A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

John F. Foley, MD

Status

Completed

Conditions

Secondary Progressive Multiple Sclerosis

Multiple Sclerosis

Clinically Isolated Syndrome

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01737372

003-001-GEN

Details and patient eligibility

About

This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.

Full description

Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.

This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.

Enrollment

49 patients

Sex

All

Ages

18 to 68 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

able to understand and agree to informed consent;
male or female patients 18-68 years of age
no disease modifying therapy 60 days prior to Baseline
EDSS score of less than or equal to 3.0 if a CIS patient; or less than or equal to 7.5 if SPMS patient
Labs within normal range no greater than 2 times the ULN or at the discretion of the PI
weight 46 kilograms to 127 kilograms inclusive
no active systemic infection
not currently pregnant or breast feeding
no history of corticosteroid treatment or relapse within 60 days prior to Baseline.

Exclusion criteria

not able to understand informed consent
if any of the inclusion criteria is not met
HIV infection, or current active Hepatitis B or C infection, positive HCVAb or HBsAG or HBcAB
positive pregnancy test
patient withdraws consent
Coumadin use within 60 days prior to Baseline