OT ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 193 | プラダー・ウィリ症候群 | 27 |
193. プラダー・ウィリ症候群
臨床試験数 : 113 / 薬物数 : 111 - (DrugBank : 26) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 102
| 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 | 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 | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden | ||
| 2 | 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 | Withdrawn | 13 Years | 65 Years | All | 0 | Phase 2 | United States |
| 3 | 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 |
| 4 | 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 | ||
| 5 | 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 | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | France;Belgium;Netherlands;Germany;Italy | ||
| 6 | NCT05657860 (ClinicalTrials.gov) | December 17, 2020 | 12/12/2022 | Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome | A Double Blind, Placebo Controlled, Fixed-Flexible Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome | Prader-Willi Syndrome;Aggression;Self-Injurious Behavior;Pathologic Processes;Behavioral Symptoms;Intellectual Disability;Neurobehavioral Manifestations;Neurologic Manifestations;Nervous System Diseases;Abnormalities, Multiple;Congenital Abnormalities;Chromosome Disorders;Genetic Diseases, Inborn;Obesity;Overnutrition;Nutrition Disorders;Antihypertensive Agents;Neurotransmitter Agents;Molecular Mechanisms of Pharmacological Action;Physiological Effects of Drugs;Skin-Picking | Drug: Guanfacine Extended Release;Other: Placebo | Maimonides Medical Center | NULL | Recruiting | 6 Years | 35 Years | All | 33 | Phase 4 | United States |
| 7 | 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 | Completed | N/A | 92 Days | All | 52 | Phase 3 | France |
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | France;Belgium;Germany;Netherlands;Italy | ||
| 11 | 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 | ||
| 12 | 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 | |||
| 13 | 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 | ||
| 14 | 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 |
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 | ||||
| 22 | 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 |
| 23 | 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 | ||||
| 24 | 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 | |||
| 25 | EUCTR2012-005325-67-FR (EUCTR) | 25/05/2022 | 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 - OTBB2 | Prader Willi Syndrom 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 | Centre Hospitalier de Toulouse | NULL | NA | Female: yes Male: yes | 18 | Phase 2 | France | |||
| 26 | 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 | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | France;Belgium;Germany;Netherlands;Italy | |||
| 27 | 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 |