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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Multiple Sclerosis Secondary Progressive Multiple Sclerosis Clinically Isolated Syndrome

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.

Study Design

Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
Study Start Date : November 2012
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Secondary Progressive MS (SPMS)
Secondary Progressive MS participants
Clinically Isolated Syndrome (CIS)
Clinically isolated syndrome participants
Healthy participants
No immunological or neurological illnesses.

Outcome Measures

Primary Outcome Measures :
  1. To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Correlate microRNA profiles with clinical and CSF inflammation indexes [ Time Frame: baseline ]

Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid and blood may be stored for future immunological, cell product and microRNA testing related to the primary outcome of the this study.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

45 participants will be enrolled into a study to examine the microRNA and cell products profile in both cerebrospinal fluid (CSF) and blood. Study population will consist of a total of: 20 CIS patients defined as patients having a single attack (or the appearance of one or more symptoms characteristic of MS) high risk of developing MS, when no other diseases or causes are apparent.

20 SPMS patients 5 normal, non-diseased controls


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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
John F. Foley, MD
Genzyme, a Sanofi Company
Principal Investigator: John F Foley, MD Rocky Mountain MS Research Group, LLC
More Information

Responsible Party: John F. Foley, MD, President and Sponsor-Investigator, Rocky Mountain MS Research Group, LLC
ClinicalTrials.gov Identifier: NCT01737372     History of Changes
Other Study ID Numbers: 003-001-GEN
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John F. Foley, MD, Rocky Mountain MS Research Group, LLC:
Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Clinically Isolated Syndrome

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases