Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label Pilot Study of Purified Tea-derived Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy.|
- Muscle Function [ Time Frame: 8 weeks ]
- Muscle Stength [ Time Frame: 8 weeks ]
- -(-)Epicatechin Pharmacokinetics [ Time Frame: 8 Weeks ]Standard clinical safety panel including: hematologic, hepatologic, renal and metabolic profiles
- Normalization of Muscle Stucture [ Time Frame: 8 weeks ]Evaluation by histology, Western Blot, immunostain and electron microscopy
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment with Epicatechin
Purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.
purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.
Other Name: dietary supplement
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.
This 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856868
|Contact: Erica Goude, BA CCRPemail@example.com|
|United States, California|
|University of California, Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Erica Goude, BA CCRP 916-734-0968 firstname.lastname@example.org|
|Principal Investigator: Craig M McDonald, MD|
|Sub-Investigator: Erik K Henricson, MPH|
|Sub-Investigator: Richard T Abresch, MS|
|Sub-Investigator: Frank Sharp, MD|
|Sub-Investigator: Glenn Jickling, MD|
|Sub-Investigator: Bjorn E Oskarsson, MD|
|Principal Investigator:||Craig M McDonald, MD||University of California, Davis|
|Study Director:||Erik K Henricson, MPH||University of California, Davis|