Clinical trials: Prader Willi Syndrome
Prader-Willi Syndrome
PWS European Blood Bank for Infants and Controls From 0 to 48 Months
The present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in PWS.
- Trial name
- NCT02529085
- Testing
- blood samples
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Prader-Willi Syndrome, Hyperphagia
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
- Trial name
- ZEPHYR (NCT03790865)
- Testing
- Livoletide
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 158 people
- Sponsor
- Millendo Therapeutics SAS
Microdeletion Syndromes, Trisomy 21
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA
The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on…
- Conditions
- Microdeletion Syndromes, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- Microdel Triad (NCT02109770)
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Natera, Inc.
Prader-Willi Syndrome
Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions…
- Trial name
- NCT03858023
- Testing
- Hippotherapy
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Samsung Medical Center
Prader-Willi Syndrome
Brain Olfactory Pathways in Prader-Willi Syndrome
Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.
- Trial name
- PRADOL (NCT07006207)
- Testing
- olfactory stimulation, functional MRI
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Toulouse
Silver Russell Syndrome, Prader-Willi Syndrome
Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome
There is currently no drug with pediatric marketing authorization capable of limiting the advance in bone maturation of children with aggressive adrenarche.
- Trial name
- ANASILPRA (NCT01520467)
- Testing
- Anastrozole
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Central Adrenal Insufficiency, Prader-Willi Syndrome
Assessment of CAI in Adults With PWS.
Introduction: The prevalence and clinical significance of central adrenal insufficiency (CAI) in adult patients with Prader Willi Syndrome (PWS) remains unclear.
- Trial name
- NCT04700644
- Where
- Poland
- Volunteers
- 21 people
- Sponsor
- Medical University of Warsaw
Prader-Willi Syndrome
Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
- Trial name
- PWS (NCT05198362)
- Testing
- Tesomet
- Where
- United States
- Sponsor
- Saniona
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
Obesity, Prader Willi Syndrome
Macronutrient Regulation of Ghrelin and Peptide YY
The hyperghrelinemia of children with PWS provides a unique model by which to explore the hormonal and metabolic effects of orexigenic hormones in normal and pathologic conditions.
- Trial name
- NCT02464514
- Testing
- High carbohydrate meal, High fat meal
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Duke University
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, Aggression
Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS).
- Conditions
- Prader-Willi Syndrome, Aggression, Self-Injurious Behavior, Pathologic Processes
- Trial name
- PWS-GXR (NCT05657860)
- Testing
- Guanfacine Extended Release
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Maimonides Medical Center
Prader-Willi Syndrome
PWS Outcomes Assessment Study
This is a longitudinal study during which qualitative interviews will be conducted with caregivers of Soleno C601/C602 study subjects.
- Trial name
- NCT04102839
- Testing
- Interview
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Soleno Therapeutics, Inc.
Prader-Willi Syndrome
Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years
Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome.
- Trial name
- Oxyjeune (NCT03114371)
- Testing
- Oxytocin
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Toulouse
Prader-Willi Syndrome
Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies
Background: Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder arising from the lack of expression of paternally inherited imprinted genes on chromosome 15q11-q13.
- Trial name
- OTBB (NCT01548521)
- Testing
- Oxytocin
- Where
- France
- Volunteers
- 5 people
- Sponsor
- University Hospital, Toulouse
Prader-Willi Syndrome
Stress and Brain Response Using MEG in PWS
Individuals with Prader-Willi Syndrome (PWS) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges.
- Trial name
- NCT04032639
- Where
- 2 sites in Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Prader-Willi Syndrome
Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
This is a placebo-controlled clinical trial to assess the utility of Guanfacine Extended Release (GXR) in the management of patients with Prader Willi Syndrome (PWS) who have significant aggression or self-injury.
- Trial name
- NCT04066088
- Testing
- Guanfacine extended release (GXR)
- Where
- United States
- Sponsor
- NYU Langone Health
Prader-Willi Syndrome, Self-Injurious Behavior
Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome
Prader-Willi syndrome (PWS) is a genetic disorder usually caused by the deletion of a specific gene. One of the symptoms of PWS is self-injurious behavior (SIB); a common form of SIB in PWS patients is skin picking.
- Trial name
- NCT00065923
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study followed by two open label extension periods.
- Trial name
- 2016-003694-18 (NCT03149445)
- Testing
- Tesofensine/Metoprolol
- Where
- 2 sites in Czechia, Hungary
- Volunteers
- 18 people
- Sponsor
- Saniona
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