NCT06455332 Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
| NCT ID | NCT06455332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Clinically Isolated Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-07-17 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06455332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Clinically Isolated Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06455332 currently recruiting?
Yes, NCT06455332 is actively recruiting participants. Contact the research team at juliette.bochu@chu-lille.fr for enrollment information.
Where is the NCT06455332 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT06455332 clinical trial?
NCT06455332 is sponsored by University Hospital, Lille. The trial plans to enroll 200 participants.