Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients

An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Sclerosis
What is being tested?: Brain MRI, Spinal Cord MRI and Retinal imaging
Type of treatment: Injection or infusion
How many people: 200 participants
Where: 1 siteFrance
Study dates: 25 Jun 2019to Mar 2027
Phase: Observational
Are there results?: Not yet: the study is under way

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
No healthy volunteers
Adult, Older adult

Study population: The study population is composed of consecutive adult patients, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of Nîmes University Hospital (CHU). The patients recruited will have an EDSS score comprised between 0 - 7.0.

Who may be able to join

The patient has been correctly informed.
The patient must have given their informed and signed consent.
The patient must be insured or beneficiary of a health insurance plan.
The patient is at least (≥)18 years old.
The patient has experienced a CIS, has currently a RRMS or progressive MS with:
Less than 10 years of disease duration;
With or without DMD;
EDSS score 0 - 7.0.

Who cannot join

The patient is in an exclusion period determined by a previous study.
The patient is under judicial protection.
The patient refuses to sign the consent.
It is impossible to correctly inform the patient (Inability to understand the study, language problem).
The patient is pregnant or breast-feeding.
Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.

Show all 12Show fewer

Patient with MRI contra-indications.
patient has a contraindication to gadolinium injection
The patient has bilateral optic neuritis or other significant ophthalmological antecedent
Patient is having a relapse or has had a relapse in the last 3 months
The patient has a severe psychiatric illness
The patient has severe chronic alcoholism

Trial locations and contacts

1 site in 1 country.

France1 site

CHU de Nimes
Nîmes, 30029

Other trials in France

About this study

Official title: Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients

Conditions: Multiple Sclerosis
Being tested: Brain MRI, Spinal Cord MRI, Retinal imaging
Keywords: GFAP, NfL
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brain MRIDiagnostic test
- Axial DWI with ADC card
- Axial 2D TSE T2/DP or 3DT2
- Gadolinium injection (0.1 mmol/kg)
- 3D Fluid-attenuated inversion recovery
- 3D T1 with Gadolinium injection.
Spinal Cord MRIDiagnostic test
Sagittal T2 Sagittal T1 with Gadolinium injection
Retinal imagingDiagnostic test
spectral-domain high definition optical coherence tomography

Study groups in NCT04860947
Study group	Role	What they receive
MS patients		Not described Receives: Diagnostic Test: Brain MRI; Diagnostic Test: Spinal Cord MRI; Diagnostic Test: Retinal imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in serum Neurofilament Light Chain serum levels since baseline
pg/mL; measured by digital ELISA
Measured: Baseline; 1 year
Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline
pg/mL; measured by digital ELISA
Measured: Baseline; 1 year
Change in Ganglion Cell Complex thickness since baseline
Measured by Optical Coherence Tomography
Measured: Baseline; 1 year
Change in whole brain volume since baseline
Assessed by MRI
Measured: Baseline; 1 year
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: Baseline
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 3 years

Secondary outcomes (165)

Whole brain volume
assessed by MRI
Measured: Inclusion
Whole brain volume
assessed by MRI
Measured: 6 Months
Whole brain volume
assessed by MRI
Measured: 1 Year
Whole brain volume
assessed by MRI
Measured: 2 years
Whole brain volume
assessed by MRI
Measured: 3 Years
Whole brain volume
assessed by MRI
Measured: 4 Years
Whole brain volume
assessed by MRI
Measured: 5 years
Whole brain volume
assessed by MRI
Measured: any relapse (max 5 years)
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: Inclusion
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 6 Months
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 1 year
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 18 months
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 2 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 2.5 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 3 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 3.5 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 4 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 4.5 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: 5 years
Expanded Disability Status Scale
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Measured: Any relapse (Maximum 5 years)
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: Inclusion
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 6 Months
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 1 Year
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 18 Months
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 2 years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 3 Years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 4 Years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: 5 Years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
assessed by Optical Coherence Tomography
Measured: Any relapse (maximum 5 Years)
Gadolinium-enhanced lesions
assessed by MRI
Measured: Inclusion
Gadolinium-enhanced lesions
assessed by MRI
Measured: 6 Months
Gadolinium-enhanced lesions
assessed by MRI
Measured: 1 Year
Gadolinium-enhanced lesions
assessed by MRI
Measured: 2 years
Gadolinium-enhanced lesions
assessed by MRI
Measured: 3 Years
Gadolinium-enhanced lesions
assessed by MRI
Measured: 4 Years
Gadolinium-enhanced lesions
assessed by MRI
Measured: 5 Years
Gadolinium-enhanced lesions
assessed by MRI
Measured: Any relapse (Maximum 5 Years)
T2 lesion volume,
assessed by MRI
Measured: Inclusion
T2 lesion volume,
assessed by MRI
Measured: 6 Months
T2 lesion volume,
assessed by MRI
Measured: 1 Year
T2 lesion volume,
assessed by MRI
Measured: 2 years
T2 lesion volume,
assessed by MRI
Measured: 3 Years
T2 lesion volume,
assessed by MRI
Measured: 4 Years
T2 lesion volume,
assessed by MRI
Measured: 5 years
T2 lesion volume,
assessed by MRI
Measured: Any relapse (maximum 5 years)
Grey matter atrophy
assessed by MRI
Measured: Inclusion
Grey matter atrophy
assessed by MRI
Measured: 6 Months
Grey matter atrophy
assessed by MRI
Measured: 1 Year
Grey matter atrophy
assessed by MRI
Measured: 2 years
Grey matter atrophy
assessed by MRI
Measured: 3 Years
Grey matter atrophy
assessed by MRI
Measured: 4 Years
Grey matter atrophy
assessed by MRI
Measured: 5 Years
Grey matter atrophy
assessed by MRI
Measured: Any relapse (maximum 5 Years)
White matter atrophy
assessed by MRI
Measured: Inclusion
White matter atrophy
assessed by MRI
Measured: 6 Months
White matter atrophy
assessed by MRI
Measured: 1 Year
White matter atrophy
assessed by MRI
Measured: 2 years
White matter atrophy
assessed by MRI
Measured: 3 Years
White matter atrophy
assessed by MRI
Measured: 4 Years
White matter atrophy
assessed by MRI
Measured: 5 years
White matter atrophy
assessed by MRI
Measured: Any relapse (maximum 5 years)
Thalamic atrophy
assessed by MRI
Measured: Inclusion
Thalamic atrophy
assessed by MRI
Measured: 6 Months
Thalamic atrophy
assessed by MRI
Measured: 1 Year
Thalamic atrophy
assessed by MRI
Measured: 2 years
Thalamic atrophy
assessed by MRI
Measured: 3 Years
Thalamic atrophy
assessed by MRI
Measured: 4 Years
Thalamic atrophy
assessed by MRI
Measured: 5 years
Thalamic atrophy
assessed by MRI
Measured: Any relapse (maximum 5 years)
Disease modifying drugs classification
Drug class (1st, 2nd or 3rd line)
Measured: Inclusion
Disease modifying drugs classification
Drug class (1st, 2nd or 3rd line)
Measured: until end of study (5 years)
serum NfL levels
pg/mL; measured by digital ELISA
Measured: 6 Months
serum GFAP levels
pg/mL; measured by digital ELISA
Measured: 6 Months
serum NfL levels
pg/mL; measured by digital ELISA
Measured: 2 years
serum GFAP levels
pg/mL; measured by digital ELISA
Measured: 2 years
serum NfL levels
pg/mL; measured by digital ELISA
Measured: 3 years
serum GFAP levels
pg/mL; measured by digital ELISA
Measured: 3 years
serum NfL levels
pg/mL; measured by digital ELISA
Measured: 4 years
serum GFAP levels
pg/mL; measured by digital ELISA
Measured: 4 years
serum NfL levels
pg/mL; measured by digital ELISA
Measured: 5 years
serum GFAP levels
pg/mL; measured by digital ELISA
Measured: 5 years
serum NfL levels
pg/mL; measured by digital ELISA
Measured: Any relapse (maximum 5 years)
serum GFAP levels
pg/mL; measured by digital ELISA
Measured: Any relapse (maximum 5 years)
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: Inclusion
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: 6 Months
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: 1 Year
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: 2 years
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: 3 years
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: 4 years
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: 5 years
Multiple Sclerosis Functional Composite
21-item test that includes 3 different functional subtests: the timed 25-Foot Walk, the 9-Hole Peg Test and the Paced Auditory Serial Addition Test (PASAT)
Measured: Any relapse (maximum 5 years)
Time to walk 100 meters
Seconds
Measured: Inclusion
Time to walk 100 meters
Seconds
Measured: 6 Months
Time to walk 100 meters
Seconds
Measured: 1 Year
Time to walk 100 meters
Seconds
Measured: 2 years
Time to walk 100 meters
Seconds
Measured: 3 years
Time to walk 100 meters
Seconds
Measured: 4 years
Time to walk 100 meters
Seconds
Measured: 5 years
Time to walk 100 meters
Seconds
Measured: Any relapse (maximum 5 years)
2 Minute walking distance
Meters
Measured: Inclusion
2 Minute walking distance
Meters
Measured: 6 Months
2 Minute walking distance
Meters
Measured: 1 Year
2 Minute walking distance
Meters
Measured: 2 years
2 Minute walking distance
Meters
Measured: 3 years
2 Minute walking distance
Meters
Measured: 4 years
2 Minute walking distance
Meters
Measured: 5 years
2 Minute walking distance
Meters
Measured: Any relapse (maximum 5 years)
Cognitive Impairment
Symbol Digit Modalities Test
Measured: Inclusion
Cognitive Impairment
Symbol Digit Modalities Test
Measured: 6 months
Cognitive Impairment
Symbol Digit Modalities Test
Measured: 1 Year
Cognitive Impairment
Symbol Digit Modalities Test
Measured: 2 years
Cognitive Impairment
Symbol Digit Modalities Test
Measured: 3 years
Cognitive Impairment
Symbol Digit Modalities Test
Measured: 4 years
Cognitive Impairment
Symbol Digit Modalities Test
Measured: 5 years
Cognitive Impairment
Symbol Digit Modalities Test
Measured: Any relapse (maximum 5 years)
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: Inclusion
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: 6 Months
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: 1 Year
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: 2 years
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: 3 years
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: 4 years
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: 5 years
Cognitive evaluation
Brief International Cognitive Assessment for Multiple Sclerosis
Measured: Any relapse (maximum 5 years)
Health-related quality of life
EQ-5D-5L
Measured: Inclusion
Health-related quality of life
EQ-5D-5L
Measured: 6 Months
Health-related quality of life
EQ-5D-5L
Measured: 1 Year
Health-related quality of life
EQ-5D-5L
Measured: 2 years
Health-related quality of life
EQ-5D-5L
Measured: 3 years
Health-related quality of life
EQ-5D-5L
Measured: 4 years
Health-related quality of life
EQ-5D-5L
Measured: 5 years
Health-related quality of life
EQ-5D-5L
Measured: Any relapse (maximum 5 years)
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: Inclusion
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 6 Months
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 1 Year
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 2 years
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 3 years
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 4 years
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: 5 years
Impact of MS on daily life
Multiple Sclerosis Impact Scale (MSIS-29)
Measured: Any relapse (maximum 5 years)
Fatigue
Modified Fatigue Impact Scale
Measured: Inclusion
Fatigue
Modified Fatigue Impact Scale
Measured: 6 Months
Fatigue
Modified Fatigue Impact Scale
Measured: 1 Year
Fatigue
Modified Fatigue Impact Scale
Measured: 2 years
Fatigue
Modified Fatigue Impact Scale
Measured: 3 years
Fatigue
Modified Fatigue Impact Scale
Measured: 4 years
Fatigue
Modified Fatigue Impact Scale
Measured: 5 years
Fatigue
Modified Fatigue Impact Scale
Measured: Any relapse (maximum 5 years)
Visual acuity
0= low, 10= good
Measured: Inclusion
Visual acuity
0= low, 10= good
Measured: 6 Months
Visual acuity
0= low, 10= good
Measured: 1 Year
Visual acuity
0= low, 10= good
Measured: 2 years
Visual acuity
0= low, 10= good
Measured: 3 years
Visual acuity
0= low, 10= good
Measured: 4 years
Visual acuity
0= low, 10= good
Measured: 5 years
Visual acuity
0= low, 10 good
Measured: Any relapse (maximum 5 years)
Low contrast visual acuity
0= low, 10 good
Measured: Inclusion
Low contrast visual acuity
0= low, 10 good
Measured: 6 Months
Low contrast visual acuity
0= low, 10 good
Measured: 1 Year
Low contrast visual acuity
0= low, 10 good
Measured: 2 years
Low contrast visual acuity
0= low, 10 good
Measured: 3 years,
Low contrast visual acuity
0= low, 10 good
Measured: 4 years
Low contrast visual acuity
0= low, 10 good
Measured: 5 years
Low contrast visual acuity
0= low, 10 good
Measured: Any relapse (maximum 5 years)
Relapse description
monofocal, plurifocal
Measured: At relapse (maximum 5 years)
Number of new lesions
Measured by MRI
Measured: At relapse (maximum 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 2019Mar 2027

First posted27 Apr 2021
Study start25 Jun 2019
Primary completionMar 2027 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de NīmesThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04860947
Sponsor's protocol ID: CIVI/2018/ET-01
Other IDs: 2018-A03152-53
Acronym: NFL OCT
Status last verified: Oct 2026
First submitted: 16 Apr 2021
Last updated: 22 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients
ClinicalTrials.gov ID: NCT04860947
Acronym / sponsor ID: NFL OCT / CIVI/2018/ET-01
Conditions: Multiple Sclerosis
Keywords: GFAP, NfL
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 200 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
Collaborators: Institut de Recherches en Biothérapie
Study start: 25 Jun 2019 (actual)
Primary completion: Mar 2027 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 27 Apr 2021 (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.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
MS patients	–	Diagnostic Test: Brain MRI, Diagnostic Test: Spinal Cord MRI, Diagnostic Test: Retinal imaging

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population is composed of consecutive adult patients, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of Nîmes University Hospital (CHU). The patients recruited will have an EDSS score comprised between 0 - 7.0.

Key inclusion criteria (8 listed)

The patient has been correctly informed.
The patient must have given their informed and signed consent.
The patient must be insured or beneficiary of a health insurance plan.
The patient is at least (≥)18 years old.
The patient has experienced a CIS, has currently a RRMS or progressive MS with:

Key exclusion criteria (12 listed)

The patient is in an exclusion period determined by a previous study.
The patient is under judicial protection.
The patient refuses to sign the consent.
It is impossible to correctly inform the patient (Inability to understand the study, language problem).
The patient is pregnant or breast-feeding.

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
Brain MRI* Axial DWI with ADC card * Axial 2D TSE T2/DP or 3DT2 * Gadolinium injection (0.1 mmol/kg) * 3D Fluid-attenuated inversion recovery * 3D T1 with Gadolinium injection.	Diagnostic test	MS patients
Spinal Cord MRISagittal T2 Sagittal T1 with Gadolinium injection	Diagnostic test	MS patients
Retinal imagingspectral-domain high definition optical coherence tomography	Diagnostic test	MS patients

Primary outcome

Change in serum Neurofilament Light Chain serum levels since baseline
Time frame: Baseline; 1 year
pg/mL; measured by digital ELISA
Change in serum Glial Fibrillary Acidic Protein (GFAP) serum levels since baseline
Time frame: Baseline; 1 year
pg/mL; measured by digital ELISA
Change in Ganglion Cell Complex thickness since baseline
Time frame: Baseline; 1 year
Measured by Optical Coherence Tomography
Change in whole brain volume since baseline
Time frame: Baseline; 1 year
Assessed by MRI
Expanded Disability Status Scale
Time frame: Baseline
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)
Expanded Disability Status Scale
Time frame: 3 years
Eight functional systems scored on a scale of 0 (no disability) to 5 or 6 (more severe disability)

165 secondary outcomes

Whole brain volume
Time frame: Inclusion
Whole brain volume
Time frame: 6 Months
Whole brain volume
Time frame: 1 Year
Whole brain volume
Time frame: 2 years
Whole brain volume
Time frame: 3 Years
Whole brain volume
Time frame: 4 Years
Whole brain volume
Time frame: 5 years
Whole brain volume
Time frame: any relapse (max 5 years)
Expanded Disability Status Scale
Time frame: Inclusion
Expanded Disability Status Scale
Time frame: 6 Months
Expanded Disability Status Scale
Time frame: 1 year
Expanded Disability Status Scale
Time frame: 18 months
Expanded Disability Status Scale
Time frame: 2 years
Expanded Disability Status Scale
Time frame: 2.5 years
Expanded Disability Status Scale
Time frame: 3 years
Expanded Disability Status Scale
Time frame: 3.5 years
Expanded Disability Status Scale
Time frame: 4 years
Expanded Disability Status Scale
Time frame: 4.5 years
Expanded Disability Status Scale
Time frame: 5 years
Expanded Disability Status Scale
Time frame: Any relapse (Maximum 5 years)
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: Inclusion
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 6 Months
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 1 Year
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 18 Months
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 2 years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 3 Years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 4 Years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: 5 Years
Peripapillary Retinal Nerve Fibre Layer atrophy and Ganglion Cell Complex thickness
Time frame: Any relapse (maximum 5 Years)
Gadolinium-enhanced lesions
Time frame: Inclusion
Gadolinium-enhanced lesions
Time frame: 6 Months
Gadolinium-enhanced lesions
Time frame: 1 Year
Gadolinium-enhanced lesions
Time frame: 2 years
Gadolinium-enhanced lesions
Time frame: 3 Years
Gadolinium-enhanced lesions
Time frame: 4 Years
Gadolinium-enhanced lesions
Time frame: 5 Years
Gadolinium-enhanced lesions
Time frame: Any relapse (Maximum 5 Years)
T2 lesion volume,
Time frame: Inclusion
T2 lesion volume,
Time frame: 6 Months
T2 lesion volume,
Time frame: 1 Year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.

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Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis

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.

Eric Thouvenot principal investigator

CHU Nimes

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in serum Neurofilament Light Chain serum levels since baseline (time frame: Baseline; 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860947.

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 22 Oct 2026.