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
  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:


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
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014