193. プラダー・ウィリ症候群 ［臨床試験数：72，薬物数：77（DrugBank：26），標的遺伝子数：49，標的パスウェイ数：59］
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.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04066088 | December 2019 | 2 September 2019 | Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome | Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome | Prader-Willi Syndrome | Other: Placebo;Drug: Guanfacine extended release (GXR) | NYU Langone Health | Winthrop University Hospital | Not recruiting | 6 Years | 35 Years | All | 33 | Phase 4 | United States |
| 2 | NCT03831425 | November 1, 2019 | 30 September 2019 | Mitochondrial Complex I Dysfunction in PWS | Mitochondrial Complex I Dysfunction in Prader Willi Syndrome: A New Therapeutic Target | Prader-Willi Syndrome | Dietary Supplement: Coenzyme Q10;Other: Placebo | The Hospital for Sick Children | Foundation for Prader-Willi Research | Not recruiting | 13 Years | 18 Years | All | 14 | Phase 3 | |
| 3 | NCT04086810 | October 15, 2019 | 30 September 2019 | An Open-Label Study of DCCR Tablet in Patients With PWS | An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: DCCR | Soleno Therapeutics, Inc. | Not recruiting | 4 Years | N/A | All | 105 | Phase 3 | ||
| 4 | NCT03848481 | September 2019 | 15 April 2019 | CBDV vs Placebo in Children With Prader-Willi Syndrome (PWS) | Cannabidivarin (CBDV) vs Placebo in Children With Prader-Willi Syndrome (PWS) | Prader-Willi Syndrome | Drug: Placebo;Drug: CBDV Compound | Montefiore Medical Center | Foundation for Prader-Willi Research | Not recruiting | 5 Years | 30 Years | All | 26 | Phase 2 | United States |
| 5 | ChiCTR1900022809 | 2019-05-01 | 30 April 2019 | Efficacy and safety of growth hormone in the treatment of Prader-Willi syndrome | Efficacy and safety of growth hormone in the treatment of Prader-Willi syndrome | Prader-Willi syndrome | control group:Routine treatment such as rehabilitation;Treated group:treatment with growth hormone; | Children's Hospital of Zhejiang University School of Medicine | Not Recruiting | Both | control group:20;Treated group:50; | N/A | China | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03790865 | March 26, 2019 | 4 November 2019 | Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome | 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 | Prader-Willi Syndrome;Hyperphagia | Drug: Placebo;Drug: Livoletide | Millendo Therapeutics SAS | Recruiting | 4 Years | 65 Years | All | 150 | Phase 2/Phase 3 | United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom | |
| 7 | EUCTR2018-003062-13-ES | 20/03/2019 | 30 April 2019 | A 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 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 SAS | Authorised | Female: yes Male: yes | 150 | Phase 2;Phase 3 | France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom | |||
| 8 | NCT03649477 | November 20, 2018 | 4 November 2019 | Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome | Phase 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 Syndrome | Drug: intranasal carbetocin Dose 1;Drug: intranasal carbetocin Dose 2;Drug: placebo | Levo Therapeutics, Inc. | Recruiting | 7 Years | 18 Years | All | 175 | Phase 3 | United States;Canada | |
| 9 | NCT03714373 | October 1, 2018 | 28 October 2019 | Open-Label Extension Study of Diazoxide Choline in Patients With Prader-Willi Syndrome | An Open-Label, Long-Term Safety Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: DCCR | Soleno Therapeutics, Inc. | Recruiting | 4 Years | N/A | All | 105 | Phase 3 | United States;United Kingdom | |
| 10 | NCT03458416 | September 6, 2018 | 24 June 2019 | A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome | A Multicenter, Open-Label Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Cannabidiol Oral Solution | INSYS Therapeutics Inc | Recruiting | 8 Years | 17 Years | All | 66 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02844933 | June 6, 2018 | 24 June 2019 | Cannabidiol Oral Solution for the Treatment of Subjects With Prader-Willi Syndrome | A 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 Syndrome | Prader-Willi Syndrome | Drug: Cannabidiol;Drug: Placebo | INSYS Therapeutics Inc | Recruiting | 8 Years | 17 Years | All | 66 | Phase 2 | United States | |
| 12 | NCT03440814 | May 9, 2018 | 22 October 2019 | A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome | A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: DCCR;Drug: Placebo for DCCR | Soleno Therapeutics, Inc. | Recruiting | 4 Years | N/A | All | 105 | Phase 3 | United States;United Kingdom | |
| 13 | NCT03197662 | April 11, 2018 | 28 October 2019 | Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome | Phase 2 Study: Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Children and Adolescents With Prader-Willi Syndrome | Prader-Willi Syndrome;Hyperphagia | Drug: Intranasal Oxytocin (IN-OXT);Drug: Matched Placebo | Montefiore Medical Center | Recruiting | 5 Years | 17 Years | All | 50 | Phase 2 | United States | |
| 14 | NCT03274856 | February 20, 2018 | 15 July 2019 | A Study of GLWL-01 in Patients With Prader-Willi Syndrome | A Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics of GLWL-01 in the Treatment of Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: GLWL-01;Drug: Placebo | GLWL Research Inc. | Not recruiting | 16 Years | 65 Years | All | 19 | Phase 2 | United States;Canada | |
| 15 | NCT03548480 | January 1, 2018 | 18 June 2018 | Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment | Targeting the Gut Microbiome for Prader-Willi Syndrome Treatment | Prader-Willi Syndrome | Dietary Supplement: Placebo;Dietary Supplement: Probiotic | Fundació Sant Joan de Déu | Recruiting | 2 Years | 19 Years | All | 40 | N/A | Spain | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2018-003062-13-FR | 28 February 2019 | A 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 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 SAS | Not Available | Female: yes Male: yes | 150 | Phase 2;Phase 3 | United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||||
| 17 | EUCTR2017-003423-30-NL | 12/12/2017 | 8 January 2018 | Intranasal administration of oxytocin in children with Prader-Willi syndrome | Randomized, 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 Foundation | Authorised | Female: yes Male: yes | 33 | Phase 2;Phase 3 | Netherlands | |||
| 18 | NCT03277157 | December 8, 2017 | 9 September 2019 | B. Lactis B94 Effects of Gastrointestinal Function | The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study | Quality of Life | Dietary Supplement: B. lactis B94;Dietary Supplement: Placebo | University of Florida | Lallemand Health Solutions | Not recruiting | 18 Years | 75 Years | All | 28 | N/A | United States |
| 19 | NCT03245762 | August 1, 2017 | 11 June 2018 | Intranasal Oxytocin for Infants With Prader-Willi Syndrome | Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study | Prader-Willi Syndrome | Drug: Oxytocin;Drug: Placebo | University of Florida | Prader-Willi Syndrome Association | Not recruiting | N/A | 6 Months | All | 15 | Phase 1/Phase 2 | United States |
| 20 | EUCTR2017-002164-41-ES | 03/07/2017 | 21 August 2017 | Study 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 Taulí | Authorised | Female: yes Male: yes | Phase 4 | Spain | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02893618 | July 2017 | 19 September 2016 | A 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 Syndrome | Drug: Diazoxide choline controlled-release tablet | Essentialis, Inc. | Not recruiting | 18 Years | 65 Years | Both | 32 | Phase 2 | ||
| 22 | NCT03616509 | June 19, 2017 | 20 August 2018 | GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition | Treatment With Growth Hormone in Adults With PWS, Effect on Muscular Tone Evaluated by Functional MRI, Relationship With Strength and Body Composition | Prader-Willi Syndrome | Drug: Growth hormone;Drug: Placebo | Corporacion Parc Tauli | Parc de Salut Mar | Not recruiting | 18 Years | N/A | All | 30 | Phase 4 | Spain |
| 23 | NCT03149445 | March 30, 2017 | 3 December 2018 | Co-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 Syndrome | Drug: Tesofensine/Metoprolol;Drug: Placebos | Saniona | Recruiting | 18 Years | 30 Years | All | 15 | Phase 2 | Czechia | |
| 24 | EUCTR2016-003694-18-CZ | 18/01/2017 | 28 February 2019 | Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome | 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) 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 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/S | Authorised | Female: yes Male: yes | 35 | Phase 2 | Hungary;Czech Republic | |||
| 25 | NCT03081832 | January 2017 | 11 February 2019 | Follow-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 Syndrome | Drug: Oxytocin;Other: Control | University Hospital, Toulouse | Not recruiting | 3 Years | 4 Years | All | 34 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2016-003694-18-HU | 22/12/2016 | 15 October 2018 | Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome | 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) 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 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/S | Authorised | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Hungary | |||
| 27 | EUCTR2016-003820-22-NL | 22/12/2016 | 23 January 2017 | Intranasal administration of oxytocin in children with Prader-Willi Syndrome | Intranasal 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 Pharmaceutical Form: Nasal spray | Dutch Growth Research Foundation | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | ||||
| 28 | NCT03114371 | November 28, 2016 | 10 December 2018 | Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years | Effects 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 Syndrome | Drug: Oxytocin;Drug: Placebo | University Hospital, Toulouse | Recruiting | 3 Years | 12 Years | All | 40 | N/A | France | |
| 29 | NCT03031626 | September 1, 2016 | 22 October 2019 | Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome | Comparison 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 Study | Sleep Apnea, Central;Prader-Willi Syndrome | Biological: Medical Air vs Oxygen | The Hospital for Sick Children | Recruiting | N/A | 2 Years | All | 10 | Phase 4 | Canada | |
| 30 | EUCTR2016-003273-18-FR | 30 April 2019 | Oxytocin 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: Syntocinon Pharmaceutical Form: Nasal spray Pharmaceutical form of the placebo: Nasal spray Route of administration of the placebo: Nasal use | University Hospital of Toulouse | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2014-004415-37-IT | 10/11/2015 | 26 February 2018 | Effect of liraglutide for weight management in children with Prader-Willi Syndrome | Effect 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 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/S | Authorised | Female: yes Male: yes | 60 | Phase 3 | Turkey;Australia;Netherlands;New Zealand;Italy;France;United States;European Union;Canada | |||
| 32 | NCT02527200 | November 9, 2015 | 22 October 2019 | Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome | Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome. | Metabolism and Nutrition Disorder;Obesity | Drug: liraglutide;Drug: placebo | Novo Nordisk A/S | Recruiting | 6 Years | 18 Years | All | 59 | Phase 3 | United States;Australia;Canada;France;Italy;Netherlands;New Zealand;Turkey | |
| 33 | NCT02629991 | October 2015 | 11 June 2018 | Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome | Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome | Prader-Willi Syndrome;Hyperphagia | Drug: Intranasal Oxytocin (IN-OXT);Drug: Matched Placebo | Montefiore Medical Center | Foundation for Prader-Willi Research | Not recruiting | 5 Years | 18 Years | All | 24 | Phase 2 | United States |
| 34 | EUCTR2015-000660-33-SE | 30/09/2015 | 2 May 2016 | A 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 placebo | Randomized, 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 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 Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 35 | NCT02013258 | March 2015 | 11 June 2018 | Oxytocin Trial in Prader-Willi Syndrome | Oxytocin Trial in Prader-Willi Syndrome | Prader Willi Syndrome | Drug: Intranasal oxytocin;Other: Placebo | University of Florida | National Institutes of Health (NIH) | Not recruiting | 5 Years | 11 Years | All | 24 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT02311673 | February 2015 | 27 August 2018 | Ph 2 Trial to Evaluate Safety & Efficacy of RM-493 in Obese Patients With Prader-Willi Syndrome | A 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 Behaviors | Prader-Willi Syndrome | Drug: RM-493;Drug: Placebo | Rhythm Pharmaceuticals, Inc. | Not recruiting | 16 Years | 65 Years | All | 40 | Phase 2 | United States | |
| 37 | EUCTR2014-001670-34-ES | 26/01/2015 | 9 May 2016 | A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi Syndrome | A 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 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 Pharma | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Spain;Italy | |||
| 38 | NCT02179151 | September 2014 | 16 December 2017 | Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome | Randomized, 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 Months | Prader-Willi Syndrome;Obesity | Drug: ZGN-440 for Injectable Suspension;Drug: ZGN-440 Placebo for Injectable Suspension | Zafgen, Inc. | Not recruiting | 12 Years | 65 Years | All | 108 | Phase 3 | United States | |
| 39 | NCT02205450 | September 2014 | 19 February 2015 | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | Prader-Willi Syndrome | Drug: Recombinant Somatropin | Corporacion Parc Tauli | Not recruiting | N/A | 2 Years | Both | 15 | N/A | Spain | |
| 40 | EUCTR2013-004134-15-NL | 15/07/2014 | 22 May 2017 | Intranasal administration of oxytocin in children and young-adults with Prader-Willi syndrome | Intranasal 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 Pharmaceutical Form: Nasal spray Pharmaceutical form of the placebo: Nasal spray Route of administration of the placebo: Intranasal use (Noncurrent) | Dutch Growth Research Foundation | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT02204163 | June 2014 | 15 July 2019 | Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome | A 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 Syndrome | Prader-Willi Syndrome | Drug: Eutropin;Drug: Genotropin | LG Life Sciences | Not recruiting | N/A | N/A | All | 34 | Phase 3 | Korea, Republic of | |
| 42 | NCT02804373 | June 2014 | 5 November 2018 | Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome | Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Oxytocin (OXT) continuous;Drug: Placebo;Drug: Placebo continuous;Drug: Oxytocin | University Hospital, Toulouse | Recruiting | 18 Years | 50 Years | All | 39 | Phase 2/Phase 3 | France | |
| 43 | NCT02034071 | April 2014 | 12 September 2016 | Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome | A Dose Titration Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome With a Double-Blind, Placebo-Controlled, Randomized Withdrawal Extension | Prader-Willi Syndrome | Drug: DCCR;Drug: Placebo | Essentialis, Inc. | Not recruiting | 10 Years | 22 Years | Both | 13 | Phase 1/Phase 2 | United States | |
| 44 | EUCTR2013-004437-33-FR | 17/03/2014 | 7 May 2018 | Effets de l'administration intranasale répétée d'ocytocine chez des patients adultes présentant un syndrome de Prader-Willi | Effets 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: Syntocinon Pharmaceutical Form: Nasal spray Pharmaceutical form of the placebo: Nasal spray Route of administration of the placebo: Intranasal use (Noncurrent) | Centre Hospitalier de Toulouse | Authorised | Female: yes Male: yes | 39 | Phase 3 | France | |||
| 45 | NCT02368379 | March 2014 | 5 February 2018 | Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome | Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome | Prader Willi Syndrome;Adrenal Insufficiency | Other: Low dose (1 mcg) ACTH stimulation test;Other: Overnight metyrapone test | Nationwide Children's Hospital | Not recruiting | 2 Years | N/A | All | 23 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT01968187 | January 2014 | 3 August 2015 | Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome | Hyperphagia in Prader-Willi Syndrome | Drug: FE 992097;Drug: Placebo | Ferring Pharmaceuticals | Not recruiting | 10 Years | 18 Years | Both | 38 | Phase 2 | United States | ||
| 47 | NCT01818921 | June 2013 | 8 August 2016 | An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome | Randomized, 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 Extension | Obesity;Over-weight;Prader-Willi Syndrome | Drug: ZGN-440 sterile diluent;Drug: 1.2 mg ZGN-440 for injectable suspension;Drug: 1.8 mg ZGN-440 for injectable suspension | Zafgen, Inc. | Not recruiting | 16 Years | 65 Years | Both | 17 | Phase 2 | United States | |
| 48 | NCT02205034 | May 2013 | 16 December 2017 | Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants | Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants | Prader Willi Syndrome | Drug: oxytocin | University Hospital, Toulouse | Not recruiting | 1 Month | 5 Months | All | 18 | Phase 1/Phase 2 | France | |
| 49 | NCT02810483 | December 2012 | 11 June 2018 | Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks | Randomized, 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 Weeks | Prader-Willi Syndrome | Drug: Topiramate;Drug: Placebo Comparator | Assistance Publique - Hôpitaux de Paris | Not recruiting | 12 Years | 45 Years | All | 69 | Phase 3 | France | |
| 50 | EUCTR2011-001313-14-NL | 17/10/2012 | 22 October 2012 | 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 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 | 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. 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 foundation | Authorised | Female: yes Male: yes | Netherlands | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT01520467 | April 2012 | 5 September 2016 | Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome | Efficacy 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 Syndrome | Silver Russell Syndrome;Prader-Willi Syndrome | Drug: Anastrozole;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Not recruiting | 5 Years | 12 Years | Both | 27 | N/A | France | |
| 52 | NCT01444898 | March 2012 | 19 October 2017 | Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome | Effects of Exenatide on Obesity and Appetite in Overweight Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Exenatide | Children's Hospital Los Angeles | Not recruiting | 13 Years | 20 Years | All | 10 | N/A | United States | |
| 53 | NCT01542242 | February 2012 | 21 December 2015 | Liraglutide Use in Prader-Willi Syndrome | Diabetes Mellitus Type 2;Prader Willi Syndrome | Drug: Liraglutide | Vancouver General Hospital | Novo Nordisk A/S | Not recruiting | 19 Years | N/A | Male | 1 | Phase 4 | Canada | |
| 54 | EUCTR2010-023179-25-GB | 13/09/2011 | 19 March 2012 | Effects of exenatide on appetite and ghrelin levels in patients with Prader-Willi Syndrome - Effects of exenatide on appetite and ghrelin in Prader-Willi Syndrome | Effects 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) 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 Trust | UNIVERSITY OF LIVERPOOL | Authorised | Female: yes Male: yes | United Kingdom | ||||
| 55 | NCT01401244 | July 14, 2011 | 16 December 2017 | Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers | A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers | Genetic Disorder;Prader-Willi Syndrome;Growth Disorder;Idiopathic Short Stature;Healthy | Drug: somatropin | Novo Nordisk A/S | Not recruiting | 18 Years | 40 Years | All | 30 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT01548521 | July 2011 | 16 December 2017 | Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies | Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies and Effect on Suck and Food Intake. | Prader-Willi Syndrome | Drug: Oxytocin | University Hospital, Toulouse | Not recruiting | N/A | 5 Months | All | 5 | Phase 1/Phase 2 | France | |
| 57 | EUCTR2010-022370-14-FR | 2 October 2017 | Evaluation 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 | Evaluation 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: Syntocinon Pharmaceutical Form: Nasal spray* | Centre Hospitalier de Toulouse | Not Available | Female: yes Male: yes | Phase 2 | France | |||||
| 58 | NCT01038570 | June 2009 | 16 December 2017 | Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus Placebo | Evaluation 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 Study | Prader Willi Syndrome | Drug: Syntocinon®/- Spray;Drug: Physiological serum (Sodium chloride) | University Hospital, Toulouse | Not recruiting | 18 Years | N/A | All | 24 | Phase 2 | France | |
| 59 | NCT01298180 | January 2009 | 8 June 2015 | Is 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 Deficiency | Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsy | University Hospital, Toulouse | Not recruiting | 1 Year | 5 Years | Both | 111 | Phase 4 | France | |
| 60 | EUCTR2008-004612-12-FR | 06/11/2008 | 19 March 2012 | Existe 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 TOULOUSE | Authorised | Female: yes Male: yes | France | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT00705172 | November 2008 | 19 February 2015 | Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome | Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS) | Genetic Disorder;Prader-Willi Syndrome | Drug: somatropin | Novo Nordisk A/S | Not recruiting | N/A | 15 Years | Both | 41 | N/A | Denmark;Germany;Switzerland | |
| 62 | EUCTR2007-004716-31-NL | 05/03/2008 | 22 May 2017 | Effects 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 | Effects 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: Genotropin Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Dutch Growth Foundation | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| 63 | EUCTR2007-006305-25-SE | 15/02/2008 | 19 March 2012 | Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi Syndrome | Effects 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 Level: LLT Classification code 10029883 Term: Obesity | Trade Name: ACOMPLIA 20 mg film-coated tablets Pharmaceutical Form: Film-coated tablet | Karolinska University Hospital | Not Recruiting | Female: yes Male: yes | Sweden | |||||
| 64 | NCT00551343 | October 2007 | 19 February 2015 | Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome | Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome. | Prader-Willi Syndrome | Drug: Exenatide | Garvan Institute of Medical Research | Recruiting | 18 Years | 45 Years | Both | 20 | N/A | Australia | |
| 65 | NCT00603109 | August 2007 | 19 February 2015 | Effect of Rimonabant on Weight Gain and Body Composition in Adults With Prader Willi Syndrome | Effect of Rimonabant, a Cannabinoid Receptor 1 Antagonist on Weight Gain and Body Composition in Adults With Prader Willi Syndrome. | Prader-willi Syndrome | Drug: rimonabant;Drug: placebo | Weill Medical College of Cornell University | National Institutes of Health (NIH);PWSAUSA | Recruiting | 18 Years | 35 Years | Both | 18 | Phase 3 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2007-000469-39-FI | 02/05/2007 | 18 March 2013 | An 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 | An 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 CAS Number: 12629015 | Oy Eli Lilly Finland Ab | Not Recruiting | Female: yes Male: yes | Phase 4 | Finland | ||||
| 67 | NCT00399893 | December 2006 | 19 October 2017 | Octreotide 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-study | Prader-Willi Syndrome | Drug: Octreotide;Drug: Placebo | Duke University | National Institutes of Health (NIH);National Center for Research Resources (NCRR);Novartis | Not recruiting | 5 Years | 21 Years | All | 5 | N/A | United States |
| 68 | NCT01613495 | August 2005 | 26 August 2019 | Ghrelin Suppression by Octreotide in Prader-Willi | Ghrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi Syndrome | Prader Willis Syndrome | Drug: Placebo;Drug: Octreotide | Oregon Health and Science University | Not recruiting | 18 Years | N/A | Male | 2 | N/A | ||
| 69 | NCT00372125 | April 2005 | 19 September 2016 | Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome | Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Norditropin SimpleXx | Karolinska University Hospital | Novo Nordisk A/S | Not recruiting | 18 Years | 50 Years | Both | 46 | N/A | Denmark;Norway;Sweden |
| 70 | NCT00444964 | April 2005 | 19 February 2015 | Growth Hormone Use in Adults With Prader-Willi Syndrome | Growth Hormone Use in Adults With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Nutropin AQ | Children's Mercy Hospital Kansas City | Recruiting | 16 Years | 60 Years | Both | 10 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT00175305 | August 2004 | 19 February 2015 | Prader-Willi Syndrome and Appetite | Effect of Somatostatin on Ghrelin Concentrations, Food Seeking Behaviour and Weight in Patients With Prader-Willi Syndrome | Hyperphagia;Prader-Willi Syndrome | Drug: Sandostatin LAR | University of British Columbia | Not recruiting | 10 Years | 17 Years | Both | 10 | Phase 3 | Canada | |
| 72 | NCT00065923 | July 2002 | 19 February 2015 | Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome | Topiramate Effects on SIB in Prader-Willi Syndrome | Prader-Willi Syndrome;Self-Injurious Behavior | Drug: Topiramate | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 18 Years | 66 Years | Both | 10 | N/A | United States |