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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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This will be a double blind placebo controlled trial of Polyphenon E as a treatment for MS.

The primary outcome will be the changes in NAA levels over one year. Secondary outcomes will be changes in brain atrophy over one year. 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 EDSS, MS functional composite components and a cognitive test battery.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Polyphenon E 400mg twice a day

Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.

Group Type EXPERIMENTAL

Polyphenon E

Intervention Type DRUG

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.

Placebo

Matching placebo capsules.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching placebo capsules

Interventions

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Polyphenon E

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.

Intervention Type DRUG

Placebo

Matching placebo capsules

Intervention Type OTHER

Other Intervention Names

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EGCG epigallocatechin gallate Green tea extract

Eligibility Criteria

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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)