Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Recruiting now · Not applicable

Conditions studied: Clinically Isolated Syndrome, Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06455332

Run by

University Hospital, Lille

People needed

200

Starts

2025-07-17

Expected to finish

2028-07-01

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hôpital Roger Salengro — Lille, France (enrolling)

Full record on ClinicalTrials.gov

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