Multiple SclerosisPROMISENCT05962177
Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic
A study testing Magnetic Resonance Imaging, Blood withdrawal and Neuropsychological tests in people with Multiple Sclerosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Magnetic Resonance Imaging, Blood withdrawal and Neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2023to Jun 2030
- Phase
- Interventional
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients over 18 and under 60 years of age
- Patients with Relapsing-remitting MS without relapse for at least 6 months
- EDSS<6 at time of inclusion
Who cannot join
- Secondary progressive MS or Primary progressive MS at time of inclusion
- Evidence of disease progression (clinical or radiological)
- Change in treatment within 6 months prior to inclusion
- Subject with a contraindication to MRI (claustrophobia, pacemaker, etc.)
- Inability to follow the follow-up planned by the study
- Pregnant or breastfeeding women
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- Patient not affiliated to the social security system or not benefiting from such a system
- Adult protected by law or patient under guardianship or curatorship
- Failure to obtain written informed consent after a reflection period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Neurology Department, Hopital Gui de Chauliac
Montpellier
Xavier Ayrignac, Medical Doctor, 0467337202, x-ayrignac@chu-montpellier.fr
About this study
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data.
The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients.
Read more
The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed.
Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc.
It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible.
This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS).
The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).
Read the detailed description
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET : Natalizumab, Fingolimod, Ocrelizumab, Rituximab, Ofatumumab, Cladribine) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET : Beta interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data.
The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients.
The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed.
Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc.
It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible.
This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS).
The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).
3 groups of interest will be studied and included in the study:
- Group 1: RRMS with medium efficacy treatment (interferon beta, glatiramer acetate, Teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease (n=175 patients)
- Group 2: RRMS with high efficacy treatment (Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod, Cladribine: n=175 patients)
- Group 3: Untreated RRMS (n=50 patients)
- Conditions
- Multiple Sclerosis
- Being tested
- Magnetic Resonance Imaging, Blood withdrawal, Neuropsychological tests
- Keywords
- Multiple sclerosis, MRI, Longitudinal cohort, Real life, Biomarkers
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Magnetic Resonance Imaging
Blood withdrawalOther
Blood withdrawal
Neuropsychological testsOther
Neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment | Experimental | Moderately effective treatment includes interferon beta, glatiramer acetate, Teriflunomide, dimethyl Fumarate and monomethyl fumarate n= 175 patients Receives: Other: Magnetic Resonance Imaging; Other: Blood withdrawal; Other: Neuropsychological tests |
| Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment | Experimental | Highly effective treatment includes Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod and Cladribine n= 175 patients Receives: Other: Magnetic Resonance Imaging; Other: Blood withdrawal; Other: Neuropsychological tests |
| Untreated relapsing-remitting Multiple sclerosis | Experimental | Patients untreated for relapsing-remitting Multiple sclerosis n= 50 patients Receives: Other: Magnetic Resonance Imaging; Other: Blood withdrawal; Other: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total brain atrophy
Total brain atrophy measured with T1 MRI scans
Measured: 3 years after Day 1
Secondary outcomes (30)
Quantitative analysis: analysis of FLAIR hypersignals number
Analysis of FLAIR hypersignals numbers (lesion load)
Measured: 3 years after Day 1
Quantitative analysis: analysis of FLAIR hypersignals volume
Analysis of FLAIR hypersignals volume
Measured: 3 years after Day 1
Qualitative analysis: analysis of central vein lesions
Identification and quantification of central vein lesions on SWI
Measured: 3 years after Day 1
Qualitative analysis: analysis of peripheral rim lesion
Identification and quantification of peripheral rim lesions on SWI
Measured: 3 years after Day 1
Quantitative analysis: measurement of mean diffusivity
measurement of the mean diffusivity using diffusion tensor analysis
Measured: 3 years after Day 1
Quantitative analysis: measurement of anisotropy fraction
measurement of anisotropy fraction using diffusion tensor analysis
Measured: 3 years after Day 1
Quantitative analysis: measurement of cerebral blood flow (CBF)
cerebral blood flow analysis on 3DPCASL
Measured: 3 years after Day 1
Changes in serum light chain neurofilament values
Changes in serum light chain neurofilament values in patients with RRMS patients according to the treatment line (high efficacy treatment vs. medium efficacy treatment)
Measured: 3 years after Day 1
Clinical assessment scale: relapses
Clinical assessment scales (absolute changes and reaching threshold values): Relapses
Measured: 3 years after Day 1
Clinical assessment scale: Expanded Disability Status Scale (EDSS)
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Measured: 3 years after Day 1
Clinical assessment scale: Computerized Speed Cognitive Test (CSCT)
" Computerized Speed Cognitive Test " (CSCT) provides screening for cognitive impairment in MS patients
Measured: 3 years after Day 1
Clinical assessment scale: Six-Minute Walk Test (6MWT)
Six-Minute Walk Test
Measured: 3 years after Day 1
Clinical assessment scale: 9-Hole Peg Test (9-HPT)
The 9-HPT is a brief, standardized, quantitative test of upper extremity function.
Measured: 3 years after Day 1
Clinical assessment scale: Timed 25-Foot Walk (T25-FW)
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
Measured: 3 years after Day 1
Quality of life scale: The 5-level EQ-5D questionnaire (EQ5D-5L)
EQ5D5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Measured: 3 years after Day 1
Quality of life scale: The Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) assesses the severity of pain and its impact on functioning.
Measured: 3 years after Day 1
Quality of life scale: DN4
The "Douleur Neuropathique 4 questions" questionnaire is a 4 questions questionnaire on neuropathic pain rating from 0 to 10; If the patient's score is 4/10 or more, the test is positive When the practitioner suspects neuropathic pain, the DN4 questionnaire is useful as a diagnostic tool.
Measured: 3 years after Day 1
Fatigue scale: Chalder Fatigue Scale
Chalder Fatigue Scale is a self-administered questionnaire for measuring the extent and severity of fatigue.
Measured: 3 years after Day 1
Fatigue scale: Modified Fatigue Impact Scale (MFIS)
Modified Fatigue Impact Scale (MFIS) provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning.
Measured: 3 years after Day 1
Sleep scale: Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is used to assess daytime sleepiness.The ESS is a self-administered questionnaire with 8 questions. ESS score can range from 0 to 24. A global score greater than ten is diagnostic of excessive daytime sleepiness .
Measured: 3 years after Day 1
Depression scale: Beck Depression Inventory (BID)
The Beck Depression Inventory (BDI) contains 21 items and identifies symptoms and attitudes associated with depression.
Measured: 3 years after Day 1
Anxiety scale: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Generalized Anxiety Disorder 7-Item Scale measures seven anxiety symptoms.
Measured: 3 years after Day 1
Headaches scale: ef-ID Migraine
ef-ID Migraine guide towards the diagnosis of migraine
Measured: 3 years after Day 1
Exploratory criteria:Serum Glial Fibrillary Acidic Protein (GFAP)
Serum GFAP
Measured: 3 years after Day 1
Exploratory criteria: Pittsburgh Sleep Quality Index (PSQI) questionnaire
Evaluation of habitual sleep quality trough a validated questionnaire. 19 items where each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 3 years after Day 1
Exploratory criteria: Idiopathic Hypersomnia Severity Hypersomnia Scale (IHSS)
Patient-reported questionnaire assessing the severity of excessive sleepiness, prolonged sleep duration, cognitive impairment and sleep inertia. The total score ranges from 0 to 50, with higher scores indicating more severe symptoms.
Measured: 3 years after Day 1
Exploratory criteria: RU SATED score
The Regularity, Sleep Quality, Alertness, Timing, Efficiency, Duration scale for sleep (RU SATED) ranges from 0 to 30, with higher scores indicating better sleep health.
Measured: 3 years after Day 1
Exploratory criteria: Insomnia Severity Index (ISI)
The Insomnia Severity Index is a seven item-scale scored on a five-point scale (from 0 to 4). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Measured: 3 years after Day 1
Exploratory criteria: Headaches Impact Test (HIT-6)
HIT-6 addresses six main domains affected by headaches, including pain, social functioning, role functioning, cognitive functioning, vitality and psychological stress.
Little or no impact: 49 or less ; some impact: 50-55 ; substantial impact: 56-59 ; severe impact: 60-78
Measured: 3 years after Day 1
Exploratory criteria: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Measured: 3 years after Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start11 Sep 2023
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962177
- Sponsor's protocol ID
- RECHMPL20_0422
- Acronym
- PROMISE
- Status last verified
- Sep 2025
- First submitted
- 15 Jun 2023
- Last updated
- 16 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic
- ClinicalTrials.gov ID
- NCT05962177
- Acronym / sponsor ID
- PROMISE / RECHMPL20_0422
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, MRI, Longitudinal cohort, Real life, Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 27 Jul 2023 (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.
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data.
The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients.
The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed.
Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc.
It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible.
This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS).
The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).
Detailed description
Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET : Natalizumab, Fingolimod, Ocrelizumab, Rituximab, Ofatumumab, Cladribine) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET : Beta interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients > 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data.
The measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients.
The progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed.
Nevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc.
It is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible.
This study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS).
The main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).
3 groups of interest will be studied and included in the study:
- Group 1: RRMS with medium efficacy treatment (interferon beta, glatiramer acetate, Teriflunomide, dimethyl fumarate, monomethyl fumarate) of the disease (n=175 patients)
- Group 2: RRMS with high efficacy treatment (Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod, Cladribine: n=175 patients)
- Group 3: Untreated RRMS (n=50 patients)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment | Experimental | Other: Magnetic Resonance Imaging, Other: Blood withdrawal, Other: Neuropsychological testsModerately effective treatment includes interferon beta, glatiramer acetate, Teriflunomide, dimethyl Fumarate and monomethyl fumarate n= 175 patients |
| Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment | Experimental | Other: Magnetic Resonance Imaging, Other: Blood withdrawal, Other: Neuropsychological testsHighly effective treatment includes Natalizumab, Ocrelizumab, Rituximab, Ofatumumab, Fingolimod and Cladribine n= 175 patients |
| Untreated relapsing-remitting Multiple sclerosis | Experimental | Other: Magnetic Resonance Imaging, Other: Blood withdrawal, Other: Neuropsychological testsPatients untreated for relapsing-remitting Multiple sclerosis n= 50 patients |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients over 18 and under 60 years of age
- Patients with Relapsing-remitting MS without relapse for at least 6 months
- EDSS<6 at time of inclusion
Key exclusion criteria (9 listed)
- Secondary progressive MS or Primary progressive MS at time of inclusion
- Evidence of disease progression (clinical or radiological)
- Change in treatment within 6 months prior to inclusion
- Subject with a contraindication to MRI (claustrophobia, pacemaker, etc.)
- Inability to follow the follow-up planned by the study
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging | Other | Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment, Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment, Untreated relapsing-remitting Multiple sclerosis |
| Blood withdrawalBlood withdrawal | Other | Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment, Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment, Untreated relapsing-remitting Multiple sclerosis |
| Neuropsychological testsNeuropsychological tests | Other | Relapsing-remitting Multiple sclerosis benefiting from a highly effective treatment, Relapsing-remitting Multiple sclerosis benefiting from a moderately effective treatment, Untreated relapsing-remitting Multiple sclerosis |
Primary outcome
Total brain atrophy
Time frame: 3 years after Day 1
Total brain atrophy measured with T1 MRI scans
30 secondary outcomes
Quantitative analysis: analysis of FLAIR hypersignals number
Time frame: 3 years after Day 1
Quantitative analysis: analysis of FLAIR hypersignals volume
Time frame: 3 years after Day 1
Qualitative analysis: analysis of central vein lesions
Time frame: 3 years after Day 1
Qualitative analysis: analysis of peripheral rim lesion
Time frame: 3 years after Day 1
Quantitative analysis: measurement of mean diffusivity
Time frame: 3 years after Day 1
Quantitative analysis: measurement of anisotropy fraction
Time frame: 3 years after Day 1
Quantitative analysis: measurement of cerebral blood flow (CBF)
Time frame: 3 years after Day 1
Changes in serum light chain neurofilament values
Time frame: 3 years after Day 1
Clinical assessment scale: relapses
Time frame: 3 years after Day 1
Clinical assessment scale: Expanded Disability Status Scale (EDSS)
Time frame: 3 years after Day 1
Clinical assessment scale: Computerized Speed Cognitive Test (CSCT)
Time frame: 3 years after Day 1
Clinical assessment scale: Six-Minute Walk Test (6MWT)
Time frame: 3 years after Day 1
Clinical assessment scale: 9-Hole Peg Test (9-HPT)
Time frame: 3 years after Day 1
Clinical assessment scale: Timed 25-Foot Walk (T25-FW)
Time frame: 3 years after Day 1
Quality of life scale: The 5-level EQ-5D questionnaire (EQ5D-5L)
Time frame: 3 years after Day 1
Quality of life scale: The Brief Pain Inventory (BPI)
Time frame: 3 years after Day 1
Quality of life scale: DN4
Time frame: 3 years after Day 1
Fatigue scale: Chalder Fatigue Scale
Time frame: 3 years after Day 1
Fatigue scale: Modified Fatigue Impact Scale (MFIS)
Time frame: 3 years after Day 1
Sleep scale: Epworth Sleepiness Scale (ESS)
Time frame: 3 years after Day 1
Depression scale: Beck Depression Inventory (BID)
Time frame: 3 years after Day 1
Anxiety scale: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: 3 years after Day 1
Headaches scale: ef-ID Migraine
Time frame: 3 years after Day 1
Exploratory criteria:Serum Glial Fibrillary Acidic Protein (GFAP)
Time frame: 3 years after Day 1
Exploratory criteria: Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: 3 years after Day 1
Exploratory criteria: Idiopathic Hypersomnia Severity Hypersomnia Scale (IHSS)
Time frame: 3 years after Day 1
Exploratory criteria: RU SATED score
Time frame: 3 years after Day 1
Exploratory criteria: Insomnia Severity Index (ISI)
Time frame: 3 years after Day 1
Exploratory criteria: Headaches Impact Test (HIT-6)
Time frame: 3 years after Day 1
Exploratory criteria: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: 3 years after Day 1
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 16 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Blood withdrawal and Neuropsychological tests in people with 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 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?
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?
Contact Xavier AYRIGNAC, Medical Doctor (0467337202, x-ayrignac@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total brain atrophy (time frame: 3 years after Day 1). 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 16 Sep 2025.