Clinical trials: Prader Willis Syndrome
Prader Willi Syndrome, Childhood Obesity
Family-based Intervention for Youth With Prader-Willi Syndrome: The Active Play at Home Study
Compared to other children, those with disability have additional challenges to being physically active. Prader-Willi Syndrome (PWS) is a genetic form of childhood obesity that is characterized by hypotonia, growth hormone…
- Trial name
- APAH (NCT02058342)
- Testing
- Active Play at Home
- Where
- 2 sites in United States
- Volunteers
- 115 people
- Sponsor
- California State University, Fullerton
Prader-Willi Syndrome
Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.
The objective of this study is to collect data on tolerance and effects of early treatment with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare these infants with not treated age-matched…
- Trial name
- OT2SUITE (NCT03081832)
- Testing
- Oxytocin, Control
- Where
- France
- Volunteers
- 34 people
- Sponsor
- University Hospital, Toulouse
Prader-Willi Syndrome
A Study of GLWL-01 in Patients With Prader-Willi Syndrome
The aim of this study is to evaluate efficacy, safety, and pharmacokinetics of GLWL-01 in the treatment of patients with Prader-Willi Syndrome (PWS).
- Trial name
- NCT03274856
- Testing
- GLWL-01
- Where
- 7 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- GLWL Research Inc.
Prader-Willi Syndrome
Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome
Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population.
- Trial name
- NCT01444898
- Testing
- Exenatide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital Los Angeles
Prader-Willi Syndrome
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state.
- Trial name
- NCT03101826
- Testing
- Listening Project Protocol
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Indiana University
Prader-willi Syndrome
Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome
The purpose of this study is to evaluate the effect of rimonabant, a cannabinoid receptor-1 blocking drug, on the appetite, body weight, body fat and growth hormone level of subjects with Prader-Willi Syndrome (PWS).
- Trial name
- PWS (NCT00603109)
- Testing
- rimonabant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Weill Medical College of Cornell University
Prader-Willi Syndrome
A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome
The purpose of this Phase 1 study is to evaluate the pharmacokinetics (PK) and safety of a single dose of CSTI-500 10 mg in subjects with Prader-Willi syndrome (PWS) between 13 and 50 years of age with a genetically confirmed…
- Trial name
- NCT05504395
- Testing
- CSTI-500
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- ConSynance Therapeutics
Prader-Willi Syndrome, Obesity
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding…
- Trial name
- PWSGUT (NCT05541003)
- Testing
- NBT-NM108
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Rutgers, The State University of New Jersey
Prader-Willi Syndrome, Obesity
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.
- Trial name
- bestPWS (NCT02179151)
- Testing
- ZGN-440 for Injectable Suspension
- Where
- 15 sites in United States
- Volunteers
- 108 people
- Sponsor
- Zafgen, Inc.
Prader-Willi Syndrome, Excessive Daytime Sleepiness
Impact of Bright Light Therapy on Prader-Willi Syndrome
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight
- Trial name
- PWS-LT (NCT05939453)
- Testing
- Bright Light Therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Maimonides Medical Center
Hyperphagia in Prader-Willi Syndrome
Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)
- Trial name
- NCT06173531
- Testing
- Carbetocin
- Where
- 30 sites in United States, Canada and 4 more
- Volunteers
- 175 people
- Sponsor
- ACADIA Pharmaceuticals Inc.
Diabetes Mellitus Type 2, Prader Willi Syndrome
Liraglutide Use in Prader-Willi Syndrome
Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss in…
- Trial name
- NCT01542242
- Testing
- Liraglutide
- Where
- Canada
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Vancouver General Hospital
Prader-Willi Syndrome
Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the…
- Trial name
- PRADOTIM (NCT02804373)
- Testing
- Oxytocin (OXT) continuous, Oxytocin
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Toulouse
Prader-Willi Syndrome
Natural History Study of Serious Medical Events in PWS
PATH for PWS is a study to help researchers better understand serious medical events in PWS over a 4-year period, as well as evaluate how PWS-related behaviors change over time.
- Trial name
- PATH for PWS (NCT03718416)
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Foundation for Prader-Willi Research
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome
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.
- Trial name
- NCT05701774
- Testing
- DCCR
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 77 people
- Sponsor
- Soleno Therapeutics, Inc.
Prader-Willi Syndrome, Obesity
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
This is a Phase 2, 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.
- Conditions
- Prader-Willi Syndrome, Obesity, Hyperphagia
- Trial name
- NCT06772597
- Testing
- Setmelanotide
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Prader-Willi Syndrome
Home-based SSP on Individuals With PWS
The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state.
- Trial name
- NCT03871751
- Testing
- Safe and Sound Protocol
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Indiana University
Prader-Willi Syndrome
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome
This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are…
- Trial name
- NCT02034071
- Testing
- DCCR
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Essentialis, Inc.
Hypothalamic Obesity
A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity
Hypothalamic obesity (HO) is an obesity secondary to an alteration of the functioning of the hypothalamus, the central organ of energy homeostasis.
- Trial name
- OH_APADIET (NCT03673813)
- Volunteers
- 16 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Prader-Willi Syndrome
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.
- Trial name
- NCT06366464
- Testing
- Pitolisant tablet
- Where
- 57 sites in United States, Australia and 11 more
- Volunteers
- 134 people
- Sponsor
- Harmony Biosciences Management, Inc.