Clinically Isolated SyndromeHdeFIMSNCT06455332
Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
A study testing Optic nerve MRI sequence in people with Clinically Isolated Syndrome and Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Clinically Isolated Syndrome, Multiple Sclerosis
- What is being tested?
- Optic nerve MRI sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Roger Salengro
Lille, 59037
Olivier Outteryck
About this study
Official 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
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.
- Conditions
- Clinically Isolated Syndrome, Multiple Sclerosis
- Being tested
- Optic nerve MRI sequence
- Keywords
- Clinically isolated syndrome, Multiple sclerosis, MRI, Optical coherence tomography, Optic nerve, Diagnostic criteria
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Optic nerve MRI sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve involvement defined by occurrence of a recent clinical episode of ON
Measured: assessed at baseline
Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)
Measured: 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
Measured: assessed every 6 months during 24 months
Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)
Measured: assessed at baseline
Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS
Measured: 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
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)
Measured: 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
Measured: assessed at Month 0, Month 6, Month 12, Month 18, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Isolated SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Amiens University Hospital, Boulogne sur Mer Hospital Center, Centre Hospitalier VALENCIENNES, Centre Hospitalier de Roubaix, Centre Hospitalier de Lens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455332
- Sponsor's protocol ID
- 2021_0474
- Acronym
- HdeFIMS
- Status last verified
- Aug 2025
- First submitted
- 23 May 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06455332
- Acronym / sponsor ID
- HdeFIMS / 2021_0474
- Conditions
- Clinically Isolated Syndrome, Multiple Sclerosis
- Keywords
- Clinically isolated syndrome, Multiple sclerosis, MRI, Optical coherence tomography, Optic nerve, Diagnostic criteria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Amiens University Hospital, Boulogne sur Mer Hospital Center, Centre Hospitalier VALENCIENNES, Centre Hospitalier de Roubaix, Centre Hospitalier de Lens
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients will part of the same follow-up study. | Experimental | Other: Optic nerve MRI sequenceAll patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve MRI sequenceSystematic 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 | Other | All patients will part of the same follow-up study. |
Primary outcome
Optic nerve involvement defined by occurrence of a recent clinical episode of ON
Time frame: assessed at baseline
Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)
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
Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)
Time frame: assessed at baseline
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
2 secondary outcomes
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
Time frame: assessed at Month 0, Month 6, Month 12, Month 18, Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic nerve MRI sequence in people with Clinically Isolated Syndrome and Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliette Bochu (0320444145, juliette.bochu@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve involvement defined by occurrence of a recent clinical episode of ON (time frame: assessed at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.