BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00382629|
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : February 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Remitting Multiple Sclerosis||Drug: BHT-3009 0.5 mg Drug: BHT-3009 1.5 mg Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||BHT-3009 Immunotherapy in Relapsing Remitting Multiple Sclerosis|
|Study Start Date :||February 2006|
|Estimated Study Completion Date :||June 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382629
|Study Director:||Frank Valone, MD||Bayhill Therapeutics|