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(-)- 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.
 
ClinicalTrials.gov Identifier: NCT03236662
Recruitment Status : Completed
First Posted : August 2, 2017
Results First Posted : July 26, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
Cardero Therapeutics, Inc.
Information provided by (Responsible Party):
Craig McDonald, MD, University of California, Davis

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Follistatin [ Time Frame: 48 weeks ]
    blood biomarker concentration

  2. Plasma Myostatin [ Time Frame: 48 weeks ]
    blood biomarker concentration

  3. Plasma Nitrates/ SNO [ Time Frame: 48 weeks ]
    blood biomarker concentration

  4. Plasma BNP [ Time Frame: 48 weeks ]
    blood biomarker concentration

  5. Plasma Creatine Kinase [ Time Frame: 48 weeks ]
    blood biomarker concentration

  6. Plasma MMP-9 [ Time Frame: 48 weeks ]
    blood biomarker concentration

  7. Plasma TNF-Alpha [ Time Frame: 48 weeks ]
    blood biomarker concentration

  8. Plasma TGF-Beta [ Time Frame: 48 weeks ]
    blood biomarker concentration

  9. Plasma Follistatin:Myostain Ratio [ Time Frame: 48 weeks ]
    Ratio of plasma follistatin to plasma myostatin


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.


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

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%
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03236662


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Craig McDonald, MD
Cardero Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Craig McDonald, MD, University of California, Davis:
Study Protocol and Statistical Analysis Plan  [PDF] June 15, 2015
Informed Consent Form  [PDF] August 20, 2015

More Information
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Responsible Party: Craig McDonald, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT03236662    
Other Study ID Numbers: 767161
First Posted: August 2, 2017    Key Record Dates
Results First Posted: July 26, 2021
Last Update Posted: November 24, 2021
Last Verified: November 2021
Keywords provided by Craig McDonald, MD, University of California, Davis:
BMD
Becker muscular dystrophy
epicatechin
clinical trial
neuromuscular disease
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked