Prader-Willi syndrome

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Information
Disease name
Prader-Willi syndrome
Disease ID
DOID:11983
Description
"A chromosomal disease that is characterized by weak muscle tone, feeding difficulties, poor growth, and delayed development. Beginning in childhood, affected individuals develop an insatiable appetite, which leads to chronic overeating and obesity." [url:https\://ghr.nlm.nih.gov/condition/prader-willi-syndrome, url:https\://www.ncbi.nlm.nih.gov/books/NBK1330/]
Disease area statistics
[No Data.]
Chromosome band
[No Data.]
Annotation
Genes Mutation Description Source Links
NCT ID Status Phase Summary Start date Completion date
NCT03848481 Active, not recruiting Phase 2 CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) November 23, 2020 October 2024
NCT05701774 Active, not recruiting Phase 3 Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome January 31, 2023 June 2028
NCT04257929 Active, not recruiting Phase 2 A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension December 9, 2020 September 7, 2028
NCT00375089 Completed Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity September 2006 January 2014
NCT00444964 Completed Phase 3 Growth Hormone Use in Adults With Prader-Willi Syndrome April 2005 January 1, 2012
NCT00551343 Completed N/A Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome October 2007 September 2008
NCT00705172 Completed Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome November 2008 November 2008
NCT00800852 Completed Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome
NCT02205450 Completed Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell September 2014 July 29, 2019
NCT00065923 Completed N/A Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome July 2002
NCT00372125 Completed N/A Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome April 2005 March 2010
NCT00932932 Completed Cortisol Activity in Patients With Prader-Willi Syndrome and Healthy Controls February 2009 August 2010
NCT01298180 Completed Phase 4 Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? January 2009 May 2013
NCT01401244 Completed Phase 1 Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers July 14, 2011 September 27, 2011
NCT01444898 Completed N/A Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome March 2012 December 2013
NCT01479322 Completed Plasma Adiponectin Level and Vascular Endothelial and Smooth Muscle Cell Function in Children With Prader-Willi Syndrome January 2007 July 2007
NCT01523288 Completed The Intestinal Function in People With Prader-Willi Syndrome February 2011 January 2012
NCT01548521 Completed Phase 1/Phase 2 Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies July 2011 April 2012
NCT01622751 Completed Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome January 2007 June 2007
NCT01818921 Completed Phase 2 An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome June 2013 November 2013
NCT01863017 Completed N/A Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome April 2013 October 6, 2016
NCT02034071 Completed Phase 1/Phase 2 Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome April 2014 May 2015
NCT02204163 Completed Phase 3 Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome June 2014 December 2017
NCT00004351 Completed Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes September 1999
NCT02311673 Completed Phase 2 Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome March 19, 2015 October 26, 2016
NCT02381457 Completed SNP-based Microdeletion and Aneuploidy RegisTry (SMART) April 2015 June 2020
NCT02529085 Completed N/A PWS European Blood Bank for Infants and Controls From 0 to 48 Months March 2013 June 1, 2017
NCT02629991 Completed Phase 2 Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome October 2015 May 2018
NCT02670694 Completed Sleep Abnormalities in Rare Genetic Disorders: AS, RTT, and PW June 2011 July 2013
NCT02804373 Completed Phase 2/Phase 3 Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome June 2014 June 18, 2019
NCT03081832 Completed N/A Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants. January 2017 December 2018
NCT03114371 Completed N/A Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years November 28, 2016 January 11, 2019
NCT03245762 Completed Phase 1/Phase 2 Intranasal Oxytocin for Infants With Prader-Willi Syndrome August 1, 2017 January 4, 2018
NCT03274856 Completed Phase 2 A Study of GLWL-01 in Patients With Prader-Willi Syndrome February 20, 2018 June 12, 2019
NCT03440814 Completed Phase 3 A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome May 9, 2018 May 1, 2020
NCT03548480 Completed N/A Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment January 1, 2018 January 31, 2019
NCT03565081 Completed N/A Effects of Progressive Elastic Band Resistance Training February 1, 2016 December 31, 2016
NCT03616509 Completed Phase 4 GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition June 19, 2017 July 26, 2019
NCT03649477 Completed Phase 3 Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome November 20, 2018 July 9, 2022
NCT03689621 Completed N/A Proof of Concept Study of Vagus Nerve Stimulation January 1, 2016 December 31, 2018
NCT03714373 Completed Phase 3 Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period October 1, 2018 August 17, 2023
NCT03718416 Completed Natural History Study of Serious Medical Events in PWS September 28, 2018 January 31, 2024
NCT04150991 Completed N/A Fiber Intervention on Gut Microbiota in Children With Prader-Willi Syndrome July 1, 2019 February 22, 2023
NCT04283578 Completed Phase 3 Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome March 10, 2020 March 14, 2022
NCT04526379 Completed N/A Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation September 7, 2020 April 27, 2022
NCT04685057 Completed N/A Probiotic Treatment for Prader-Willi Syndrome January 11, 2021 June 30, 2022
NCT04697381 Completed Phase 3 Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS February 9, 2021 April 15, 2024
NCT04700644 Completed Assessment of CAI in Adults With PWS. May 15, 2020 June 6, 2020
NCT05298085 Completed Phase 2/Phase 3 Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome April 5, 2022 April 11, 2023
NCT05322096 Completed Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome September 22, 2022 April 10, 2024
NCT05504395 Completed Phase 1 A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome November 14, 2022 February 21, 2023
NCT05541003 Completed Phase 2 Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome January 6, 2023 May 30, 2023
NCT05761184 Completed Characterization of Serum Proteome in Subjects With Prader Willi Syndrome (PROTEOMARKER) April 28, 2022 October 28, 2022
NCT05783791 Completed Development of a Newborn Screening Assay for Angelman Syndrome and Prader-Willi Syndrome April 20, 2023 July 21, 2023
NCT03836300 Enrolling by invitation N/A Parent and Infant Inter(X)Action Intervention (PIXI) November 30, 2018 June 30, 2025
NCT03655223 Enrolling by invitation Early Check: Expanded Screening in Newborns October 15, 2018 December 31, 2025
NCT06279052 Not yet recruiting N/A Adolescent Projections During Transition in Prader-Willi Syndrome March 1, 2024 December 1, 2024
NCT04484051 Not yet recruiting Growth Hormone Study in Adults With Prader-Willi Syndrome March 24, 2023 October 1, 2026
NCT06295315 Recruiting Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome April 21, 2023 December 31, 2024
NCT05657860 Recruiting Phase 4 Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome December 17, 2020 January 18, 2024
NCT06366464 Recruiting Phase 3 A Study of Pitolisant in Patients With Prader-Willi Syndrome April 30, 2024 July 2027
NCT04032639 Recruiting Stress and Brain Response Using MEG in PWS May 30, 2019 May 2024
NCT05778032 Recruiting Biological Age Assessment in Adults With Prader-Willi Syndrome (ETABIOLPWS) May 25, 2022 December 31, 2023
NCT06448871 Recruiting Ultrasound to Assess Sarcopenia in Prader Willi Syndrome October 17, 2022 June 30, 2024
NCT04463316 Recruiting GROWing Up With Rare GENEtic Syndromes October 1, 2018 January 1, 2030
NCT05791604 Recruiting N/A The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics April 1, 2023 July 31, 2026
NCT05938543 Recruiting N/A Cerebellar TMS and Satiety in Prader-Willi Syndrome September 1, 2023 August 2025
NCT05939453 Recruiting N/A Impact of Bright Light Therapy on Prader-Willi Syndrome October 1, 2023 June 2025
NCT04768803 Recruiting Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity June 10, 2021 December 15, 2023
NCT05032326 Recruiting Phase 3 Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial September 7, 2021 April 1, 2025
NCT02829684 Recruiting Register of Patients With Prader-Willi Syndrome March 2009 December 2026
NCT03031626 Recruiting Phase 4 Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome September 1, 2016 December 15, 2024
NCT05153434 Recruiting Phase 2 A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome May 27, 2022 March 1, 2024
NCT03197662 Recruiting Phase 2 Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome April 11, 2018 August 31, 2023
NCT05249998 Recruiting N/A Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education November 6, 2021 April 2024
NCT05945576 Recruiting IDMet (RaDiCo Cohort) (RaDiCo-IDMet) March 10, 2017 March 10, 2032
NCT06144645 Recruiting Phase 3 A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS January 8, 2024 December 1, 2027
NCT05879614 Suspended Phase 2 An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001) September 1, 2023 June 30, 2024
NCT03101826 Terminated N/A Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory November 1, 2017 March 8, 2023
NCT03871751 Terminated N/A Home-based SSP on Individuals With PWS April 8, 2019 December 16, 2019
NCT02179151 Terminated Phase 3 Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome September 2014 October 2016
NCT05098509 Terminated Phase 2/Phase 3 A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome April 13, 2022 October 31, 2022
NCT00399893 Terminated N/A Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS) December 2006 September 2010
NCT02810483 Terminated Phase 3 Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks December 2012 June 2016
NCT03458416 Terminated Phase 2 A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome September 6, 2018 July 31, 2019
NCT03790865 Terminated Phase 2/Phase 3 Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome March 25, 2019 May 25, 2020
NCT02844933 Terminated Phase 2 Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome May 9, 2018 July 31, 2019
NCT00603109 Terminated Phase 3 Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome August 2007 January 2009
NCT00175305 Terminated Phase 3 Prader-Willi Syndrome and Appetite August 2004 October 2007
NCT02263781 Unknown status N/A PREPL in Health and Disease October 2014 January 2015
NCT02297022 Unknown status Phase 1 Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome October 2014 October 2016
NCT03554031 Unknown status Phase 3 A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome April 14, 2018 January 1, 2020
NCT03324906 Unknown status N/A Effects of Transcranial Direct Current Stimulation (tDCS) on Individuals With Prader-Willi Syndrome May 8, 2017 November 2019
NCT00808548 Unknown status Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome December 2008 December 2009
NCT03858023 Unknown status N/A Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome August 2016 December 2019
NCT02893618 Unknown status Phase 2 A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR) July 2017 December 2017
NCT01520467 Unknown status N/A Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome April 2012 October 2016
NCT04102839 Unknown status PWS Outcomes Assessment Study July 15, 2019 March 31, 2021
NCT04086810 Withdrawn Phase 3 An Open-Label Study of DCCR Tablet in Patients With PWS October 2019 October 2019
NCT04066088 Withdrawn Phase 4 Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome December 1, 2019 August 21, 2020
NCT04396470 Withdrawn Phase 1/Phase 2 tVNS in Children With Prader-Willi Syndrome July 2020 July 2021
NCT05387798 Withdrawn Phase 3 A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome January 2023 August 2025
NCT05198362 Withdrawn Phase 2 Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome December 28, 2021 December 9, 2022
NCT03831425 Withdrawn Phase 2 Mitochondrial Complex I Dysfunction in PWS June 1, 2023 June 2024
Disase is a (Disease Ontology)
DOID:0080014
Cross Reference ID (Disease Ontology)
GARD:5575
Cross Reference ID (Disease Ontology)
ICD10CM:Q87.11
Cross Reference ID (Disease Ontology)
ICD9CM:759.81
Cross Reference ID (Disease Ontology)
MESH:D011218
Cross Reference ID (Disease Ontology)
MIM:176270
Cross Reference ID (Disease Ontology)
NCI:C75463
Cross Reference ID (Disease Ontology)
ORDO:739
Cross Reference ID (Disease Ontology)
SNOMEDCT_US_2023_03_01:205794007
Cross Reference ID (Disease Ontology)
UMLS_CUI:C0032897
Exact Synonym (Disease Ontology)
Prader Willi syndrome
OrphaNumber from OrphaNet (Orphanet)
739
MeSH unique ID (MeSH (Medical Subject Headings))
D011218