NCT00103974

Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Bayhill Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BHT-3009-01

Timeline

• Start date: 2004-07-01
• Completion: 2007-03-01
• First posted: 2005-02-18
• Last updated: 2008-04-07

Locations

4 sites across 2 countries: United States, Canada