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NCT03369106 Clinical Trial

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

Multiple Sclerosis Clinical Trial

— SEP-BIO-PROG  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03369106
Other study ID # C16-114
Secondary ID 2017-A01844-49
Status Not yet recruiting
Phase N/A
First received November 28, 2017
Last updated December 5, 2017
Start date December 15, 2017
Est. completion date June 15, 2022

Study information
Verified date November 2017
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Céline Louapre, MD, PhD
Phone +33 1 42 16 57 66
Email celine.louapre@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date June 15, 2022
Est. primary completion date December 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

- Concomittant severe or uncontrolled disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Composite severity score calculation
Neurological examination, cognitive testing, and MRI exam

Locations
Country Name City State
France CIC Neurosciences Institut du Cerveau et de la Moelle Epinière Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Expanded disability status scale Change in the neurological assessment of disability related to multiple sclerosis Baseline and 18 months
Secondary Change in neuropsychological scores Change in the battery of neuropsychological tests adapted for multiple sclerosis Baseline and 18 months
Secondary Change in T2 lesion volume Change in volume of T2 lesion in the white matter Baseline and 18 months
Secondary Grey matter volume change Change in cerebral grey matter volume Baseline and 18 months
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