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

Multiple Sclerosis Clinical Trial

Official title:

Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02011451
• Other study ID #: 4818-A-1
• Secondary ID: 4816-A-1
• Status: Withdrawn
• Phase: Phase 2
• First received: December 10, 2013
• Last updated: September 23, 2016
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 95% Pure ECGC capsules 200mg
Theaphenon 95% 95% Pure EGCG
• Placebo Comparator:

Locations

Country	Name	City	State
United States	LSU Health Sciences Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in NAA levels adjusted for water content.	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.	6 months	No
Secondary	Brain Atrophy	Difference between the two groups in brain atrophy as measured by SIENA	6 months	No