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 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00148512
(ClinicalTrials.gov)
March 20037/9/2005A 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 FluctuationsA 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 DiseaseDrug: 1. Tesofensine (NS 2330)Boehringer IngelheimNULLCompleted42 Years80 YearsBoth254Phase 2Austria;France;Germany;Netherlands;Spain;United Kingdom;El Salvador

193. プラダー・ウィリ症候群


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000127-12-SE
(EUCTR)
03/01/202208/11/2021A 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 extensionA 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/SNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Spain;Belgium;Ireland;Australia;United Kingdom;New Zealand;Italy;Sweden
2NCT03149445
(ClinicalTrials.gov)
March 30, 20173/4/2017Co-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 SyndromeDrug: Tesofensine/Metoprolol;Drug: PlacebosSanionaNULLCompleted18 Years30 YearsAll18Phase 2Czechia
3EUCTR2016-003694-18-CZ
(EUCTR)
18/01/201704/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA 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/SNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Hungary;Czech Republic
4EUCTR2016-003694-18-HU
(EUCTR)
22/12/201613/10/2016Safety and efficacy of tesofensine/metoprolol in subjects with Prader-Willi syndromeA 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/SNULLNot 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): noCzech Republic;Hungary