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

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ClinicalTrials.gov Identifier: NCT03541226

Recruitment Status : Recruiting

First Posted : May 30, 2018

Last Update Posted : September 11, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University Hospital, Lille

Study Description

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.

Condition or disease
Clinically Isolated Syndrome Multiple Sclerosis

Study Design

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Study Type :	Observational
Estimated Enrollment :	134 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome
Study Start Date :	September 2014
Estimated Primary Completion Date :	September 2021
Estimated Study Completion Date :	September 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0 [ Time Frame: At 5 years ]

Secondary Outcome Measures :

Occurrence of a second push [ Time Frame: At 5 years ]
Occurrence of progression of the EDSS (Expanded Disability Status Scale) score [ Time Frame: At 5 years ]
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,
Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC) [ Time Frame: At 5 years ]
variation of parameters measuring axonal pain / degeneration in MRI [ Time Frame: At 5 years ]
variation of parameters measuring axonal pain / degeneration in OCT [ Time Frame: At 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patient with clinically isolated syndrome (CIS)

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541226

Contacts

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Contact: Olivier Outteryck, MD,PhD		olivier.outteryck@chru-lille.fr
Contact: Patrick Vermersch, MD,PhD		patrick.vermersch@chru-lille.fr

Locations

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France
Hôpital Roger Salengro, CHRU de Lille	Recruiting
Lille, France
Sub-Investigator: Patrick Vermersch, MD,PhD
Principal Investigator: Olivier Outteryck, MD

Sponsors and Collaborators

University Hospital, Lille

Investigators

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Principal Investigator:	Olivier Outteryck, MD, PhD	University Hospital, Lille

More Information

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Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT03541226
Other Study ID Numbers:	2012_56 2013-A00475-40 ( Other Identifier: ID-RCB number, ANSM )
First Posted:	May 30, 2018 Key Record Dates
Last Update Posted:	September 11, 2020
Last Verified:	July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Multiple Sclerosis Syndrome Disease Pathologic Processes Demyelinating Autoimmune Diseases, CNS	Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases

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