Viewing Study NCT00103974



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Study NCT ID: NCT00103974
Status: COMPLETED
Last Update Posted: 2008-04-07
First Post: 2005-02-17

Brief Title: Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
Sponsor: Bayhill Therapeutics
Organization: Bayhill Therapeutics

Study Overview

Official Title: A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
Status: COMPLETED
Status Verified Date: 2008-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin Lipitor in patients with multiple sclerosis MS
Detailed Description: This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin Lipitor in patients with multiple sclerosis MS

Patients with MS are thought to have an immune response that attacks certain proteins in the brain including myelin basic protein Myelin basic protein is a protein that makes up part of the outside layer of nerve cells BHT-3009 is an investigational immunotherapy product that is designed to alter the immune response to myelin basic protein and make the response less harmful BHT-3009 contains the DNA gene for myelin basic protein

Three different doses of BHT-3009 will be tested to determine if there are any differences in safety or effects on immunity This is the first clinical research study of BHT-3009 Laboratory studies have shown that BHT-3009 and atorvastatin given together alters the immune response to myelin basic protein and makes the response less harmful

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