Status:
ACTIVE_NOT_RECRUITING
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
Institut de Recherches en Biothérapie
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as pr...
Eligibility Criteria
Inclusion
- The patient has been correctly informed.
- The patient must have given their informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
- The patient is at least (≥)18 years old.
- The patient has experienced a CIS, has currently a RRMS or progressive MS with:
- Less than 10 years of disease duration;
- With or without DMD;
- EDSS score 0 - 7.0.
Exclusion
- The patient is in an exclusion period determined by a previous study.
- The patient is under judicial protection.
- The patient refuses to sign the consent.
- It is impossible to correctly inform the patient (Inability to understand the study, language problem).
- The patient is pregnant or breast-feeding.
- Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
- Patient with MRI contra-indications.
- patient has a contraindication to gadolinium injection
- The patient has bilateral optic neuritis or other significant ophthalmological antecedent
- Patient is having a relapse or has had a relapse in the last 3 months
- The patient has a severe psychiatric illness
- The patient has severe chronic alcoholism
Key Trial Info
Start Date :
June 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04860947
Start Date
June 25 2019
End Date
June 1 2026
Last Update
February 26 2024
Active Locations (1)
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1
CHU de Nimes
Nîmes, France, 30029