Observational Study in Multiple System Atrophy
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- The patient must be aged between ≥40 and ≤75 years, at baseline.
- The patient must be diagnosed with possible or probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C), according to the Gilman criteria (version 2).
- The patient must have an anticipated survival of at least 3 years in the opinion of the study investigator, at baseline.
- The patient had onset of motor MSA symptoms within 5 years prior to the baseline visit in the judgement of the study investigator.
- The patient must have an UMSARS Part I score of ≤16 (omitting question 11 on sexual function), at baseline.
- The patient must have normal cognition (i.e., Montreal Cognitive Assessment [MoCA] score ≥22), at baseline.
- The patient's caregiver must have approximately 3 hours per week contact with the patient and be available and able to accompany the patient to routine clinical visits throughout the study, to provide information on the patient's functional abilities.
- The patient/patient's legally acceptable representative, and the patient's caregiver are willing to provide written voluntary informed consent.
- The patient's treatments are prescribed according to routine clinical practice and local guidelines/regulations.
EXCLUSION CRITERIA
Exclusion criteria:
- The patient has evidence (clinical or on MRI) and/or history of any serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a diagnosis other than MSA.
- The patient has two or more blood relatives with a history of MSA.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol.
- The patient has previously been enroled in this study.
- The patient is a member of the study personnel or of their immediate family or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Multiple System Atrophy
Age (in years)
40 - 75
Participants needed
90
Est. Completion Date
May 30, 2031
Treatment type
OBSERVATIONAL
Sponsor
H. Lundbeck A/S
ClinicalTrials.gov identifier
NCT05453058
Study number
20058N
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?