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Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study (SEP-BIO-PROG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03369106
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Composite severity score calculation

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Multiple Sclerosis siblings
Group of siblings having multiple sclerosis, n=120 Composite severity score calculation for all subjects
Other: Composite severity score calculation
Neurological examination, cognitive testing, and MRI exam




Primary Outcome Measures :
  1. Change of Expanded disability status scale [ Time Frame: Baseline and 18 months ]
    Change in the neurological assessment of disability related to multiple sclerosis


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multiple Sclerosis siblings Group of siblings having multiple sclerosis, n=120
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369106


Contacts
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Contact: Céline Louapre, MD, PhD +33 1 42 16 57 66 celine.louapre@aphp.fr

Locations
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France
CIC Neurosciences Institut du Cerveau et de la Moelle Epinière
Paris, France, 75013
Contact: Céline Louapre, MD, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Céline Louapre, MD, PhD Institut du Cerveau et de la Moelle Epinière
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03369106    
Other Study ID Numbers: C16-114
2017-A01844-49 ( Registry Identifier: RCB )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases