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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 6 | 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 | ||
| 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 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |