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Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis (AMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201470
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Progressive Multiple Sclerosis Controls Multiple Sclerosis Other: Blood withdrawal Other: MRI Other: Neurologic / neuropsychologic tests - Patients Other: Neurologic / neuropsychologic tests - Controls Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MS patients
Patients with atypical MS identified in our cohort
Other: Blood withdrawal
Measurement of serum neurofilaments light chain and GFAP

Other: MRI
Cervical and cerebral MRI without contrast injection

Other: Neurologic / neuropsychologic tests - Patients
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)

Active Comparator: Controls Other: Blood withdrawal
Measurement of serum neurofilaments light chain and GFAP

Other: MRI
Cervical and cerebral MRI without contrast injection

Other: Neurologic / neuropsychologic tests - Controls
NHPT, T25FW, CSCT




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject must have given his informed consent and signed the consent form.
  • 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:

  • Patients who are protected or unable to give their consent.
  • 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 has taken or is in the course of treatment: 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:

  • 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

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): NCT04201470


Contacts
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Contact: Xavier Ayrignac, MD +33687202393 x-ayrignac@chu-montpellier.fr
Contact: Frédéric Pinna 04 67 33 95 18 f-pinna@chu-montpellier.fr

Locations
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France
CHU Montpellier Recruiting
Montpellier, France, 34000
Contact: Xavier Ayrignac, MD    +33687202393    x-ayrignac@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04201470    
Other Study ID Numbers: UF 9891
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Atypical multiple sclerosis
Cavitary multiple sclerosis
Myelocortical multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases