研究单位：[1]H. Lundbeck A/S[2]Beijing Tiantan Hospital, Capital Medical University,Beijing,China,100050[3]Beijing Xuanwu Hospital, Capital Medical University,Beijing,China,100053[4]Beijing Hospital,Beijing,China,100730[5]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences,Beijing,China,100730[6]Xiangya Hospital of Central South University,Changsha,China,410008[7]West China Hospital of Sichuan University,Chengdu,China,610041[8]Ruijin Hospital of Shanghai Jiaotong University School of Medicine,Shanghai,China,200025[9]Huashan Hospital of Fudan University,Shanghai,China,200040[10]The Second Affiliated Hospital of Soochow University,Suzhou,China,215004[11]Hopital Pellegrin,Bourdeaux,France,33076[12]Hôpital Neurologique - HCL,Bron Cedex,France,69677[13]Pitié-Salpêtrière hospital,Paris,France,75013[14]Hôpitaux Universitaires de Strasbourg,Strasbourg,France,67098[15]Chu Toulouse,Toulouse,France,31093[16]TU Dresden,Dresden,Germany,01307[17]UKSH, Campus Kiel,Kiel,Germany,24105[18]IRCCS IStituto delle Scienze Neurologiche di Bologna,Bologna,Italy,40139[19]Fondazione IRCCS Ca' Granda Ospedale Maggiore,Milano,Italy,20122
研究目的：
Talisman is global clinical study (20058N) in Multiple System Atrophy (MSA) patients. It will be conducted in two regions (China and the European Union [EU]). There will be common study objectives between China and EU regions (including prospective assessments for MSA disease progression during routine clinical visits for MSA), and this will allow for data (on common objectives) to be presented overall and stratified by region. There will also be study objectives specific to each region: 1) the clinical assessment for MSA (Unified MSA Rating Scale [UMSARS]) has not been validated using standardised methods in China, and so the psychometric properties of the Chinese version of the UMSARS will be examined in Chinese patients in this study; 2) there will be retrospective assessments and prospective protocol-mandated assessments (of Magnetic Resonance Imaging [MRI] and bloods biomarkers) and study visits for EU patients. Because some study objectives are the same for China and the EU (i.e., prospective assessments during routine clinical visits for MSA), and other objectives are specific to each region, there will be one regional protocol for China and one regional protocol for the EU; each describing the study assessments relevant to each region.
