Stopped earlyPhase 2Relapsing and progressiveNCT01451723

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Unusual high frequency of elevated liver function tests.

What was tested

Treatment tested

  • Sinecatechins

    Unknown

Placebo or sham

  • Placebo

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Polyphenon E 400mg Twice a Day61 (16.7%)
Placebo50 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Rate of Change in NAA Levels Adjusted for Water Content.

    1 year

    MRI lesionsBlood or spinal fluid markers

Other measures (1)

  • Brain Atrophy

    1 year

    Brain volume loss

Who could take part

Relapsing and progressive · 18 to 60

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Jul 2011

    2. Main results due

      Feb 2013

    3. Finished

      Feb 2013

    4. Results posted

      Mar 2014

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