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

January 30, 2014 updated by: Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans

Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo capsules.
Other: Placebo
Matching placebo capsules
Experimental: Polyphenon E 400mg twice a day
Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.
Drug: 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.
Other Names:
  • EGCG
  • Green tea extract
  • epigallocatechin gallate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Change in NAA Levels Adjusted for Water Content.
Time Frame: 1 year
The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Atrophy
Time Frame: 1 year
Difference between the two groups in brain atrophy as measured by SIENA
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jesus F Lovera, MD, LSUHSC-New Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23AT004433-02 (U.S. NIH Grant/Contract)
  • K23AT004433 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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