Trial Outcomes & Findings for Safety of Polyphenon E in Multiple Sclerosis Pilot Study (NCT NCT00836719)
NCT ID: NCT00836719
Last Updated: 2013-06-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
six months
Results posted on
2013-06-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Polyphenon E in Multiple Sclerosis Pilot Study
Baseline characteristics by cohort
| Measure |
Polyphenon E
n=10 Participants
Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day.
|
|---|---|
|
Age Continuous
|
45 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
|
Type of MS
Relapsing Remitting
|
9 participants
n=99 Participants
|
|
Type of MS
Secondary Progressive
|
1 participants
n=99 Participants
|
|
Expanded Disability Status Scale
|
4 points
n=99 Participants
|
|
Disease duration
|
14 years
n=99 Participants
|
PRIMARY outcome
Timeframe: six monthsOutcome measures
| Measure |
Polyphenon E
n=10 Participants
Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day.
|
|---|---|
|
Number of Participants Experiencing Serious Adverse Events
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthspercent change from baseline to exit in NAA levels adjusted for creatine levels
Outcome measures
| Measure |
Polyphenon E
n=10 Participants
Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day.
|
|---|---|
|
Change in Brain NAA Level as Measured by MR Spectroscopy
|
10 percentage change from baseline
Interval 3.4 to 16.2
|
Adverse Events
Polyphenon E
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Polyphenon E
n=10 participants at risk
Standarized green tea extract containing 50% EGCG
Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.
Two capsules twice a day.
|
|---|---|
|
Investigations
ALT
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Pain other abdomen NOS
|
20.0%
2/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
4/10 • Number of events 4
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
20.0%
2/10 • Number of events 2
|
|
General disorders
fatigue
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
restless legs
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Otitis media
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Shingles
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
sinusitis
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
subconjunctival hemorrage
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
upper respiratory infection
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
10.0%
1/10 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place