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Completed

NCT Number: NCT04201470

Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Inclusion criteria

specific to Patients:

  • 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)

Exclusion criteria

  • 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 anterior or evolutionary neurological pathology other than the 3 entities defined in the inclusion criteria
  • Subject presenting or having had a history of severe group 2 or 3 head trauma according to the Masters classification
  • Patient receiving high dose corticosteroid therapy in the 3 months prior to inclusion in the study

Exclusion criteria

specific to Patients:

  • 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 ...)
  • Patient having had an outbreak of the disease in the 3 months prior to inclusion in the study

Exclusion criteria

specific to Controls:

  • 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
  • In the period of exclusion relating to another protocol or for which the annual amount of the maximum indemnities of 4500 € has been reached

Treatment and study plan

blood withdrawal

Other

Measurement of serum neurofilaments light chain and GFAP

MRI

Other

Cervical and cerebral MRI without contrast injection

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)

Neurologic / neuropsychologic tests - Controls

Other

NHPT, T25FW, CSCT

Primary outcomes

  1. Serum neurofilaments light chain

    Time frame: Between baseline (day 0) and day 60

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

Secondary outcomes

  1. Serum GFAP

    Time frame: Between baseline (day 0) and day 60

    Evaluation of serum GFAP levels in patients with atypical MS and comparison with controls and patients with classical MS

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders

Acronym: AMIS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2019
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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