NCT06455332

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Jul 2025Jul 2028

First Submitted

Initial submission to the registry

May 23, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 17, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

May 23, 2024

Last Update Submit

August 19, 2025

Conditions

Clinically Isolated SyndromeMultiple Sclerosis

Keywords

Clinically isolated syndromeMultiple sclerosisMRIOptical coherence tomographyOptic nerveDiagnostic criteria

Outcome Measures

Primary Outcomes (5)

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

    assessed at baseline

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

    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

    assessed every 6 months during 24 months

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

    assessed at baseline

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

    assessed every 6 months during 24 months

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

All patients will part of the same follow-up study.

EXPERIMENTAL

All patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended.

Other: Optic nerve MRI sequence

Interventions

Optic nerve MRI sequenceOTHER

Systematic 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

All patients will part of the same follow-up study.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Juliette Bochu

CONTACT

0320444145juliette.bochu@chu-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 12, 2024

Study Start

July 17, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)