Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Inclusion Criteria

• •Diagnosis of MS by McDonald criteria
• •Relapsing-remitting MS or secondary progressive MS
• •Stable therapy with Copaxone, Rebif, Betaseron or Avonex 30 mcg for at least six months
• •EDSS Score less than or equal to 7.0
• •Ages 18-60.
• •Participants must have normal organ and marrow function as defined below:
• •1. Leukocytes ≥3,000/µL
• •2. Absolute neutrophil count ≥1,500/µL
• •3. Platelets ≥100,000/µL
• •4. Total bilirubin ≤local upper limit of normal
• •5. AST (SGOT) ≤local upper limit of normal
• •6. ALT (SGPT) ≤local upper limit of normal
• •7. Creatinine ≤local upper limit of normal
• •History of renal or liver disease.
• •Consumption of green tea or supplements containing green tea or tea extract within 30 days prior to enrollment.
• •Participants may not participate in any other clinical trial involving investigational agents during the study, or within six months prior to enrolling in the study.
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Polyphenon E, tea, or any of the inactive ingredients present in the active or placebo capsules, including gelatin.
• •History of allergic reactions to gadolinium or any other condition contraindicated for MRI.
• •Uncontrolled, clinically-relevant active illness (aside from MS) including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
• •Inability to complete the baseline MRI scan
• •Pregnant women
• •Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, diverticulitis, colitis, hemorrhoids)