193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details
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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | NCT02179151 (ClinicalTrials.gov) | September 2014 | 25/6/2014 | Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome | Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months | Prader-Willi Syndrome;Obesity | Drug: ZGN-440 for Injectable Suspension;Drug: ZGN-440 Placebo for Injectable Suspension | Zafgen, Inc. | NULL | Terminated | 12 Years | 65 Years | All | 108 | Phase 3 | United States |
| 6 | NCT01818921 (ClinicalTrials.gov) | June 2013 | 21/3/2013 | An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome | Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension | Obesity;Over-weight;Prader-Willi Syndrome | Drug: ZGN-440 sterile diluent;Drug: 1.2 mg ZGN-440 for injectable suspension;Drug: 1.8 mg ZGN-440 for injectable suspension | Zafgen, Inc. | NULL | Completed | 16 Years | 65 Years | Both | 17 | Phase 2 | United States |