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Prader-Willi Syndrome clinical trials

View clinical trials related to Prader-Willi Syndrome.

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NCT ID: NCT05783791 Completed - Clinical trials for Prader-Willi Syndrome

Development of a Newborn Screening Assay for Angelman Syndrome and Prader-Willi Syndrome

Start date: April 20, 2023
Phase:
Study type: Observational

The overall purpose of this project is to establish the capability of screening for Angelman syndrome (AS) and Prader-Willi syndrome (PWS) in public health newborn screening (NBS) programs, with an aim of developing and validating a screening test for AS and PWS.

NCT ID: NCT05761184 Completed - Clinical trials for Prader-Willi Syndrome

Characterization of Serum Proteome in Subjects With Prader Willi Syndrome (PROTEOMARKER)

PROTEOMARKER
Start date: April 28, 2022
Phase:
Study type: Observational

The lack of serum markers that can be used to identify the levels of steatosis in obese subjects, or that can indicate a rapid progression of the metabolic disease, in which it is very often difficult to perform analyzes with imaging techniques, limits the current evolution from a generalized medicine to a personalized medicine. With the project proposal the aim is to identify serum markers for the characterization of steatosis in subjects affected by genetic obesity, which will most likely also be used in metabolic obesity.

NCT ID: NCT05541003 Completed - Obesity Clinical Trials

Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome

PWSGUT
Start date: January 6, 2023
Phase: Phase 2
Study type: Interventional

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 behavior in PWS patients.

NCT ID: NCT05504395 Completed - Clinical trials for Prader-Willi Syndrome

A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome

Start date: November 14, 2022
Phase: Phase 1
Study type: Interventional

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 diagnosis of PWS.

NCT ID: NCT05322096 Completed - Clinical trials for Prader-Willi Syndrome

Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome

Start date: September 22, 2022
Phase: Phase 2
Study type: Interventional

RGH-706 is a novel, potent, and orally active MCHR1 antagonist drug candidate discovered and being developed by Gedeon Richter Plc. for weight management. This will be the first Phase 2, proof-of-concept study using RGH-706 and is the third study in the clinical development program for RGH-706. The aim of this study is to evaluate the efficacy, safety, and tolerability of RGH-706 in patients with Prader-Willi Syndrome (PWS).

NCT ID: NCT05298085 Completed - Clinical trials for Prader-Willi Syndrome

Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome

DYSMOT
Start date: April 5, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS). This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.

NCT ID: NCT04700644 Completed - Clinical trials for Prader-Willi Syndrome

Assessment of CAI in Adults With PWS.

Start date: May 15, 2020
Phase:
Study type: Observational

Introduction: The prevalence and clinical significance of central adrenal insufficiency (CAI) in adult patients with Prader Willi Syndrome (PWS) remains unclear. Aim: To assess the prevalence of CAI in adults with PWS and to analyse the effects of replacement therapy with hydrocortisone (HCT) in patients with suspected CAI. Material and Methods: Twenty one adult patients with PWS were evaluated. Based on peak cortisol at the 30 minute of the high dose short Synacthen test (HDSST), patients were divided into three groups: CAI (central adrenal insufficiency) - peak cortisol <500nmol/L, intermediate (partial AI) - peak cortisol ≥500 nmol/L and <600 nmol/L and AS (adrenal sufficiency) - peak cortisol ≥ 600 nmol/L. In patients with diagnosed CAI HCT replacement treatment was initiated. Body weight, body fat percentage, signs, and symptoms of CAI were evaluated after 6 and 12 months of treatment.

NCT ID: NCT04697381 Completed - Clinical trials for Prader-Willi Syndrome

Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS

Start date: February 9, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of Japanese participants with PWS.

NCT ID: NCT04685057 Completed - Clinical trials for Prader-Willi Syndrome

Probiotic Treatment for Prader-Willi Syndrome

Start date: January 11, 2021
Phase: N/A
Study type: Interventional

A whole new research area studying the function of intestinal microorganisms, also known as gut microbiota, has emerged during the last decade. As a result, dietary supplementation with specific bacteria (or probiotics) holds great promise as a therapeutic strategy for a wide range of diseases, from obesity to anxiety and depression, all of which are major characteristics of Prader-Willi syndrome (PWS). The main objective of the current proposal is to determine the effects of Bifidobacterium animalis subsp. lactis (strain BPL1) supplementation in children and young adults with PWS. Specifically, participants will receive placebo or BPL1 for 6 months, and then this phase will be followed by a 6-month extension period in which all participants will receive BPL1. This study will allow us to 1) determine the effects on fat mass and glucose metabolism; and 2) explore the effects on mental health symptoms by studying potential structural changes in the brain by magnetic resonance imaging (MRI) as well as using a number of psychiatric questionnaires.

NCT ID: NCT04597645 Completed - Sarcopenia Clinical Trials

Prader-Willi Syndrome Body Composition

Start date: May 6, 2020
Phase: N/A
Study type: Interventional

Adults aged over 18 years, with the diagnosis of Prader-willi syndrome will be recruited through the hospital's outpatient clinic for either as intervention group receiving therapeutic elastic band training, or as control group receiving usual care for a total of 16 weeks. Body composition, physical capacity, and serum changes will be assessed before and after the intervention.