Status:
COMPLETED
Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
Lead Sponsor:
Bayhill Therapeutics
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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).
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00103974
Start Date
July 1 2004
End Date
March 1 2007
Last Update
April 7 2008
Active Locations (4)
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1
Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
2
USC, LAC & USC Medical Center
Los Angeles, California, United States, 90033
3
University of British Columbia, MS Research
Vancouver, British Columbia, Canada, V6T 2B5
4
Montreal Neurological Institute, Clinical Research Unit and MS clinic
Montreal, Quebec, Canada, H3A 2B4