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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737372
• Other study ID #: 003-001-GEN
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: November 8, 2016
• Start date: November 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Rocky Mountain MS Research Group, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Rocky Mountain MS Clinic	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
John F. Foley, MD	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.		baseline	No
Secondary	Correlate microRNA profiles with clinical and CSF inflammation indexes		baseline	No