RecruitingNot Applicable

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

France200 participantsStarted 2025-07-17

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: assessed at baseline

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

Timeframe: assessed at baseline

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

Timeframe: assessed every 6 months during 24 months

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

Timeframe: assessed at baseline

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

Timeframe: assessed every 6 months during 24 months

Trial details

NCT IDNCT06455332

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

Contact for this trial

Juliette Bochu

0320444145 juliette.bochu@chu-lille.fr

View on ClinicalTrials.gov More Clinically Isolated Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: assessed at baseline

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

Timeframe: assessed at baseline

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

Timeframe: assessed every 6 months during 24 months

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

Timeframe: assessed at baseline

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

Timeframe: assessed every 6 months during 24 months