A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
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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 |
- 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 ]
- 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 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
SPMS
Secondary Progressive MS participants
|
|
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 |
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| Contact: Kavitha Damal, PhD | 801-408-4584 | kdamal@rockymountainmsclinic.com |
| Contact: Tammy Hoyt, MS | 801-408-4584 | thoyt@rockymountainmsclinic.com |
| United States, Utah | |
| Rocky Mountain MS Clinic | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| Contact: Kavitha Damal, PhD 801-408-4584 | |
| Contact: Tammy Hoyt, MS 801-408-4584 | |
| Principal Investigator: John F Foley, MD | |
| Sub-Investigator: Viktoria Kaplan, MD | |
| 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: | November 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rocky Mountain MS Research Group, LLC:
|
Multiple sclerosis secondary progressive MS Clinically isolated syndrome |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Chronic Progressive Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013