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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01737372

Enrollment

Registered

2012-11-29

Start date

2012-11-30

Completion date

2016-10-31

Last updated

2016-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically Isolated Syndrome, Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Keywords

Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Clinically Isolated Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 68 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Correlate microRNA profiles with clinical and CSF inflammation indexes	baseline

Countries

United States

Outcome results