NCT01451723

Brief Summary

The hypothesis is that Polyphenon E 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 year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 multiple-sclerosis

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

October 11, 2011

Results QC Date

December 10, 2013

Last Update Submit

January 30, 2014

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisPolyphenon EGreen teaEGCGEpigallocatechin-galleatePlaceboRandomized controlled trial

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, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD \<30 will be used. A spatial anysotropic exponential covariance structure will be used.

    1 year

Secondary Outcomes (1)

  • Brain Atrophy

    1 year

Study Arms (2)

Polyphenon E 400mg twice a day

EXPERIMENTAL

Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.

Drug: Polyphenon E

Placebo

PLACEBO COMPARATOR

Matching placebo capsules.

Other: Placebo

Interventions

Polyphenon EDRUG

Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food.

Also known as: EGCG, epigallocatechin gallate, Green tea extract
Polyphenon E 400mg twice a day
PlaceboOTHER

Matching placebo capsules

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSu Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

  • Lovera J, Ramos A, Devier D, Garrison V, Kovner B, Reza T, Koop D, Rooney W, Foundas A, Bourdette D. Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies. J Neurol Sci. 2015 Nov 15;358(1-2):46-52. doi: 10.1016/j.jns.2015.08.006. Epub 2015 Aug 7.

    PMID: 26298797DERIVED

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

polyphenon Eepigallocatechin gallateTea

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Limitations and Caveats

The study was halted prematurely because of the high incidence of liver function abnormalities

Results Point of Contact

Title
Jesus Lovera MD
Organization
Louisiana Health Sciences Center-New Orleans
jlover@lsuhsc.edu
50-903 9302

Study Officials

  • Jesus F Lovera, MD

    LSUHSC-New Orleans

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MsPH

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 14, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 14, 2014

Results First Posted

March 14, 2014

Record last verified: 2014-01

Locations

US(1)