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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS
Time Frame: assessed every 6 months during 24 months
Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)
Time Frame: assessed at baseline
Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)
Time Frame: assessed at baseline
Optic nerve involvement defined by occurrence of a recent clinical episode of ON
Time Frame: 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
Time Frame: assessed every 6 months during 24 months
Secondary Outcomes
- 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)
- 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)