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NCT04860947Active, not recruiting

Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients

Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
200 (actual)
First submitted
16 Apr 2021
Start date
25 Jun 2019
Primary completion date
31 Mar 2027
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
NCT number
NCT04860947

What you commit to

  • Study type: Observational
  • Participants enrolled: 200
  • From 25 Jun 2019 to the primary completion date, 31 Mar 2027
  • 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

  • The patient is in an exclusion period determined by a previous study.

Other illness

  • The patient has a severe psychiatric illness

Other

  • The patient is under judicial protection.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient (Inability to understand the study, language problem).
  • The patient is pregnant or breast-feeding.
  • Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
  • Patient with MRI contra-indications.
  • patient has a contraindication to gadolinium injection
  • The patient has bilateral optic neuritis or other significant ophthalmological antecedent
  • Patient is having a relapse or has had a relapse in the last 3 months
  • The patient has severe chronic alcoholism

Who the study is looking for

  • The patient has been correctly informed.
  • The patient must have given their informed and signed consent.
  • The patient must be insured or beneficiary of a health insurance plan.
  • The patient is at least (≥)18 years old.
  • The patient has experienced a CIS, has currently a RRMS or progressive MS with:
    • Less than 10 years of disease duration;
    • With or without DMD;
    • EDSS score 0 - 7.0.

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
CHU de Nîmes
Coordinator of this site? Confirm its status
NîmesFranceUnknown status

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