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NCT05453058

Observational Study in Multiple System Atrophy

Sponsor: H. Lundbeck A/S

View on ClinicalTrials.gov

Summary

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.

Official title: TALISMAN - Tracking Longitudinal Changes in MSA - International Natural History Study

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

90

Start Date

2022-06-25

Completion Date

2031-05-30

Last Updated

2025-12-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort

Biomarker assessments are mandated in this protocol (i.e., they are not expected to be done as part of routine clinical practice). These assessments will be conducted within the same time window as the observational assessments (at approx. 6-month intervals) and are mandated by protocol if not conducted as per clinical practice.

Locations (8)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Beijing Xuanwu Hospital, Capital Medical University

Beijing, China

Beijing Hospital

Beijing, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Xiangya Hospital of Central South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Huashan Hospital of Fudan University

Shanghai, China

The Second Affiliated Hospital of Soochow University

Suzhou, China