Trial Outcomes & Findings for Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents (NCT NCT02964377)
NCT ID: NCT02964377
Last Updated: 2021-12-21
Results Overview
Pharmacokinetic evaluation for dose-response evaluation.
COMPLETED
PHASE1/PHASE2
15 participants
Pre-dose and 2 hours post-dose at baseline
2021-12-21
Participant Flow
Participant milestones
| Measure |
Cohort 1
(+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
(+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
(+)- Epicatechin at 75mg/day at two times per day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=5 Participants
(+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
(+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
(+)- Epicatechin at 75mg/day at two times per day.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.2 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
11.9 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
12.8 years
STANDARD_DEVIATION 2.8 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Pre-dose and 2 hours post-dose at baselinePopulation: One Cohort 3 participant post-dose sample was missed.
Pharmacokinetic evaluation for dose-response evaluation.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=4 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak)
Trough
|
15.1 nM
Standard Deviation 10.4
|
33.9 nM
Standard Deviation 7.9
|
20.6 nM
Standard Deviation 43.6
|
|
Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak)
Peak
|
481.2 nM
Standard Deviation 477.6
|
551.2 nM
Standard Deviation 284.9
|
3899.3 nM
Standard Deviation 1217.6
|
PRIMARY outcome
Timeframe: Week 4Pharmacokinetic evaluation for dose-response evaluation.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak)
Trough
|
84.2 nM
Standard Deviation 47.6
|
163.8 nM
Standard Deviation 84.5
|
179.1 nM
Standard Deviation 398.1
|
|
Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak)
Peak
|
742.8 nM
Standard Deviation 442.7
|
601 nM
Standard Deviation 357
|
5590.8 nM
Standard Deviation 1729.9
|
PRIMARY outcome
Timeframe: Baseline, Week 4 and Week 8Evaluation of follistatin:myostatin ratio from plasma samples.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Laboratory Outcome: Absolute Plasma Follistatin:Myostatin Ratio at Baseline, Week 4 and Week 8
Baseline
|
1.82 Ratio of follistatin to myostatin (AU)
Standard Deviation 0.71
|
1.76 Ratio of follistatin to myostatin (AU)
Standard Deviation 0.74
|
3.31 Ratio of follistatin to myostatin (AU)
Standard Deviation 0.91
|
|
Laboratory Outcome: Absolute Plasma Follistatin:Myostatin Ratio at Baseline, Week 4 and Week 8
Week 4
|
3.61 Ratio of follistatin to myostatin (AU)
Standard Deviation 0.78
|
3.41 Ratio of follistatin to myostatin (AU)
Standard Deviation 1.24
|
5.26 Ratio of follistatin to myostatin (AU)
Standard Deviation 0.87
|
|
Laboratory Outcome: Absolute Plasma Follistatin:Myostatin Ratio at Baseline, Week 4 and Week 8
Week 8
|
4.02 Ratio of follistatin to myostatin (AU)
Standard Deviation 1.55
|
3.94 Ratio of follistatin to myostatin (AU)
Standard Deviation 1.23
|
5.7 Ratio of follistatin to myostatin (AU)
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Week 8Population: Missing data due to poor image quality.
Evaluation of change in cardiac volume and performance, as measured by the mean percent of baseline ejection fraction using Cardiac MRI, measured at 8 weeks.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=2 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Clinical Outcome: Mean Percent of Baseline Cardiac Ejection Fraction by MRI
|
98.19 percentage
Standard Deviation 14.92
|
96.23 percentage
Standard Deviation 9.66
|
92.27 percentage
Standard Deviation 14.98
|
PRIMARY outcome
Timeframe: Study duration (8 weeks)Treatment-related laboratory abnormalities, defined as values outside of the typical range for Duchenne Muscular Dystrophy. Safety laboratory tests included blood chemistry panel, complete blood count w/ differential panel, \& urinalysis assessments for clinical safety monitoring.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Safety: Number of Participants Who Experienced Treatment-Related Laboratory Abnormalities
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Laboratory Outcome: Absolute Values of Nitric Oxide (AU) Measured by ELISA
Baseline
|
0.65 AU
Standard Deviation 0.17
|
0.63 AU
Standard Deviation 0.14
|
0.57 AU
Standard Deviation 0.21
|
|
Laboratory Outcome: Absolute Values of Nitric Oxide (AU) Measured by ELISA
Week 4
|
0.82 AU
Standard Deviation 0.31
|
1.06 AU
Standard Deviation 0.16
|
0.93 AU
Standard Deviation 0.36
|
|
Laboratory Outcome: Absolute Values of Nitric Oxide (AU) Measured by ELISA
Week 8
|
0.99 AU
Standard Deviation 0.28
|
1.14 AU
Standard Deviation 0.15
|
0.92 AU
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Laboratory Outcome: Absolute Values of Carbonylation (AU) Measured by ELISA
Baseline
|
12.85 AU
Standard Deviation 2.38
|
15.7 AU
Standard Deviation 1.74
|
12.45 AU
Standard Deviation 3.91
|
|
Laboratory Outcome: Absolute Values of Carbonylation (AU) Measured by ELISA
Week 4
|
9.95 AU
Standard Deviation 1.72
|
12.2 AU
Standard Deviation 2.08
|
7.18 AU
Standard Deviation 2.74
|
|
Laboratory Outcome: Absolute Values of Carbonylation (AU) Measured by ELISA
Week 8
|
9.07 AU
Standard Deviation 1.41
|
10.47 AU
Standard Deviation 1.91
|
6.64 AU
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Laboratory Outcome: Absolute Values of Follistatin (AU) Measured by ELISA
Baseline
|
527.24 AU
Standard Deviation 282.06
|
555.71 AU
Standard Deviation 382.28
|
1011.25 AU
Standard Deviation 247.39
|
|
Laboratory Outcome: Absolute Values of Follistatin (AU) Measured by ELISA
Week 4
|
891.43 AU
Standard Deviation 278.51
|
795.71 AU
Standard Deviation 352.83
|
1356.25 AU
Standard Deviation 117.13
|
|
Laboratory Outcome: Absolute Values of Follistatin (AU) Measured by ELISA
Week 8
|
951.43 AU
Standard Deviation 312.39
|
914.29 AU
Standard Deviation 350.17
|
1351.25 AU
Standard Deviation 148.95
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Laboratory Outcome: Absolute Values of Myostatin (AU) Measured by ELISA
Week 8
|
247.07 AU
Standard Deviation 69.7
|
233.67 AU
Standard Deviation 78.47
|
241.67 AU
Standard Deviation 51.67
|
|
Laboratory Outcome: Absolute Values of Myostatin (AU) Measured by ELISA
Baseline
|
282.33 AU
Standard Deviation 69.7
|
302.33 AU
Standard Deviation 91.15
|
316.6 AU
Standard Deviation 88.7
|
|
Laboratory Outcome: Absolute Values of Myostatin (AU) Measured by ELISA
Week 4
|
247.67 AU
Standard Deviation 66.94
|
239 AU
Standard Deviation 90.2
|
263.67 AU
Standard Deviation 56.16
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8Population: Missing data due to equipment malfunction
Quantitative upper extremity reachable workspace will be assessed using the XBox Kinect system. The KINECT Upper Extremity Reachable Workspace test measures surface area of a reachable workspace "bubble", normalized to the size of the individual, noted as the RSA or Reachable Surface Area. The Total RSA measure is the sum of four quadrants dividing superior and inferior medial and lateral spaces. A total score of 1 indicates a typical reachable workspace, while lower scores indicate restrictions in one or more of the four quadrants.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=4 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Clinical Outcome: Percent of Normalized Upper Extremity Reachable Surface Area at Week 4 and Week 8
Baseline
|
44 % normalized reachable surface area
Standard Deviation 33.9
|
89.9 % normalized reachable surface area
Standard Deviation 24.6
|
33 % normalized reachable surface area
Standard Deviation 23.2
|
|
Clinical Outcome: Percent of Normalized Upper Extremity Reachable Surface Area at Week 4 and Week 8
Week 4
|
63.7 % normalized reachable surface area
Standard Deviation 44.4
|
84.4 % normalized reachable surface area
Standard Deviation 32.9
|
35.8 % normalized reachable surface area
Standard Deviation 21.4
|
|
Clinical Outcome: Percent of Normalized Upper Extremity Reachable Surface Area at Week 4 and Week 8
Week 8
|
47.9 % normalized reachable surface area
Standard Deviation 51.2
|
92.7 % normalized reachable surface area
Standard Deviation 35.4
|
41.5 % normalized reachable surface area
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8The standardized Performance of Upper Limb (PUL) measure will be assessed at baseline and after 4 \& 8 weeks. The Performance of the Upper Limb module is an observer-administered performance battery of upper extremity mobility tasks for the shoulder (upper, 6 items, 12 points), elbow (middle, 9 items, 17 points) and wrist/hand (distal, 7 items, 13 points). Higher scores indicate higher level of function. Total score ranges from 0-42 points and is the sum of the scores for the three subscales (10 upper, 10 mid, and 14 distal).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Clinical Outcome: Total Score Using Performance of the Upper Limb Assessment
Baseline
|
19.8 score on a scale
Standard Deviation 5.4
|
30.8 score on a scale
Standard Deviation 6.8
|
27 score on a scale
Standard Deviation 10.6
|
|
Clinical Outcome: Total Score Using Performance of the Upper Limb Assessment
Week 4
|
21.4 score on a scale
Standard Deviation 6.8
|
32 score on a scale
Standard Deviation 5.8
|
26.8 score on a scale
Standard Deviation 9.9
|
|
Clinical Outcome: Total Score Using Performance of the Upper Limb Assessment
Week 8
|
22 score on a scale
Standard Deviation 5.8
|
31.8 score on a scale
Standard Deviation 5.4
|
25.6 score on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8The Assisted Six-Minute Cycle Test is an ergometer-based assessment of upper limb function. Test results indicate the maximum number of ergometer revolutions achieved in six-minutes, with higher numbers indicating a greater degree of functional capacity.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Clinical Outcome: Mean Maximal Attained Revolutions Per 6-minute Cycle Test
Baseline
|
177.4 revolutions
Standard Deviation 112.4
|
362.6 revolutions
Standard Deviation 82.8
|
330.8 revolutions
Standard Deviation 172.5
|
|
Clinical Outcome: Mean Maximal Attained Revolutions Per 6-minute Cycle Test
Week 4
|
194.4 revolutions
Standard Deviation 80.4
|
415 revolutions
Standard Deviation 77.2
|
348.2 revolutions
Standard Deviation 222.3
|
|
Clinical Outcome: Mean Maximal Attained Revolutions Per 6-minute Cycle Test
Week 8
|
199 revolutions
Standard Deviation 96.6
|
387 revolutions
Standard Deviation 54
|
356.8 revolutions
Standard Deviation 275.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 8The PODCI instrument was developed by Daltroy and colleagues with support by the Pediatric Orthopaedic Society of North America (POSNA). The PODCI is a 108-item questionnaire that evaluates global functioning in the pediatric orthopedic population utilizing four components: upper extremity functioning, transfers and basic mobility, sports and physical functioning and a comfort/pain score. Global functioning is assessed by the average of the four previous scores. All scales are scored from zero to 100, with 100 representing the highest level of functioning and least pain. The PODCI asks questions such as "During the last week, was it easy or hard for you to … lift heavy books".
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Person-Reported Outcome: Upper Extremity Standardized Mean Score Using Pediatric Outcomes Data Collection Instrument (PODCI) Quality of Life Instrument
Baseline
|
32 score on a scale
Standard Deviation 12.9
|
62.6 score on a scale
Standard Deviation 24.6
|
66 score on a scale
Standard Deviation 22.3
|
|
Person-Reported Outcome: Upper Extremity Standardized Mean Score Using Pediatric Outcomes Data Collection Instrument (PODCI) Quality of Life Instrument
Week 4
|
31.2 score on a scale
Standard Deviation 16.4
|
74.6 score on a scale
Standard Deviation 18.3
|
72.6 score on a scale
Standard Deviation 21.3
|
|
Person-Reported Outcome: Upper Extremity Standardized Mean Score Using Pediatric Outcomes Data Collection Instrument (PODCI) Quality of Life Instrument
Week 8
|
36.2 score on a scale
Standard Deviation 12.3
|
71 score on a scale
Standard Deviation 21.6
|
62.6 score on a scale
Standard Deviation 32.1
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 4 and Week 8The Performance of Upper Limb module (PUL) for DMD was designed according to a specific contextual framework of upper limb function in both ambulant and non-ambulant individuals with DMD. The UL-PROM closely linked to this motor performance based clinician-reported outcome measure, was developed to evaluate manual ability related to activities of daily living (ADL) that cannot be observed in a clinical setting. Items were selected in relation to the different domains of the PUL from proximal to distal performance in order to cover the full range of upper limb functions. The questionnaire consists of 33 items covering four domains (3 points each for Food/Nutrition 7 items, Self Care 8 items, Household/Environment 6 items, Leisure/Communication 12 items). Higher scores indicate greater function, with total score being a sum of the subscale scores (Ranging from 0 to 99).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Person-Reported Outcome: Mean Person-Reported Outcome Measure Upper Limb (PROM-UL) Functional Capacity Score
Week 8
|
62.6 score on a scale
Standard Deviation 15
|
87.6 score on a scale
Standard Deviation 6.3
|
78.8 score on a scale
Standard Deviation 18.5
|
|
Person-Reported Outcome: Mean Person-Reported Outcome Measure Upper Limb (PROM-UL) Functional Capacity Score
Baseline
|
73.6 score on a scale
Standard Deviation 19.8
|
88.4 score on a scale
Standard Deviation 7.9
|
79.2 score on a scale
Standard Deviation 24.1
|
|
Person-Reported Outcome: Mean Person-Reported Outcome Measure Upper Limb (PROM-UL) Functional Capacity Score
Week 4
|
64 score on a scale
Standard Deviation 14.5
|
87.4 score on a scale
Standard Deviation 7.6
|
82.8 score on a scale
Standard Deviation 20.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 8Population: 3 of the participants were unable to undergo the procedure and thus were not included in the analysis.
Cardiac MRI using tagged imaging detects changes in heart muscle contractility in people with DMD. It measures how the heart deforms throughout the cardiac cycle, and is used to calculate strain on the heart muscle. Peak strain is a measure of distortion in the heart muscle during contraction versus when it is at rest. Mid-ventricular peak circumferential strain is a sensitive marker of cardiac function and can detect effects of therapeutic interventions. Strain is expressed in the negative, so more negative measurements indicate a healthy state while less negative measurements (closer to zero) indicate an unhealthy state.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=4 Participants
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=3 Participants
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
Clinical Outcome: Mean Strain Index (Ecc%) of Cardiac Mid-Ventricular Strain by MRI
Baseline
|
-16.65 Ecc%
Standard Deviation 4.31
|
-17.38 Ecc%
Standard Deviation 2.17
|
-11.46 Ecc%
Standard Deviation 1.34
|
|
Clinical Outcome: Mean Strain Index (Ecc%) of Cardiac Mid-Ventricular Strain by MRI
Week 8
|
-16.8 Ecc%
Standard Deviation 1.39
|
-17.67 Ecc%
Standard Deviation 2.9
|
-10.71 Ecc%
Standard Deviation 6.0
|
Adverse Events
Cohort 1
Cohort 2
Cohort 3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=5 participants at risk
8-weeks open-label (+)- Epicatechin at 25mg/day twice per day
|
Cohort 2
n=5 participants at risk
8-weeks open-label (+)- Epicatechin at 25mg/day three times per day
|
Cohort 3
n=5 participants at risk
8-weeks open-label (+)- Epicatechin at 75mg/day at two times per day
|
|---|---|---|---|
|
General disorders
Headache
|
40.0%
2/5 • Number of events 3 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
60.0%
3/5 • Number of events 5 • 8 weeks
|
|
General disorders
Stomach upset
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Cardiac disorders
Troponin elevation
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 2 • 8 weeks
|
60.0%
3/5 • Number of events 4 • 8 weeks
|
|
General disorders
Seasonal cold
|
40.0%
2/5 • Number of events 2 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
General disorders
Sinus congestion
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash (diaper rash)
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Gastrointestinal disorders
Nausea/vomiting
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Strep throat
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
General disorders
Flu-like symptoms
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough, lower respiratory congestion
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
General disorders
Body aches
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
|
Eye disorders
Vision, diagnosed as needing glasses
|
20.0%
1/5 • Number of events 1 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
|
Blood and lymphatic system disorders
Elevated triglycerides
|
0.00%
0/5 • 8 weeks
|
20.0%
1/5 • Number of events 2 • 8 weeks
|
0.00%
0/5 • 8 weeks
|
Additional Information
Dr. Craig McDonald, Professor and Chair
UC Davis Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place