Trial Outcomes & Findings for Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II (NCT NCT01451723)
NCT ID: NCT01451723
Last Updated: 2014-03-14
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2014-03-14
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
study halted
|
6
|
5
|
Baseline Characteristics
Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II
Baseline characteristics by cohort
| Measure |
Polyphenon E 400mg Twice a Day
n=6 Participants
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
n=5 Participants
Matching placebo capsules.
Placebo: Matching placebo capsules
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
47 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: No subjects completed either the six or twelve month point so no data was available for analysis.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearDifference between the two groups in brain atrophy as measured by SIENA
Outcome measures
Outcome data not reported
Adverse Events
Polyphenon E 400mg Twice a Day
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Polyphenon E 400mg Twice a Day
n=6 participants at risk
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
n=5 participants at risk
Matching placebo capsules.
Placebo: Matching placebo capsules
|
|---|---|---|
|
Hepatobiliary disorders
Elevated liver enzymes
|
16.7%
1/6 • Number of events 1 • 1 year
|
0.00%
0/5 • 1 year
|
Other adverse events
| Measure |
Polyphenon E 400mg Twice a Day
n=6 participants at risk
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
n=5 participants at risk
Matching placebo capsules.
Placebo: Matching placebo capsules
|
|---|---|---|
|
Hepatobiliary disorders
elevated liver enzymes
|
83.3%
5/6 • Number of events 5 • 1 year
|
0.00%
0/5 • 1 year
|
Additional Information
Jesus Lovera MD
Louisiana Health Sciences Center-New Orleans
Phone: 50-903 9302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place