Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094172
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2004-10-14
Brief Title:
Atorvastatin Lipitor Therapy in Patients With Clinically Isolated Syndrome CIS at Risk for Multiple Sclerosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis ITN020AI
Status:
COMPLETED
Status Verified Date:
2017-03
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:
STAYCIS
Brief Summary:
Patients who have been diagnosed with clinically isolated syndrome CIS often develop problems related to the central nervous system which controls the nerves in the body Some of these patients may later be diagnosed with multiple sclerosis MS a progressive disease of the nervous system The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients
Study hypothesis Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance
Study hypothesis Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance
Detailed Description:
CIS is a single clinical event indicating temporary disruption of normal nerve function CIS patients may have a loss of vision in one eye trouble with balance double vision numbness in the face and tingling numbness or weakness in the arms or legs Some CIS patients may develop MS but others may not Studies have shown that when CIS is accompanied by magnetic resonance imaging MRI-detected brain lesions that are consistent with those seen in MS there is a high risk of a second neurologic event and a diagnosis of MS within several years This study will evaluate the efficacy of atorvastatin an antihyperlipidemic in the prevention of MS in CIS patients
This study will last 18 months All participants must complete a 3- to 5-day course of corticosteroids at least 28 days before the baseline evaluations This corticosteroid therapy must be initiated within 60 days of CIS onset Participants will be randomly assigned to receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months Study visits will occur at screening and every 3 months thereafter until the end of the 18-month study Blood collection will occur at selected visits and other additional evaluations will be performed at Months 1 and 2 Selected participants will undergo MRI brain scans Participants will be offered interferon beta-1a Avonex free of charge if they develop disease activity Participants will be instructed to report any change in their health status to their treating physician within 48 hours of the onset of symptoms
This study will last 18 months All participants must complete a 3- to 5-day course of corticosteroids at least 28 days before the baseline evaluations This corticosteroid therapy must be initiated within 60 days of CIS onset Participants will be randomly assigned to receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months Study visits will occur at screening and every 3 months thereafter until the end of the 18-month study Blood collection will occur at selected visits and other additional evaluations will be performed at Months 1 and 2 Selected participants will undergo MRI brain scans Participants will be offered interferon beta-1a Avonex free of charge if they develop disease activity Participants will be instructed to report any change in their health status to their treating physician within 48 hours of the onset of symptoms
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