BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis
The purpose of this study is to determine if BHT-3009 decreases inflammation (measured by gadolinium enhancing MRI lesions) in the brains of people with relapsing remitting multiple sclerosis.
Relapsing Remitting Multiple Sclerosis
Drug: BHT-3009 0.5 mg
Drug: BHT-3009 1.5 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis|
- Evaluate the effect of BHT-3009 on the mean four-week rate of occurrence of new gadolinium (Gd) enhancing MRI lesions in relapsing remitting MS.
- Evaluate the safety and tolerability of intramuscular injections of BHT-3009 given for a total of one year.
- Evaluate the effect of BHT-3009 on other cranial MRI measures.
- Describe the effect of BHT-3009 therapy on relapse rate.
- Describe the effect of BHT-3009 on subject disability scores.
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||June 2007|
People with multiple sclerosis are thought to have abnormal immunity. Usually the body's immune system attacks only foreign substances, but people with MS have abnormal immunity, where the immune system attacks normal proteins, one of which is a protein found in the brain called MBP (myelin basic protein). This abnormal immunity causes inflammation in the brain resulting in nerve damage. BHT-3009 is a drug that is designed to decrease this abnormal immunity to MBP. BHT-3009 is a DNA plasmid that contains the gene for MBP. Plasmids are circular pieces of DNA that are being tested in clinical trials for their ability to alter patients' immune systems. Two different doses of BHT-3009 will be tested to determine if there are any differences in their safety or effects on inflammation.
Treatment in this study is 3 doses every two weeks for 6 weeks, followed by a dose every 4 weeks for a total of 13 doses in 44 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382629
|Study Director:||Frank Valone, MD||Bayhill Therapeutics|