193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details
臨床試験数 : 111 / 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03831425 (ClinicalTrials.gov) | May 1, 2022 | 22/1/2019 | 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 | Recruiting | 13 Years | 18 Years | All | 14 | Phase 2 | Canada |
| 2 | NCT05153434 (ClinicalTrials.gov) | March 24, 2022 | 30/11/2021 | A Study of Oral ARD-101 in Patients With Prader-Willi Syndrome | A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: ARD-101 | Aardvark Therapeutics, Inc. | Children's Hospital Colorado | Recruiting | 17 Years | 65 Years | All | 12 | Phase 2 | United States |
| 3 | NCT05098509 (ClinicalTrials.gov) | March 15, 2022 | 22/9/2021 | A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi Syndrome | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi Syndrome | Prader-Willi Syndrome | Drug: RAD011;Drug: Placebo | Radius Pharmaceuticals, Inc. | NULL | Not yet recruiting | 8 Years | 65 Years | All | 220 | Phase 2/Phase 3 | United States |
| 4 | EUCTR2021-000127-12-SE (EUCTR) | 03/01/2022 | 08/11/2021 | A 16-week phase 2b, double-blind, placebo-controlled, Multi center, dose finding safety and efficacy study to evaluate overall safety and tolerability of Tesomet ( tesofensine and metoprolol) in subjects with Prader-Willi Syndrome, and with an optional 38-week open-label extension | A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi center, 16-week Dose finding, Safety and Efficacy Study with Open-label Extension Period of Tesomet in Adult and Adolescent Subjects with Prader-Willi Syndrome | Prader-Willi Syndrome MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tesomet INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE CITRATE INN or Proposed INN: Metoprolol Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.) Product Name: Tesomet INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE CITRATE INN or Proposed INN: Metoprolol Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.) Product Name: Tesomet INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE CITRATE INN or Proposed INN: Metoprolol Other descriptive name: METOPROLOL SUCCINATE (PH. EUR.) | Saniona A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden | ||
| 5 | NCT05198362 (ClinicalTrials.gov) | December 28, 2021 | 5/1/2022 | Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome | A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome | Prader-Willi Syndrome | Other: Placebo;Drug: Tesomet | Saniona | NULL | Recruiting | 13 Years | 65 Years | All | 120 | Phase 2 | United States |
| 6 | NCT05032326 (ClinicalTrials.gov) | September 7, 2021 | 24/6/2021 | Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial | Long-term Interventional Follow-up Study up to 4 Years of Age of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial and Comparison With an Untreated Cohort of Children With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Follow-up study of the treated cohort;Other: Follow-up study of the untreated cohort | University Hospital, Toulouse | NULL | Recruiting | 12 Months | 36 Months | All | 80 | Phase 3 | France |
| 7 | EUCTR2019-002385-12-NL (EUCTR) | 26/08/2021 | 08/09/2020 | Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome | Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome: a study of the safety and efficacy on oral and social skills and, feeding behavior of intranasal administrations of oxytocin vs. placebo (phase iii clinical trial) - OTBB3 | Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Oxytocin INN or Proposed INN: OXYTOCIN Other descriptive name: OXYTOCIN | University Hospital of Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | France;Belgium;Germany;Netherlands | ||
| 8 | EUCTR2019-002385-12-DE (EUCTR) | 07/07/2021 | 21/04/2021 | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 | Prader-Willi Syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Oxytocin INN or Proposed INN: OXYTOCIN Other descriptive name: OXYTOCIN | University Hospital of Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | France;Belgium;Netherlands;Germany | ||
| 9 | ChiCTR2100046551 | 2021-05-18 | 2021-05-21 | Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatment | Application of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome | Prader-Willi sydrome | Prader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none; | Cai Jinhua | NULL | Recruiting | 0 | 16 | Both | Prader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40; | N/A | China |
| 10 | EUCTR2019-000735-61-NL (EUCTR) | 06/04/2021 | 04/08/2020 | Treatment with N-acetylcysteine for skin picking in children and young adults with PWS | N- acetylcysteine treatment for skin picking in children and young adults with PWS: a randomized, controlled, cross-over trial. | Prader-Willi syndrome MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Fluimucil (acetylcysteine) Product Name: Fluimucil Product Code: R05CB01 | Dutch Growth Research Foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 2;Phase 3 | Netherlands | ||
| 11 | NCT04768803 (ClinicalTrials.gov) | March 15, 2021 | 16/2/2021 | Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity | Circulating Levels of Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and / or Overweight, and / or Obesity | Angelman Syndrome;Smith-Magenis Syndrome;X Fragile Syndrome;Epilepsy;Prader-Willi Syndrome | Biological: acylated and unacylated ghrelin dosages | University Hospital, Toulouse | NULL | Not yet recruiting | 3 Years | 50 Years | All | 300 | NULL | |
| 12 | NCT04697381 (ClinicalTrials.gov) | February 9, 2021 | 4/1/2021 | Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS | A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) | Prader-Willi Syndrome | Biological: somatropin - GH naïve pediatric cohort;Biological: somatropin - GH treated cohort;Biological: somatropin - adult cohort | Pfizer | NULL | Active, not recruiting | N/A | N/A | All | 32 | Phase 3 | Japan |
| 13 | JPRN-jRCT2031200351 | 09/02/2021 | 08/02/2021 | Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS | A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) - NA | Prader-Willi Syndrome | Biological: somatropin - GH naive pediatric cohort somatropin 0.245 mg/kg/week Biological: somatropin - GH treated cohort somatropin 0.084 mg/kg/week Biological: somatropin - adult cohort somatropin 0.084 mg/kg/week | Nagashima Masahito | NULL | Recruiting | >= | Not applicable | Both | 30 | Phase 3 | Japan |
| 14 | NCT04685057 (ClinicalTrials.gov) | January 11, 2021 | 2/12/2020 | Probiotic Treatment for Prader-Willi Syndrome | Probiotics as a Long-term Treatment Strategy for Prader-Willi Syndrome | Prader-Willi Syndrome | Dietary Supplement: Placebo;Dietary Supplement: Probiotic;Dietary Supplement: Follow-up probiotic | Fundació Sant Joan de Déu | NULL | Enrolling by invitation | 6 Years | 30 Years | All | 50 | Phase 1/Phase 2 | Spain |
| 15 | ChiCTR2000040947 | 2021-01-01 | 2020-12-16 | The safety and effectiveness of rapamycin (sirolimus) in the treatment of Prader-Willi syndrome | The safety and effectiveness of rapamycin (sirolimus) in the treatment of Prader-Willi syndrome | Prader-Willi syndrome | rapamycin group:rapamycin 1mg qd po; | Peking Union Medical College Hospital | NULL | Recruiting | Both | rapamycin group:30; | China | |||
| 16 | NCT04257929 (ClinicalTrials.gov) | December 9, 2020 | 29/1/2020 | A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension | Prader-Willi Syndrome | Drug: Pitolisant oral tablets;Drug: Placebo oral tablet | Harmony Biosciences, LLC | NULL | Recruiting | 6 Years | 65 Years | All | 60 | Phase 2 | United States |
| 17 | ChiCTR2000039618 | 2020-12-01 | 2020-11-03 | Diagnostic accuracy of RNA molecular markers in Prader Willi syndrome | Diagnostic accuracy of RNA molecular markers in Prader Willi syndrome | Prader-Willi syndrome | Gold Standard:Methylation specific multiplex ligation probe amplification (MS-MLPA) combined with chromosome G-banding karyotype analysis and array comparative genomic hybridization (array CGH).;Index test:Detection of ribonucleic acid molecular markers.; | Children's Hospital Affiliated to Medical College of Zhejiang University | NULL | Recruiting | Both | Target condition:20;Difficult condition:0 | China | |||
| 18 | NCT03848481 (ClinicalTrials.gov) | November 23, 2020 | 19/2/2019 | CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) | Cannabidivarin (CBDV) vs. Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) | Prader-Willi Syndrome | Drug: CBDV Compound;Drug: Placebo | Montefiore Medical Center | Foundation for Prader-Willi Research;GW Pharmaceuticals Ltd. | Recruiting | 5 Years | 30 Years | All | 26 | Phase 2 | United States |
| 19 | NCT04484051 (ClinicalTrials.gov) | October 1, 2020 | 15/7/2020 | Global Growth Hormone Study in Adults With Prader-Willi Syndrome | Global Growth Hormone Study in Adults With Prader-Willi Syndroom | Prader-Willi Syndrome | Drug: Somatropin;Drug: Placebo | Erasmus Medical Center | Pfizer;Foundation for Prader-Willi Research;Prader-Willi Fonds | Not yet recruiting | 30 Years | N/A | All | 50 | Phase 3 | Australia;Netherlands |
| 20 | NCT04283578 (ClinicalTrials.gov) | March 10, 2020 | 19/2/2020 | Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome | Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo | Prader-Willi Syndrome | Drug: OT;Drug: Placebo comparator | University Hospital, Toulouse | International Clinical Trials Association;Epidemiological and Clinical Research Information Network | Active, not recruiting | N/A | 92 Days | All | 48 | Phase 3 | France |
| 21 | EUCTR2018-003062-13-FR (EUCTR) | 25/02/2020 | 21/11/2018 | 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 INN or Proposed INN: Livoletide INN or Proposed INN: Livoletide | Millendo Therapeutics SAS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | United States;France;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 22 | ChiCTR1900027464 | 2019-12-01 | 2019-11-14 | Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age | Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age | Prader-Willi syndrome | control group:Single rhGH therapy;observation group:Anastrazole combined with growth hormone therapy; | Children's Hospital of Zhejiang University School of Medicine | NULL | Pending | Male | control group:20;observation group:20; | Phase 4 | China | ||
| 23 | NCT04066088 (ClinicalTrials.gov) | December 1, 2019 | 21/8/2019 | 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 | Withdrawn | 6 Years | 35 Years | All | 0 | Phase 4 | United States |
| 24 | NCT04086810 (ClinicalTrials.gov) | October 2019 | 10/9/2019 | 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. | NULL | Withdrawn | 4 Years | N/A | All | 0 | Phase 3 | NULL |
| 25 | EUCTR2018-004216-22-GB (EUCTR) | 25/09/2019 | 27/06/2019 | A study to determine the safety of the study drug Diazoxide Choline Controlled-Release Tablet after being given for a long time to patients with the genetic disorder Prader-Willi Syndrome. | An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome | Hyperphagia associated with Prader-Willi Syndrome (PWS) MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: diazoxide choline Product Code: DCCR INN or Proposed INN: Diazoxide choline Other descriptive name: DIAZOXIDE CHOLINE | Soleno Therapeutics UK Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;United Kingdom | ||
| 26 | EUCTR2019-002385-12-FR (EUCTR) | 27/08/2019 | 12/06/2019 | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 | Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Oxytocin INN or Proposed INN: OXYTOCIN Other descriptive name: OXYTOCIN | University Hospital of Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 27 | EUCTR2018-003062-13-GB (EUCTR) | 11/07/2019 | 06/12/2018 | 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 INN or Proposed INN: Livoletide Product Name: Livoletide Product Code: AZP-531 INN or Proposed INN: Livoletide | Millendo Therapeutics SAS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom | ||
| 28 | EUCTR2018-003062-13-NL (EUCTR) | 10/07/2019 | 09/04/2019 | 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 INN or Proposed INN: Livoletide Product Name: Livoletide Product Code: AZP-531 INN or Proposed INN: Livoletide | Millendo Therapeutics SAS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom | ||
| 29 | EUCTR2018-003062-13-BE (EUCTR) | 07/06/2019 | 25/03/2019 | 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 INN or Proposed INN: Livoletide Product Name: Livoletide Product Code: AZP-531 INN or Proposed INN: Livoletide | Millendo Therapeutics SAS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | France;United States;Spain;Belgium;Australia;Netherlands;United Kingdom | ||
| 30 | ChiCTR1900022809 | 2019-05-01 | 2019-04-26 | 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 | NULL | Pending | Both | control group:20;Treated group:50; | N/A | China | ||
| 31 | EUCTR2018-004215-50-GB (EUCTR) | 23/04/2019 | 12/08/2019 | A study to evaluate the effects of a medicine named diazoxide choline in patients with the genetic disorder Prader-Willi syndrome. | A Randomized, Double-Blind, Placebo-Controlled Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients with Prader-Willi Syndrome | Hyperphagia associated with Prader-Willi Syndrome. MedDRA version: 20.0;Level: PT;Classification code 10020710;Term: Hyperphagia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: diazoxide choline Product Code: DCCR INN or Proposed INN: Diazoxide choline Other descriptive name: DIAZOXIDE CHOLINE | Soleno Therapeutics UK Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Kingdom | ||
| 32 | NCT03790865 (ClinicalTrials.gov) | March 25, 2019 | 28/12/2018 | 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 Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome;Hyperphagia | Drug: Livoletide;Drug: Placebo | Millendo Therapeutics SAS | NULL | Terminated | 4 Years | 65 Years | All | 158 | Phase 2/Phase 3 | United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom |
| 33 | EUCTR2018-003062-13-IT (EUCTR) | 20/03/2019 | 07/10/2020 | 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 | A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR | Prader-Willi Syndrome MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: D.3.2 Product code where applicable13: Product Code: [AZP-531] | Millendo Therapeutics SAS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 34 | EUCTR2018-003062-13-ES (EUCTR) | 20/03/2019 | 18/01/2019 | 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 INN or Proposed INN: Livoletide Product Name: Livoletide Product Code: AZP-531 INN or Proposed INN: Livoletide | Millendo Therapeutics SAS | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom | ||
| 35 | NCT03649477 (ClinicalTrials.gov) | November 20, 2018 | 24/8/2018 | 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: 3.2 mg intranasal carbetocin;Drug: 9.6 mg intranasal carbetocin;Drug: placebo | Levo Therapeutics, Inc. | NULL | Active, not recruiting | 7 Years | 18 Years | All | 130 | Phase 3 | United States;Australia;Canada |
| 36 | NCT03714373 (ClinicalTrials.gov) | October 1, 2018 | 27/9/2018 | 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. | NULL | Active, not recruiting | 4 Years | N/A | All | 105 | Phase 3 | United States;United Kingdom |
| 37 | NCT03458416 (ClinicalTrials.gov) | September 6, 2018 | 2/3/2018 | 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 | Benuvia Therapeutics Inc. | NULL | Terminated | 8 Years | 17 Years | All | 7 | Phase 2 | United States |
| 38 | NCT02844933 (ClinicalTrials.gov) | June 6, 2018 | 22/7/2016 | 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 | Benuvia Therapeutics Inc. | NULL | Terminated | 8 Years | 17 Years | All | 7 | Phase 2 | United States |
| 39 | NCT03440814 (ClinicalTrials.gov) | May 9, 2018 | 13/2/2018 | 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. | NULL | Completed | 4 Years | N/A | All | 127 | Phase 3 | United States;United Kingdom |
| 40 | NCT03554031 (ClinicalTrials.gov) | April 14, 2018 | 30/5/2018 | A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome | A Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Recombinant Human Growth Hormone (rhGH) Injection | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of Medicine | Unknown status | 1 Month | 5 Years | All | 30 | Phase 3 | China |
| 41 | NCT03197662 (ClinicalTrials.gov) | April 11, 2018 | 19/6/2017 | 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 | NULL | Recruiting | 5 Years | 17 Years | All | 50 | Phase 2 | United States |
| 42 | NCT03274856 (ClinicalTrials.gov) | February 20, 2018 | 5/9/2017 | 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. | NULL | Completed | 16 Years | 65 Years | All | 19 | Phase 2 | United States;Canada |
| 43 | NCT03548480 (ClinicalTrials.gov) | January 1, 2018 | 2/5/2018 | 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 | NULL | Completed | 2 Years | 19 Years | All | 39 | N/A | Spain |
| 44 | EUCTR2017-003423-30-NL (EUCTR) | 12/12/2017 | 04/10/2017 | 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 | Dutch Growth Research Foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 33 | Phase 2;Phase 3 | Netherlands | ||
| 45 | NCT03277157 (ClinicalTrials.gov) | December 8, 2017 | 7/9/2017 | 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 | Completed | 18 Years | 75 Years | All | 28 | N/A | United States |
| 46 | NCT03245762 (ClinicalTrials.gov) | August 1, 2017 | 7/8/2017 | 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 | Completed | N/A | 6 Months | All | 15 | Phase 1/Phase 2 | United States |
| 47 | EUCTR2017-002164-41-ES (EUCTR) | 03/07/2017 | 21/06/2017 | 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 INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Fundació Parc Taulí | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Spain | |||
| 48 | NCT02893618 (ClinicalTrials.gov) | July 2017 | 30/8/2016 | 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. | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 32 | Phase 2 | NULL |
| 49 | NCT03616509 (ClinicalTrials.gov) | June 19, 2017 | 27/7/2018 | 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 | Completed | 18 Years | N/A | All | 30 | Phase 4 | Spain |
| 50 | NCT03149445 (ClinicalTrials.gov) | March 30, 2017 | 3/4/2017 | 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 | NULL | Completed | 18 Years | 30 Years | All | 18 | Phase 2 | Czechia |
| 51 | EUCTR2016-003694-18-CZ (EUCTR) | 18/01/2017 | 04/10/2016 | 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 INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE Trade Name: Metoprololsuccinat ”Orion” 25mg INN or Proposed INN: metoprolol Other descriptive name: METOPROLOL SUCCINATE | Saniona A/S | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Hungary;Czech Republic | ||
| 52 | NCT03081832 (ClinicalTrials.gov) | January 2017 | 10/3/2017 | 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 | NULL | Completed | 3 Years | 4 Years | All | 34 | N/A | France |
| 53 | EUCTR2016-003820-22-NL (EUCTR) | 22/12/2016 | 12/10/2016 | 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 | Dutch Growth Research Foundation | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 54 | EUCTR2016-003694-18-HU (EUCTR) | 22/12/2016 | 13/10/2016 | 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 INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE Trade Name: Metoprololsuccinat Orion 25mg INN or Proposed INN: metoprolol Other descriptive name: METOPROLOL SUCCINATE | Saniona A/S | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary | ||
| 55 | NCT03114371 (ClinicalTrials.gov) | November 28, 2016 | 10/3/2017 | 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 | NULL | Completed | 3 Years | 12 Years | All | 40 | N/A | France |
| 56 | EUCTR2016-003273-18-FR (EUCTR) | 14/11/2016 | 22/08/2016 | 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 | University Hospital of Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France | ||
| 57 | NCT03031626 (ClinicalTrials.gov) | September 1, 2016 | 20/1/2017 | 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 | NULL | Recruiting | N/A | 2 Years | All | 10 | Phase 4 | Canada |
| 58 | EUCTR2015-000660-33-BE (EUCTR) | 21/03/2016 | 17/08/2015 | 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|EU | Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Subcutaneous Beloranib in Suspension Product Code: ZGN-440 INN or Proposed INN: Beloranib Other descriptive name: Beloranib | Zafgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 59 | EUCTR2014-004415-37-NL (EUCTR) | 07/03/2016 | 17/08/2015 | 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: 18.1;Level: PT;Classification code 10029883;Term: Obesity;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Saxenda INN or Proposed INN: LIRAGLUTIDE | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;United States;European Union;Canada;Turkey;Australia;Netherlands;Italy;New Zealand | ||
| 60 | EUCTR2014-004415-37-IT (EUCTR) | 10/11/2015 | 29/07/2015 | 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 INN or Proposed INN: LIRAGLUTIDE | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;United States;European Union;Canada;Turkey;Australia;Netherlands;New Zealand;Italy | ||
| 61 | NCT02527200 (ClinicalTrials.gov) | November 9, 2015 | 17/8/2015 | 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 | NULL | Completed | 6 Years | 18 Years | All | 56 | Phase 3 | United States;Australia;Canada;France;Italy;Netherlands;New Zealand;Turkey |
| 62 | EUCTR2015-000660-33-FR (EUCTR) | 29/10/2015 | 04/12/2015 | 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|EU | Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome MedDRA version: 18.1;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Subcutaneous Beloranib in Suspension Product Code: ZGN-440 INN or Proposed INN: Beloranib Other descriptive name: Beloranib | Zafgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 63 | EUCTR2014-001670-34-FR (EUCTR) | 01/10/2015 | 24/06/2015 | 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: 18.0;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: HLT;Classification code 10003022;Term: Appetite disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: AZP-531 Product Code: AZP-531 INN or Proposed INN: INN Not yet proposed | Alize Pharma | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Spain;Italy | ||
| 64 | NCT02629991 (ClinicalTrials.gov) | October 2015 | 18/10/2015 | 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 | Unknown status | 5 Years | 18 Years | All | 24 | Phase 2 | United States |
| 65 | EUCTR2015-000660-33-SE (EUCTR) | 30/09/2015 | 11/08/2015 | 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 INN or Proposed INN: Beloranib Other descriptive name: Beloranib | Zafgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 66 | EUCTR2014-001670-34-IT (EUCTR) | 31/08/2015 | 08/07/2015 | 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: 18.0;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: HLT;Classification code 10003022;Term: Appetite disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: AZP-531 Product Code: AZP-531 INN or Proposed INN: INN Not yet proposed | Alize Pharma | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Spain;Italy | ||
| 67 | EUCTR2015-000660-33-ES (EUCTR) | 12/08/2015 | 13/08/2015 | 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|EU | Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Subcutaneous Beloranib in Suspension Product Code: ZGN-440 INN or Proposed INN: Beloranib Other descriptive name: Beloranib | Zafgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 68 | NCT02013258 (ClinicalTrials.gov) | March 2015 | 11/12/2013 | 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) | Completed | 5 Years | 11 Years | All | 24 | Phase 1 | United States |
| 69 | NCT02311673 (ClinicalTrials.gov) | February 2015 | 25/11/2014 | 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. | NULL | Completed | 16 Years | 65 Years | All | 40 | Phase 2 | United States |
| 70 | EUCTR2014-001670-34-ES (EUCTR) | 26/01/2015 | 24/10/2014 | 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 INN or Proposed INN: INN Not yet proposed | Alize Pharma | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Spain;Italy | ||
| 71 | NCT02179151 (ClinicalTrials.gov) | September 2014 | 25/6/2014 | 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. | NULL | Terminated | 12 Years | 65 Years | All | 108 | Phase 3 | United States |
| 72 | NCT02205450 (ClinicalTrials.gov) | September 2014 | 30/7/2014 | 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 | NULL | Not yet recruiting | N/A | 2 Years | Both | 15 | N/A | Spain |
| 73 | EUCTR2013-004134-15-NL (EUCTR) | 15/07/2014 | 20/03/2014 | 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 | Dutch Growth Research Foundation | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 74 | NCT02204163 (ClinicalTrials.gov) | June 2014 | 25/7/2014 | 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 | NULL | Completed | N/A | N/A | All | 34 | Phase 3 | Korea, Republic of |
| 75 | NCT02804373 (ClinicalTrials.gov) | June 2014 | 10/7/2015 | 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 | NULL | Completed | 18 Years | 50 Years | All | 50 | Phase 2/Phase 3 | France |
| 76 | NCT02034071 (ClinicalTrials.gov) | April 2014 | 8/1/2014 | 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. | NULL | Completed | 10 Years | 22 Years | Both | 13 | Phase 1/Phase 2 | United States |
| 77 | EUCTR2013-004437-33-FR (EUCTR) | 18/03/2014 | 08/09/2015 | 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 | Centre Hospitalier de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 39 | Phase 3 | France | ||
| 78 | NCT02368379 (ClinicalTrials.gov) | March 2014 | 5/2/2015 | 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 | NULL | Completed | 2 Years | N/A | All | 23 | N/A | United States |
| 79 | NCT01968187 (ClinicalTrials.gov) | January 2014 | 9/10/2013 | 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 | NULL | Completed | 10 Years | 18 Years | Both | 38 | Phase 2 | United States | |
| 80 | NCT01818921 (ClinicalTrials.gov) | June 2013 | 21/3/2013 | 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. | NULL | Completed | 16 Years | 65 Years | Both | 17 | Phase 2 | United States |
| 81 | NCT02205034 (ClinicalTrials.gov) | May 2013 | 22/7/2014 | 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 | NULL | Completed | 1 Month | 5 Months | All | 18 | Phase 1/Phase 2 | France |
| 82 | NCT02810483 (ClinicalTrials.gov) | December 2012 | 17/5/2016 | 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 | NULL | Terminated | 12 Years | 45 Years | All | 69 | Phase 3 | France |
| 83 | EUCTR2011-001313-14-NL (EUCTR) | 17/10/2012 | 12/01/2012 | Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. | Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. - Young Adult Prader Willi study | Prader Willi Syndrome MedDRA version: 14.1;Level: LLT;Classification code 10041331;Term: Somatotrophin;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made. Product Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: growth hormone | Dutch growth research foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 84 | NCT01520467 (ClinicalTrials.gov) | April 2012 | 25/1/2012 | 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 | NULL | Active, not recruiting | 5 Years | 12 Years | Both | 27 | N/A | France |
| 85 | NCT01444898 (ClinicalTrials.gov) | March 2012 | 27/9/2011 | 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 | NULL | Completed | 13 Years | 20 Years | All | 10 | N/A | United States |
| 86 | NCT01542242 (ClinicalTrials.gov) | February 2012 | 21/2/2012 | Liraglutide Use in Prader-Willi Syndrome | Diabetes Mellitus Type 2;Prader Willi Syndrome | Drug: Liraglutide | Vancouver General Hospital | Novo Nordisk A/S | Terminated | 19 Years | N/A | Male | 1 | Phase 4 | Canada | |
| 87 | EUCTR2010-023179-25-GB (EUCTR) | 13/09/2011 | 27/07/2011 | 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) INN or Proposed INN: exenatide | Aintree University Hospital NHS Foundation Trust | UNIVERSITY OF LIVERPOOL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 88 | NCT01401244 (ClinicalTrials.gov) | July 14, 2011 | 20/7/2011 | 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 | NULL | Completed | 18 Years | 40 Years | All | 30 | Phase 1 | United States |
| 89 | NCT01548521 (ClinicalTrials.gov) | July 2011 | 30/12/2011 | 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 | NULL | Completed | N/A | 5 Months | All | 5 | Phase 1/Phase 2 | France |
| 90 | NCT01038570 (ClinicalTrials.gov) | June 2009 | 16/11/2009 | 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 | NULL | Completed | 18 Years | N/A | All | 24 | Phase 2 | France |
| 91 | NCT01298180 (ClinicalTrials.gov) | January 2009 | 6/11/2009 | 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 | NULL | Completed | 1 Year | 5 Years | All | 111 | Phase 4 | France |
| 92 | EUCTR2008-004612-12-FR (EUCTR) | 06/11/2008 | 14/11/2008 | 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 Trade Name: omnitrope Product Name: OMNITROPE | CHU TOULOUSE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 93 | NCT00705172 (ClinicalTrials.gov) | November 2008 | 24/6/2008 | 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 | NULL | Completed | N/A | 15 Years | Both | 41 | N/A | Denmark;Germany;Switzerland |
| 94 | EUCTR2007-004716-31-NL (EUCTR) | 05/03/2008 | 06/11/2007 | 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 | Dutch Growth Foundation | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 95 | EUCTR2007-006305-25-SE (EUCTR) | 15/02/2008 | 03/01/2008 | 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;Classification code 10029883;Term: Obesity | Trade Name: ACOMPLIA 20 mg film-coated tablets | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 96 | NCT00551343 (ClinicalTrials.gov) | October 2007 | 29/10/2007 | 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 | NULL | Completed | 18 Years | 45 Years | All | 20 | N/A | Australia |
| 97 | NCT00603109 (ClinicalTrials.gov) | August 2007 | 15/1/2008 | 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 |
| 98 | EUCTR2007-000469-39-FI (EUCTR) | 02/05/2007 | 12/02/2007 | 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 | Oy Eli Lilly Finland Ab | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Finland | |||
| 99 | NCT00399893 (ClinicalTrials.gov) | December 2006 | 14/11/2006 | 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 | Terminated | 5 Years | 21 Years | All | 5 | N/A | United States |
| 100 | NCT01613495 (ClinicalTrials.gov) | August 2005 | 13/4/2011 | 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 | NULL | Active, not recruiting | 18 Years | N/A | Male | 2 | N/A | NULL |
| 101 | NCT00372125 (ClinicalTrials.gov) | April 2005 | 5/9/2006 | 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 | Completed | 18 Years | 50 Years | Both | 46 | N/A | Denmark;Norway;Sweden |
| 102 | NCT00444964 (ClinicalTrials.gov) | April 2005 | 6/3/2007 | 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 | NULL | Recruiting | 16 Years | 60 Years | Both | 10 | Phase 3 | United States |
| 103 | NCT00175305 (ClinicalTrials.gov) | August 2004 | 9/9/2005 | 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 | NULL | Terminated | 10 Years | 17 Years | Both | 10 | Phase 3 | Canada |
| 104 | NCT00065923 (ClinicalTrials.gov) | July 2002 | 1/8/2003 | 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) | NULL | Completed | 18 Years | 66 Years | Both | 10 | N/A | United States |
| 105 | EUCTR2010-022370-14-FR (EUCTR) | 15/11/2010 | 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 | Centre Hospitalier de Toulouse | NULL | NA | Female: yes Male: yes | Phase 2 | France | ||||
| 106 | EUCTR2021-000094-91-FR (EUCTR) | 01/04/2021 | EFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA IN CHILDREN AND ADOLESCENTS WITH PRADER WILLI SYNDROME | EFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA RELATED TO OROPHARYNGO-OESOPHAGEAL DYSMOTILITY TRANSIT IN CHILDREN AND ADOLESCENTS WITH PRADER-WILLI SYNDROME: A PHASE 3 STUDY (DYSMOT) - DYSMOT | Prader-Willi Syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: OXYTOCIN Product Code: H01BB02 | Toulouse University Hospital | NULL | NA | Female: yes Male: yes | 36 | Phase 3 | France | |||
| 107 | EUCTR2020-006161-11-FR (EUCTR) | 21/04/2021 | FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIAL | LONG -TERM INTERVENTIONAL FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIAL AND COMPARISON WITH AN UNTREATED COHORT OF CHILDREN WITH PRADER-WILLI SYNDROME - OTBB3 Follow-Up | Prader-willi syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: oxytocin | Toulouse University Hospital | NULL | NA | Female: yes Male: yes | 80 | Phase 3 | France | |||
| 108 | EUCTR2019-002385-12-BE (EUCTR) | 06/03/2020 | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 | Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Oxytocin INN or Proposed INN: OXYTOCIN Other descriptive name: OXYTOCIN | University Hospital of Toulouse | NULL | NA | Female: yes Male: yes | 48 | Phase 3 | France;Belgium | |||
| 109 | EUCTR2014-004415-37-FR (EUCTR) | 04/08/2015 | 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 INN or Proposed INN: LIRAGLUTIDE | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;France;European Union;Canada;Turkey;Australia;Netherlands;Italy;New Zealand | |||
| 110 | EUCTR2019-002385-12-IT (EUCTR) | 04/06/2021 | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME | OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3 | Prader-Willi Syndrom;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Oxytocin Product Code: [H01BB02] INN or Proposed INN: OSSITOCINA Other descriptive name: Oxytocin | University Hospital Toulouse | NULL | NA | Female: yes Male: yes | 48 | Phase 3 | France;Belgium;Netherlands;Germany;Italy | |||
| 111 | EUCTR2011-003432-32-FR (EUCTR) | 13/10/2011 | N/A | N/A - TOPRADER | MedDRA version: 14.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Trade Name: Topiramate Product Name: Topiramate INN or Proposed INN: topiramate | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France |