193. プラダー・ウィリ症候群 [臨床試験数:95,薬物数:104(DrugBank:27),標的遺伝子数:50,標的パスウェイ数:63

Searched query = "Prader-Willi syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04257929December 202029/1/2020A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label ExtensionA Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label ExtensionPrader-Willi SyndromeDrug: Pitolisant oral tablets;Drug: Placebo oral tabletHarmony Biosciences, LLCNULLRecruiting6 Years65 YearsAll60Phase 2United States
2NCT03848481November 202019/2/2019CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)Cannabidivarin (CBDV) vs. Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)Prader-Willi SyndromeDrug: CBDV Compound;Drug: PlaceboMontefiore Medical CenterFoundation for Prader-Willi Research;GW Pharmaceuticals Ltd.Recruiting5 Years30 YearsAll26Phase 2United States
3NCT04484051October 1, 202015/7/2020Global Growth Hormone Study in Adults With Prader-Willi SyndromeGlobal Growth Hormone Study in Adults With Prader-Willi SyndroomPrader-Willi SyndromeDrug: Somatropin;Drug: PlaceboErasmus Medical CenterPfizer;Foundation for Prader-Willi Research;Prader-Willi FondsNot yet recruiting30 YearsN/AAll50Phase 3Australia;Netherlands
4NCT04283578March 10, 202019/2/2020Oxytocin Treatment in Neonates and Infants With Prader-Willi SyndromeOxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs PlaceboPrader-Willi SyndromeDrug: OT;Drug: Placebo comparatorUniversity Hospital, ToulouseInternational Clinical Trials Association;Epidemiological and Clinical Research Information NetworkRecruitingN/A92 DaysAll48Phase 3France
5EUCTR2018-003062-13-FR25/02/202021/11/2018A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6ChiCTR19000274642019-12-012019-11-14Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone ageEfficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age Prader-Willi syndromecontrol group:Single rhGH therapy;observation group:Anastrazole combined with growth hormone therapy;Children's Hospital of Zhejiang University School of MedicineNULLPendingMalecontrol group:20;observation group:20;China
7NCT04066088December 1, 201921/8/2019Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi SyndromeDose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi SyndromePrader-Willi SyndromeOther: Placebo;Drug: Guanfacine extended release (GXR)NYU Langone HealthWinthrop University HospitalWithdrawn6 Years35 YearsAll0Phase 4United States
8NCT03831425November 1, 201922/1/2019Mitochondrial Complex I Dysfunction in PWSMitochondrial Complex I Dysfunction in Prader Willi Syndrome: A New Therapeutic TargetPrader-Willi SyndromeDietary Supplement: Coenzyme Q10;Other: PlaceboThe Hospital for Sick ChildrenFoundation for Prader-Willi ResearchNot yet recruiting13 Years18 YearsAll14Phase 3NULL
9NCT04086810October 15, 201910/9/2019An Open-Label Study of DCCR Tablet in Patients With PWSAn Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: DCCRSoleno Therapeutics, Inc.NULLNot yet recruiting4 YearsN/AAll105Phase 3NULL
10EUCTR2018-004216-22-GB25/09/201927/06/2019A study to determine the safety of the study drug Diazoxide Choline Controlled-Release Tablet after being given for a long time to patients with the genetic disorder Prader-Willi Syndrome.An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome Hyperphagia associated with Prader-Willi Syndrome (PWS)
MedDRA version: 20.0Level: PTClassification code 10020710Term: HyperphagiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: diazoxide choline
Product Code: DCCR
INN or Proposed INN: Diazoxide choline
Other descriptive name: DIAZOXIDE CHOLINE
Soleno Therapeutics UK Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-002385-12-FR27/08/201912/06/2019OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]University Hospital of ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
12EUCTR2018-003062-13-GB11/07/201906/12/2018A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
13EUCTR2018-003062-13-NL10/07/201909/04/2019A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
14EUCTR2018-003062-13-BE07/06/201925/03/2019A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Spain;Belgium;Australia;Netherlands;United Kingdom
15ChiCTR19000228092019-05-012019-04-26Efficacy and safety of growth hormone in the treatment of Prader-Willi syndromeEfficacy and safety of growth hormone in the treatment of Prader-Willi syndrome Prader-Willi syndromecontrol group:Routine treatment such as rehabilitation;Treated group:treatment with growth hormone;Children's Hospital of Zhejiang University School of MedicineNULLPendingBothcontrol group:20;Treated group:50;N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-004215-50-GB23/04/201912/08/2019A study to evaluate the effects of a medicine named diazoxide choline in patients with the genetic disorder Prader-Willi syndrome.A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome Hyperphagia associated with Prader-Willi Syndrome.
MedDRA version: 20.0 Level: PT Classification code 10020710 Term: Hyperphagia System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Soleno Therapeutics UK Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;United Kingdom
17NCT03790865March 26, 201928/12/2018Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi SyndromeA Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Livoletide;Drug: PlaceboMillendo Therapeutics SASNULLTerminated4 Years65 YearsAll158Phase 2/Phase 3United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom
18EUCTR2018-003062-13-IT20/03/201907/10/2020A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: D.3.2 Product code where applicable13:
Product Code: [AZP-531]
Millendo Therapeutics SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
19EUCTR2018-003062-13-ES20/03/201918/01/2019A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom
20NCT03649477November 20, 201824/8/2018Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi SyndromePhase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)Prader-Willi SyndromeDrug: intranasal carbetocin Dose 1;Drug: intranasal carbetocin Dose 2;Drug: placeboLevo Therapeutics, Inc.NULLActive, not recruiting7 Years18 YearsAll130Phase 3United States;Australia;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03714373October 1, 201827/9/2018Open-Label Extension Study of Diazoxide Choline in Patients With Prader-Willi SyndromeAn Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: DCCRSoleno Therapeutics, Inc.NULLActive, not recruiting4 YearsN/AAll105Phase 3United States;United Kingdom
22NCT03458416September 6, 20182/3/2018A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi SyndromeA Multicenter, Open-Label Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: Cannabidiol Oral SolutionBenuvia Therapeutics Inc.NULLTerminated8 Years17 YearsAll7Phase 2United States
23NCT02844933June 6, 201822/7/2016Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi SyndromeA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi SyndromePrader-Willi SyndromeDrug: Cannabidiol;Drug: PlaceboBenuvia Therapeutics Inc.NULLTerminated8 Years17 YearsAll7Phase 2United States
24NCT03440814May 9, 201813/2/2018A Study of Diazoxide Choline in Patients With Prader-Willi SyndromeA Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: DCCR;Drug: Placebo for DCCRSoleno Therapeutics, Inc.NULLCompleted4 YearsN/AAll127Phase 3United States;United Kingdom
25NCT03554031April 14, 201830/5/2018A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromeA Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: Recombinant Human Growth Hormone (rhGH) InjectionGeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of MedicineUnknown status1 Month5 YearsAll30Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03197662April 11, 201819/6/2017Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi SyndromePhase 2 Study: Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Children and Adolescents With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Intranasal Oxytocin (IN-OXT);Drug: Matched PlaceboMontefiore Medical CenterNULLRecruiting5 Years17 YearsAll50Phase 2United States
27NCT03274856February 20, 20185/9/2017A Study of GLWL-01 in Patients With Prader-Willi SyndromeA Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics of GLWL-01 in the Treatment of Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: GLWL-01;Drug: PlaceboGLWL Research Inc.NULLCompleted16 Years65 YearsAll19Phase 2United States;Canada
28NCT03548480January 1, 20182/5/2018Targeting the Gut Microbiome for Prader-Willi Syndrome TreatmentTargeting the Gut Microbiome for Prader-Willi Syndrome TreatmentPrader-Willi SyndromeDietary Supplement: Placebo;Dietary Supplement: ProbioticFundació Sant Joan de DéuNULLCompleted2 Years19 YearsAll39N/ASpain
29EUCTR2017-003423-30-NL12/12/201704/10/2017Intranasal administration of oxytocin in children with Prader-Willi syndromeRandomized, double-blind, placebo-controlled oxytocin and dose-response trial in children with Prader-Willi syndrome.Effects on social behaviour. Prader-Willi syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Dutch Growth Research FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
33Phase 2;Phase 3Netherlands
30NCT03277157December 8, 20177/9/2017B. Lactis B94 Effects of Gastrointestinal FunctionThe Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind StudyQuality of LifeDietary Supplement: B. lactis B94;Dietary Supplement: PlaceboUniversity of FloridaLallemand Health SolutionsCompleted18 Years75 YearsAll28N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03245762August 1, 20177/8/2017Intranasal Oxytocin for Infants With Prader-Willi SyndromeIntranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 StudyPrader-Willi SyndromeDrug: Oxytocin;Drug: PlaceboUniversity of FloridaPrader-Willi Syndrome AssociationCompletedN/A6 MonthsAll15Phase 1/Phase 2United States
32EUCTR2017-002164-41-ES03/07/201721/06/2017Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures.Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition. Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit.
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Genotonorm Miniquick 0,2 mg
INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Spain
33NCT02893618July 201730/8/2016A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)A 5 Treatment Period Crossover Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)Prader-Willi SyndromeDrug: Diazoxide choline controlled-release tabletEssentialis, Inc.NULLNot yet recruiting18 Years65 YearsBoth32Phase 2NULL
34NCT03616509June 19, 201727/7/2018GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body CompositionTreatment With Growth Hormone in Adults With PWS, Effect on Muscular Tone Evaluated by Functional MRI, Relationship With Strength and Body CompositionPrader-Willi SyndromeDrug: Growth hormone;Drug: PlaceboCorporacion Parc TauliParc de Salut MarUnknown status18 YearsN/AAll30Phase 4Spain
35NCT03149445March 30, 20173/4/2017Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Multi-centre Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)Confirmed Genetic Diagnosis of Prader-Willi SyndromeDrug: Tesofensine/Metoprolol;Drug: PlacebosSanionaNULLCompleted18 Years30 YearsAll18Phase 2Czechia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-003694-18-CZ18/01/201704/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) Second 12 weeks open label extension Prader Willi syndrome (PWS)
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Tesofensine
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE
Trade Name: Metoprololsuccinat ”Orion” 25mg
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Saniona A/SNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Hungary;Czech Republic
37NCT03081832January 201710/3/2017Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.Long Term Evaluation of Infants Aged From 3 to 4 Years Old Included in the Ancient Study (Repeated Administrations of Oxytocin in Infants With Prader Willi Syndrome Aged From 0 to 6 Months) and Comparison With Not Treated and Age-matched Prader Willi Syndrome Infants (OT2SUITE)Prader-Willi SyndromeDrug: Oxytocin;Other: ControlUniversity Hospital, ToulouseNULLCompleted3 Years4 YearsAll34N/AFrance
38EUCTR2016-003694-18-HU22/12/201613/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) A 12 weeks open label extension Prader Willi syndrome (PWS)
MedDRA version: 20.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Saniona A/SNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noCzech Republic;Hungary
39EUCTR2016-003820-22-NL22/12/201612/10/2016Intranasal administration of oxytocin in children with Prader-Willi SyndromeIntranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour. - Intranasal administration of oxytocin in children with PWS Prader-Willi syndrome
MedDRA version: 19.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Dutch Growth Research FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
40NCT03114371November 28, 201610/3/2017Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 YearsEffects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.Prader-Willi SyndromeDrug: Oxytocin;Drug: PlaceboUniversity Hospital, ToulouseNULLCompleted3 Years12 YearsAll40N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-003273-18-FR14/11/201622/08/2016Oxytocin intranasal administrations in children with Prader-Willi syndrome aged from 3 to 12 years.Effects of intranasal administrations of oxytocin on beahvioural troubles, hyperphagia and social skills in children with Prader-Willi syndrome aged from 3 to 12 years. - OXYJEUNE Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: SyntocinonUniversity Hospital of ToulouseNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France
42NCT03031626September 1, 201620/1/2017Oxygen Versus Medical Air for Treatment of CSA in Prader Will SyndromeComparison of Therapeutic Oxygen Versus Medical Air for the Treatment of Central Sleep Apnea in Infants and Children With Prader Willi Syndrome: A Proof of Concept StudySleep Apnea, Central;Prader-Willi SyndromeBiological: Medical Air vs OxygenThe Hospital for Sick ChildrenNULLRecruitingN/A2 YearsAll10Phase 4Canada
43EUCTR2015-000660-33-BE21/03/201617/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden
44EUCTR2014-004415-37-NL07/03/201617/08/2015Effect of liraglutide for weight management in children with Prader-Willi SyndromeEffect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome. A randomised, placebo controlled, parallel group, multi-centre, multinational trial with a 16-week double-blind period and 36-week open-label period Obesity(Prader-Willi syndrome)
MedDRA version: 18.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Saxenda
INN or Proposed INN: LIRAGLUTIDE
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60United States;European Union;Canada;Turkey;Australia;Netherlands;New Zealand
45EUCTR2014-004415-37-IT10/11/201529/07/2015Effect of liraglutide for weight management in children with Prader-Willi SyndromeEffect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome. A randomised, placebo controlled, parallel group, multi-centre, multinational trial with a 16-week double-blind period and 36-week open-label period Obesity(Prader-Willi syndrome)
MedDRA version: 18.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Saxenda
INN or Proposed INN: LIRAGLUTIDE
Novo Nordisk A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Turkey;Australia;Netherlands;New Zealand;Italy;France;United States;European Union;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02527200November 9, 201517/8/2015Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi SyndromeEffect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.Metabolism and Nutrition Disorder;ObesityDrug: liraglutide;Drug: placeboNovo Nordisk A/SNULLCompleted6 Years18 YearsAll56Phase 3United States;Australia;Canada;France;Italy;Netherlands;New Zealand;Turkey
47EUCTR2015-000660-33-FR29/10/201504/12/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.1 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Zafgen Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
48EUCTR2014-001670-34-FR01/10/201524/06/2015A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA Phase IIa, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and effects of AZP-531, an Unacylated Ghrelin analog, on food-related behavior in patients with Prader-Willi Syndrome Prader-Willi Syndrome
MedDRA version: 18.0Level: HLGTClassification code 10003018Term: Appetite and general nutritional disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0Level: HLTClassification code 10003022Term: Appetite disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed
Alize PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
49NCT02629991October 201518/10/2015Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi SyndromeOxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Intranasal Oxytocin (IN-OXT);Drug: Matched PlaceboMontefiore Medical CenterFoundation for Prader-Willi ResearchUnknown status5 Years18 YearsAll24Phase 2United States
50EUCTR2015-000660-33-SE30/09/201511/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS II Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Canada;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2014-001670-34-IT31/08/201508/07/2015A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA Phase IIa, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and effects of AZP-531, an Unacylated Ghrelin analog, on food-related behavior in patients with Prader-Willi Syndrome Prader-Willi Syndrome
MedDRA version: 18.0Level: HLGTClassification code 10003018Term: Appetite and general nutritional disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0Level: HLTClassification code 10003022Term: Appetite disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed
Alize PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
52EUCTR2015-000660-33-ES12/08/201513/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
53NCT02013258March 201511/12/2013Oxytocin Trial in Prader-Willi SyndromeOxytocin Trial in Prader-Willi SyndromePrader Willi SyndromeDrug: Intranasal oxytocin;Other: PlaceboUniversity of FloridaNational Institutes of Health (NIH)Completed5 Years11 YearsAll24Phase 1United States
54NCT02311673February 201525/11/2014Ph 2 Trial to Evaluate Safety & Efficacy of RM-493 in Obese Patients With Prader-Willi SyndromeA Ph 2, Randomized, Double-Blind, Placebo-controlled Pilot Study to Assess the Effects of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist, in Obese Subjects With Prader-Willi Syndrome (PWS) on Safety, Weight Reduction, and Food-Related BehaviorsPrader-Willi SyndromeDrug: RM-493;Drug: PlaceboRhythm Pharmaceuticals, Inc.NULLCompleted16 Years65 YearsAll40Phase 2United States
55EUCTR2014-001670-34-ES26/01/201524/10/2014A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA Phase IIa, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and effects of AZP-531, an Unacylated Ghrelin analog, on food-related behavior in patients with Prader-Willi Syndrome Prader-Willi Syndrome
MedDRA version: 17.1Level: HLGTClassification code 10003018Term: Appetite and general nutritional disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 17.1Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1Level: HLTClassification code 10003022Term: Appetite disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed
Alize PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02179151September 201425/6/2014Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi SyndromeRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 MonthsPrader-Willi Syndrome;ObesityDrug: ZGN-440 for Injectable Suspension;Drug: ZGN-440 Placebo for Injectable SuspensionZafgen, Inc.NULLTerminated12 Years65 YearsAll108Phase 3United States
57NCT02205450September 201430/7/2014Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of SabadellExperience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of SabadellPrader-Willi SyndromeDrug: Recombinant SomatropinCorporacion Parc TauliNULLNot yet recruitingN/A2 YearsBoth15N/ASpain
58EUCTR2013-004134-15-NL15/07/201420/03/2014Intranasal administration of oxytocin in children and young-adults with Prader-Willi syndromeIntranasal administration of oxytocin in children and young adults with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled trial. Effects on satiety and food intake, and social behaviour. - Intranasal administration of oxytocin in PWS Prader-Willi syndrome
MedDRA version: 17.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Dutch Growth Research FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
59NCT02804373June 201410/7/2015Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi SyndromeEffects of Intranasal Administration of Oxytocin in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Oxytocin (OXT) continuous;Drug: Placebo;Drug: Placebo continuous;Drug: OxytocinUniversity Hospital, ToulouseNULLCompleted18 Years50 YearsAll50Phase 2/Phase 3France
60NCT02204163June 201425/7/2014Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi SyndromeA Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi SyndromePrader-Willi SyndromeDrug: Eutropin;Drug: GenotropinLG Life SciencesNULLCompletedN/AN/AAll34Phase 3Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02034071April 20148/1/2014Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi SyndromeA Dose Titration Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal ExtensionPrader-Willi SyndromeDrug: DCCR;Drug: PlaceboEssentialis, Inc.NULLCompleted10 Years22 YearsBoth13Phase 1/Phase 2United States
62EUCTR2013-004437-33-FR18/03/201408/09/2015Effets de l'administration intranasale répétée d'ocytocine chez des patients adultes présentant un syndrome de Prader-WilliEffets de l'administration intranasale répétée d'ocytocine chez des patients adultes présentant un syndrome de Prader-Willi. - PRADOTIM Prader-Willi syndrom
MedDRA version: 18.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: SyntocinonCentre Hospitalier de ToulouseNULLNot RecruitingFemale: yes
Male: yes
39Phase 3France
63NCT02368379March 20145/2/2015Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi SyndromeDiagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi SyndromePrader Willi Syndrome;Adrenal InsufficiencyOther: Low dose (1 mcg) ACTH stimulation test;Other: Overnight metyrapone testNationwide Children's HospitalNULLCompleted2 YearsN/AAll23N/AUnited States
64NCT01968187January 20149/10/2013Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi SyndromeHyperphagia in Prader-Willi SyndromeDrug: FE 992097;Drug: PlaceboFerring PharmaceuticalsNULLCompleted10 Years18 YearsBoth38Phase 2United States
65NCT01818921June 201321/3/2013An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi SyndromeRandomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label ExtensionObesity;Over-weight;Prader-Willi SyndromeDrug: ZGN-440 sterile diluent;Drug: 1.2 mg ZGN-440 for injectable suspension;Drug: 1.8 mg ZGN-440 for injectable suspensionZafgen, Inc.NULLCompleted16 Years65 YearsBoth17Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02205034May 201322/7/2014Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS InfantsEvaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS InfantsPrader Willi SyndromeDrug: oxytocinUniversity Hospital, ToulouseNULLCompleted1 Month5 MonthsAll18Phase 1/Phase 2France
67NCT02810483December 201217/5/2016Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 WeeksRandomized, Placebo Controlled Double-blind Study of the Efficacy of Topiramate on the Symptoms of Irritability - Impulsivity, Overeating and Self-harm in a Population of Patients Suffering From Prader Willi Syndrome Over 8 WeeksPrader-Willi SyndromeDrug: Topiramate;Drug: Placebo ComparatorAssistance Publique - Hôpitaux de ParisNULLTerminated12 Years45 YearsAll69Phase 3France
68EUCTR2011-001313-14-NL17/10/201212/01/2012Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS.Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. - Young Adult Prader Willi study Prader Willi Syndrome
MedDRA version: 14.1Level: LLTClassification code 10041331Term: SomatotrophinSystem Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made.
Product Name: Genotropin
INN or Proposed INN: SOMATROPIN
Other descriptive name: growth hormone
Dutch growth research foundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
69NCT01520467April 201225/1/2012Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi SyndromeEfficacy and Tolerance of Treatment With an Aromatase Inhibitor (Anastrozole) to Limit the Progression of Bone Maturation Related to Pathological Adrenarche in Children With Silver-Russell or Prader-Willi SyndromeSilver Russell Syndrome;Prader-Willi SyndromeDrug: Anastrozole;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting5 Years12 YearsBoth27N/AFrance
70NCT01444898March 201227/9/2011Effects of Exenatide on Overweight Adolescents With Prader-Willi SyndromeEffects of Exenatide on Obesity and Appetite in Overweight Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: ExenatideChildren's Hospital Los AngelesNULLCompleted13 Years20 YearsAll10N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT01542242February 201221/2/2012Liraglutide Use in Prader-Willi SyndromeDiabetes Mellitus Type 2;Prader Willi SyndromeDrug: LiraglutideVancouver General HospitalNovo Nordisk A/STerminated19 YearsN/AMale1Phase 4Canada
72EUCTR2010-023179-25-GB13/09/201127/07/2011Effects of exenatide on appetite and ghrelin levels in patients with Prader-Willi Syndrome - Effects of exenatide on appetite and ghrelin in Prader-Willi SyndromeEffects of exenatide on appetite and ghrelin levels in patients with Prader-Willi Syndrome - Effects of exenatide on appetite and ghrelin in Prader-Willi Syndrome Ghrelin levels in patients with Prader Willi Syndrome and healthy controls and response of ghrelin levels to a single exenatide injection compared with placebo (0.9% sodium chloride) injection.
MedDRA version: 14.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Byetta
Product Name: Byetta
Product Code: EU/1/06/362/003: 5µg (1 pen)
INN or Proposed INN: exenatide
Aintree University Hospital NHS Foundation TrustUNIVERSITY OF LIVERPOOLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
73NCT01401244July 14, 201120/7/2011Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult VolunteersA Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult VolunteersGenetic Disorder;Prader-Willi Syndrome;Growth Disorder;Idiopathic Short Stature;HealthyDrug: somatropinNovo Nordisk A/SNULLCompleted18 Years40 YearsAll30Phase 1United States
74NCT01548521July 201130/12/2011Tolerance of Intranasal Administration of OT in Prader-Willi Newborn BabiesTolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies and Effect on Suck and Food Intake.Prader-Willi SyndromeDrug: OxytocinUniversity Hospital, ToulouseNULLCompletedN/A5 MonthsAll5Phase 1/Phase 2France
75NCT01038570June 200916/11/2009Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus PlaceboEvaluation of the Effect of the Oxytocin Administered in Nasal Pulverizing on the Social Skills, the Stress, the Anxiety and the Eating Habits at Grown-up Patients Presenting a Syndrome of Prader-Willi: Pilot StudyPrader Willi SyndromeDrug: Syntocinon®/- Spray;Drug: Physiological serum (Sodium chloride)University Hospital, ToulouseNULLCompleted18 YearsN/AAll24Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01298180January 20096/11/2009Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?Prader-Willi Syndrome;Growth Hormone DeficiencyDrug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsyUniversity Hospital, ToulouseNULLCompleted1 Year5 YearsBoth111Phase 4France
77EUCTR2008-004612-12-FR06/11/200814/11/2008Existe t-il une sensibilité accrue à l’hormone de croissance chez les enfants présentant un syndrome de Prader-Willi ?Existe t-il une sensibilité accrue à l’hormone de croissance chez les enfants présentant un syndrome de Prader-Willi ? - syndrome de Prader-Willi- déficit en hormone de croissance
MedDRA version: 9.1Level: LLTClassification code 10036476Term: Prader-Willi syndrome
Trade Name: genotonorm
Product Name: GENOTONORM
Trade Name: omnitrope
Product Name: OMNITROPE
CHU TOULOUSENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
78NCT00705172November 200824/6/2008Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi SyndromeEfficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS)Genetic Disorder;Prader-Willi SyndromeDrug: somatropinNovo Nordisk A/SNULLCompletedN/A15 YearsBoth41N/ADenmark;Germany;Switzerland
79EUCTR2007-004716-31-NL05/03/200806/11/2007Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWSEffects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS Prader-Willi Syndrome
MedDRA version: 9.1Level: LLTClassification code 10036476Term: Prader-Willi syndrome
Trade Name: GenotropinDutch Growth FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
80EUCTR2007-006305-25-SE15/02/200803/01/2008Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi SyndromeEffects of rimonabant (Acomplia) on obesity in adults with Prader-Willi Syndrome Obese adults with Prader Willi Syndrome
MedDRA version: 9.1Level: LLTClassification code 10036476Term: Prader-Willi syndrome
MedDRA version: 9.1Level: LLTClassification code 10029883Term: Obesity
Trade Name: ACOMPLIA 20 mg film-coated tabletsKarolinska University HospitalNULLNot RecruitingFemale: yes
Male: yes
Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00551343October 200729/10/2007Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi SyndromeContribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.Prader-Willi SyndromeDrug: ExenatideGarvan Institute of Medical ResearchNULLCompleted18 Years45 YearsAll20N/AAustralia
82NCT00603109August 200715/1/2008Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi SyndromeEffect of Rimonabant, a Cannabinoid Receptor 1 Antagonist on Weight Gain and Body Composition in Adults With Prader Willi Syndrome.Prader-willi SyndromeDrug: rimonabant;Drug: placeboWeill Medical College of Cornell UniversityNational Institutes of Health (NIH);PWSAUSARecruiting18 Years35 YearsBoth18Phase 3United States
83EUCTR2007-000469-39-FI02/05/200712/02/2007An Open Label Follow-up Study of Patients Who Participated in Clinical Study B9R-HL-GDDV. A Phase IV, one-arm follow-up study to assess final adult results of GH treatment in patients with the Prader-Willi Syndrome. - NAAn Open Label Follow-up Study of Patients Who Participated in Clinical Study B9R-HL-GDDV. A Phase IV, one-arm follow-up study to assess final adult results of GH treatment in patients with the Prader-Willi Syndrome. - NA Prader-Willi syndrome
MedDRA version: 9.1Level: LLTClassification code 10036476Term: Prader-Willi syndrome
Trade Name: Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten
INN or Proposed INN: SOMATROPIN
Oy Eli Lilly Finland AbNULLNot RecruitingFemale: yes
Male: yes
Phase 4Finland
84NCT00399893December 200614/11/2006Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)Investigation of the Developmental, Nutritional and Hormonal Regulation of Ghrelin in Children and Young Adults With Prader-Willi Syndrome (PWS): Octreotide Intervention Sub-studyPrader-Willi SyndromeDrug: Octreotide;Drug: PlaceboDuke UniversityNational Institutes of Health (NIH);National Center for Research Resources (NCRR);NovartisTerminated5 Years21 YearsAll5N/AUnited States
85NCT01613495August 200513/4/2011Ghrelin Suppression by Octreotide in Prader-WilliGhrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi SyndromePrader Willis SyndromeDrug: Placebo;Drug: OctreotideOregon Health and Science UniversityNULLActive, not recruiting18 YearsN/AMale2N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00444964April 20056/3/2007Growth Hormone Use in Adults With Prader-Willi SyndromeGrowth Hormone Use in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Nutropin AQChildren's Mercy Hospital Kansas CityNULLRecruiting16 Years60 YearsBoth10Phase 3United States
87NCT00372125April 20055/9/2006Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi SyndromeNordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Norditropin SimpleXxKarolinska University HospitalNovo Nordisk A/SCompleted18 Years50 YearsBoth46N/ADenmark;Norway;Sweden
88NCT00175305August 20049/9/2005Prader-Willi Syndrome and AppetiteEffect of Somatostatin on Ghrelin Concentrations, Food Seeking Behaviour and Weight in Patients With Prader-Willi SyndromeHyperphagia;Prader-Willi SyndromeDrug: Sandostatin LARUniversity of British ColumbiaNULLTerminated10 Years17 YearsBoth10Phase 3Canada
89NCT00065923July 20021/8/2003Treatment of Self-Injurious Behavior in Individuals With Prader-Willi SyndromeTopiramate Effects on SIB in Prader-Willi SyndromePrader-Willi Syndrome;Self-Injurious BehaviorDrug: TopiramateEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted18 Years66 YearsBoth10N/AUnited States
90EUCTR2019-002385-12-NL08/09/2020Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndromeOxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome: a study of the safety and efficacy on oral and social skills and, feeding behavior of intranasal administrations of oxytocin vs. placebo (phase iii clinical trial) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2010-022370-14-FR15/11/2010Evaluation de la tolérance d'une administration intra-nasale d'ocytocine chez des nourrissons présentant un syndrome de Prader-Willi et de son effet sur la succion et la prise alimentaire. - OTBBEvaluation de la tolérance d'une administration intra-nasale d'ocytocine chez des nourrissons présentant un syndrome de Prader-Willi et de son effet sur la succion et la prise alimentaire. - OTBB Syndrome de Prader Willi
MedDRA version: 12.1Level: LLTClassification code 10036476Term: Prader-Willi syndrome
Trade Name: SyntocinonCentre Hospitalier de ToulouseNULLNAFemale: yes
Male: yes
Phase 2France
92EUCTR2019-002385-12-BE06/03/2020OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROMEOXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium
93EUCTR2014-004415-37-FR04/08/2015Effect of liraglutide for weight management in children with Prader-Willi SyndromeEffect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome. A randomised, placebo controlled, parallel group, multi-centre, multinational trial with a 16-week double-blind period and 36-week open-label period Obesity(Prader-Willi syndrome)
MedDRA version: 18.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: Saxenda
INN or Proposed INN: LIRAGLUTIDE
Novo Nordisk A/SNULLNAFemale: yes
Male: yes
60Phase 3United States;France;European Union;Canada;Turkey;Australia;Netherlands;Italy;New Zealand
94EUCTR2011-003432-32-FR13/10/2011N/AN/A - TOPRADER
MedDRA version: 14.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
95EUCTR2019-000735-61-NL04/08/2020Treatment with N-acetylcysteine for skin picking in children and young adults with PWSN- acetylcysteine treatment for skin picking in children and young adults with PWS: a randomized, controlled, cross-over trial. Prader-Willi syndrome
MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Fluimucil (acetylcysteine)
Product Name: Fluimucil
Product Code: R05CB01
Dutch Growth Research FoundationNULLNAFemale: yes
Male: yes
35Phase 2;Phase 3Netherlands