Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
NCT ID: NCT00103974
Last Updated: 2008-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2004-07-31
2007-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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BHT-3009-01
Eligibility Criteria
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Inclusion Criteria
* Patients with relapsing remitting MS or secondary progressive MS are eligible.
* 1-5 gadolinium enhancing (Gd+) lesions on the first Screening MRI or relapse in the previous 2 years, or disease worsening in the previous 2 years
* Clinically stable for \> 1 month before screening evaluation and during screening. Patients who are stable on approved therapy are eligible only if they have intolerable side effects or other medical reasons for discontinuing approved therapy.
* Off interferon for \> 1 month before screening evaluation.
* Off immunosuppressive and cytotoxic therapy (e.g. mitoxantrone, cladrabine) \>12 months or \> 6 months with CD4 count \> 400.
* EDSS ≥ 2.5 and \< 7.0.
* Female or male, age \> 18 years.
* Able to give informed consent.
* WBC and platelets in normal range, hemoglobin \> 10.0 g/dl.
* AST, ALT, bilirubin \< upper limit of normal.
* Creatinine \< upper limit of normal.
* CPK \< upper limit of normal.
Exclusion Criteria
* \>5 Gd+ lesions on the first Screening MRI.
* Previous vaccine therapy, stem cell transplantation or total lymphoid radiation.
* Glatiramer within previous 12 months.
* Treatment with any statin in the previous 6 months or elevated cholesterol that requires treatment with a statin.
* Pregnant or lactating women.
* Unwilling to use a medically acceptable form of birth control.
* History of positive test for HIV, hepatitis B or hepatitis C.
* Clinically significant ECG abnormalities.
* Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
* Implanted pacemakers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
* History of intolerable adverse events with statin therapy.
18 Years
65 Years
ALL
No
Sponsors
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Bayhill Therapeutics
INDUSTRY
Principal Investigators
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Frank Valone, MD
Role: STUDY_DIRECTOR
Bayhill Therapeutics
Locations
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Barrow Neurology Clinics
Phoenix, Arizona, United States
USC, LAC & USC Medical Center
Los Angeles, California, United States
University of British Columbia, MS Research
Vancouver, British Columbia, Canada
Montreal Neurological Institute, Clinical Research Unit and MS clinic
Montreal, Quebec, Canada
Countries
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References
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Bar-Or A, Vollmer T, Antel J, Arnold DL, Bodner CA, Campagnolo D, Gianettoni J, Jalili F, Kachuck N, Lapierre Y, Niino M, Oger J, Price M, Rhodes S, Robinson WH, Shi FD, Utz PJ, Valone F, Weiner L, Steinman L, Garren H. Induction of antigen-specific tolerance in multiple sclerosis after immunization with DNA encoding myelin basic protein in a randomized, placebo-controlled phase 1/2 trial. Arch Neurol. 2007 Oct;64(10):1407-15. doi: 10.1001/archneur.64.10.nct70002. Epub 2007 Aug 13.
Related Links
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Click here for more information about this study: BHT-3009-01
Other Identifiers
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BHT-3009-01
Identifier Type: -
Identifier Source: org_study_id