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

NCT03369106 | Active Not Recruiting

• 2 other identifiers: C16-1142017-A01844-49
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 18 months

Secondary Outcomes (3)

• Change in neuropsychological scores

  Baseline and 18 months

• Change in T2 lesion volume

  Baseline and 18 months

• Grey matter volume change

  Baseline and 18 months

Study Arms (1)

Multiple Sclerosis siblings

Group of siblings having multiple sclerosis, n=120 Composite severity score calculation for all subjects

Other: Composite severity score calculation

Interventions

Composite severity score calculation OTHER

Neurological examination, cognitive testing, and MRI exam

Multiple Sclerosis siblings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple Sclerosis siblings Group of siblings having multiple sclerosis, n=120

You may qualify if:

• 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

You may not qualify if:

• Concomitant severe or uncontrolled disease

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CIC Neurosciences Institut du Cerveau et de la Moelle Epinière

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Céline Louapre, MD, PhD

  Institut du Cerveau et de la Moelle Epinière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 11, 2017
• Study Start: February 6, 2018
• Primary Completion: December 15, 2020
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)