Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
Bayhill Therapeutics
ClinicalTrials.gov Identifier:
NCT00103974
First received: February 17, 2005
Last updated: April 4, 2008
Last verified: February 2008

February 17, 2005
April 4, 2008
July 2004
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00103974 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Multiple Sclerosis
Biological: BHT-3009-01
Not Provided
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. Epub 2007 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2007
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00103974
BHT-3009-01
Not Provided
Not Provided
Bayhill Therapeutics
Not Provided
Study Director: Frank Valone, MD Bayhill Therapeutics
Bayhill Therapeutics
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP