Running, not recruitingRelapsing and progressiveNCT04860947

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Brain MRI
  • Spinal Cord MRI
  • Retinal imaging

What it measured

Main measures

  • Change in serum Neurofilament Light Chain serum levels since baseline

    Baseline; 1 year

    Blood or spinal fluid markers
  • Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline

    Baseline; 1 year

    Blood or spinal fluid markers
  • Change in Ganglion Cell Complex thickness since baseline

    Baseline; 1 year

    Retina scans (OCT)
  • Change in whole brain volume since baseline

    Baseline; 1 year

    MRI lesionsBrain volume loss
  • Expanded Disability Status Scale

    Baseline

    Disability progression
  • Expanded Disability Status Scale

    3 years

    Disability progression

Other measures (165)

  • Whole brain volume

    Inclusion

    MRI lesionsBrain volume loss
  • Whole brain volume

    6 Months

    MRI lesionsBrain volume loss
  • Whole brain volume

    1 Year

    MRI lesionsBrain volume loss
  • Whole brain volume

    2 years

    MRI lesionsBrain volume loss
  • Whole brain volume

    3 Years

    MRI lesionsBrain volume loss
  • Whole brain volume

    4 Years

    MRI lesionsBrain volume loss
  • Whole brain volume

    5 years

    MRI lesionsBrain volume loss
  • Whole brain volume

    any relapse (max 5 years)

    MRI lesionsBrain volume loss
  • Expanded Disability Status Scale

    Inclusion

    Disability progression
  • Expanded Disability Status Scale

    6 Months

    Disability progression

Who could take part

Relapsing and progressive · 18 and over

Inclusion Criteria: * 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. Exclusion Criteria: * The patient is in an exclusion period determined by a previous study. * 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 a severe psychiatric illness * The patient has severe chronic alcoholism

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jun 2019

      2. Main results due

        Mar 2027

      3. Finished

        Mar 2027

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