Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome (CIS)

NCT03541226 | Completed

• 2 other identifiers: 2012_562013-A00475-40
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop tools to detect, measure, monitor and predict axonal damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to consider as early as possible an adaptation of the background treatment in patients with MS. patients with radiological criteria of poor long-term clinical course.

Conditions

Clinically Isolated Syndrome; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0

  At 5 years

Secondary Outcomes (5)

• Occurrence of a second push

  At 5 years

• Occurrence of progression of the EDSS (Expanded Disability Status Scale) score

  At 5 years

• Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC)

  At 5 years

• variation of parameters measuring axonal pain / degeneration in MRI

  At 5 years

• variation of parameters measuring axonal pain / degeneration in OCT

  At 5 years

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patient with clinically isolated syndrome (CIS)

You may qualify if:

• Any patient who has had a CIS of less than 4 months (+/- 15 days), with at least 1 inflammatory lesion on his initial brain MRI or with normal brain MRI associated with the presence of oligoclonal bands in the CSF,

You may not qualify if:

• Atypical CIS for a first relapse of multiple sclerosis (extensive myelitis, bilateral retrobulbar optic neuritis immediately)
• CIS dating more than 4 months (+/- 15 days)
• Corticotherapy in the last 4 weeks

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Olivier Outteryck, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: September 1, 2014
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)