PA, TN, TX, UT, WA, CANADA |
|
| Phase 4 | FPWR | Enrolling | Daytime Sleepiness | 6 + | 3 w |
REMOTE |
|
| Interventional | FPWR | Enrolling | Hyperphagia | 18-64 | 3 w |
MA |
|
| Phase 2 | Montefiore Medical Center | Enrolling | Behavior | 5 - 30 | 12 w |
NY |
|
| Phase 2 | Aardvark Therapeutics | complete | Hyperphagia | 17-65 | 4 w | CA, CO | |
|
RGH-706 |
Phase 2 | Gedeon Richter | Enrollment Complete |
Hyperphagia | 17+ |
Enrollment |
|
|
DCCR |
Phase 3 | Soleno Therapeutics | Complete Top-Line Results Available | Hyperphagia | 4+ | complete | complete |
Click on the pins for information about trials that are currently recruiting.
| Study / Link | Investigator | Status | Area of Research | Ages | Length | Site Locations |
| FPWR & CombinedBrain | Recruiting | Urine and Blood Samples | All | 1 visit | Philadelphia, Seattle, Atlanta, Kansas City, Los Angeles | |
| Dr. Scott Hall | Recruiting | Skin Picking | 12-17 | 1 visit | Stanford, CA | |
| Dr. Bridgette Kelleher | Recruiting | Support for caregivers | 2-35 | varies | remote | |
| Dr. Anastasia Dimitropoulos | Recruiting | Intervention Curriculum | 8-20 | n/a | remote | |
| FPWR | Enrolling | Natural History | ALL | ongoing | virtual |
FPWR does not endorse or recommend any specific study. Our goal is to provide information to help members of the PWS community decide whether participation in a clinical trial is right for them and their loved one with PWS. Anyone considering participating in a clinical trial should discuss the matter with his or her physician.
The Foundation for Prader-Willi Research (federal tax id 31-1763110) is a nonprofit corporation with federal tax exempt status as a public charity under section 501(c)(3).
The mission of FPWR is to eliminate the challenges of Prader-Willi syndrome through the advancement of research and therapeutic development.
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