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Prader-Willi Syndrome clinical trials

View clinical trials related to Prader-Willi Syndrome.

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NCT ID: NCT06448871 Recruiting - Metabolic Syndrome Clinical Trials

Ultrasound to Assess Sarcopenia in Prader Willi Syndrome

PWS
Start date: October 17, 2022
Phase:
Study type: Observational

The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

NCT ID: NCT06366464 Recruiting - Clinical trials for Prader-Willi Syndrome

A Study of Pitolisant in Patients With Prader-Willi Syndrome

Start date: April 30, 2024
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT06295315 Recruiting - Clinical trials for Prader-Willi Syndrome

Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome

PROPSICOPWS
Start date: April 21, 2023
Phase:
Study type: Observational

The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated.

NCT ID: NCT06173531 Recruiting - Clinical trials for Hyperphagia in Prader-Willi Syndrome

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

Start date: November 27, 2023
Phase: Phase 3
Study type: Interventional

12-week, randomized, double-blind, placebo-controlled, parallel-group study of carbetocin nasal spray for the treatment of hyperphagia in Prader-Willi syndrome (PWS)

NCT ID: NCT06144645 Recruiting - Clinical trials for Prader-Willi Syndrome

A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS

VNS4PWS
Start date: January 8, 2024
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05945576 Recruiting - Clinical trials for Prader-Willi Syndrome

IDMet (RaDiCo Cohort) (RaDiCo-IDMet)

IDMet
Start date: March 10, 2017
Phase:
Study type: Observational

The goal of this observational study is to describe the natural history of imprinting disorders (IDs) according to their metabolic profile in all patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center. The main questions it aims to answer are: - Can we identify common metabolic profiles for all imprinted diseases? - Which imprinting disorders have an impact on the metabolic profiles of IDs? - Which are the metabolic risks associated to IDs? - Can we use the metabolic profiles for the clinical classification and prognosis of IDs? - Are there common therapeutic approaches for all IDs?

NCT ID: NCT05939453 Recruiting - Body Weight Clinical Trials

Impact of Bright Light Therapy on Prader-Willi Syndrome

PWS-LT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05938543 Recruiting - Clinical trials for Prader-Willi Syndrome

Cerebellar TMS and Satiety in Prader-Willi Syndrome

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05791604 Recruiting - Clinical trials for Prader-Willi Syndrome

The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Prader-Willi syndrome (PWS) is a rare genetic disease, with hyperappetite and severe obesity. At present, there is no effective drugs and interventions to help control the appetite of PWS patients. More and more evidence has shown that gut microbiota is closely related to obesity. Probiotics and prebiotics can improve the structure of gut microbiota, thus improve blood lipid levels and other biochemical indicators of obese people. Therefore, this study intends to explore the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain of PWS children.

NCT ID: NCT05778032 Recruiting - Clinical trials for Prader-Willi Syndrome

Biological Age Assessment in Adults With Prader-Willi Syndrome (ETABIOLPWS)

ETABIOLPWS
Start date: May 25, 2022
Phase:
Study type: Observational

The primary objective of the study is to compare, in a cohort of obese subjects with PWS hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo (VB), Italy, the age acceleration calculated at study entry (T0) with the age acceleration measured at the end of a 3-week multidisciplinary metabolic rehabilitation program (T1). Secondary objectives are to correlate the biological age with the anthropometric characteristics (with particular reference to the body composition), the glycometabolic picture, the main parameters and cardiovascular risk factors, the therapy (previous and concomitant) with rhGH and the cognitive function (mainly, the IQ).