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Trial record 6 of 88 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Dystrophies"

(-)- Epicatechin Becker Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT03236662
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 7, 2016
August 2, 2017
August 2, 2017
November 2016
November 2017   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
May 2018
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, Senior)
No
Contact: Alina Nicorici, BS 916-734-0968 arnicorici@ucdavis.edu
United States
 
 
NCT03236662
767161
No
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Cardero Therapeutics, Inc.
Not Provided
University of California, Davis
July 2017

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