TESOFENSINE ( DrugBank: Tesofensine )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 1 |
| 193 | プラダー・ウィリ症候群 | 4 |
6. パーキンソン病
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| 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 | NCT00148512 (ClinicalTrials.gov) | March 2003 | 7/9/2005 | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations | A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS) | Parkinson Disease | Drug: 1. Tesofensine (NS 2330) | Boehringer Ingelheim | NULL | Completed | 42 Years | 80 Years | Both | 254 | Phase 2 | Austria;France;Germany;Netherlands;Spain;United Kingdom;El Salvador |
193. プラダー・ウィリ症候群
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
| 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 | NCT03149445 (ClinicalTrials.gov) | March 30, 2017 | 3/4/2017 | Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) | A Double-blind, Randomized, Placebo-controlled, Multiple-dose, Multi-centre Safety and Efficacy Study of Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) | Confirmed Genetic Diagnosis of Prader-Willi Syndrome | Drug: Tesofensine/Metoprolol;Drug: Placebos | Saniona | NULL | Completed | 18 Years | 30 Years | All | 18 | Phase 2 | Czechia |
| 3 | EUCTR2016-003694-18-CZ (EUCTR) | 18/01/2017 | 04/10/2016 | Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome | A double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) Second 12 weeks open label extension | Prader Willi syndrome (PWS) 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: Tesofensine INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE Trade Name: Metoprololsuccinat ”Orion” 25mg INN or Proposed INN: metoprolol Other descriptive name: METOPROLOL SUCCINATE | Saniona A/S | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Hungary;Czech Republic | ||
| 4 | EUCTR2016-003694-18-HU (EUCTR) | 22/12/2016 | 13/10/2016 | Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndrome | A double-blind, randomized, placebo-controlled, multiple-dose, multi-centre safety and efficacy study of co-administration of tesofensine/metoprolol in subjects with Prader-Willi syndrome (PWS) A 12 weeks open label extension | Prader Willi syndrome (PWS) 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: Tesofensine INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE INN or Proposed INN: Tesofensine Other descriptive name: TESOFENSINE Trade Name: Metoprololsuccinat Orion 25mg INN or Proposed INN: metoprolol Other descriptive name: METOPROLOL SUCCINATE | Saniona A/S | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary |