(-)- Epicatechin Becker Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03236662
Recruitment Status : Completed
First Posted : August 2, 2017
Last Update Posted : June 8, 2018
Cardero Therapeutics, Inc.
Information provided by (Responsible Party):
Craig McDonald, MD, University of California, Davis

November 7, 2016
August 2, 2017
June 8, 2018
November 2016
November 2017   (Final data collection date for primary outcome measure)
  • Plasma Follistatin [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Myostatin [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Nitrates/ SNO [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma BNP [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Creatine Kinase [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma MMP-9 [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma TNF-Alpha [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma TGF-Beta [ Time Frame: 48 weeks ]
    blood biomarker concentration
  • Plasma Follistatin:Myostain Ratio [ Time Frame: 48 weeks ]
    Ratio of plasma follistatin to plasma myostatin
Peripheral venous blood will be collected to evaluate blood biomarkers [ Time Frame: 48 weeks ]
Biomarkers: Plasma Follistatin, Plasma Myostatin, Plasma Follistatin: Plasma Myostatin ratio, Plasma Nitrates/ SNO, Plasma BNP, Plasma Creatine Kinase, Plasma MMP-9, Plasma TNF-Alpha, Plasma TGF-Beta
Complete list of historical versions of study NCT03236662 on Archive Site
  • Graded exercise test using a recumbent cycle ergometer [ Time Frame: baseline and at 2-minute intervals ]
    blood lactate measured
  • 6-minute walk test [ Time Frame: 48 weeks ]
    Measurements recorded will include 25-meter split times and total distance traveled.
Same as current
Exploratory Proteomics [ Time Frame: 48 weeks ]
Collection of plasma samples for proteomics analysis.
Same as current
(-)- Epicatechin Becker Muscular Dystrophy
UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy
This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in patients with Becker muscular dystrophy who participated in the earlier trial. This single center study will enroll up to 10 adults 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 screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the study will be presence of one or more biologic or strength and performance outcome measures that yield a response magnitude that allows for sufficient power in a Phase II B study with a sample size of 30 individuals.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Becker Muscular Dystrophy
Drug: (-)-Epicatechin
Experimental: Treatment
(-)-epicatechin 50mg twice per day (100mg per day total dose)
Intervention: Drug: (-)-Epicatechin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2017
November 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prior participation in UCD0113 BMD epicatechin pilot study
  • Male
  • Age 18 years to 70 years
  • Average to low daily physical activity
  • Ability to ambulate for 75 meters without assistive devices
  • Diagnosis of BMD confirmed by at least one the following:
  • Dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical BMD, or
  • 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
  • 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
  • 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.
  • Hematology profile within normal range
  • Baseline laboratory safety chemistry profile within normal range
  • No plan to change exercise regimen during study participation
  • 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).

Exclusion Criteria:

  • Currently enrolled in another treatment clinical trial.
  • History of significant concomitant illness or significant impairment of renal or hepatic function.
  • Use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication.
  • Regular participation in vigorous exercise.
  • Symptomatic heart failure with cardiac ejection fraction <25%
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Craig McDonald, MD, University of California, Davis
Craig McDonald, MD
Cardero Therapeutics, Inc.
Not Provided
University of California, Davis
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP