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

NCT ID: NCT02011451

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

95% Pure ECGC capsules 200mg

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

Group Type: EXPERIMENTAL

95% Pure ECGC capsules 200mg

Intervention Type: DRUG

Theaphenon 95% 95% Pure EGCG

Sugar pill

Matched placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo Comparator:

Intervention Type: DRUG

Interventions

95% Pure ECGC capsules 200mg

Theaphenon 95% 95% Pure EGCG

Intervention Type: DRUG

Placebo Comparator:

Intervention Type: DRUG

Other Intervention Names

Theaphenon 95%; "Sugar pill"

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

• 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)

Exclusion Criteria

• MS relapse within the 30 days prior to enrollment
• A primary progressive form of MS.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Jesus Lovera MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LSU Health Sciences Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

4816-A-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4818-A-1

Identifier Type: -

Identifier Source: org_study_id