Trial · NCT02964377
Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents
NCT02964377, Phase 1, Phase 2, Completed, Craig McDonald, MD; results first posted 2021-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents. Trials, record NCT02964377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02964377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents
- NCT number
- NCT02964377
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Craig McDonald, MD
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- (+)- Epicatechin
- First posted
- 2016-11-16
- Last updated
- 2021-12-21
- Results first posted
- 2021-12-21
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Pre-dose and 2 hours post-dose at baseline | Pharmacokinetic evaluation for dose-response evaluation. |
| Primary | Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Week 4 | Pharmacokinetic evaluation for dose-response evaluation. |
| Primary | Laboratory Outcome: Absolute Plasma Follistatin:Myostatin Ratio at Baseline, Week 4 and Week 8 | Baseline, Week 4 and Week 8 | Evaluation of follistatin:myostatin ratio from plasma samples. |
| Primary | Clinical Outcome: Mean Percent of Baseline Cardiac Ejection Fraction by MRI | Week 8 | 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. |
| Primary | Safety: Number of Participants Who Experienced Treatment-Related Laboratory Abnormalities | 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. |
| Primary | Laboratory Outcome: Absolute Values of Nitric Oxide (AU) Measured by ELISA | Baseline, Week 4, Week 8 | Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA). |
| Primary | Laboratory Outcome: Absolute Values of Carbonylation (AU) Measured by ELISA | Baseline, Week 4, Week 8 | Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA). |
| Primary | Laboratory Outcome: Absolute Values of Follistatin (AU) Measured by ELISA | Baseline, Week 4, Week 8 | Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA). |
| Primary | Laboratory Outcome: Absolute Values of Myostatin (AU) Measured by ELISA | Baseline, Week 4, Week 8 | Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Clinical Outcome: Percent of Normalized Upper Extremity Reachable Surface Area at Week 4 and Week 8 | Baseline, Week 4, Week 8 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Pre-dose and 2 hours post-dose at baseline | One Cohort 3 participant post-dose sample was missed. | nM | MEAN |
| PRIMARY | Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Week 4 | nM | MEAN | |
| PRIMARY | Laboratory Outcome: Absolute Plasma Follistatin:Myostatin Ratio at Baseline, Week 4 and Week 8 | Baseline, Week 4 and Week 8 | Ratio of follistatin to myostatin (AU) | MEAN | |
| PRIMARY | Clinical Outcome: Mean Percent of Baseline Cardiac Ejection Fraction by MRI | Week 8 | Missing data due to poor image quality. | percentage | MEAN |
| PRIMARY | Safety: Number of Participants Who Experienced Treatment-Related Laboratory Abnormalities | Study duration (8 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Laboratory Outcome: Absolute Values of Nitric Oxide (AU) Measured by ELISA | Baseline, Week 4, Week 8 | AU | MEAN | |
| PRIMARY | Laboratory Outcome: Absolute Values of Carbonylation (AU) Measured by ELISA | Baseline, Week 4, Week 8 | AU | MEAN | |
| PRIMARY | Laboratory Outcome: Absolute Values of Follistatin (AU) Measured by ELISA | Baseline, Week 4, Week 8 | AU | MEAN | |
| PRIMARY | Laboratory Outcome: Absolute Values of Myostatin (AU) Measured by ELISA | Baseline, Week 4, Week 8 | AU | MEAN | |
| SECONDARY | Clinical Outcome: Percent of Normalized Upper Extremity Reachable Surface Area at Week 4 and Week 8 | Baseline, Week 4, Week 8 | Missing data due to equipment malfunction | % normalized reachable surface area | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 1 | Trough | 15.1 | Standard Deviation 10.4 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 2 | Trough | 33.9 | Standard Deviation 7.9 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 3 | Trough | 20.6 | Standard Deviation 43.6 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 1 | Peak | 481.2 | Standard Deviation 477.6 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 2 | Peak | 551.2 | Standard Deviation 284.9 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 3 | Peak | 3899.3 | Standard Deviation 1217.6 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 1 | Trough | 84.2 | Standard Deviation 47.6 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 2 | Trough | 163.8 | Standard Deviation 84.5 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 3 | Trough | 179.1 | Standard Deviation 398.1 | nM |
| Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak) | Cohort 1 | Peak | 742.8 | Standard Deviation 442.7 | nM |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 5 | |
| Overall Study | STARTED | Cohort 2 | 5 | |
| Overall Study | STARTED | Cohort 3 | 5 | |
| Overall Study | COMPLETED | Cohort 1 | 5 | |
| Overall Study | COMPLETED | Cohort 2 | 5 | |
| Overall Study | COMPLETED | Cohort 3 | 5 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 3 | 0 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Cohort 1 | 2 | 5 | 3 |
| other | Headache | General disorders | Cohort 2 | 0 | 5 | 0 |
| other | Headache | General disorders | Cohort 3 | 3 | 5 | 5 |
| other | Stomach upset | General disorders | Cohort 1 | 0 | 5 | 0 |
| other | Stomach upset | General disorders | Cohort 2 | 0 | 5 | 0 |
| other | Stomach upset | General disorders | Cohort 3 | 1 | 5 | 1 |
| other | Troponin elevation | Cardiac disorders | Cohort 1 | 0 | 5 | 0 |
| other | Troponin elevation | Cardiac disorders | Cohort 2 | 1 | 5 | 2 |
| other | Troponin elevation | Cardiac disorders | Cohort 3 | 3 | 5 | 4 |
| other | Seasonal cold | General disorders | Cohort 1 | 2 | 5 | 2 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 5 |
| Total, all-cause mortality | Cohort 2 | 0 | 5 |
| Total, all-cause mortality | Cohort 3 | 0 | 5 |
| Total, other adverse events | Cohort 1 | 4 | 5 |
| Total, other adverse events | Cohort 2 | 2 | 5 |
| Total, other adverse events | Cohort 3 | 4 | 5 |
| Total, serious adverse events | Cohort 1 | 0 | 5 |
| Total, serious adverse events | Cohort 2 | 0 | 5 |
| Total, serious adverse events | Cohort 3 | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02964377
GET https://conductscience.org/api/trials/v1/NCT02964377/results?page=2