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

Multiple Sclerosis Clinical Trial

— cinocis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03541226
• Other study ID #: 2012_56
• Secondary ID: 2013-A00475-40
• Status: Recruiting
• Start date: September 2014
• Est. completion date: September 2021

Study information

• Verified date: July 2020
• Source: University Hospital, Lille
• Contact: Olivier Outteryck, MD,PhD
• Email: olivier.outteryck[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Syndrome

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of the disease defined by Expanded Disability Status Scale (EDSS) = 2.0		At 5 years
Secondary	Occurrence of a second push		At 5 years
Secondary	Occurrence of progression of the EDSS (Expanded Disability Status Scale) score	The scale evaluated the pyramidal, cerebellar, sensory, visual and mental functions . These make it possible to obtain a quotation between 0 and 10. The walk is called "normal" from 0 to 3.5. The walk is hampered from 4 and impossible from 7.5. The coast of 10 corresponds to the death of the patient.; This measure differentiates two groups: severe EDSS and non-severe EDSS group,	At 5 years
Secondary	Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC)		At 5 years
Secondary	variation of parameters measuring axonal pain / degeneration in MRI		At 5 years
Secondary	variation of parameters measuring axonal pain / degeneration in OCT		At 5 years