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

Primary Purpose

Multiple Sclerosis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

95% Pure ECGC capsules 200mg

Placebo Comparator:

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Green Tea, ECGC, Theaphenon, Randomized placebo controlled trial, NAA, Spectroscopy, Brain Atrophy, SIENA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

LSU Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

95% Pure ECGC capsules 200mg

Sugar pill

Arm Description

95% Pure ECGC capsules 200mg three times a day with food for 6 months

Matched placebo capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Brain Atrophy

Difference between the two groups in brain atrophy as measured by SIENA

Full Information

NCT ID

NCT02011451

First Posted

December 10, 2013

Last Updated

September 23, 2016

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

National Multiple Sclerosis Society

1. Study Identification

Unique Protocol Identification Number

NCT02011451

Brief Title

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

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Withdrawn

Why Stopped

unable to enroll

Study Start Date

December 2015 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, Green Tea, ECGC, Theaphenon, Randomized placebo controlled trial, NAA, Spectroscopy, Brain Atrophy, SIENA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

95% Pure ECGC capsules 200mg

Arm Type

Experimental

Arm Description

95% Pure ECGC capsules 200mg three times a day with food for 6 months

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

Matched placebo capsules

Intervention Type

Drug

Intervention Name(s)

95% Pure ECGC capsules 200mg

Other Intervention Name(s)

Theaphenon 95%

Intervention Description

Theaphenon 95% 95% Pure EGCG

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator:

Other Intervention Name(s)

"Sugar pill"

Primary Outcome Measure Information:

Title

Rate of change in NAA levels adjusted for water content.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Brain Atrophy

Description

Difference between the two groups in brain atrophy as measured by SIENA

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

Facility Information:

Facility Name

LSU Health Sciences Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

12. IPD Sharing Statement

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

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