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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01737372
Other study ID # 003-001-GEN
Secondary ID
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


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
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