Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

This will be a double blind placebo controlled trial of Theaphenon 95% (95% pure
Epigallo-catechin-galleate [EGCG]) as a treatment for MS.

The primary outcome will be the changes in N-Acety-Aspartate (NAA) levels over six months.
Secondary outcomes will be changes in brain atrophy over over six months. As an exploratory
outcome we will correlate changes in NAA levels with free Plasma levels of EGCG 8 hours
after the morning dose.

Exploratory outcomes include disability progression by Expanded Disability Status Scale
(EDSS), multiple sclerosis functional composite components and a cognitive test battery.

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:

- Leukocytes ≥3,000/µL

- Absolute neutrophil count ≥1,500/µL

- Platelets ≥100,000/µL

- Total bilirubin ≤local upper limit of normal

- AST (SGOT) ≤local upper limit of normal

- ALT (SGPT) ≤local upper limit of normal

- Creatinine ≤local upper limit of normal

Exclusion Criteria:

- MS relapse within the 30 days prior to enrollment

- A primary progressive form of MS.

- Previous treatment prior to study entry as follows: complete radiation ablation of
the bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,
cyclophosphamide, Natalizumab or other immunomodulatory or immunosuppressant
therapies except the DMT's included in the inclusion criteria and methylprednisone
for relapses within prior nine months.

- 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)