193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details


臨床試験数 : 111 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03831425
(ClinicalTrials.gov)
May 1, 202222/1/2019Mitochondrial 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 ResearchRecruiting13 Years18 YearsAll14Phase 2Canada
2NCT05153434
(ClinicalTrials.gov)
March 24, 202230/11/2021A Study of Oral ARD-101 in Patients With Prader-Willi SyndromeA Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients With Prader-Willi SyndromePrader-Willi SyndromeDrug: ARD-101Aardvark Therapeutics, Inc.Children's Hospital ColoradoRecruiting17 Years65 YearsAll12Phase 2United States
3NCT05098509
(ClinicalTrials.gov)
March 15, 202222/9/2021A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi SyndromeA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi SyndromePrader-Willi SyndromeDrug: RAD011;Drug: PlaceboRadius Pharmaceuticals, Inc.NULLNot yet recruiting8 Years65 YearsAll220Phase 2/Phase 3United States
4EUCTR2021-000127-12-SE
(EUCTR)
03/01/202208/11/2021A 16-week phase 2b, double-blind, placebo-controlled, Multi center, dose finding safety and efficacy study to evaluate overall safety and tolerability of Tesomet ( tesofensine and metoprolol) in subjects with Prader-Willi Syndrome, and with an optional 38-week open-label extensionA Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi center, 16-week Dose finding, Safety and Efficacy Study with Open-label Extension Period of Tesomet in Adult and Adolescent Subjects with Prader-Willi Syndrome Prader-Willi Syndrome
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]
Product Name: Tesomet
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE CITRATE
INN or Proposed INN: Metoprolol
Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.)
Product Name: Tesomet
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE CITRATE
INN or Proposed INN: Metoprolol
Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.)
Product Name: Tesomet
INN or Proposed INN: Tesofensine
Other descriptive name: TESOFENSINE CITRATE
INN or Proposed INN: Metoprolol
Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.)
Saniona A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden
5NCT05198362
(ClinicalTrials.gov)
December 28, 20215/1/2022Study of Tesomet With Open-label Extension in Subjects With Prader-Willi SyndromeA Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi SyndromePrader-Willi SyndromeOther: Placebo;Drug: TesometSanionaNULLRecruiting13 Years65 YearsAll120Phase 2United States
6NCT05032326
(ClinicalTrials.gov)
September 7, 202124/6/2021Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical TrialLong-term Interventional Follow-up Study up to 4 Years of Age of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial and Comparison With an Untreated Cohort of Children With Prader-Willi SyndromePrader-Willi SyndromeDrug: Follow-up study of the treated cohort;Other: Follow-up study of the untreated cohortUniversity Hospital, ToulouseNULLRecruiting12 Months36 MonthsAll80Phase 3France
7EUCTR2019-002385-12-NL
(EUCTR)
26/08/202108/09/2020Oxytocin 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 ToulouseNULLNot RecruitingFemale: yes
Male: yes
48Phase 3France;Belgium;Germany;Netherlands
8EUCTR2019-002385-12-DE
(EUCTR)
07/07/202121/04/2021OXYTOCIN 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 Syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;Belgium;Netherlands;Germany
9ChiCTR2100046551
2021-05-182021-05-21Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatmentApplication of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome Prader-Willi sydromePrader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none;Cai JinhuaNULLRecruiting016BothPrader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40;N/AChina
10EUCTR2019-000735-61-NL
(EUCTR)
06/04/202104/08/2020Treatment 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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 FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 2;Phase 3Netherlands
11NCT04768803
(ClinicalTrials.gov)
March 15, 202116/2/2021Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or ObesityCirculating Levels of Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and / or Overweight, and / or ObesityAngelman Syndrome;Smith-Magenis Syndrome;X Fragile Syndrome;Epilepsy;Prader-Willi SyndromeBiological: acylated and unacylated ghrelin dosagesUniversity Hospital, ToulouseNULLNot yet recruiting3 Years50 YearsAll300NULL
12NCT04697381
(ClinicalTrials.gov)
February 9, 20214/1/2021Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWSA PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS)Prader-Willi SyndromeBiological: somatropin - GH naïve pediatric cohort;Biological: somatropin - GH treated cohort;Biological: somatropin - adult cohortPfizerNULLActive, not recruitingN/AN/AAll32Phase 3Japan
13JPRN-jRCT2031200351
09/02/202108/02/2021Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWSA PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) - NA Prader-Willi SyndromeBiological: somatropin - GH naive pediatric cohort
somatropin 0.245 mg/kg/week
Biological: somatropin - GH treated cohort
somatropin 0.084 mg/kg/week
Biological: somatropin - adult cohort
somatropin 0.084 mg/kg/week
Nagashima MasahitoNULLRecruiting>=Not applicableBoth30Phase 3Japan
14NCT04685057
(ClinicalTrials.gov)
January 11, 20212/12/2020Probiotic Treatment for Prader-Willi SyndromeProbiotics as a Long-term Treatment Strategy for Prader-Willi SyndromePrader-Willi SyndromeDietary Supplement: Placebo;Dietary Supplement: Probiotic;Dietary Supplement: Follow-up probioticFundació Sant Joan de DéuNULLEnrolling by invitation6 Years30 YearsAll50Phase 1/Phase 2Spain
15ChiCTR2000040947
2021-01-012020-12-16The safety and effectiveness of rapamycin (sirolimus) in the treatment of Prader-Willi syndromeThe safety and effectiveness of rapamycin (sirolimus) in the treatment of Prader-Willi syndrome Prader-Willi syndromerapamycin group:rapamycin 1mg qd po;Peking Union Medical College HospitalNULLRecruitingBothrapamycin group:30;China
16NCT04257929
(ClinicalTrials.gov)
December 9, 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
17ChiCTR2000039618
2020-12-012020-11-03Diagnostic accuracy of RNA molecular markers in Prader Willi syndromeDiagnostic accuracy of RNA molecular markers in Prader Willi syndrome Prader-Willi syndromeGold Standard:Methylation specific multiplex ligation probe amplification (MS-MLPA) combined with chromosome G-banding karyotype analysis and array comparative genomic hybridization (array CGH).;Index test:Detection of ribonucleic acid molecular markers.;Children's Hospital Affiliated to Medical College of Zhejiang UniversityNULLRecruitingBothTarget condition:20;Difficult condition:0China
18NCT03848481
(ClinicalTrials.gov)
November 23, 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
19NCT04484051
(ClinicalTrials.gov)
October 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
20NCT04283578
(ClinicalTrials.gov)
March 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 NetworkActive, not recruitingN/A92 DaysAll48Phase 3France
21EUCTR2018-003062-13-FR
(EUCTR)
25/02/202021/11/2018A 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
22ChiCTR1900027464
2019-12-012019-11-14Efficacy 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;Phase 4China
23NCT04066088
(ClinicalTrials.gov)
December 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
24NCT04086810
(ClinicalTrials.gov)
October 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.NULLWithdrawn4 YearsN/AAll0Phase 3NULL
25EUCTR2018-004216-22-GB
(EUCTR)
25/09/201927/06/2019A 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: 20.0;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]
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
26EUCTR2019-002385-12-FR
(EUCTR)
27/08/201912/06/2019OXYTOCIN 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]Product Name: Oxytocin
INN or Proposed INN: OXYTOCIN
Other descriptive name: OXYTOCIN
University Hospital of ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
27EUCTR2018-003062-13-GB
(EUCTR)
11/07/201906/12/2018A 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
28EUCTR2018-003062-13-NL
(EUCTR)
10/07/201909/04/2019A 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
29EUCTR2018-003062-13-BE
(EUCTR)
07/06/201925/03/2019A 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
30ChiCTR1900022809
2019-05-012019-04-26Efficacy 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
31EUCTR2018-004215-50-GB
(EUCTR)
23/04/201912/08/2019A 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]
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 finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Kingdom
32NCT03790865
(ClinicalTrials.gov)
March 25, 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
33EUCTR2018-003062-13-IT
(EUCTR)
20/03/201907/10/2020A 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 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: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
34EUCTR2018-003062-13-ES
(EUCTR)
20/03/201918/01/2019A 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
35NCT03649477
(ClinicalTrials.gov)
November 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: 3.2 mg intranasal carbetocin;Drug: 9.6 mg intranasal carbetocin;Drug: placeboLevo Therapeutics, Inc.NULLActive, not recruiting7 Years18 YearsAll130Phase 3United States;Australia;Canada
36NCT03714373
(ClinicalTrials.gov)
October 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
37NCT03458416
(ClinicalTrials.gov)
September 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
38NCT02844933
(ClinicalTrials.gov)
June 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
39NCT03440814
(ClinicalTrials.gov)
May 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
40NCT03554031
(ClinicalTrials.gov)
April 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
41NCT03197662
(ClinicalTrials.gov)
April 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
42NCT03274856
(ClinicalTrials.gov)
February 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
43NCT03548480
(ClinicalTrials.gov)
January 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
44EUCTR2017-003423-30-NL
(EUCTR)
12/12/201704/10/2017Intranasal 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
45NCT03277157
(ClinicalTrials.gov)
December 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
46NCT03245762
(ClinicalTrials.gov)
August 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
47EUCTR2017-002164-41-ES
(EUCTR)
03/07/201721/06/2017Study 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: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
48NCT02893618
(ClinicalTrials.gov)
July 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
49NCT03616509
(ClinicalTrials.gov)
June 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 MarCompleted18 YearsN/AAll30Phase 4Spain
50NCT03149445
(ClinicalTrials.gov)
March 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
51EUCTR2016-003694-18-CZ
(EUCTR)
18/01/201704/10/2016Safety 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: 20.0;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]
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
52NCT03081832
(ClinicalTrials.gov)
January 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
53EUCTR2016-003694-18-HU
(EUCTR)
22/12/201613/10/2016Safety 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]
Product Name: Tesofensine
INN or Proposed INN: Tesofensine
Other descriptive 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 Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary
54EUCTR2016-003820-22-NL
(EUCTR)
22/12/201612/10/2016Intranasal 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: 19.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
55NCT03114371
(ClinicalTrials.gov)
November 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
56EUCTR2016-003273-18-FR
(EUCTR)
14/11/201622/08/2016Oxytocin 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
57NCT03031626
(ClinicalTrials.gov)
September 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
58EUCTR2015-000660-33-BE
(EUCTR)
21/03/201617/08/2015A 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: 18.0;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]
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
59EUCTR2014-004415-37-NL
(EUCTR)
07/03/201617/08/2015Effect 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: 18.1;Level: PT;Classification code 10029883;Term: Obesity;System 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/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;European Union;Canada;Turkey;Australia;Netherlands;Italy;New Zealand
60EUCTR2014-004415-37-IT
(EUCTR)
10/11/201529/07/2015Effect 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: 18.0;Level: PT;Classification code 10029883;Term: Obesity;System 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/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;European Union;Canada;Turkey;Australia;Netherlands;New Zealand;Italy
61NCT02527200
(ClinicalTrials.gov)
November 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
62EUCTR2015-000660-33-FR
(EUCTR)
29/10/201504/12/2015A 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]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
63EUCTR2014-001670-34-FR
(EUCTR)
01/10/201524/06/2015A 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: 18.0;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: HLT;Classification code 10003022;Term: Appetite disorders;System 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
64NCT02629991
(ClinicalTrials.gov)
October 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
65EUCTR2015-000660-33-SE
(EUCTR)
30/09/201511/08/2015A 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: 18.0;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]
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
66EUCTR2014-001670-34-IT
(EUCTR)
31/08/201508/07/2015A 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: 18.0;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: HLT;Classification code 10003022;Term: Appetite disorders;System 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
67EUCTR2015-000660-33-ES
(EUCTR)
12/08/201513/08/2015A 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: 18.0;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]
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
68NCT02013258
(ClinicalTrials.gov)
March 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
69NCT02311673
(ClinicalTrials.gov)
February 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
70EUCTR2014-001670-34-ES
(EUCTR)
26/01/201524/10/2014A 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: 17.1;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 17.1;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;Level: HLT;Classification code 10003022;Term: Appetite disorders;System 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
71NCT02179151
(ClinicalTrials.gov)
September 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
72NCT02205450
(ClinicalTrials.gov)
September 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
73EUCTR2013-004134-15-NL
(EUCTR)
15/07/201420/03/2014Intranasal 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: 17.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
74NCT02804373
(ClinicalTrials.gov)
June 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
75NCT02204163
(ClinicalTrials.gov)
June 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
76NCT02034071
(ClinicalTrials.gov)
April 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
77EUCTR2013-004437-33-FR
(EUCTR)
18/03/201408/09/2015Effets 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: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
78NCT02368379
(ClinicalTrials.gov)
March 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
79NCT01968187
(ClinicalTrials.gov)
January 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
80NCT01818921
(ClinicalTrials.gov)
June 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
81NCT02205034
(ClinicalTrials.gov)
May 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
82NCT02810483
(ClinicalTrials.gov)
December 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
83EUCTR2011-001313-14-NL
(EUCTR)
17/10/201212/01/2012Young 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: 14.1;Level: LLT;Classification code 10041331;Term: Somatotrophin;System 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
84NCT01520467
(ClinicalTrials.gov)
April 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
85NCT01444898
(ClinicalTrials.gov)
March 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
86NCT01542242
(ClinicalTrials.gov)
February 201221/2/2012Liraglutide Use in Prader-Willi SyndromeDiabetes Mellitus Type 2;Prader Willi SyndromeDrug: LiraglutideVancouver General HospitalNovo Nordisk A/STerminated19 YearsN/AMale1Phase 4Canada
87EUCTR2010-023179-25-GB
(EUCTR)
13/09/201127/07/2011Effects 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: 14.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System 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
88NCT01401244
(ClinicalTrials.gov)
July 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
89NCT01548521
(ClinicalTrials.gov)
July 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
90NCT01038570
(ClinicalTrials.gov)
June 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
91NCT01298180
(ClinicalTrials.gov)
January 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 YearsAll111Phase 4France
92EUCTR2008-004612-12-FR
(EUCTR)
06/11/200814/11/2008Existe 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: 9.1;Level: LLT;Classification code 10036476;Term: 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
93NCT00705172
(ClinicalTrials.gov)
November 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
94EUCTR2007-004716-31-NL
(EUCTR)
05/03/200806/11/2007Effects 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: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome
Trade Name: GenotropinDutch Growth FoundationNULLNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
95EUCTR2007-006305-25-SE
(EUCTR)
15/02/200803/01/2008Effects 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: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome
MedDRA version: 9.1;Classification code 10029883;Term: Obesity
Trade Name: ACOMPLIA 20 mg film-coated tabletsKarolinska University HospitalNULLNot RecruitingFemale: yes
Male: yes
Sweden
96NCT00551343
(ClinicalTrials.gov)
October 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
97NCT00603109
(ClinicalTrials.gov)
August 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
98EUCTR2007-000469-39-FI
(EUCTR)
02/05/200712/02/2007An 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: 9.1;Level: LLT;Classification code 10036476;Term: 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
99NCT00399893
(ClinicalTrials.gov)
December 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
100NCT01613495
(ClinicalTrials.gov)
August 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
101NCT00444964
(ClinicalTrials.gov)
April 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
102NCT00372125
(ClinicalTrials.gov)
April 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
103NCT00175305
(ClinicalTrials.gov)
August 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
104NCT00065923
(ClinicalTrials.gov)
July 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
105EUCTR2010-022370-14-FR
(EUCTR)
15/11/2010Evaluation 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: 12.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome
Trade Name: SyntocinonCentre Hospitalier de ToulouseNULLNAFemale: yes
Male: yes
Phase 2France
106EUCTR2019-002385-12-BE
(EUCTR)
06/03/2020OXYTOCIN 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
107EUCTR2019-002385-12-IT
(EUCTR)
04/06/2021OXYTOCIN 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
Product Code: [H01BB02]
INN or Proposed INN: OSSITOCINA
Other descriptive name: Oxytocin
University Hospital ToulouseNULLNAFemale: yes
Male: yes
48Phase 3France;Belgium;Netherlands;Germany;Italy
108EUCTR2021-000094-91-FR
(EUCTR)
01/04/2021EFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA IN CHILDREN AND ADOLESCENTS WITH PRADER WILLI SYNDROMEEFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA RELATED TO OROPHARYNGO-OESOPHAGEAL DYSMOTILITY TRANSIT IN CHILDREN AND ADOLESCENTS WITH PRADER-WILLI SYNDROME: A PHASE 3 STUDY (DYSMOT) - DYSMOT Prader-Willi Syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: OXYTOCIN
Product Code: H01BB02
Toulouse University HospitalNULLNAFemale: yes
Male: yes
36Phase 3France
109EUCTR2014-004415-37-FR
(EUCTR)
04/08/2015Effect 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: 18.0;Level: PT;Classification code 10029883;Term: Obesity;System 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/SNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;European Union;Canada;Turkey;Australia;Netherlands;Italy;New Zealand
110EUCTR2011-003432-32-FR
(EUCTR)
13/10/2011N/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]
Trade Name: Topiramate
Product Name: Topiramate
INN or Proposed INN: topiramate
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
111EUCTR2020-006161-11-FR
(EUCTR)
21/04/2021FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIALLONG -TERM INTERVENTIONAL FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIAL AND COMPARISON WITH AN UNTREATED COHORT OF CHILDREN WITH PRADER-WILLI SYNDROME - OTBB3 Follow-Up Prader-willi syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: oxytocinToulouse University HospitalNULLNAFemale: yes
Male: yes
80Phase 3France