Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis

NCT04201470 | Completed

• 1 other identifier: RECHMPL17_0381
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic inflammatory disorders of the central nervous system include various disorders of which multiple sclerosis is the most common. Besides multiple sclerosis, other distinct disorders including for example anti-AQP4 (aquaporine-4) and anti-MOG (Myelin oligodendrocyte glycoprotein) NMOSD (Neuromyelitis optica spectrum disorder) have been well characterized and are now known to be distinct from MS. some patient belonging to MS spectrum have recently being characterized but unusual MRI findings have mimicking inherited leukoencephalopathies and leukodystrophies. Whether these patients with atypical phenotype represent a separate disease distinct from MS or belong to MS spectrum is not clear. The objectives are to evaluate a series of 15 patients with atypical forms of MS using non-conventional MRI techniques and biological biomarkers (serum neurofilaments light chain) and to compare them with classical MS patients (15 relapsing remitting patients and 15 progressive patients) and 15 controls. the hypothesize is that these patients with atypical MS have a more severe neurodegenerative process.

Conditions

Relapsing Remitting Multiple Sclerosis; Progressive Multiple Sclerosis; Controls; Multiple Sclerosis

Keywords

Atypical multiple sclerosis; Cavitary multiple sclerosis; Myelocortical multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Serum neurofilaments light chain

  Evaluation of serum neurofilaments light chain levels in patients with atypical MS and comparison with controls and patients with classical MS

  Between baseline (day 0) and day 60

Secondary Outcomes (1)

• Serum GFAP

  Between baseline (day 0) and day 60

Study Arms (2)

MS patients

EXPERIMENTAL

Patients with atypical MS identified in our cohort

Other: Blood withdrawal; Other: MRI; Other: Neurologic / neuropsychologic tests - Patients

Controls

ACTIVE COMPARATOR

Other: Blood withdrawal; Other: MRI; Other: Neurologic / neuropsychologic tests - Controls

Interventions

Blood withdrawal OTHER

Measurement of serum neurofilaments light chain and GFAP

Controls; MS patients

MRI OTHER

Cervical and cerebral MRI without contrast injection

Controls; MS patients

Neurologic / neuropsychologic tests - Patients OTHER

EDSS (Expanded Disability Status Scale), NHPT (Nine Hole Peg Test), T25FW (Timed 25-Foot Walk Test), 6MWT (Six-Minute Walk Test), CSCT (Computerized version of the Symbol Digit Modalities Test)

MS patients

Neurologic / neuropsychologic tests - Controls OTHER

NHPT, T25FW, CSCT

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must have given his informed consent and signed the consent form (if patient is protected by the law due to the study pathology, the consent will be signed his tutor or guardian ; if patient is unable to read or sign the consent form due to the study pathology, the consent will be signed by his family/trusted person)
• The subject is at least 18 years old (≥).
• Affiliate or beneficiary of a social security scheme
• Patients with atypical form of MS
• OR patients with RRMS (Relapsing-Remitting Multiple Sclerosis)
• OR patients with PPMS (Primary Progressive Multiple Sclerosis)
• (Patients will be matched on EDSS score (+/-1) and age (+/-5) ; Controls will be matched with patients on age)

You may not qualify if:

• Pregnant or lactating women.
• Vulnerable people.
• Simultaneous participation in any other research protocol.
• Contraindication to the realization of an MRI (ferromagnetic ocular or cerebral foreign bodies close to nerve structures, pace-maker, cochlear implants)
• Claustrophobic subject
• Subject presenting a neurodegenerative disease (Parkinson, Alzheimer ...)
• Subject presenting psychiatric disorders like psychosis, excluding anxio-depressive episode
• Subject presenting a systemic pathology with neurological manifestation
• Subject presenting or having had a history of severe group 2 or 3 head trauma according to the Masters classification
• Patient who is taking, or who has taken in the last year, one of the following treatments: Fingolimod, or any Monoclonal Antibody (Natalizumab, Rituximab, Ocrelizumab, Alemtuzumab ...)
• Subjects who are protected or unable to give their consent
• Subject with anterior or progressive neurological pathology
• Patient being treated or having taken any Monoclonal Antibody

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 17, 2019
• Study Start: December 9, 2019
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)