Trial record 27 of 357 for:    "Muscular Dystrophies"

(-)- 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03236662
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Cardero Therapeutics, Inc.
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Becker Muscular Dystrophy Drug: (-)-Epicatechin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UCD0115B: An Open-label Extension Study of Purified Epicatechin to Improve Mitochondrial Function, Strength and Skeletal Muscle Exercise Response in Becker Muscular Dystrophy
Study Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: Treatment
(-)-epicatechin 50mg twice per day (100mg per day total dose)
Drug: (-)-Epicatechin

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Graded exercise test using a recumbent cycle ergometer [ Time Frame: baseline and at 2-minute intervals ]
    blood lactate measured

  2. 6-minute walk test [ Time Frame: 48 weeks ]
    Measurements recorded will include 25-meter split times and total distance traveled.

Other Outcome Measures:
  1. Exploratory Proteomics [ Time Frame: 48 weeks ]
    Collection of plasma samples for proteomics analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03236662

Contact: Alina Nicorici, BS 916-734-0968

United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Alina Nicorici, BS    916-734-0968   
Principal Investigator: Craig M McDonald, MD         
Sub-Investigator: Erik K Henricson, PhD, MPH         
Sponsors and Collaborators
University of California, Davis
Cardero Therapeutics, Inc.

Responsible Party: University of California, Davis Identifier: NCT03236662     History of Changes
Other Study ID Numbers: 767161
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017

Keywords provided by University of California, Davis:
Becker muscular dystrophy
clinical trial
neuromuscular disease

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked