Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Pat
A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- BHT-3009-01
What it measured
Main measures
Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.
SafetyDetermine dose of BHT-3009 and regimen for phase II testing.
Other measures (3)
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
Blood or spinal fluid markers
Who could take part
Relapsing and progressive · 18 to 65
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Jul 2004
Finished
Mar 2007