Observational Study in Multiple System Atrophy (NCT05453058) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study in Multiple System Atrophy
China90 participantsStarted 2022-06-25
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
Percentage change in brain volume in brain regions-of-interest (ROIs), as measured by volumetric MRI (vMRI).
Timeframe: baseline, 6 months, 12 months
4
Percentage change in tissue integrity in ROIs, as measured by diffusion-tensor imaging (DTI) MRI.
. 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.
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.