Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT00103974|
Recruitment Status : Completed
First Posted : February 18, 2005
Last Update Posted : April 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Biological: BHT-3009-01||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis|
|Study Start Date :||July 2004|
|Study Completion Date :||March 2007|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|