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

This study has been terminated.
(Unusual high frequency of elevated liver function tests.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT01451723
First received: October 11, 2011
Last updated: January 30, 2014
Last verified: January 2014
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: Polyphenon E
Other: Placebo

  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
No text entered.

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 400mg Twice a Day

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.

Placebo

Matching placebo capsules.

Placebo: Matching placebo capsules


Participant Flow:   Overall Study
    Polyphenon E 400mg Twice a Day     Placebo  
STARTED     6     5  
COMPLETED     0     0  
NOT COMPLETED     6     5  
study halted                 6                 5  



  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 400mg Twice a Day

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.

Placebo

Matching placebo capsules.

Placebo: Matching placebo capsules

Total Total of all reporting groups

Baseline Measures
    Polyphenon E 400mg Twice a Day     Placebo     Total  
Number of Participants  
[units: participants]
  6     5     11  
Age  
[units: years]
Mean ± Standard Deviation
  49.6  ± 6.2     47  ± 7.6     48.2  ± 6.9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     5     11  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     4     5     9  
Male     2     0     2  
Race (NIH/OMB)  
[units: 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     0     0     0  
White     6     5     11  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     6     5     11  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     6     5     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Change in NAA Levels Adjusted for Water Content.   [ Time Frame: 1 year ]

2.  Secondary:   Brain Atrophy   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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 halted prematurely because of the high incidence of liver function abnormalities  


Results Point of Contact:  
Name/Title: Jesus Lovera MD
Organization: Louisiana Health Sciences Center-New Orleans
phone: 50-903 9302
e-mail: jlover@lsuhsc.edu


No publications provided


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: K23 AT004433-02, K23AT004433-02, K23AT004433
Study First Received: October 11, 2011
Results First Received: December 10, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration