Relapsing Remitting Multiple SclerosisAMISNCT04201470
Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis
A study testing Blood withdrawal, MRI and Neurologic / neuropsychologic tests - Patients in people with Relapsing Remitting Multiple Sclerosis and Progressive Multiple Sclerosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Controls
- What is being tested?
- Blood withdrawal, MRI and Neurologic / neuropsychologic tests - Patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to 23 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 ...)
Show all 17Show fewer
- 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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders
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.
Read more
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
- Being tested
- Blood withdrawal, MRI, Neurologic / neuropsychologic tests - Patients, Neurologic / neuropsychologic tests - Controls
- Keywords
- Atypical multiple sclerosis, Cavitary multiple sclerosis, Myelocortical multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalOther
Measurement of serum neurofilaments light chain and GFAP
MRIOther
Cervical and cerebral MRI without contrast injection
Neurologic / neuropsychologic tests - PatientsOther
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 - ControlsOther
NHPT, T25FW, CSCT
| Study group | Role | What they receive |
|---|---|---|
| MS patients | Experimental | Patients with atypical MS identified in our cohort Receives: Other: Blood withdrawal; Other: MRI; Other: Neurologic / neuropsychologic tests - Patients |
| Controls | Active comparator | Not described Receives: Other: Blood withdrawal; Other: MRI; Other: Neurologic / neuropsychologic tests - Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between baseline (day 0) and day 60
Secondary outcomes (1)
Serum GFAP
Evaluation of serum GFAP levels in patients with atypical MS and comparison with controls and patients with classical MS
Measured: Between baseline (day 0) and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start9 Dec 2019
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201470
- Sponsor's protocol ID
- RECHMPL17_0381
- Acronym
- AMIS
- Status last verified
- Sep 2025
- First submitted
- 10 Dec 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders
- ClinicalTrials.gov ID
- NCT04201470
- Acronym / sponsor ID
- AMIS / RECHMPL17_0381
- Conditions
- Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Controls, Multiple Sclerosis
- Keywords
- Atypical multiple sclerosis, Cavitary multiple sclerosis, Myelocortical multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS patients | Experimental | Other: Blood withdrawal, Other: MRI, Other: Neurologic / neuropsychologic tests - PatientsPatients with atypical MS identified in our cohort |
| Controls | Active comparator | Other: Blood withdrawal, Other: MRI, Other: Neurologic / neuropsychologic tests - Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalMeasurement of serum neurofilaments light chain and GFAP | Other | Controls, MS patients |
| MRICervical and cerebral MRI without contrast injection | Other | Controls, MS patients |
| Neurologic / neuropsychologic tests - PatientsEDSS (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) | Other | MS patients |
| Neurologic / neuropsychologic tests - ControlsNHPT, T25FW, CSCT | Other | Controls |
Primary outcome
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
1 secondary outcome
Serum GFAP
Time frame: Between baseline (day 0) and day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood withdrawal, MRI and Neurologic / neuropsychologic tests - Patients in people with Relapsing Remitting Multiple Sclerosis and Progressive Multiple Sclerosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum neurofilaments light chain (time frame: Between baseline (day 0) and day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.