Clinical trial Recruiting at 1 site Observational Ages 18 and up

Spinal fluid immunoglobulin free light chains to predict multiple sclerosis course

Official title: Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis

Run by Brugmann University Hospital · NCT05072691 · Data updated 2026-11-12

This will test whether measuring immunoglobulin free light chains in spinal fluid can help predict future disease course in adults with multiple sclerosis or optic neuritis.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorBrugmann University Hospital
Academic / other
Locations1 site (Brussels)
StatusRecruiting
StartedJuly 14, 2020
Main results expectedJanuary 1, 2030
Study endsJanuary 1, 2030
Registry record updatedOctober 6, 2025
Trial IDNCT05072691 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with multiple sclerosis according to the 2017 McDonald criteria or with optic neuritis who are undergoing lumbar puncture and brain MRI as part of their diagnostic work-up are ideal candidates.

Probably not a fit

Patients who do not undergo lumbar puncture, lack follow-up clinical or MRI data, or have alternative neurological diagnoses are unlikely to benefit from this test.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will measure cerebrospinal fluid (CSF) immunoglobulin free light chains (FLC) in adults diagnosed with multiple sclerosis by the 2017 McDonald criteria or with optic neuritis who are undergoing lumbar puncture and brain MRI as part of routine care. FLC levels will be compared with oligoclonal band status and correlated with clinical outcomes including conversion from clinically isolated syndrome to definite MS and disability measured by the Expanded Disability Status Scale (EDSS). The protocol uses quantitative FLC assays to address reproducibility and dynamic range limitations of OCB testing. Routine clinical follow-up and imaging data will be used to determine whether baseline CSF FLC predicts longer-term disease course.

Why it matters

Potential benefit: If successful, this could provide a quantitative spinal fluid marker to better predict disease course and help personalize treatment decisions.

How similar studies have gone: Small prior studies have shown CSF free light chains can be more sensitive and specific than oligoclonal bands for diagnosing MS and have suggested prognostic value, but large prospective validation is still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 at the time of enrollment
* Diagnosis of multiple sclerosis according to 2017 McDonald diagnostic criteria or optic neuritis (fulfilling or not criteria for multiple sclerosis, i.e. clinically isolated syndrome)
* Receiving both lumbar puncture and brain MRI for the routine diagnostic work-up

Exclusion Criteria:

• None

Where it's running

  • CHU Brugmann
    Brussels, Belgium
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.