Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Polyphenon E; Placebo
Intervention description: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food.; Matching placebo capsules
Intervention MeSH terms: Epigallocatechin gallate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Polyphenon E; Green tea; EGCG; Epigallocatechin-galleate; Placebo; Randomized controlled trial

Summary:

      The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple
      Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate
      (a chemical that reflects the number of neurons and their metabolism) over one year between
      people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS
      treated with a matching sugar pill.
    

Eligibility criteria:

        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

        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)