Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Louisiana State University Health Sciences Center in New Orleans
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT02011451
First received: December 10, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The hypothesis is that 95% pure EGCG 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 six between people with MS treated with EGCG at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.


Condition Intervention Phase
Multiple Sclerosis
Drug: 95% Pure ECGC capsules 200mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • Rate of change in NAA levels adjusted for water content. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The rate of change will be calculated using all the time points available (baseline,3 and 6 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %cerebrospinal fluid (CSF) and % lesion volume as covariates. All the voxels available for each subject where estimates have a standard deviation(SD) <30 will be used. A spatial anisotropic exponential covariance structure will be used.


Secondary Outcome Measures:
  • Brain Atrophy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Difference between the two groups in brain atrophy as measured by SIENA


Estimated Enrollment: 48
Study Start Date: January 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 95% Pure ECGC capsules 200mg
95% Pure ECGC capsules 200mg three times a day with food for 6 months
Drug: 95% Pure ECGC capsules 200mg
Other Name: Theaphenon 95%
Placebo Comparator: Sugar pill
Matched placebo capsules

Detailed Description:

This will be a double blind placebo controlled trial of Theaphenon 95% (95% pure Epigallo-catechin-galleate [EGCG]) as a treatment for MS.

The primary outcome will be the changes in N-Acety-Aspartate (NAA) levels over six months. Secondary outcomes will be changes in brain atrophy over over six months. 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 Expanded Disability Status Scale (EDSS), multiple sclerosis functional composite components and a cognitive test battery.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • Leukocytes ≥3,000/µL
    • Absolute neutrophil count ≥1,500/µL
    • Platelets ≥100,000/µL
    • Total bilirubin ≤local upper limit of normal
    • AST (SGOT) ≤local upper limit of normal
    • ALT (SGPT) ≤local upper limit of normal
    • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011451

Locations
United States, Louisiana
LSU Health Sciences Center Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Jesus F Lovera, MD    504-903-9302    jlover@lsuhsc.edu   
Principal Investigator: Jesus F Lovera, MD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
National Multiple Sclerosis Society
  More Information

No publications provided

Responsible Party: Jesus Lovera MD, Assistant Professor, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02011451     History of Changes
Other Study ID Numbers: 4818-A-1, 4816-A-1
Study First Received: December 10, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Multiple Sclerosis
Green Tea
ECGC
Theaphenon
Randomized placebo controlled trial
NAA
Spectroscopy
Brain Atrophy
SIENA

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014