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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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