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 193. Prader-Willi syndrome
 [ 72 clinical trials,    77 drugs(DrugBank: 26 drugs),    49 target genes / 59 target pathways

Searched query = "Prader Willi syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

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No.TrialIDDate_
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1NCT04066088December 20192 September 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 HospitalNot recruiting6 Years35 YearsAll33Phase 4United States
2NCT03831425November 1, 201930 September 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 recruiting13 Years18 YearsAll14Phase 3
3NCT04086810October 15, 201930 September 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.Not recruiting4 YearsN/AAll105Phase 3
4NCT03848481September 201915 April 2019CBDV vs Placebo in Children With Prader-Willi Syndrome (PWS)Cannabidivarin (CBDV) vs Placebo in Children With Prader-Willi Syndrome (PWS)Prader-Willi SyndromeDrug: Placebo;Drug: CBDV CompoundMontefiore Medical CenterFoundation for Prader-Willi ResearchNot recruiting5 Years30 YearsAll26Phase 2United States
5ChiCTR19000228092019-05-0130 April 2019Efficacy and safety of growth hormone in the treatment of Prader-Willi syndromeEfficacy and safety of growth hormone in the treatment of Prader-Willi syndromePrader-Willi syndromecontrol group:Routine treatment such as rehabilitation;Treated group:treatment with growth hormone;Children's Hospital of Zhejiang University School of MedicineNot RecruitingBothcontrol group:20;Treated group:50;N/AChina
No.TrialIDDate_
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6NCT03790865March 26, 20194 November 2019Effects 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 Analog, on Food-related Behaviors in Patients With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Placebo;Drug: LivoletideMillendo Therapeutics SASRecruiting4 Years65 YearsAll150Phase 2/Phase 3United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom
7EUCTR2018-003062-13-ES20/03/201930 April 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 - ZEPHYRPrader-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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Livoletide
CAS Number: 1088543-62-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: Livoletide
Product Code: AZP-531
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Livoletide
CAS Number: 1088543-62-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 16-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Millendo Therapeutics SASAuthorised Female: yes
Male: yes
150Phase 2;Phase 3France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom
8NCT03649477November 20, 20184 November 2019Phase 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.Recruiting7 Years18 YearsAll175Phase 3United States;Canada
9NCT03714373October 1, 201828 October 2019Open-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.Recruiting4 YearsN/AAll105Phase 3United States;United Kingdom
10NCT03458416September 6, 201824 June 2019A 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 SolutionINSYS Therapeutics IncRecruiting8 Years17 YearsAll66Phase 2United States
No.TrialIDDate_
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11NCT02844933June 6, 201824 June 2019Cannabidiol 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: PlaceboINSYS Therapeutics IncRecruiting8 Years17 YearsAll66Phase 2United States
12NCT03440814May 9, 201822 October 2019A 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.Recruiting4 YearsN/AAll105Phase 3United States;United Kingdom
13NCT03197662April 11, 201828 October 2019Intranasal 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 CenterRecruiting5 Years17 YearsAll50Phase 2United States
14NCT03274856February 20, 201815 July 2019A 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.Not recruiting16 Years65 YearsAll19Phase 2United States;Canada
15NCT03548480January 1, 201818 June 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 DéuRecruiting2 Years19 YearsAll40N/ASpain
No.TrialIDDate_
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agemin
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16EUCTR2018-003062-13-FR28 February 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 - ZEPHYRPrader-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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Livoletide
CAS Number: 1088543-62-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: Livoletide
CAS Number: 1088543-62-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 16-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Millendo Therapeutics SASNot Available Female: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
17EUCTR2017-003423-30-NL12/12/20178 January 2018Intranasal 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
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Noncurrent)
Dutch Growth Research FoundationAuthorisedFemale: yes
Male: yes
33Phase 2;Phase 3Netherlands
18NCT03277157December 8, 20179 September 2019B. 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 SolutionsNot recruiting18 Years75 YearsAll28N/AUnited States
19NCT03245762August 1, 201711 June 2018Intranasal 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 AssociationNot recruitingN/A6 MonthsAll15Phase 1/Phase 2United States
20EUCTR2017-002164-41-ES03/07/201721 August 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
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON
Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.2-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Fundació Parc TaulíAuthorisedFemale: yes
Male: yes
Phase 4Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
21NCT02893618July 201719 September 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.Not recruiting18 Years65 YearsBoth32Phase 2
22NCT03616509June 19, 201720 August 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 MarNot recruiting18 YearsN/AAll30Phase 4Spain
23NCT03149445March 30, 20173 December 2018Co-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: PlacebosSanionaRecruiting18 Years30 YearsAll15Phase 2Czechia
24EUCTR2016-003694-18-CZ18/01/201728 February 2019Safety 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 extensionPrader 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tesofensine
CAS Number: 195875-86-6
Current Sponsor code: NS2330
Other descriptive name: TESOFENSINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Trade Name: Metoprololsuccinat ”Orion” 25mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 23750-
Saniona A/SAuthorised Female: yes
Male: yes
35Phase 2Hungary;Czech Republic
25NCT03081832January 201711 February 2019Follow-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, ToulouseNot recruiting3 Years4 YearsAll34N/AFrance
No.TrialIDDate_
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26EUCTR2016-003694-18-HU22/12/201615 October 2018Safety 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 extensionPrader 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tesofensine
CAS Number: 195875-86-6
Current Sponsor code: NS2330
Other descriptive name: TESOFENSINE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: Tesofensine
CAS Number: 195875-86-6
Current Sponsor code: NS2330
Other descriptive name: TESOFENSINE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-
Trade Name: Metoprololsuccinat Orion 25mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: metoprolol
Other descriptive name: METOPROLOL SUCCINATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 23750-
Saniona A/SAuthorisedFemale: yes
Male: yes
35Phase 2Czech Republic;Hungary
27EUCTR2016-003820-22-NL22/12/201623 January 2017Intranasal 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 PWSPrader-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
Pharmaceutical Form: Nasal spray
Dutch Growth Research FoundationNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
28NCT03114371November 28, 201610 December 2018Oxytocin 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, ToulouseRecruiting3 Years12 YearsAll40N/AFrance
29NCT03031626September 1, 201622 October 2019Oxygen 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 ChildrenRecruitingN/A2 YearsAll10Phase 4Canada
30EUCTR2016-003273-18-FR30 April 2019Oxytocin 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. - OXYJEUNEPrader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Syntocinon
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Nasal use
University Hospital of ToulouseNot Recruiting Female: yes
Male: yes
40Phase 3France
No.TrialIDDate_
enrollement
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31EUCTR2014-004415-37-IT10/11/201526 February 2018Effect 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 periodObesity (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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Novo Nordisk A/SAuthorisedFemale: yes
Male: yes
60Phase 3Turkey;Australia;Netherlands;New Zealand;Italy;France;United States;European Union;Canada
32NCT02527200November 9, 201522 October 2019Effect 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/SRecruiting6 Years18 YearsAll59Phase 3United States;Australia;Canada;France;Italy;Netherlands;New Zealand;Turkey
33NCT02629991October 201511 June 2018Oxytocin 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 ResearchNot recruiting5 Years18 YearsAll24Phase 2United States
34EUCTR2015-000660-33-SE30/09/20152 May 2016A 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 IIImprovement 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
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Beloranib
CAS Number: 251111-30-5
Current Sponsor code: ZGN-440
Other descriptive name: Beloranib
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Powder for suspension for injection
Route of administration of the placebo: Subcutaneous use
Zafgen Inc.Not RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Canada;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
35NCT02013258March 201511 June 2018Oxytocin Trial in Prader-Willi SyndromeOxytocin Trial in Prader-Willi SyndromePrader Willi SyndromeDrug: Intranasal oxytocin;Other: PlaceboUniversity of FloridaNational Institutes of Health (NIH)Not recruiting5 Years11 YearsAll24Phase 1United States
No.TrialIDDate_
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36NCT02311673February 201527 August 2018Ph 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.Not recruiting16 Years65 YearsAll40Phase 2United States
37EUCTR2014-001670-34-ES26/01/20159 May 2016A 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 SyndromePrader-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
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: INN Not yet proposed
Current Sponsor code: AZP-531
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.2-
Pharmaceutical form of the placebo: Lyophilisate for solution for injection
Route of administration of the placebo: Subcutaneous use
Alize PharmaNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
38NCT02179151September 201416 December 2017Double-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.Not recruiting12 Years65 YearsAll108Phase 3United States
39NCT02205450September 201419 February 2015Experience 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 TauliNot recruitingN/A2 YearsBoth15N/ASpain
40EUCTR2013-004134-15-NL15/07/201422 May 2017Intranasal 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 PWSPrader-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
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Noncurrent)
Dutch Growth Research FoundationNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
No.TrialIDDate_
enrollement
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PhaseCountries
41NCT02204163June 201415 July 2019Study 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 SciencesNot recruitingN/AN/AAll34Phase 3Korea, Republic of
42NCT02804373June 20145 November 2018Effects 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, ToulouseRecruiting18 Years50 YearsAll39Phase 2/Phase 3France
43NCT02034071April 201412 September 2016Clinical 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.Not recruiting10 Years22 YearsBoth13Phase 1/Phase 2United States
44EUCTR2013-004437-33-FR17/03/20147 May 2018Effets 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. - PRADOTIMPrader-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: Syntocinon
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Noncurrent)
Centre Hospitalier de ToulouseAuthorisedFemale: yes
Male: yes
39Phase 3France
45NCT02368379March 20145 February 2018Diagnosis 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 HospitalNot recruiting2 YearsN/AAll23N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
46NCT01968187January 20143 August 2015Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi SyndromeHyperphagia in Prader-Willi SyndromeDrug: FE 992097;Drug: PlaceboFerring PharmaceuticalsNot recruiting10 Years18 YearsBoth38Phase 2United States
47NCT01818921June 20138 August 2016An 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.Not recruiting16 Years65 YearsBoth17Phase 2United States
48NCT02205034May 201316 December 2017Evaluation 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, ToulouseNot recruiting1 Month5 MonthsAll18Phase 1/Phase 2France
49NCT02810483December 201211 June 2018Study 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 ParisNot recruiting12 Years45 YearsAll69Phase 3France
50EUCTR2011-001313-14-NL17/10/201222 October 2012Young adult Prader-Willi Study Effects 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 Effects 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 studyPrader 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.
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629-01-5
Current Sponsor code: 2007-189-2
Other descriptive name: growth hormone
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 0.33 -
Dutch growth research foundationAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
51NCT01520467April 20125 September 2016Aromatase 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 ParisNot recruiting5 Years12 YearsBoth27N/AFrance
52NCT01444898March 201219 October 2017Effects 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 AngelesNot recruiting13 Years20 YearsAll10N/AUnited States
53NCT01542242February 201221 December 2015Liraglutide Use in Prader-Willi SyndromeDiabetes Mellitus Type 2;Prader Willi SyndromeDrug: LiraglutideVancouver General HospitalNovo Nordisk A/SNot recruiting19 YearsN/AMale1Phase 4Canada
54EUCTR2010-023179-25-GB13/09/201119 March 2012Effects 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 SyndromeGhrelin 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)
Pharmaceutical Form: Injection
INN or Proposed INN: exenatide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use
Aintree University Hospital NHS Foundation TrustUNIVERSITY OF LIVERPOOLAuthorisedFemale: yes
Male: yes
United Kingdom
55NCT01401244July 14, 201116 December 2017Bioequivalence 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/SNot recruiting18 Years40 YearsAll30Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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sponsor
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agemin
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agemax
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Target_
size
PhaseCountries
56NCT01548521July 201116 December 2017Tolerance 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, ToulouseNot recruitingN/A5 MonthsAll5Phase 1/Phase 2France
57EUCTR2010-022370-14-FR2 October 2017Evaluation 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. - OTBBSyndrome de Prader Willi
MedDRA version: 12.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome
Trade Name: Syntocinon
Pharmaceutical Form: Nasal spray*
Centre Hospitalier de ToulouseNot AvailableFemale: yes
Male: yes
Phase 2France
58NCT01038570June 200916 December 2017Comparative 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, ToulouseNot recruiting18 YearsN/AAll24Phase 2France
59NCT01298180January 20098 June 2015Is 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, ToulouseNot recruiting1 Year5 YearsBoth111Phase 4France
60EUCTR2008-004612-12-FR06/11/200819 March 2012Existe 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
Pharmaceutical Form: Injection*
Trade Name: omnitrope
Product Name: OMNITROPE
Pharmaceutical Form: Injection*
CHU TOULOUSEAuthorisedFemale: yes
Male: yes
France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
61NCT00705172November 200819 February 2015Retrospective 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/SNot recruitingN/A15 YearsBoth41N/ADenmark;Germany;Switzerland
62EUCTR2007-004716-31-NL05/03/200822 May 2017Effects 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 PWSPrader-Willi Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome
Trade Name: Genotropin
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Dutch Growth FoundationNot RecruitingFemale: yes
Male: yes
Phase 4Netherlands
63EUCTR2007-006305-25-SE15/02/200819 March 2012Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi SyndromeEffects of rimonabant (Acomplia) on obesity in adults with Prader-Willi SyndromeObese adults with Prader Willi Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome
MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
Trade Name: ACOMPLIA 20 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Karolinska University HospitalNot RecruitingFemale: yes
Male: yes
Sweden
64NCT00551343October 200719 February 2015Gut 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 ResearchRecruiting18 Years45 YearsBoth20N/AAustralia
65NCT00603109August 200719 February 2015Effect 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
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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Target_
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PhaseCountries
66EUCTR2007-000469-39-FI02/05/200718 March 2013An 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. - NAPrader-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
CAS Number: 12629015
Oy Eli Lilly Finland AbNot RecruitingFemale: yes
Male: yes
Phase 4Finland
67NCT00399893December 200619 October 2017Octreotide 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);NovartisNot recruiting5 Years21 YearsAll5N/AUnited States
68NCT01613495August 200526 August 2019Ghrelin 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 UniversityNot recruiting18 YearsN/AMale2N/A
69NCT00372125April 200519 September 2016Nordic 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/SNot recruiting18 Years50 YearsBoth46N/ADenmark;Norway;Sweden
70NCT00444964April 200519 February 2015Growth Hormone Use in Adults With Prader-Willi SyndromeGrowth Hormone Use in Adults With Prader-Willi SyndromePrader-Willi SyndromeDrug: Nutropin AQChildren's Mercy Hospital Kansas CityRecruiting16 Years60 YearsBoth10Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT00175305August 200419 February 2015Prader-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 ColumbiaNot recruiting10 Years17 YearsBoth10Phase 3Canada
72NCT00065923July 200219 February 2015Treatment 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)Not recruiting18 Years66 YearsBoth10N/AUnited States

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