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15 Prader-Willi Syndrome Trials Near You
Power is an online platform that helps thousands of Prader-Willi Syndrome patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerCarbetocin Nasal Spray for Prader-Willi Syndrome
Columbus, Ohio
To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:5 - 30
Key Eligibility Criteria
Disqualifiers:Cerebrovascular Disease, Epilepsy, Psychotic Disorder, Others
160 Participants Needed
Carbetocin Nasal Spray for Prader-Willi Syndrome
Columbus, Ohio
12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:5 - 30
Key Eligibility Criteria
Disqualifiers:Schaaf-Yang Syndrome, Cardiovascular Disorder, Epilepsy, Others
Must Not Be Taking:Prostaglandins, Oxytocin, Desmopressin, Others
170 Participants Needed
Vagus Nerve Stimulation for PWS
Columbus, Ohio
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.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 40
Key Eligibility Criteria
Disqualifiers:Pregnancy, Serious Mental Illness, Cardiac Disease, Epilepsy, Others
102 Participants Needed
DCCR for Prader-Willi Syndrome
Columbus, Ohio
The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:4+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Recent Investigational Study
83 Participants Needed
Pitolisant for Prader-Willi Syndrome
Cincinnati, Ohio
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 include assessing the impact of pitolisant on:
* Irritable and disruptive behaviors
* Hyperphagia
* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6+
Key Eligibility Criteria
Disqualifiers:Sleep Apnea, Hypersomnia, Others
134 Participants Needed
Pitolisant for Prader-Willi Syndrome
Cincinnati, Ohio
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Prader Willi syndrome (PWS) ages 6 to 65 years.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:6 - 65
Key Eligibility Criteria
Disqualifiers:Other Genetic Disorders, Untreated OSA, Psychosis, Renal Disease, Others
Must Not Be Taking:Strong CYP2D6 Inhibitors
65 Participants Needed
ARD-101 for Prader-Willi Syndrome
Nashville, Tennessee
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 when taking ARD-101?
Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects.
Eligible participants will:
* Take ARD-101 or a placebo every day for 12 weeks.
* Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo.
* Patients/Caregivers will keep a daily diary.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:13+
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Cancer, Others
Must Not Be Taking:Weight Agents, Glucocorticoids
90 Participants Needed
Tirzepatide for Weight Loss in Prader-Willi Syndrome and Obesity
Nashville, Tennessee
This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and/or hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 26
Key Eligibility Criteria
Disqualifiers:Pregnancy, Pancreatitis, Diabetes, Cancer, Others
Must Not Be Taking:Weight Loss Drugs, Insulin, GLP1A, DPP4
36 Participants Needed
Atomoxetine for Obesity
Nashville, Tennessee
This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common cause of genetic obesity disorders. Atomoxetine was selected for this pilot trial because it has been shown to increase brain-derived neurotrophic factor (BDNF) within the central nervous system and in peripheral circulation. Targeting BDNF is a specific strategy for treating MC4R abnormalities because BDNF functions as a downstream mediator of MC4R signaling.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:6+
Key Eligibility Criteria
Disqualifiers:Hypertension, Asthma, Depression, Others
Must Not Be Taking:Stimulants, MAO Inhibitors
20 Participants Needed
Physical Activity Program for Intellectual Disability
Chapel Hill, North Carolina
Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)/age-related dementias (ARD).
Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals.
Procedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Alzheimer's, Dementia, Others
376 Participants Needed
PIXI for Neurogenetic Disorders
Research Triangle Park, North Carolina
This trial tests a program called PIXI, which helps parents of infants with genetic disorders. The program educates parents about their baby's condition, coaches them on how to interact with their baby, and provides family support. The goal is to improve the baby's development and family well-being.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:< 99
Key Eligibility Criteria
Disqualifiers:Blindness, Severe Hearing Impairment
120 Participants Needed
Bright Light Therapy for Prader-Willi Syndrome
Brooklyn, New York
This trial tests if light therapy can reduce daytime sleepiness in children with Prader-Willi Syndrome by helping them feel more awake during the day and sleep better at night. Light therapy has been explored for daytime sleepiness and insomnia in various conditions, including Parkinson's disease and dementia.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 88
Key Eligibility Criteria
Disqualifiers:Eye Conditions, Psychosis, Mania, Others
Must Not Be Taking:Photosensitizing Medications
30 Participants Needed
rTMS for Prader-Willi Syndrome
Belmont, Massachusetts
This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study hyperphagia and satiety in Prader-Willi syndrome.
TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about how TMS might improve hyperphagia in Prader-Willi syndrome.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Neurological Disorder, Head Trauma, Seizures, Others
20 Participants Needed
Setmelanotide for Prader-Willi Syndrome
Gainesville, Florida
This is a Phase 2, single-center, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelanotide for up to 26 weeks.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 65
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Disorders, Others
Must Not Be Taking:Weight Modulating Medications
20 Participants Needed
ARD-101 for Prader-Willi Syndrome
Aurora, Colorado
A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:17 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
18 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
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Bask GillCEO at Power
Frequently Asked Questions
How much do Prader-Willi Syndrome clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.How do Prader-Willi Syndrome clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Prader-Willi Syndrome trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Prader-Willi Syndrome is 12 months.How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.Do I need to be insured to participate in a Prader-Willi Syndrome medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.What are the newest Prader-Willi Syndrome clinical trials ?
Most recently, we added Tirzepatide for Weight Loss in Prader-Willi Syndrome and Obesity, Atomoxetine for Obesity and Setmelanotide for Prader-Willi Syndrome to the Power online platform.Popular Searches
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