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Multiple System AtrophyTALISMANNCT05453058

Observational Study in Multiple System Atrophy

An observational study of Multiple System Atrophy, run by H. Lundbeck A/S at 8 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Multiple System Atrophy
What is being tested?
plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort
How many people
90 participants
Where
8 sitesChina
Study dates
25 Jun 2022to 30 May 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Approximately 140 patients with relatively early MSA from China and EU are expected to be enroled in this study during a 9-month enrolment.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100050

  • Beijing Xuanwu Hospital, Capital Medical University

    Beijing, 100053

  • Beijing Hospital

    Beijing, 100730

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, 100730

  • Xiangya Hospital of Central South University

    Changsha, 410008

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Huashan Hospital of Fudan University

    Shanghai, 200040

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

Other trials in China

About this study

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

Read the detailed description

Multiple system atrophy (MSA) is a sporadic, rapidly progressing neurodegenerative disorder. Most MSA patients are diagnosed between 50 to 60 years of age and the mean survival time is 6 to 10 years from symptom onset, with few surviving more than 15 years from symptom onset. The rapid progression and complexity of the disease, as well as its unresponsiveness to drugs, such as Levodopa for parkinsonian symptoms, makes MSA a challenging disease to treat. Based on the predominant motor features at the time of clinical evaluation, MSA is classified as either MSA with predominant parkinsonism (MSA-P) or MSA with predominant cerebellar ataxia (MSA-C).

MSA is an orphan and rare disease. The prevalence estimate of MSA is 3 to 5 per 100,000 in the general population. The prevalence estimate ranges from 2 to 5 per 100,000 in the United States and European Union (EU) and from 7 to 20 per 100,000 in Japan. MSA-P comprises approximately 70% of cases in the US and EU, whilst MSA-C comprises approximately 70% of cases in Japan.

Blood and MRI biomarkers have been evaluated in MSA patients. NfL (Neurofilament light protein) levels are increased in the cerebrospinal fluid (CSF) and plasma of patients with MSA and correlate with MSA disease severity, as measured by the unified MSA rating scale (UMSARS). An accurate estimate of NfL levels over time could help monitor MSA prognosis and help define the timepoints that could be targeted for effective treatment.

Furthermore, MSA patients with abnormal brain MRI findings have faster clinical progression of MSA, as evaluated with the UMSARS total score and UMSARS Part II (clinical examination). A recent review on the role of MRI in MSA noted that whilst MRI is a promising tool for diagnosing and monitoring disease progression; well-designed, large, prospective studies are needed before MRI biomarkers could be incorporated into a neuroimaging-supported diagnosis of MSA. The knowledge gained from this study should help improve understanding of biomarkers and other disease progression outcomes in MSA. This could allow MSA disease progression to be monitored and therefore treated more effectively. Insights into the natural course of disease in MSA patients in the EU will be combined and compared with data on the natural course of disease in MSA patients in China, as part of a larger global cohort. Specifically, the natural course of MSA will be explored in patients in China (using [Chinese versions of] the same prospective observational assessments as the current prospective protocol in the EU). This will allow for data collected prospectively during routine visits for MSA in China to be combined and compared with data collected prospectively during routine visits for MSA in the EU.

The extension part of Talisman:

The extension of Talisman will describe early MSA disease progression and mortality assessed remotely via telephone call with either the participant or care-partner in 6-month intervals up until 60 months after enrolling in extension study. The long-term extension will generate knowledge on long-term disease progression and survival in MSA.

Being tested
plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort
Medical subject headings
Multiple System Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT05453058
Study groupRoleWhat they receive
Patients diagnosed with possible or probable MSAThis protocol does not mandate the use of any treatments. No study medication will be administered as part of study participation. Any treatment that study patients receive will be prescribed according to the recommendations given in the local SmPCs.
Receives: Diagnostic Test: plasma NfL and brain MRI (vMRI, DTI, and ASL [if feasible]) only for the EU cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To describe early MSA disease progression changes in 6-month intervals over 12-months (i.e., baseline, 6-months, 12-months)

    Disease progression will be assessed using the Unified MSA Rating Scale (UMSARS) Part I and II (scores ranging from 0-104); higher scores indicate greater impairment

    Measured: 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.

    Measured: baseline, 6 months, 12 months

  3. Percentage change in brain volume in brain regions-of-interest (ROIs), as measured by volumetric MRI (vMRI).

    Measured: baseline, 6 months, 12 months

  4. Percentage change in tissue integrity in ROIs, as measured by diffusion-tensor imaging (DTI) MRI.

    Measured: baseline, 6 months, 12 months

Secondary outcomes (11)

  1. To evaluate changes from baseline on the impact of disease progression on the quality of life (QoL) of the patient at 6 and 12 months

    Patient QoL will be measured by the European Quality of Life Five Dimensions questionnaire 5 level version (EQ-5D-5L)

    Measured: baseline, 6 months, 12 months

  2. To evaluate changes from baseline on the impact of disease progression on the quality of life (QoL) of the caregiver at 6 and 12 months

    Caregiver QoL will be measured by the Parkinsonism Carers Quality of Life scale (PQoLCarers) (score range 0-104); higher score indicate worse QoL

    Measured: baseline, 6 months, 12 months

  3. To assess changes on the burden of orthostatic hypotension at 6 and 12 months from baseline

    Othostatic hypertension will be measured by the Orthostatic Hypotension Questionnaire (OHQ) (scores ranging from 0-100); higher scores indicate greater impairment

    Measured: baseline, 6 months, 12 months

  4. To describe occurrence of MSA subtypes and disease progression in each MSA subtype

    MSA subtype (i.e., MSA-P vs MSA-C) at each study site; disease progression will be measured by UMSARS

    Measured: baseline, 6 months, 12 months

  5. To assess the prevalence of "responders to Levodopa" (as per clinical judgement) at baseline and who continue to respond at 6 and 12 months from baseline

    Measured: baseline, 6 months, 12 months

  6. To describe Levodopa dose modifications from baseline to 6 and 12 months

    Measured: baseline, 6 months, 12 months

  7. To describe patient characteristics of responders to Levodopa versus non-responders to Levodopa, including: age (in years) at MSA onset, sex (male, female), MSA diagnosis (probable versus possible), MSA subtype (MSA-P versus MSA-C).

    Measured: baseline, 6 months, 12 months

  8. To characterise MSA symptoms and their progression over time

    MSA symptoms as per the following single items in UMSARS Part I (historical review):

    • Urinary incontinence (item 10)
    • Falling (item 8)
    • Speech (item 1)
    • Swallowing (item 2)
    • Walking (item 7)

    Measured: baseline, 6 months, 12 months

  9. To assess the psychometric properties of the Chinese version of UMSARS.

    To test the reliability and validity of the Chinese version of the UMSARS

    Measured: baseline, 6 months, 12 months

  10. To confirm the psychometric properties of the UMSARS

    To confirm the reliability and validity of the UMSARS Evaluation of UMSARS equivalence using Retrospective and Prospective Cohort data

    Measured: baseline, 6 months, 12 months

  11. To describe early MSA disease progression and mortality assessed remotely in 6-month intervals up until 60 months after enrolling in extension study.

    Disease progression in the extension will be assessed using:

    • UMSARS Part I
    • Mortality (date and cause of death)

    Measured: 6-month intervals up until 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start25 Jun 2022
  3. Primary completion12 Mar 2024
  4. Study completion30 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05453058
Sponsor's protocol ID
20058N
Acronym
TALISMAN
Status last verified
Dec 2025
First submitted
16 Jun 2022
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Feng T, Wang H, Wang J, Tang B, Liu CF, Chen H, Mao W, Zhou Q, Rascol O, Meissner WG, Bidani A, Rieckmann A, Astrom DO, Chan P, Shang H, Cui L. Natural history and 12-month progression of multiple system atrophy in a Chinese cohort. BMC Neurol. 2026 Jun 12;26(1):487. doi: 10.1186/s12883-026-05037-7.

    PubMed 42286509

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple System Atrophy, run by H. Lundbeck A/S at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To describe early MSA disease progression changes in 6-month intervals over 12-months (i.e., baseline, 6-months, 12-months) (time frame: baseline, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05453058, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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