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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To describe early MSA disease progression changes in 6-month intervals over 12-months (i.e., baseline, 6-months, 12-months)
Timeframe: baseline, 6 months, 12 months
Changes from baseline to approx. 6-months after baseline and approx.12- months after baseline in plasma NfL concentrations.
Timeframe: baseline, 6 months, 12 months
Percentage change in brain volume in brain regions-of-interest (ROIs), as measured by volumetric MRI (vMRI).
Timeframe: baseline, 6 months, 12 months
Percentage change in tissue integrity in ROIs, as measured by diffusion-tensor imaging (DTI) MRI.
Timeframe: baseline, 6 months, 12 months