Serum Neurofilament Light in Multiple Sclerosis

Running, not enrolling

Conditions studied: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis

In brief

This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy.

Key facts

Study ID

NCT06282081

Run by

Dent Neuroscience Research Center

People needed

42

Starts

2024-04-09

Expected to finish

2027-03-01

Last updated by the study team

2025-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with RRMS
• Adults aged 18+ at time of screening
• Patients who are able to consent
• Patients who agree to be reasonably compliant with study protocol for the duration of the study
• Any subject who is currently being treated with an MS DMT or any subject initiating a new MS DMT throughout the duration of their participation in the study will be initiated and/or treated according to local label

You may not qualify if…

• Patients with current diagnosis of a neurodegenerative or autoimmune disease other than MS that may impact sNfL levels, in the opinion of the investigator (including but not limited to: Alzheimer's disease, Huntington's disease, Amyotrophic Lateral Sclerosis, or Parkinson's disease, systemic lupus erythematosus, rheumatoid arthritis)
• Inability to complete blood draws
• Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study
• Patients who have taken an investigational medication within five half-lives prior to screening or who plan to take an investigational medication during the study
• Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator

Where it is running

• Dent Neurologic Institute — Amherst, New York, United States

Full record on ClinicalTrials.gov

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