Clinical trial NCT02011451: Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
Official title: Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Green Tea
ECGC
Theaphenon
Randomized placebo controlled trial
NAA
Spectroscopy
Brain Atrophy
SIENA
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2013-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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)

Primary outcomes:
measure: Rate of change in NAA levels adjusted for water content.
timeFrame: 6 months
Secondary outcomes:
measure: Brain Atrophy
timeFrame: 6 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
Study officials:
References: