Predictive Value of the Optic Nerve Involvement in Clinically Isolated

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

RecruitingNot a drug-phase studyEarly (CIS/RIS)NCT06455332

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Optic nerve MRI sequence

What it measured

Main measures

  • Optic nerve involvement defined by occurrence of a recent clinical episode of ON

    assessed at baseline

  • Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)

    assessed at baseline

    MRI lesions

  • Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse

    assessed every 6 months during 24 months

    Relapses

  • Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)

    assessed at baseline

    Retina scans (OCT)

  • Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS

    assessed every 6 months during 24 months

    Relapses

Other measures (2)

  • Asymptomatic optic nerve involvement will be defined by: - asymptomatic optic nerve T2 hypersignal detected on one or both optic nerve(s) - or by GCIPL-IETD,3pm measured by OCT - or by GCIPL-IETD≥3µm measured by OCT

    assessed at baseline every 6 months during 24 months

    RelapsesMRI lesionsRetina scans (OCT)

  • Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination

    assessed at Month 0, Month 6, Month 12, Month 18, Month 24

    Relapses

Who could take part

Early (CIS/RIS) · 18 to 55

Show the full criteria

Inclusion criteria

* 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 criteria

* 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

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

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jul 2025

    2. Main results due

      Jul 2028

    3. Finished

      Jul 2028

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