Observational Study in Multiple System Atrophy

NCT05453058 | Active Not Recruiting

• 1 other identifier: 20058N
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Multiple System Atrophy

Outcome Measures

Primary Outcomes (4)

• 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

  baseline, 6 months, 12 months

• Changes from baseline to approx. 6-months after baseline and approx.12- months after baseline in plasma NfL concentrations.

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

Secondary Outcomes (11)

• 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

  baseline, 6 months, 12 months

• 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

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

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

  baseline, 6 months, 12 months

• 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

  baseline, 6 months, 12 months

Study Arms (1)

Patients diagnosed with possible or probable MSA

This 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.

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

Interventions

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

Patients diagnosed with possible or probable MSA

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (8)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100050, China

Location

Beijing Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, 100730, China

Location

Xiangya Hospital of Central South University

Changsha, 410008, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

Huashan Hospital of Fudan University

Shanghai, 200040, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, 215004, China

Location

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 12, 2022
• Study Start: June 25, 2022
• Primary Completion: March 12, 2024
• Study Completion (Estimated): May 30, 2031
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (8)