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Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study

Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03369106
Acronym
SEP-BIO-PROG
Enrollment
120
Registered
2017-12-11
Start date
2018-02-06
Completion date
2026-12-01
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief 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.

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.

Interventions

OTHERComposite severity score calculation

Neurological examination, cognitive testing, and MRI exam

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion * Multiple sclerosis relapse within one month before inclusion * Concomitant severe or uncontrolled disease

Design outcomes

Primary

MeasureTime frameDescription
Change of Expanded Disability Status Scale (EDSS)Baseline and 18 monthsChange 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.

Secondary

MeasureTime frameDescription
Change in neuropsychological scoresBaseline and 18 monthsChange in the battery of neuropsychological tests adapted for multiple sclerosis
Change in T2 lesion volumeBaseline and 18 monthsChange in volume of T2 lesion in the white matter
Grey matter volume changeBaseline and 18 monthsChange in cerebral grey matter volume

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCéline Louapre, MD, PhD

Institut du Cerveau et de la Moelle Epinière

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026