NCT01737372

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: John F. Foley, MD · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Multiple Sclerosis
• Secondary Progressive Multiple Sclerosis
• Clinically Isolated Syndrome

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2012-11-29
• Last updated: 2016-11-09

Locations

1 site across 1 country: United States