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Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Key facts

Where
Lille, FranceSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

Source: NCT06455332, who can take part

Where in France

  • Hopital Roger SalengroLille, FranceTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University Hospital, Lille
Trial code
NCT06455332
Record updated
24 August 2025
Original description
Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.Read full original descriptionShow less

Evaluation of the Predictive Value of the Optic Nerve Involvement at the Stage of Clinically Isolated Syndrome, for the Diagnosis of Clinically Definite Multiple Sclerosis and the Delay of Second Relapses' Occurrence

Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.

Inclusion: Patients between 18 and 55 years old; Occurrence of CIS ≤ 6 months; With two T2 hypersignals on brain/spinal cord MRI suggestive of MS or with oligoclonal bands; Giving their written informed consent.

Exclusion: Pathological conditions that may skew the optic nerve MRI and/or retinal OCT (diabetes mellitus, glaucoma, retinopathy, ametropia >6 dioptria); Past history of MS relapses; Extensive myelitis (>3 vertebral bodies); Bilateral optic neuritis without T2 lesions suggestive of MS; Contra-indication to MRI, gadolinium injection; Pregnancy, breast-feeding; Patients unable to consent.

ClinicalTrials.gov NCT06455332