193. Prader-Willi syndrome Clinical trials / Disease details
Clinical trials : 111 / Drugs : 120 - (DrugBank : 30) / Drug target genes : 51 - Drug target pathways : 103
| 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 | Authorised-recruitment may be ongoing or finished | 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 | Recruiting | 13 Years | 65 Years | All | 120 | Phase 2 | United States |