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Observational Study in Multiple System Atrophy

Study acronym: TALISMAN
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Completed to Active, Not Recruiting Completion date: Mar 12, 2024 to May 30, 2031 · Secondary endpoints: 10 to 11 · Study description expanded, about 54 wordsv6 Show 3 more changesShow less
    • Completion date: Mar 12, 2024 to May 30, 2031
    • Secondary endpoints: 10 to 11
    • Study description expanded, about 54 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Active, Not Recruiting to Completed Primary and study completion dates changed from estimate of May 5, 2024 to Mar 12, 2024v5 Show 1 more changeShow less
    • Primary and study completion dates changed from estimate of May 5, 2024 to Mar 12, 2024
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 140 to confirmed 90 · Study sites: 18 to 8v4 Show 2 more changesShow less
    • Enrollment target: estimated 140 to confirmed 90
    • Study sites: 18 to 8
  4. Study sites: 9 to 18v3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 5, 2022 to Jun 25, 2022 · Site details revised at 9 of 9 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 5, 2022 to Jun 25, 2022
    • Site details revised at 9 of 9 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
H. Lundbeck A/S
20 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT05453058
Lead Sponsor H. Lundbeck A/S
Conditions Multiple System Atrophy
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov