Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis|
- Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.
- Determine dose of BHT-3009 and regimen for phase II testing.
- Describe effect of treatment on antibody and T cell responses to myelin basic protein (MBP).
- Describe clinical course of treated patients.
- Explore biomarkers of MS activity
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||March 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103974
|United States, Arizona|
|Barrow Neurology Clinics|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|USC, LAC & USC Medical Center|
|Los Angeles, California, United States, 90033|
|Canada, British Columbia|
|University of British Columbia, MS Research|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Montreal Neurological Institute, Clinical Research Unit and MS clinic|
|Montreal, Quebec, Canada, H3A 2B4|
|Study Director:||Frank Valone, MD||Bayhill Therapeutics|