NCT06455332Recruiting
Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 May 2024
- Start date
- 17 Jul 2025
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- University Hospital, Lille
- Diseases
- Multiple sclerosis
- NCT number
- NCT06455332
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 17 Jul 2025 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.