A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01737372|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : November 9, 2016
|Condition or disease|
|Multiple Sclerosis Secondary Progressive Multiple Sclerosis Clinically Isolated Syndrome|
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 Type :||Observational|
|Actual Enrollment :||49 participants|
|Official Title:||A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Secondary Progressive MS (SPMS)
Secondary Progressive MS participants
Clinically Isolated Syndrome (CIS)
Clinically isolated syndrome participants
No immunological or neurological illnesses.
- To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. [ Time Frame: baseline ]
- Correlate microRNA profiles with clinical and CSF inflammation indexes [ Time Frame: baseline ]
Biospecimen Retention: Samples Without DNA
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): NCT01737372
|United States, Utah|
|Rocky Mountain MS Clinic|
|Salt Lake City, Utah, United States, 84103|
|Principal Investigator:||John F Foley, MD||Rocky Mountain MS Research Group, LLC|