Safety of Polyphenon E in Multiple Sclerosis Pilot Study

NCT00836719 | Completed Phase 1 Results DMC

• 2 other identifiers: K23AT004433-011K23AT004433-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; safety; open label; Polyphenon E; EGCG; NAA; N-acetyl-aspartate; MRI

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Serious Adverse Events

  six months

Secondary Outcomes (1)

• Change in Brain NAA Level as Measured by MR Spectroscopy

  6 months

Study Arms (1)

Polyphenon E

EXPERIMENTAL

Standarized green tea extract containing 50% EGCG

Drug: Polyphenon E

Interventions

Polyphenon E DRUG

Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.

Also known as: EGCG, Green tea extract

Polyphenon E

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
• EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)
• Ages 18-60.
• Leukocytes ≥3,000/µL
• Absolute neutrophil count ≥1,500/µL
• Platelets ≥100,000/µL
• Total bilirubin ≤local upper limit of normal
• normal AST (SGOT) ALT (SGPT)
• normal serum Creatinine
• women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document.
• Willing to drink at most one cup of black tea and two cups of coffee per day, and abstain from drinking green tea or taking supplements containing green tea or green tea compounds, for the duration of the investigation.

You may not qualify if:

• 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, cyclosporin, Natalizumab or other immunomodulatory or immunosuppressant therapies except for Copaxone or 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 or breastfeeding women.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Louisiana Health Sciences Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Related Publications (2)

• Aktas O, Prozorovski T, Smorodchenko A, Savaskan NE, Lauster R, Kloetzel PM, Infante-Duarte C, Brocke S, Zipp F. Green tea epigallocatechin-3-gallate mediates T cellular NF-kappa B inhibition and exerts neuroprotection in autoimmune encephalomyelitis. J Immunol. 2004 Nov 1;173(9):5794-800. doi: 10.4049/jimmunol.173.9.5794.

  PMID: 15494532 BACKGROUND

• 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: 26298797 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

polyphenon E; Tea

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)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

The study was a pilot study with a small sample size and no control group. The primary endpoint was futility in change in NAA thus the p-values for the primary endpoint are nominal only.

Results Point of Contact

• Title: Jesus Lovera MD
• Organization: LSU Health Sciences Center-New Orleans

jlover@lsuhsc.edu

5045686700

Study Officials

• Jesus F Lovera, MD, MSPH

  LSUHSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 27, 2013
• Results First Posted: June 27, 2013

Record last verified: 2013-05

Locations

US (1)