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

Completed

Conditions studied: Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome

In brief

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.

Key facts

Study ID

NCT01737372

Run by

John F. Foley, MD

People needed

49

Starts

2012-11-01

Expected to finish

2016-10-01

Last updated by the study team

2016-11-09

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Rocky Mountain MS Clinic — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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