Clinical trials: Prader Willis Syndrome
Prader-Willi Syndrome
A Study of CSTI-500 in Patients With Prader-Willi Syndrome
This is a proof-of-concept, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CSTI-500 in participants with genetically confirmed Prader-Willi Syndrome (PWS) who are 13 to…
- Trial name
- NCT07348601
- Testing
- CSTI-500
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- ConSynance Therapeutics
Prader-Willi Syndrome
Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
The goal of this study is to help teens with Prader-Willi Syndrome (PWS) and their families learn practical strategies for managing issues like irritability, meltdowns, and anxiety.
- Trial name
- RT-PWS (NCT07607730)
- Testing
- Regulating Together group therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Mercy Hospital Kansas City
Hyperphagia, Prader-Willi Syndrome
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
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) when used in a long term setting. It will also teach us about the safety of ARD-101.
- Conditions
- Hyperphagia, Prader-Willi Syndrome, Hyperphagia in Prader-Willi Syndrome
- Trial name
- NCT07197034
- Testing
- ARD-101
- Where
- 30 sites in United States, Australia and 3 more
- Volunteers
- 19 people
- Sponsor
- Aardvark Therapeutics, Inc.
Prader-Willi Syndrome, Constipation
The Intestinal Function in People With Prader-Willi Syndrome
The projects aim is to investigate the intestinal function of patients suffering from Prader-Willi Syndrome. The methods used are ultrasonographic measurement of the rectal diameter and gastrointestinal transit time
- Conditions
- Prader-Willi Syndrome, Constipation, Incontinence
- Trial name
- NCT01523288
- Where
- Denmark
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
Hyperphagia, Prader-Willi Syndrome
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
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.
- Trial name
- HERO (NCT06828861)
- Testing
- ARD-101
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 68 people
- Sponsor
- Aardvark Therapeutics, Inc.
Hyperphagia in Prader-Willi Syndrome
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.
- Trial name
- NCT01968187
- Testing
- FE 992097
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Ferring Pharmaceuticals
Prader-Willi Syndrome, Hyperphagia
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2)…
- Trial name
- OXT-PWS (NCT02629991)
- Testing
- Intranasal Oxytocin (IN-OXT)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Montefiore Medical Center
Prader-Willi Syndrome
Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome
The aim of this study is to study the effects of GH on body composition, lipid and glucose metabolism, physical performance and safety aspects in adults with PWS.The patients are randomized to either GH or placebo the first year…
- Trial name
- NCT00372125
- Testing
- Norditropin SimpleXx
- Where
- 3 sites in Denmark, Norway and 1 more
- Volunteers
- 46 people
- Sponsor
- Karolinska University Hospital
Prader-Willi Syndrome
A Study of Pitolisant in Participants With Prader-Willi Syndrome
The purpose of this study is to assess safety of pitolisant in eligible participants with Prader-Willi syndrome (PWS) who completed the End of Treatment (EOT) visit in a parent study (HBS-101-CL-002 [Open Label Extension (OLE)]…
- Trial name
- NCT07219485
- Testing
- Pitolisant
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Harmony Biosciences Management, Inc.
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
Prader-Willi Syndrome
Biological Age Assessment in Adults With Prader-Willi Syndrome (ETABIOLPWS)
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…
- Trial name
- ETABIOLPWS (NCT05778032)
- Testing
- Multidisciplinary metabolic rehabilitation program
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Istituto Auxologico Italiano
Prader-Willi Syndrome
Probiotic Treatment for Prader-Willi Syndrome
A whole new research area studying the function of intestinal microorganisms, also known as gut microbiota, has emerged during the last decade.
- Trial name
- NCT04685057
- Testing
- Probiotic, Follow-up probiotic
- Where
- Spain
- Volunteers
- 41 people
- Sponsor
- Fundació Sant Joan de Déu
Quality of Life
B. Lactis B94 Effects of Gastrointestinal Function
The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit time, and gastrointestinal symptoms in adults with…
- Trial name
- NCT03277157
- Testing
- B. lactis B94
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- University of Florida
Prader-Willi Syndrome, Resistance Training
Effects of Progressive Elastic Band Resistance Training
Abnormal body composition with increased body fat mass and decreased lean body mass has been found in adults with Prader-Willi syndrome (PWS), contributing to reduced physical capacity and impairment.
- Trial name
- NCT03565081
- Testing
- PWS elastic band training group
- Volunteers
- 6 people
- Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Prader-Willi Syndrome
A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome
This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011…
- Trial name
- NCT05098509
- Testing
- RAD011
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Prader-Willi Syndrome
CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)
This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.
- Trial name
- NCT03848481
- Testing
- CBDV Compound
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Eric Hollander
Prader-Willi Syndrome
Characterization of Serum Proteome in Subjects With Prader Willi Syndrome (PROTEOMARKER)
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…
- Trial name
- PROTEOMARKER (NCT05761184)
- Testing
- Serum collection for proteomic analysis
- Where
- Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Auxologico Italiano
Obesity, Prader-Willi Syndrome
Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome
The inflammatory process is involved in the pathogenesis of obesity. Prader-Willi syndrome (PWS) is a genetic model of syndromic obesity.
- Trial name
- NCT00800852
- Volunteers
- healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
Prader-Willi Syndrome, Growth Hormone Deficiency
Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth hormone (GHD).
- Trial name
- NCT01298180
- Testing
- Growth hormone (Genotonorm® or Omnitrope®), DEXA, blood tests, H.G.P.O, osseous age., biopsy
- Where
- 26 sites in France
- Volunteers
- 111 people
- Sponsor
- University Hospital, Toulouse