Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Optic nerve MRI sequence
Other interventionSystematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: All patients will part of the same follow-up study.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Optic nerve involvement defined by occurrence of a recent clinical episode of ON
Time frame
assessed at baseline2
Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)
Time frame
assessed at baseline3
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 months4
Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)
Time frame
assessed at baselineSecondary outcomes
1
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
Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination (M0, M6, M12, M18, M24)
Time frame
assessed at baseline every 6 months during 24 months2
Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination
Time frame
assessed at Month 0, Month 6, Month 12, Month 18, Month 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Région Nord-Pas de Calais, France
Collaborator
Amiens University Hospital
Collaborator
Boulogne sur Mer Hospital Center
Collaborator
Centre Hospitalier VALENCIENNES
Collaborator
Centre Hospitalier de Roubaix
Collaborator
Centre Hospitalier de Lens
Collaborator
Source ClinicalTrials.gov