Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03369106

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIC Neurosciences Institut du Cerveau et de la Moelle Epinière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Composite severity score calculation

Other

Neurological examination, cognitive testing, and MRI exam

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in neuropsychological scores

    Time frame: Baseline and 18 months

    Change in the battery of neuropsychological tests adapted for multiple sclerosis

  2. Change in T2 lesion volume

    Time frame: Baseline and 18 months

    Change in volume of T2 lesion in the white matter

  3. Grey matter volume change

    Time frame: Baseline and 18 months

    Change in cerebral grey matter volume

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Acronym: SEP-BIO-PROG

Important dates

Study start
2018
Primary completion
2020
Study completion
2026
First posted
Dec 11, 2017
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.