Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
This study has been completed.
Sponsor:
Bayhill Therapeutics
Information provided by:
Bayhill Therapeutics
ClinicalTrials.gov Identifier:
NCT00103974
First received: February 17, 2005
Last updated: April 4, 2008
Last verified: February 2008
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Biological: BHT-3009-01 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
Further study details as provided by Bayhill Therapeutics:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 30 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Definite diagnosis of multiple sclerosis by the McDonald 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:
- High-dose corticosteroids (e.g. >500 mg methylprednisolone or equivalent) within previous month.
- >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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103974
Locations
| 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 | |
| Canada, Quebec | |
| Montreal Neurological Institute, Clinical Research Unit and MS clinic | |
| Montreal, Quebec, Canada, H3A 2B4 | |
Sponsors and Collaborators
Bayhill Therapeutics
Investigators
| Study Director: | Frank Valone, MD | Bayhill Therapeutics |
More Information
Additional Information:
No publications provided by Bayhill Therapeutics
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00103974 History of Changes |
| Other Study ID Numbers: | BHT-3009-01 |
| Study First Received: | February 17, 2005 |
| Last Updated: | April 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayhill Therapeutics:
|
multiple sclerosis relapsing-remitting secondary progressive |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Butylated Hydroxytoluene Atorvastatin Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013