Multiple SclerosisINO&MSNCT07560995
Internuclear Ophthalmoplegia and Multiple Sclerosis: a Multicenter Retrospective Study
An observational study of Multiple Sclerosis and Internuclear Ophthalmoplegia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Internuclear ophthalmoplegia is a symptom frequently associated with multiple sclerosis (MS), although other etiologies are possible. Some patients do not meet the diagnostic criteria for MS at the time of the internuclear ophthalmoplegia episode but subsequently convert to MS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Internuclear Ophthalmoplegia
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The extraction of records will be performed through a search using PMSI coding within the medical files of patients hospitalized in a neurology department.
Who may be able to join
- Patients with internuclear ophthalmoplegia listed as a primary or associated diagnosis
- Patients hospitalized in a neurology department
Who cannot join
- Patients under 18 years of age
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
Les Hôpitaux Universitaires
Strasbourg, 67 200
Kévin BIGAUT, kevin.bigaut@chru-strasbourg.fr
About this study
Internuclear ophthalmoplegia is a symptom frequently associated with multiple sclerosis (MS), although other etiologies are possible. Some patients do not meet the diagnostic criteria for MS at the time of the internuclear ophthalmoplegia episode but subsequently convert to MS. Studying this specific clinical situation may help enable earlier diagnosis of MS.
The objective is to analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis and to identify factors associated with this conversion.
The study hypothesis is that the presence of internuclear ophthalmoplegia is highly suggestive of multiple sclerosis, particularly when cerebrospinal fluid-specific oligoclonal bands are present.
- Conditions
- Multiple Sclerosis, Internuclear Ophthalmoplegia
- Medical subject headings
- Multiple Sclerosis, Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Internuclear ophthalmoplegia | This is a retrospective cohort study involving patients who have experienced internuclear ophthalmoplegia. For each patient, it is determined whether a diagnosis of multiple sclerosis was established or not. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis.
Proportion of patients with isolated internuclear ophthalmoplegia who converted to multiple sclerosis during follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kévin BIGAUT, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560995
- Sponsor's protocol ID
- CE-2025-86
- Acronym
- INO&MS
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internuclear Ophthalmoplegia and Multiple Sclerosis: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07560995
- Acronym / sponsor ID
- INO&MS / CE-2025-86
- Conditions
- Multiple Sclerosis, Internuclear Ophthalmoplegia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 May 2026 (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.
Internuclear ophthalmoplegia is a symptom frequently associated with multiple sclerosis (MS), although other etiologies are possible. Some patients do not meet the diagnostic criteria for MS at the time of the internuclear ophthalmoplegia episode but subsequently convert to MS. Studying this specific clinical situation may help enable earlier diagnosis of MS.
The objective is to analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis and to identify factors associated with this conversion.
The study hypothesis is that the presence of internuclear ophthalmoplegia is highly suggestive of multiple sclerosis, particularly when cerebrospinal fluid-specific oligoclonal bands are present.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internuclear ophthalmoplegia | – | –This is a retrospective cohort study involving patients who have experienced internuclear ophthalmoplegia. For each patient, it is determined whether a diagnosis of multiple sclerosis was established or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The extraction of records will be performed through a search using PMSI coding within the medical files of patients hospitalized in a neurology department.
Key inclusion criteria (2 listed)
- Patients with internuclear ophthalmoplegia listed as a primary or associated diagnosis
- Patients hospitalized in a neurology department
Key exclusion criteria (1 listed)
- Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis.
Time frame: 1 year
Proportion of patients with isolated internuclear ophthalmoplegia who converted to multiple sclerosis during follow-up.
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 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kévin BIGAUT principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Internuclear Ophthalmoplegia, run by University Hospital, Strasbourg, France 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 May 2026. 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 Kévin BIGAUT (+33 3 88 12 60 96, kevin.bigaut@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis. (time frame: 1 year). 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 8 May 2026.