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 | 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 |
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 | |||
| 12 | 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 | ||||
| 13 | 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 | |||
| 14 | 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 |