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Safety of Polyphenon E in Multiple Sclerosis Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00836719
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: Polyphenon E
Enrollment 10
Recruitment Details Recruitment started in 9/2009 and ended 4/2010. Subjects were recruited from the LSU MS Clinic and from the community. Advertisements were placed in the quarterly MS Society newsletter and email list.
Pre-assignment Details  
Arm/Group Title Polyphenon E
Hide Arm/Group Description

Standarized green tea extract containing 50% EGCG

Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.

Two capsules twice a day.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Polyphenon E
Hide Arm/Group Description

Standarized green tea extract containing 50% EGCG

Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.

Two capsules twice a day.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
45
(39 to 56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
9
  90.0%
Male
1
  10.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
1
  10.0%
Not Hispanic or Latino
9
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  10.0%
White
8
  80.0%
More than one race
1
  10.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Type of MS  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Relapsing Remitting 9
Secondary Progressive 1
Expanded Disability Status Scale   [1] 
Median (Full Range)
Unit of measure:  Points
Number Analyzed 10 participants
4
(1 to 6.5)
[1]
Measure Description: Expanded Disability Status Scale. Scored according to Neurostatus guidelines.Vakues range from 0-10. Higher values are worse.
Disease duration  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
14
(3 to 34)
1.Primary Outcome
Title Number of Participants Experiencing Serious Adverse Events
Hide Description [Not Specified]
Time Frame six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E
Hide Arm/Group Description:

Standarized green tea extract containing 50% EGCG

Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.

Two capsules twice a day.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Change in Brain NAA Level as Measured by MR Spectroscopy
Hide Description percent change from baseline to exit in NAA levels adjusted for creatine levels
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E
Hide Arm/Group Description:

Standarized green tea extract containing 50% EGCG

Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.

Two capsules twice a day.

Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: percentage change from baseline
10
(3.4 to 16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Polyphenon E
Comments N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10
Confidence Interval 95%
3.4 to 16.2
Estimation Comments Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyphenon E
Hide Arm/Group Description

Standarized green tea extract containing 50% EGCG

Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.

Two capsules twice a day.

All-Cause Mortality
Polyphenon E
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Polyphenon E
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Polyphenon E
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Eye disorders   
subconjunctival hemorrage * 2  1/10 (10.00%)  1
Gastrointestinal disorders   
Pain other abdomen NOS * 2  2/10 (20.00%)  2
constipation * 2  1/10 (10.00%)  1
diarrhea * 2  2/10 (20.00%)  2
Nausea * 2  3/10 (30.00%)  6
vomiting * 2  1/10 (10.00%)  2
General disorders   
fatigue * 2  1/10 (10.00%)  1
Pain * 2  1/10 (10.00%)  1
Infections and infestations   
Skin infection * 2  1/10 (10.00%)  1
Otitis media * 2  1/10 (10.00%)  1
Shingles * 2  1/10 (10.00%)  1
sinusitis * 2  1/10 (10.00%)  1
upper respiratory infection * 2  2/10 (20.00%)  2
Urinary tract infection * 2  1/10 (10.00%)  1
Investigations   
ALT  1  2/10 (20.00%)  2
Metabolism and nutrition disorders   
Hyperglycemia * 2  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Back Pain * 2  1/10 (10.00%)  1
Pain in extremity * 2  4/10 (40.00%)  4
Muscle weakness lower limb * 2  2/10 (20.00%)  2
neck pain * 2  1/10 (10.00%)  1
Nervous system disorders   
Headache * 2  3/10 (30.00%)  3
restless legs * 2  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCSAE 3.0
2
Term from vocabulary, CTCAE (3.0)
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jesus Lovera MD
Organization: LSU Health Sciences Center-New Orleans
Phone: 5045686700
Responsible Party: Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00836719     History of Changes
Other Study ID Numbers: K23AT004433-01 ( U.S. NIH Grant/Contract )
K23AT004433-01 ( U.S. NIH Grant/Contract )
1K23AT004433-01 ( U.S. NIH Grant/Contract )
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: April 4, 2013
Results First Posted: June 27, 2013
Last Update Posted: June 27, 2013