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

Completed

• Conditions: Multiple Sclerosis; Clinically Isolated Syndrome; Secondary Progressive Multiple Sclerosis

• Registration Number: NCT01737372
• Lead Sponsor: John F. Foley, MD

Brief 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.	baseline

Secondary Outcome Measures

Name	Time	Method
Correlate microRNA profiles with clinical and CSF inflammation indexes	baseline

Trial Locations

Locations (1)

Rocky Mountain MS Clinic; 🇺🇸 Salt Lake City, Utah, United States