Clinical TrialID 5594
Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents
NCT02964377
Duchenne Muscular Dystrophy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5594
- Evidence Id
- 5594
- Core Evidence Id
- 5594
- Source Clinical Trial Id
- 5580
- Herb2 Clinical Trial Id
- HBCT005580
- Nct Id
- NCT02964377
- Title
- Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents
- Status
- Completed
- Phase
- Phase 1|Phase 2
- Study Result
- Yes
- Study Condition
- Duchenne Muscular Dystrophy
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: (+)- Epicatechin
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- Male
- Age
- Child
- Enrollment
- 15
- Outcome Measure
- Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak), Pharmacokinetic evaluation for dose-response evaluation., Pre-dose and 2 hours post-dose at baseline|Pharmacokinetics Outcome: Absolute Values of (+)-Epicatechin Serum Concentration, Pre-dose (Trough) and 2 Hours Post-dose (Peak), Pharmacokinetic evaluation for dose-response evaluation., Week 4|Laboratory Outcome: Absolute Plasma Follistatin:Myostatin Ratio at Baseline, Week 4 and Week 8, Evaluation of follistatin:myostatin ratio from plasma samples., Baseline, Week 4 and Week 8|Clinical Outcome: Mean Percent of Baseline Cardiac Ejection Fraction by MRI, 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., Week 8|Safety: Number of Participants Who Experienced Treatment-Related Laboratory Abnormalities, 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., Study duration (8 weeks)|Laboratory Outcome: Absolute Values of Nitric Oxide (AU) Measured by ELISA, Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA)., Baseline, Week 4, Week 8|Laboratory Outcome: Absolute Values of Carbonylation (AU) Measured by ELISA, Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA)., Baseline, Week 4, Week 8|Laboratory Outcome: Absolute Values of Follistatin (AU) Measured by ELISA, Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA)., Baseline, Week 4, Week 8|Laboratory Outcome: Absolute Values of Myostatin (AU) Measured by ELISA, Proteomics evaluation of plasma biomarkers to confirm intervention-responsive pathophysiological pathways, using enzyme-linked immunosorbent assay (ELISA)., Baseline, Week 4, Week 8
- Sponsor Collaborator
- Craig McDonald, MD|Cardero Therapeutics, Inc.
- Funded By
- OTHER
- Location
- UC Davis Medical Center, Sacramento, California, 95817, United States
- Other Id
- 951753
- Start Date
- 2016-11
- Primary Completion Date
- 2018-07
- Completion Date
- 2018-07
- First Posted
- 2016-11-16
- Results First Posted
- 2021-12-21
- Last Update Posted
- 2021-12-21
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/77/NCT02964377/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/77/NCT02964377/ICF_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02964377
- Title Cn
- Title En
- Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents
- Bilingual Status
- semi_complete