Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137176
Status:
COMPLETED
Last Update Posted:
2009-06-23
First Post:
2005-08-26
Brief Title:
EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
EARLY IFNb-1a Rebif and Atorvastatin Lipitor Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose is to determine the changes in gene expression induced by IFNb-1a Rebif and atorvastatin Lipitor combination therapy in patients with an isolated clinical syndrome suggestive of multiple sclerosis MS to identify markers of therapeutic response and to predict patients clinical response based on their in vitro response to this combination therapy measured by the gene expression levels in activated peripheral blood mononuclear cells PBMCs
Detailed Description:
Multiple Sclerosis MS is a chronic neurologic disease characterized pathologically by focal areas of inflammation demyelination axonal injury and degeneration in the central nervous system MS follows several different disease courses Approximately 90 of patients have a relapsing form of the disease We propose that atorvastatin Lipitor may enhance the immunomodulatory effects of INFb-1a Rebif in patients with clinically isolated neurological syndrome suggestive of MS This combination may be more effective in preventing development of definitive relapsing-remitting MS if administered early in the course of the disease The study will identify markers of disease activity that are selectively affected by this combination therapy Identified markers may be used in future clinical trials to predict patients clinical response and to monitor the response to treatment as a secondary outcome measure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None