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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rocky Mountain MS Research Group, LLC
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
John F. Foley, MD, Rocky Mountain MS Research Group, LLC
ClinicalTrials.gov Identifier:
NCT01737372
First received: November 27, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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
Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Clinically Isolated Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Rocky Mountain MS Research Group, LLC:

Primary Outcome Measures:
  • To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate microRNA profiles with clinical and CSF inflammation indexes [ Time Frame: baseline ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 45
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Secondary Progressive MS (SPMS)
Secondary Progressive MS participants
Clinically Isolated Syndrome (CIS)
Clinically isolated syndrome participants
Healthy participants
No immunological or neurological illnesses.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737372

Contacts
Contact: Tammy Hoyt, MS 801-408-4584 thoyt@rockymountainmsclinic.com
Contact: Laura Burr, RN 801-408-4584 lburr@rockymountainmsclinic.com

Locations
United States, Utah
Rocky Mountain MS Clinic Recruiting
Salt Lake City, Utah, United States, 84103
Contact: Tammy Hoyt, MS    801-408-4584    thoyt@rmmsc.com   
Principal Investigator: John F Foley, MD         
Sub-Investigator: Viktoria Kaplan, MD         
Sponsors and Collaborators
John F. Foley, MD
Genzyme, a Sanofi Company
Investigators
Principal Investigator: John F Foley, MD Rocky Mountain MS Research Group, LLC
  More Information

No publications provided

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
Study First Received: November 27, 2012
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Sclerosis
Syndrome
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease

ClinicalTrials.gov processed this record on October 16, 2014