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NCT Number: NCT06455332

Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

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.

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Key information

Conditions

Clinically Isolated Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro

Lille, 59037, France

Location status: Recruiting

Location contact

Olivier Outteryck

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optic nerve MRI sequence

Other

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

Primary outcomes

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

    Time frame: assessed at baseline

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

    Time frame: assessed at baseline

  3. 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

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

    Time frame: assessed at baseline

  5. 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

Secondary 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 frame: 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 (M0, M6, M12, M18, M24)

  2. 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 24

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette Bochu

CONTACT

[email protected]

0320444145

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Amiens University Hospital
  • Boulogne sur Mer Hospital Center
  • Centre Hospitalier VALENCIENNES
  • Centre Hospitalier de Lens
  • Centre Hospitalier de Roubaix
  • Région Nord-Pas de Calais, France

Registry information

Official study title

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

Acronym: HdeFIMS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2024
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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