Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242268
Status:
UNKNOWN
Last Update Posted:
2005-12-07
First Post:
2005-10-19
Brief Title:
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
Sponsor:
Alabama Neurology Associates PC
Organization:
Alabama Neurology Associates PC
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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 purpose of this study is to determine if using Avonex in combination with Zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis
Detailed Description:
Multiple Sclerosis MS is an inflammatory demyelinating disease of the Central Nervous System CNS There are many forms of MS althoughthe majority are Relapsing Remitting RRMS representing approximately 80 of the cases The disease appears to be more inflammatory in RRMS as manisfested by an increase inGadolinium enhancement on MRI and an increase in inflammatory bioassay markers
Zocor is in a class of drugs statins that are used to lower cholesterol Statins also have an anti-inflammatory effect on the CNS Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI
Zocor is in a class of drugs statins that are used to lower cholesterol Statins also have an anti-inflammatory effect on the CNS Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI
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