Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-05 @ 5:13 PM
Study NCT ID:
NCT01856868
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2013-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002392', 'term': 'Catechin'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D002839', 'term': 'Chromans'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmmcdonald@ucdavis.edu', 'phone': '(916) 734-4293', 'title': 'Dr. Craig McDonald, Professor and Chair', 'organization': 'UC Davis Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'There were 12 adverse events in six participants reported and tracked during the 8-week treatment phase of the study. Seven of the 12 events were related or possibly related to the study biopsy procedure. All adverse events were followed until resolution.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bruising at the biopsy site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-biopsy-related flulike symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'suspected varicella (shingles)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': '8 Weeks', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.17', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0434', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 Weeks', 'description': '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.', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.52', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0185', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0434', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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) .', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.36', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0078', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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.', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue Myostatin at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.25', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0082', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue Myogenin at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue Myf5 at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.232', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0238', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue MyoD at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.34', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0321', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue MEF2a at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.12', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0182', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue Dysferlin at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.25', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0371', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Structure associated indicators including dysferlin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Muscle Tissue Utrophin at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0257', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Structure associated indicators including utrophin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).', 'unitOfMeasure': 'AU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '-(-)Epicatechin Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'timeFrame': '8 Weeks', 'description': 'Pharmacokinetics sequentially after dosing will be measured.', 'reportingStatus': 'POSTED', 'populationDescription': 'Sponsor did not perform PK analysis (samples were discarded) based on availability of other published data and switched to alternative enantiomer of epicatechin in subsequent studies.'}, {'type': 'SECONDARY', 'title': 'Participants With Abnormal Treatment-Related Laboratory Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Standard safety monitoring of plasma hematologic, hepatologic, renal and metabolic parameters will be assessed. Abnormal will be defined as values outside of typical range for patients with Becker Muscular Dystrophy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Knee Extension at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.1', 'spread': '42.6', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at 8 Weeks', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '2.51', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.51', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height and weight using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Knee extension will be assessed using an isokinetic dynamometer.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not participate in the strength testing due to the advanced level of the disease.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 6-Minute Walk Distance at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '16.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '11.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Muscle function will be assessed by measuring the 6-minute walk distance', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete 8 Week exercise testing due to unrelated injury.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Stand From Supine at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.621667', 'spread': '10.19124', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.145', 'spread': '10.12084', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Muscle burst function will be assessed by time function tests.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant was unable to perform the assessment due to his advanced disease.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Elbow Flexion at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.7', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at 8 Weeks', 'categories': [{'measurements': [{'value': '5.33', 'spread': '3.79', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.159', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.79', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Elbow flexion will be assessed using an isokinetic dynamometer.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not participate in the strength testing due to the advanced level of the disease.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.\n\n(-)-epicatechin: purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '179.2', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '83.2', 'spread': '18.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced Vital Capacity (%)', 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '6-Minute Walk Distance (m)', 'classes': [{'categories': [{'measurements': [{'value': '372', 'spread': '87.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time to Stand (s)', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '2.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time to Climb 4 Stairs (s)', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '7.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time to Run 10m (s)', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-03-08', 'size': 3489348, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-22T17:14', 'hasProtocol': True}, {'date': '2014-03-24', 'size': 365491, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-07T17:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2013-05-09', 'resultsFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-22', 'studyFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Muscle Tissue PGC1alpha (AU) at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks', 'description': '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.'}, {'measure': 'Mean Change From Baseline in Muscle Tissue AMPK at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue LKB1 at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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) .'}, {'measure': 'Mean Change From Baseline in Cristae-associated Mitofillin Levels at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Mean Change From Baseline in Muscle Tissue Follistatin at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue Myostatin at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue Myogenin at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue Myf5 at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue MyoD at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue MEF2a at 8 Weeks', 'timeFrame': '8 weeks', 'description': '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).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue Dysferlin at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Structure associated indicators including dysferlin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).'}, {'measure': 'Mean Change From Baseline in Muscle Tissue Utrophin at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Structure associated indicators including utrophin will be assessed by Western using relative band intensities of the pre-treatment and post-treatment specimens with digitally quantified using ImageJ software).'}], 'secondaryOutcomes': [{'measure': '-(-)Epicatechin Pharmacokinetics', 'timeFrame': '8 Weeks', 'description': 'Pharmacokinetics sequentially after dosing will be measured.'}, {'measure': 'Participants With Abnormal Treatment-Related Laboratory Assessments', 'timeFrame': '8 weeks', 'description': 'Standard safety monitoring of plasma hematologic, hepatologic, renal and metabolic parameters will be assessed. Abnormal will be defined as values outside of typical range for patients with Becker Muscular Dystrophy.'}, {'measure': 'Change From Baseline in Knee Extension at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Knee extension will be assessed using an isokinetic dynamometer.'}, {'measure': 'Change From Baseline in 6-Minute Walk Distance at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Muscle function will be assessed by measuring the 6-minute walk distance'}, {'measure': 'Change From Baseline in Stand From Supine at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Muscle burst function will be assessed by time function tests.'}, {'measure': 'Change From Baseline in Elbow Flexion at 8 Weeks', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Elbow flexion will be assessed using an isokinetic dynamometer.'}]}, 'conditionsModule': {'keywords': ['BMD', 'Becker muscular dystrophy', 'epicatechin', 'clinical trial', 'neuromuscular disease'], 'conditions': ['Becker Muscular Dystrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/pmr/research/Index.html', 'label': 'UC Davis Neuromuscular Research Center'}]}, 'descriptionModule': {'briefSummary': '(-)-Epicatechin will be evaluated for the treatment of progressive muscle loss and impaired skeletal muscle function in Becker Muscular Dystrophy (BMD) patients.', 'detailedDescription': 'This is a proof-of-concept phase 1/2a pilot and endpoint development study that is designed to provide initial evidence of biological activity of (-)-epicatechin. Primary endpoints include initial assessment of tissue-specific evidence of efficacy from muscle biopsy samples. Secondary endpoints include measures of strength and physical function, and safety and adverse event data. Pilot endpoints include assessment of mRNA and miRNA peripheral blood profiles and validation of non-invasive near-infrared spectroscopy (NIRS) muscle perfusion studies during exercise and a recumbent cycle exercise test that may be employed as endpoints in future clinical trials.\n\nThis single center open-label pilot study will enroll 10 adults with genetically-confirmed Becker muscular dystrophy, who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the study if they meet all inclusion criteria. They will be evaluated at baseline and at screening, day 1, and weeks 1, 2, 4 and 8.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male\n* Age 18 years to 60 years\n* Average to low daily physical activity\n* Ability to ambulate for 75 meters without assistive devices\n* Diagnosis of BMD confirmed by at least one the following:\n\n * Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or\n * Gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical BMD, or\n * Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with BMD, with a typical clinical picture of BMD, or\n * Positive family history of BMD confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of BMD.\n* Nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable).\n* Hematology profile within normal range\n* Baseline laboratory safety chemistry profile within normal range\n* No plan to change exercise regimen during study participation\n\nExclusion Criteria:\n\n* Currently enrolled in another treatment clinical trial.\n* History of significant concomitant illness or significant impairment of renal or hepatic function.\n* Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication.\n* Regular participation in vigorous exercise.\n* Symptomatic heart failure with cardiac ejection fraction \\<25%"}, 'identificationModule': {'nctId': 'NCT01856868', 'briefTitle': 'Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'An Open-label Pilot Study of Purified Tea-derived Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy.', 'orgStudyIdInfo': {'id': '454352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Epicatechin', 'description': 'Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.', 'interventionNames': ['Drug: (-)-epicatechin']}], 'interventions': [{'name': '(-)-epicatechin', 'type': 'DRUG', 'otherNames': ['dietary supplement'], 'description': 'purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.', 'armGroupLabels': ['Treatment with Epicatechin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Craig M McDonald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Erik K Henricson, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Craig McDonald, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardero Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman, Department of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Craig McDonald, MD', 'investigatorAffiliation': 'University of California, Davis'}}}}