Multiple SclerosisSEP-BIO-PROGNCT03369106
Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study
An observational study of Multiple Sclerosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis. 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?
- Composite severity score calculation
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2018to Dec 2026
- 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: Multiple Sclerosis siblings Group of siblings having multiple sclerosis, n=120
Who may be able to join
- Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria)
- Sibling having Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) willing to participate to the study
- Affiliated to the French social security or equivalent
Who cannot join
- Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion
- Multiple sclerosis relapse within one month before inclusion
- Concomitant severe or uncontrolled disease
Trial locations and contacts
1 site in 1 country.
France1 site
CIC Neurosciences Institut du Cerveau et de la Moelle Epinière
Paris, 75013
About this study
This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.
Read the detailed description
The heterogeneity of multiple sclerosis evolution relies on several pathophysiological mechanisms including neuroinflammation, neurodegeneration and remyelination and repair mechanisms.
The study will identify markers of disease severity in a longitudinal cohort of patients with multiple sclerosis who are siblings (both siblings having multiple sclerosis) including: biological markers (genetic, immunological and epigenetic markers, advanced MRI markers). An integrative model to predict disease progression will be proposed based on multimodal markers.
- Conditions
- Multiple Sclerosis
- Being tested
- Composite severity score calculation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite severity score calculationOther
Neurological examination, cognitive testing, and MRI exam
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis siblings | Group of siblings having multiple sclerosis, n=120 Composite severity score calculation for all subjects Receives: Other: Composite severity score calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Expanded Disability Status Scale (EDSS)
Change in the Expanded Disability Status Scale (EDSS) which is the neurological assessment of disability related to multiple sclerosis.
The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
Measured: Baseline and 18 months
Secondary outcomes (3)
Change in neuropsychological scores
Change in the battery of neuropsychological tests adapted for multiple sclerosis
Measured: Baseline and 18 months
Change in T2 lesion volume
Change in volume of T2 lesion in the white matter
Measured: Baseline and 18 months
Grey matter volume change
Change in cerebral grey matter volume
Measured: Baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start6 Feb 2018
- Primary completion15 Dec 2020
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Céline Louapre, MD, PhD, Principal investigator, Paris Brain Institute (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369106
- Sponsor's protocol ID
- C16-114
- Other IDs
- 2017-A01844-49
- Acronym
- SEP-BIO-PROG
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2017
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fransson J, Bachelin C, Ichou F, Guillot-Noel L, Ponnaiah M, Gloaguen A, Maillart E, Stankoff B, Tenenhaus A, Fontaine B, Mochel F, Louapre C, Zujovic V. Multiple Sclerosis Patient Macrophages Impaired Metabolism Leads to an Altered Response to Activation Stimuli. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200312. doi: 10.1212/NXI.0000000000200312. Epub 2024 Oct 28.
PubMed 39467238
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
- Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study
- ClinicalTrials.gov ID
- NCT03369106
- Acronym / sponsor ID
- SEP-BIO-PROG / C16-114
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2017 (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.
This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.
Detailed description
The heterogeneity of multiple sclerosis evolution relies on several pathophysiological mechanisms including neuroinflammation, neurodegeneration and remyelination and repair mechanisms.
The study will identify markers of disease severity in a longitudinal cohort of patients with multiple sclerosis who are siblings (both siblings having multiple sclerosis) including: biological markers (genetic, immunological and epigenetic markers, advanced MRI markers). An integrative model to predict disease progression will be proposed based on multimodal markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis siblings | – | Other: Composite severity score calculationGroup of siblings having multiple sclerosis, n=120 Composite severity score calculation for all subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis siblings Group of siblings having multiple sclerosis, n=120
Key inclusion criteria (3 listed)
- Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria)
- Sibling having Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) willing to participate to the study
- Affiliated to the French social security or equivalent
Key exclusion criteria (3 listed)
- Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion
- Multiple sclerosis relapse within one month before inclusion
- Concomitant severe or uncontrolled disease
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 |
|---|---|---|
| Composite severity score calculationNeurological examination, cognitive testing, and MRI exam | Other | Multiple Sclerosis siblings |
Primary outcome
Change of Expanded Disability Status Scale (EDSS)
Time frame: Baseline and 18 months
Change in the Expanded Disability Status Scale (EDSS) which is the neurological assessment of disability related to multiple sclerosis. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
3 secondary outcomes
Change in neuropsychological scores
Time frame: Baseline and 18 months
Change in T2 lesion volume
Time frame: Baseline and 18 months
Grey matter volume change
Time frame: Baseline and 18 months
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.
- Results publication: PubMed 39467238Fransson J, Bachelin C, Ichou F, Guillot-Noel L, Ponnaiah M, Gloaguen A, Maillart E, Stankoff B, Tenenhaus A, Fontaine B, Mochel F, Louapre C, Zujovic V. Multiple Sclerosis Patient Macrophages Impaired Metabolism Leads to an Altered Response to Activation Stimuli. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200312. doi: 10.1212/NXI.0000000000200312. Epub 2024 Oct 28.
- 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.
Céline Louapre, MD, PhD principal investigator
Paris Brain Institute (ICM)
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 Institut National de la Santé Et de la Recherche Médicale, France 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 3 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 of Expanded Disability Status Scale (EDSS) (time frame: Baseline and 18 months). 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 NCT03369106, which also lists 1 linked publication.
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.