Trial · NCT01856868
Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)
NCT01856868, Phase 1, Phase 2, Completed, Craig McDonald, MD; results first posted 2021-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study). Trials, record NCT01856868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01856868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)
- NCT number
- NCT01856868
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Craig McDonald, MD
- Conditions
- Becker Muscular Dystrophy
- Interventions
- (-)-epicatechin
- First posted
- 2013-05-17
- Last updated
- 2021-12-22
- Results first posted
- 2021-12-22
- Limitations and caveats
Limitations of this study include the small number of subjects, the open-label design, and the use of within-subjects controls with BMD rather than a placebo-treated group in a randomized, double-blind, placebo-controlled trial design.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks | Baseline and 8 Weeks | Western blot measurement of the transcriptional coactivator gene PGC1alpha involved in mitochondrial biogenesis will be assessed using relative band intensities of the pre-treatment (Baseline) and post-treatment (8 Weeks) specimens with digitally quantified using ImageJ software. |
| Primary | Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks | 8 weeks | Western blot measurement of AMPK will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
| Primary | Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks | 8 weeks | Western blot measurement of LKB1 will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software) . |
| Primary | Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks | 8 weeks | Western blot measurement of Mitofillin will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software. |
| Primary | Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks | 8 weeks | Regulators of muscle growth and regeneration including follistatin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
| Primary | Mean Change From Baseline in Muscle Tissue Myostatin at 8 Weeks | 8 weeks | Regulators of muscle growth and regeneration including myostatin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
| Primary | Mean Change From Baseline in Muscle Tissue Myogenin at 8 Weeks | 8 weeks | Modulators of skeletal muscle regeneration by Western will include myogenin will be assessed using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
| Primary | Mean Change From Baseline in Muscle Tissue Myf5 at 8 Weeks | 8 weeks | Modulators of skeletal muscle regeneration My5 will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
| Primary | Mean Change From Baseline in Muscle Tissue MyoD at 8 Weeks | 8 weeks | Modulators of skeletal muscle regeneration MyoD will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
| Primary | Mean Change From Baseline in Muscle Tissue MEF2a at 8 Weeks | 8 weeks | Modulators of skeletal muscle regeneration MEF2a will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks | Baseline and 8 Weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue Myostatin at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue Myogenin at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue Myf5 at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue MyoD at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
| PRIMARY | Mean Change From Baseline in Muscle Tissue MEF2a at 8 Weeks | 8 weeks | One participant sustained a fall at home that resulted in a minor injury just prior to the 8 week evaluation and declined undergoing the 8 week biopsy. Thus, only 6 participants were analyzed. | AU | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks | Treatment With Epicatechin | Baseline | 0.55 | Standard Deviation 0.3 | AU |
| Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks | Treatment With Epicatechin | 8 Weeks | 0.86 | Standard Deviation 0.17 | AU |
| Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks | Treatment With Epicatechin | Baseline | 0.76 | Standard Deviation 0.48 | AU |
| Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks | Treatment With Epicatechin | Week 8 | 1.06 | Standard Deviation 0.52 | AU |
| Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks | Treatment With Epicatechin | Baseline | 0.67 | Standard Deviation 0.17 | AU |
| Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks | Treatment With Epicatechin | Week 8 | 0.88 | Standard Deviation 0.24 | AU |
| Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks | Treatment With Epicatechin | Baseline | 1.05 | Standard Deviation 0.36 | AU |
| Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks | Treatment With Epicatechin | Week 8 | 1.33 | Standard Deviation 0.3 | AU |
| Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks | Treatment With Epicatechin | Baseline | 0.83 | Standard Deviation 0.37 | AU |
| Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks | Treatment With Epicatechin | Week 8 | 1.11 | Standard Deviation 0.36 | AU |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With Epicatechin | 7 | |
| Overall Study | COMPLETED | Treatment With Epicatechin | 7 | |
| Overall Study | NOT COMPLETED | Treatment With Epicatechin | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Bruising at the biopsy site | Skin and subcutaneous tissue disorders | Treatment With Epicatechin | 6 | 6 | 6 |
| other | Non-biopsy-related flulike symptoms | General disorders | Treatment With Epicatechin | 2 | 6 | 2 |
| other | Rash | Skin and subcutaneous tissue disorders | Treatment With Epicatechin | 1 | 6 | 1 |
| other | suspected varicella (shingles) | Immune system disorders | Treatment With Epicatechin | 1 | 6 | 1 |
| other | Muscle soreness | General disorders | Treatment With Epicatechin | 1 | 6 | 1 |
| other | Intermittent headache | General disorders | Treatment With Epicatechin | 1 | 6 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With Epicatechin | 0 | 6 |
| Total, other adverse events | Treatment With Epicatechin | 6 | 6 |
| Total, serious adverse events | Treatment With Epicatechin | 0 | 6 |
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/NCT01856868
GET https://conductscience.org/api/trials/v1/NCT01856868/results?page=2