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

April 4, 2008 updated by: Bayhill Therapeutics

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia, MS Research
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute, Clinical Research Unit and MS clinic
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinics
    • California
      • Los Angeles, California, United States, 90033
        • USC, LAC & USC Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayhill Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

February 17, 2005

First Submitted That Met QC Criteria

February 17, 2005

First Posted (ESTIMATE)

February 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2008

Last Update Submitted That Met QC Criteria

April 4, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHT-3009-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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