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

NCT02011451 | Withdrawn Phase 2 DMC

• 2 other identifiers: 4818-A-14816-A-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Brain Atrophy

  6 months

Study Arms (2)

95% Pure ECGC capsules 200mg

EXPERIMENTAL

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

Drug: 95% Pure ECGC capsules 200mg

Sugar pill

PLACEBO COMPARATOR

Matched placebo capsules

Drug: Placebo Comparator:

Interventions

95% Pure ECGC capsules 200mg DRUG

Theaphenon 95% 95% Pure EGCG

Also known as: Theaphenon 95%

95% Pure ECGC capsules 200mg

Placebo Comparator: DRUG

Also known as: "Sugar pill"

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Sugars

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

US (1)