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

  
15 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04768803
(ClinicalTrials.gov)
March 15, 202116/2/2021Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or ObesityCirculating Levels of Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and / or Overweight, and / or ObesityAngelman Syndrome;Smith-Magenis Syndrome;X Fragile Syndrome;Epilepsy;Prader-Willi SyndromeBiological: acylated and unacylated ghrelin dosagesUniversity Hospital, ToulouseNULLNot yet recruiting3 Years50 YearsAll300NULL
2EUCTR2018-003062-13-FR
(EUCTR)
25/02/202021/11/2018A 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
3EUCTR2018-003062-13-GB
(EUCTR)
11/07/201906/12/2018A 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
4EUCTR2018-003062-13-NL
(EUCTR)
10/07/201909/04/2019A 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
5EUCTR2018-003062-13-BE
(EUCTR)
07/06/201925/03/2019A 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Spain;Belgium;Australia;Netherlands;United Kingdom
6NCT03790865
(ClinicalTrials.gov)
March 25, 201928/12/2018Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi SyndromeA 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 SyndromePrader-Willi Syndrome;HyperphagiaDrug: Livoletide;Drug: PlaceboMillendo Therapeutics SASNULLTerminated4 Years65 YearsAll158Phase 2/Phase 3United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom
7EUCTR2018-003062-13-ES
(EUCTR)
20/03/201918/01/2019A 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom
8EUCTR2018-003062-13-IT
(EUCTR)
20/03/201907/10/2020A 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 SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
9EUCTR2014-001670-34-FR
(EUCTR)
01/10/201524/06/2015A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
10EUCTR2014-001670-34-IT
(EUCTR)
31/08/201508/07/2015A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
11EUCTR2014-001670-34-ES
(EUCTR)
26/01/201524/10/2014A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
12EUCTR2010-023179-25-GB
(EUCTR)
13/09/201127/07/2011Effects of exenatide on appetite and ghrelin levels in patients with Prader-Willi Syndrome - Effects of exenatide on appetite and ghrelin in Prader-Willi SyndromeEffects 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 TrustUNIVERSITY OF LIVERPOOLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
13NCT00399893
(ClinicalTrials.gov)
December 200614/11/2006Octreotide 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-studyPrader-Willi SyndromeDrug: Octreotide;Drug: PlaceboDuke UniversityNational Institutes of Health (NIH);National Center for Research Resources (NCRR);NovartisTerminated5 Years21 YearsAll5N/AUnited States
14NCT01613495
(ClinicalTrials.gov)
August 200513/4/2011Ghrelin Suppression by Octreotide in Prader-WilliGhrelin Suppression by Sandostatin LAR® Depot (Octreotide Acetate for Injectable Suspension) in Patients With Prader-Willi SyndromePrader Willis SyndromeDrug: Placebo;Drug: OctreotideOregon Health and Science UniversityNULLActive, not recruiting18 YearsN/AMale2N/ANULL
15NCT00175305
(ClinicalTrials.gov)
August 20049/9/2005Prader-Willi Syndrome and AppetiteEffect of Somatostatin on Ghrelin Concentrations, Food Seeking Behaviour and Weight in Patients With Prader-Willi SyndromeHyperphagia;Prader-Willi SyndromeDrug: Sandostatin LARUniversity of British ColumbiaNULLTerminated10 Years17 YearsBoth10Phase 3Canada