TRACK-MSA: A Longitudinal Study to Define Outcome Measures in Multiple

Status Active, not recruiting

Clinical Trial Summary

TRACK-MSA is an observational, non-interventional, longitudinal natural history study to define changes in clinical, neurological, blood, CSF, and neuroimaging biomarkers in patients with multiple system atrophy (MSA) comparing baseline to 6-month and 1-year assessments. The study will enroll 50 patients with MSA-P or MSA-C at 2 or more participating sites.

Clinical Trial Description

TRACK-MSA is designed to relate phenotypic characteristics of participants with MSA using several modalities (i.e., clinical, quantitative motor, imaging, laboratory) in order to relate phenotypic characteristics with data derived from the study of blood and CSF ("wet biomarkers") and imaging or wearables ("dry biomarkers"). It is possible that the cohort enrolled in this study will, after study completion, be recruited into the earliest multicenter biomarker-driven clinical trials of disease modifying agents for MSA. As such, the data collected in the TRACK-MSA study could constitute a valuable observational non-interventional arm of potential disease-modifying treatments. The objective of the study will therefore be to determine the combination of measures that most sensitively detects changes over the natural course of MSA, with a goal of validating these measures for use in future clinical trials. TRACK-MSA will be a 1-year observational, longitudinal, non-interventional natural history study of patients with MSA. The study will be carried out at least at 2 sites (NYU being the primary site). All participants will be assessed at baseline, 6-month and 1-year visits. Participants will undergo clinical, neurological, quantitative motor, MRI assessments, in addition to donating blood and CSF samples at some or all of the visits. For a given participant, the same investigator should carry out the clinical assessment throughout the study where possible. It is anticipated that the study will complete enrollment in 2 years since startup, and complete all the follow-up evaluations within 3 years from startup. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04450992
Study type	Observational
Source	NYU Langone Health
Contact
Status	Active, not recruiting
Phase
Start date	June 17, 2020
Completion date	July 1, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TRACK-MSA: A Longitudinal Study to Define Outcome Measures in Multiple System Atrophy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms