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NCT06282081Active, not recruiting

Serum Neurofilament Light in Multiple Sclerosis

Serum Neurofilament Light As a Clinical Tool in Relapsing Remitting Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 14 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
42 (estimated)
First submitted
2 Feb 2024
Start date
9 Apr 2024
Primary completion date
1 Mar 2026
Lead sponsor
Dent Neuroscience Research Center
NCT number
NCT06282081

What you commit to

  • Study type: Observational
  • Planned participants: 42
  • From 9 Apr 2024 to the primary completion date, 1 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)
  • Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator

Other

  • Inability to complete blood draws
  • Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dent Neurologic Institute
Coordinator of this site? Confirm its status
AmherstUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.