NCT07560995

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients with a PMSI code H51.2 (internuclear ophthalmoplegia) listed as a primary or associated diagnosis
  • Patients hospitalized in a neurology department
  • Adult patients

You may not qualify if:

  • \- Patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires

Strasbourg, 67 200, France

Location

MeSH Terms

Conditions

Multiple SclerosisOcular Motility Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCentral Nervous System DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Kévin BIGAUT

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

May 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations