Safety of Polyphenon E in Multiple Sclerosis Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00836719
First received: February 3, 2009
Last updated: May 21, 2013
Last verified: May 2013

February 3, 2009
May 21, 2013
February 2009
November 2010   (final data collection date for primary outcome measure)
Number of Participants Experiencing Serious Adverse Events [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Frequency and severity of adverse events [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00836719 on ClinicalTrials.gov Archive Site
Change in Brain NAA Level as Measured by MR Spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
percent change from baseline to exit in NAA levels adjusted for creatine levels
  • Change in brain NAA level as measured by MR Spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in peak T1 times [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • serum levels of EGCG will be correlated with the changes in NAA and other imaging parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety of Polyphenon E in Multiple Sclerosis Pilot Study
Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis

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.

Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
Drug: Polyphenon E
Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
Other Names:
  • EGCG
  • Green tea extract
Experimental: Polyphenon E
Standarized green tea extract containing 50% EGCG
Intervention: Drug: Polyphenon E
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of MS by McDonald criteria
  • Relapsing-remitting MS or secondary progressive MS
  • Stable therapy with Copaxone, for at least six months prior to inclusion in the study or no therapy for six months in subjects refusing therapy.
  • 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.

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, 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836719
K23 AT004433-01, K23AT004433-01, 1K23AT004433-01
Yes
Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
Louisiana State University Health Sciences Center in New Orleans
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Jesus F Lovera, MD, MSPH LSUHSC
Louisiana State University Health Sciences Center in New Orleans
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP