Trial Outcomes & Findings for (-)- Epicatechin Becker Muscular Dystrophy (NCT NCT03236662)
NCT ID: NCT03236662
Last Updated: 2021-11-24
Results Overview
blood biomarker concentration
COMPLETED
PHASE2
2 participants
48 weeks
2021-11-24
Participant Flow
Participant milestones
| Measure |
Treatment
(-)-epicatechin 50mg twice per day (100mg per day total dose)
(-)-Epicatechin
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=2 Participants
(-)-epicatechin 50mg twice per day (100mg per day total dose)
(-)-Epicatechin
|
|---|---|
|
Age, Continuous
|
54 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood biomarker concentration
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
Ratio of plasma follistatin to plasma myostatin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and at 2-minute intervalsPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
blood lactate measured
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
Measurements recorded will include 25-meter split times and total distance traveled.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksPopulation: Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure.
Collection of plasma samples for proteomics analysis.
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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