A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The ...
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS....
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101. The...
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us ...
Top Cities for Prader-Willi Syndrome Clinical Trials
Prader-Willi Syndrome clinical trials are recruiting across 20 cities. Here are the cities with the most active studies:
About Prader-Willi Syndrome
Prader-Willi syndrome is a rare genetic disorder caused by loss of gene function on chromosome 15, leading to constant hunger, obesity, intellectual disability, and short stature. It is the most common genetic cause of life-threatening obesity. Management includes growth hormone therapy and strict dietary supervision.
Clinical trials are advancing new treatments for prader-willi syndrome. Currently, 4 studies are recruiting a combined 416 participants across the United States. Research is being conducted by 3 organizations including Harmony Biosciences Management, Inc., Foundation for Prader-Willi Research, Aardvark Therapeutics, Inc..
2026 Prader-Willi Syndrome Research Landscape
As of March 2026, the prader-willi syndrome clinical trial landscape includes 4 actively recruiting studies across 20 cities in the United States. These studies are collectively seeking 416 participants, with an average enrollment target of 104 per study.
Research is being led by 3 different organizations, including Harmony Biosciences Management, Inc., Foundation for Prader-Willi Research, Aardvark Therapeutics, Inc..
Geographically, prader-willi syndrome trials are most concentrated in Atlanta, Georgia (7 trials); San Diego, California (3 trials); Wilmington, Delaware (3 trials); Palo Alto, California (3 trials); Aurora, Colorado (2 trials) and 7 other cities.
Featured Prader-Willi Syndrome Studies
Highlighted recruiting studies for prader-willi syndrome, selected by enrollment size and research scope.
A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome. The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome. Secondary objectives i...
A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS
The goal of the VNS4PWS clinical study is to test the efficacy, safety, and acceptability of transcutaneous vagus nerve stimulation (tVNS) treatment in people with PWS.
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have ...
Frequently Asked Questions About Prader-Willi Syndrome Clinical Trials
Are there prader-willi syndrome clinical trials near me?
Yes, there are 4 prader-willi syndrome clinical trials currently recruiting across 20+ cities in the United States, including Atlanta, Georgia; San Diego, California; Wilmington, Delaware. Browse the studies above to find one at a location convenient for you.
How do I join a prader-willi syndrome clinical trial?
To join a prader-willi syndrome clinical trial: 1) Browse the available studies on this page, 2) Click on a study that interests you, 3) Check the study locations to find a site near you, 4) Review the eligibility criteria, and 5) Contact the study site or complete the eligibility form. The process is free and you can withdraw at any time.
Are prader-willi syndrome clinical trials free?
Yes, participation in prader-willi syndrome clinical trials is free. Study-related treatments, medical tests, and doctor visits are provided at no cost to participants. Many studies also offer compensation for your time and travel expenses.
What types of prader-willi syndrome treatments are being studied?
Current prader-willi syndrome clinical trials are testing a range of approaches. These include new drugs, combination therapies, medical devices, and other interventions sponsored by 3 research organizations.
Is it safe to participate in prader-willi syndrome clinical trials?
Clinical trials are carefully regulated by the FDA and institutional review boards (IRBs). All trials must follow strict safety protocols, and participants receive close medical monitoring throughout the study. You can withdraw from a trial at any time without penalty.
Data updated March 1, 2026 from ClinicalTrials.gov
About This Data
Clinical trial information on this page is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health (NIH) and National Library of Medicine (NLM). Study data is refreshed every hour to ensure accuracy.
Medical Disclaimer: The information provided on this page is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider before making decisions about clinical trial participation or changes to your treatment plan.
Page reviewed by the HelloStudys Research Team · Last updated March 1, 2026 · Data from ClinicalTrials.gov