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Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis (AMIS)

Primary Purpose

Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Controls

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood withdrawal
MRI
Neurologic / neuropsychologic tests - Patients
Neurologic / neuropsychologic tests - Controls
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Relapsing Remitting Multiple Sclerosis focused on measuring Atypical multiple sclerosis, Cavitary multiple sclerosis, Myelocortical multiple sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MS patients

Controls

Arm Description

Patients with atypical MS identified in our cohort

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2019
Last Updated
February 16, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04201470
Brief Title
Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis
Acronym
AMIS
Official Title
Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Controls, Multiple Sclerosis
Keywords
Atypical multiple sclerosis, Cavitary multiple sclerosis, Myelocortical multiple sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS patients
Arm Type
Experimental
Arm Description
Patients with atypical MS identified in our cohort
Arm Title
Controls
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Blood withdrawal
Intervention Description
Measurement of serum neurofilaments light chain and GFAP
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Cervical and cerebral MRI without contrast injection
Intervention Type
Other
Intervention Name(s)
Neurologic / neuropsychologic tests - Patients
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Neurologic / neuropsychologic tests - Controls
Intervention Description
NHPT, T25FW, CSCT
Primary Outcome Measure Information:
Title
Serum neurofilaments light chain
Description
Evaluation of serum neurofilaments light chain levels in patients with atypical MS and comparison with controls and patients with classical MS
Time Frame
Between baseline (day 0) and day 60
Secondary Outcome Measure Information:
Title
Serum GFAP
Description
Evaluation of serum GFAP levels in patients with atypical MS and comparison with controls and patients with classical MS
Time Frame
Between baseline (day 0) and day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

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Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis

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