Safety of Polyphenon E in Multiple Sclerosis Pilot Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Polyphenon E
Intervention description: Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; safety; open label; Polyphenon E; EGCG; NAA; N-acetyl-aspartate; MRI

Summary:

      This study is an open label 6 month study. All subjects will be treated with Polyphenon E
      (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be
      safety. Secondary outcomes are the change in NAA levels over 6 months as measured by
      MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E
      will protect neurons and thus increase NAA levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MS by McDonald criteria

          -  Relapsing-remitting MS or secondary progressive MS

          -  Stable therapy with Copaxone, for at least six months prior to inclusion in the study
             or no therapy for six months in subjects refusing therapy.

          -  EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)

          -  Ages 18-60.

          -  Leukocytes ≥3,000/µL

          -  Absolute neutrophil count ≥1,500/µL

          -  Platelets ≥100,000/µL

          -  Total bilirubin ≤local upper limit of normal

          -  normal AST (SGOT) ALT (SGPT)

          -  normal serum Creatinine

          -  women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation.

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Willing to drink at most one cup of black tea and two cups of coffee per day, and
             abstain from drinking green tea or taking supplements containing green tea or green
             tea compounds, for the duration of the investigation.

        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, cyclosporin, Natalizumab or other immunomodulatory or
             immunosuppressant therapies except for Copaxone or 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 or breastfeeding women.