193. Prader-Willi syndrome Clinical trials / Disease details
Clinical trials : 113 / Drugs : 111 - (DrugBank : 26) / Drug target genes : 48 - Drug target pathways : 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 | 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 | |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||||
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |