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

NCT01737372 | Completed

• 1 other identifier: 003-001-GEN
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Clinically Isolated Syndrome

Keywords

Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (1)

• To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis.

  baseline

Secondary Outcomes (1)

• Correlate microRNA profiles with clinical and CSF inflammation indexes

  baseline

Study Arms (3)

Secondary Progressive MS (SPMS)

Secondary Progressive MS participants

Clinically Isolated Syndrome (CIS)

Clinically isolated syndrome participants

Healthy participants

No immunological or neurological illnesses.

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• not able to understand informed consent
• 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

Sponsors & Collaborators

• John F. Foley, MD: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Rocky Mountain MS Clinic

Salt Lake City, Utah, 84103, United States

Location

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.

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John F Foley, MD

  Rocky Mountain MS Research Group, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President and Sponsor-Investigator

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)