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Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II (POEMS)

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ClinicalTrials.gov Identifier: NCT01451723
Recruitment Status : Terminated (Unusual high frequency of elevated liver function tests.)
First Posted : October 14, 2011
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
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 Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Polyphenon E
Other: Placebo
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polyphenon E 400mg Twice a Day Placebo
Hide Arm/Group Description

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

Polyphenon E: 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.

Matching placebo capsules.

Placebo: Matching placebo capsules

Period Title: Overall Study
Started 6 5
Completed 0 0
Not Completed 6 5
Reason Not Completed
study halted             6             5
Arm/Group Title Polyphenon E 400mg Twice a Day Placebo Total
Hide Arm/Group Description

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

Polyphenon E: 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.

Matching placebo capsules.

Placebo: Matching placebo capsules

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
49.6  (6.2) 47  (7.6) 48.2  (6.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
5
 100.0%
11
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
4
  66.7%
5
 100.0%
9
  81.8%
Male
2
  33.3%
0
   0.0%
2
  18.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
5
 100.0%
11
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
5
 100.0%
11
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6 5 11
1.Primary Outcome
Title Rate of Change in NAA Levels Adjusted for Water Content.
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects completed either the six or twelve month point so no data was available for analysis.
Arm/Group Title Polyphenon E 400mg Twice a Day Placebo
Hide Arm/Group Description:

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

Polyphenon E: 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.

Matching placebo capsules.

Placebo: Matching placebo capsules

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Brain Atrophy
Hide Description Difference between the two groups in brain atrophy as measured by SIENA
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E 400mg Twice a Day Placebo
Hide Arm/Group Description:

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

Polyphenon E: 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.

Matching placebo capsules.

Placebo: Matching placebo capsules

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyphenon E 400mg Twice a Day Placebo
Hide Arm/Group Description

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

Polyphenon E: 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.

Matching placebo capsules.

Placebo: Matching placebo capsules

All-Cause Mortality
Polyphenon E 400mg Twice a Day Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Polyphenon E 400mg Twice a Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/5 (0.00%)    
Hepatobiliary disorders     
Elevated liver enzymes  1  1/6 (16.67%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEv3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Polyphenon E 400mg Twice a Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      0/5 (0.00%)    
Hepatobiliary disorders     
elevated liver enzymes  1  5/6 (83.33%)  5 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEv3
The study was halted prematurely because of the high incidence of liver function abnormalities
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jesus Lovera MD
Organization: Louisiana Health Sciences Center-New Orleans
Phone: 50-903 9302
Responsible Party: Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT01451723     History of Changes
Other Study ID Numbers: K23AT004433-02 ( U.S. NIH Grant/Contract )
K23AT004433-02 ( U.S. NIH Grant/Contract )
K23AT004433 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2011
First Posted: October 14, 2011
Results First Submitted: December 10, 2013
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014