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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 |
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 |
| 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 | 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 | |||
| 10 | 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 |
| 11 | 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 | ||
| 12 | 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 |
| 13 | 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 |
| 14 | 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 | |||
| 15 | 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 |
| 16 | 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 |
| 17 | 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 |
| 18 | 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 |
| 19 | 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 | |||
| 20 | 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 | |||
| 21 | 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 | |||
| 22 | 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 |