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
Results First Received: April 4, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Intervention: Drug: Polyphenon E

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Polyphenon E

Standarized green tea extract containing 50% EGCG

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

Two capsules twice a day.


Participant Flow:   Overall Study
    Polyphenon E  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Polyphenon E

Standarized green tea extract containing 50% EGCG

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

Two capsules twice a day.


Baseline Measures
    Polyphenon E  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Median ( Full Range )
  45  
  ( 39 to 56 )  
Gender  
[units: participants]
 
Female     9  
Male     1  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     9  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     8  
More than one race     1  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     10  
Type of MS  
[units: participants]
 
Relapsing Remitting     9  
Secondary Progressive     1  
Expanded Disability Status Scale [1]
[units: points]
Median ( Full Range )
  4  
  ( 1 to 6.5 )  
Disease duration  
[units: years]
Median ( Full Range )
  14  
  ( 3 to 34 )  
[1] Expanded Disability Status Scale. Scored according to Neurostatus guidelines.Vakues range from 0-10. Higher values are worse.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Experiencing Serious Adverse Events   [ Time Frame: six months ]

2.  Secondary:   Change in Brain NAA Level as Measured by MR Spectroscopy   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: jlover@lsuhsc.edu


Publications:

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: K23 AT004433-01, K23AT004433-01, 1K23AT004433-01
Study First Received: February 3, 2009
Results First Received: April 4, 2013
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration