Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
Brief 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.


Options:
A: Inclusion Criteria:

* Patients with relapsing-remitting multiple sclerosis
* stable treatment with glatiramer acetate at least 6 months prior to inclusion
* Expanded disability status scale \< 4.5
* Normal weight, overweight

Exclusion Criteria:

* Primary or secondary progressive forms of multiple sclerosis
* Clinically relevant heart, lung, liver, kidney diseases
* Habitual caffeine intake over 300 mg per day
* Habitual consumption of green tea
* Alcohol or drug abuse
B: Inclusion Criteria:

* Diagnosis of SPMS
* Age 40-70 years
* Able to understand English and able to give informed consent

Exclusion Criteria:

* Unable to undergo MRI testing
* For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
* For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
* Pregnant or breast-feeding.
* Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
* Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
* Other immunosuppressants or chemotherapies taken in the last 12 months
* Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
* IV or oral steroids taken in the past 60 days.
* Lipoic acid taken in the past 60 days.
* Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications
C: 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.
D: Inclusion Criteria:

* Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
* With an EDSS score ≥ 3
* Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
* Ambulatory at inclusion
* Able to undergo evaluation
* Informed written consent

Non-inclusion Criteria:

* Regular consumption of cranberry within 3 months before inclusion
* Symptomatic urinary tract infection at inclusion
* Chronic renal failure (creatinin clearance \< 10ml/min)
* Patients with urinary permanent catheterization
* Patients with hyperuricemia and risk of uric acid lithiasis
* Patients with oral anticoagulant treatment (antivitamins K)
* Peptic ulcer
* Intolerance to cranberry and/or excipients
* Urinary tract infections antibioprophylaxis

Answer: C