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Trial record 1 of 1 for:    NCT01183767
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Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy (SUNIMUD)

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ClinicalTrials.gov Identifier: NCT01183767
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE August 17, 2010
First Posted Date  ICMJE August 18, 2010
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE December 30, 2010
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
safety and tolerability [ Time Frame: 12 months ]
safety and tolerability in terms of number of adverse events in which a causal relationship with the test substance cannot be excluded, and GLDH values.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
safety and tolerability [ Time Frame: 18 months ]
safety and tolerability in terms of number of adverse events in which a causal relationship with the test substance cannot be excluded, and GLDH values.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
efficacy [ Time Frame: 36 months ]
changes in the means of the 6 minute walk test (baseline to visit after month 36).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy
Official Title  ICMJE Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy
Brief Summary

The aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot study is to investigate safety and tolerance of Epigallocatechin-Gallate (EGCG, the major polyphenol in green tea) in patients with muscular dystrophy of the Duchenne type.

In a second step the investigators want to investigate the effect of EGCG on the course of the Duchenne condition.

Detailed Description

Duchenne muscular dystrophy (DMD) is the most frequent neuromuscular condition to occur in childhood and youth. The course of the disease is progressive, and life expectancy is severely curtailed by the participation of the respiratory muscles and/or by progressive cardiomyopathy.

DMD derives from mutations in the DMD gene which leads to a loss of the protein dystrophin. Secondary inflammatory/immunological reactions contribute to the progressive course of the disease (1,2).

No curative therapy yet exists. Administration of steroids is the only established medical treatment. Symptomatic measures are also available, such as orthopaedic operations, the treatment of cardiomyopathy or, in advanced stages, home mechanical ventilation.

In studies involving experiments on cells and animals, Epigallocatechin-Gallate (EGCG, the major polyphenol in green tea) has shown a neuroprotective effect. The neuroprotective mechanism of action is probably based on several factors, including EGCG's modulation of several signal transduction pathways, its influence on the expression of genes regulating cell survival or programmed cell death, as well as its modulation of mitochondrial function.

The mdx mouse is the best-investigated animal model of a dystrophin-negative muscular dystrophy. Administration of EGCG in the mdx mouse led to both a reduction in the proportion of fibre necroses as well as to a less pronounced proliferation of connective tissue in the muscle (3,4), and also to an improvement in clinical symptoms (5,6).

Therefore, the investigators want to investigate safety and tolerance of EGCG in a dosage of up to 10mg/kg in patients with muscular dystrophy of the Duchenne type in this multicentre, prospective, double blind, placebo controlled, randomized pilot study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Duchenne Muscular Dystrophy
Intervention  ICMJE
  • Drug: Epigallocatechin-Gallate
    EGCG in a dosage of up to 10mg/kg body weight
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: EGCG
    Epigallocatechin-Gallate (EGCG)
    Intervention: Drug: Epigallocatechin-Gallate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2018)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2010)
40
Actual Study Completion Date  ICMJE September 6, 2018
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Duchenne muscular dystrophy
  • age 5-10 years
  • ability to walk without support
  • informed consent by the parents

Exclusion Criteria:

  • another serious organic disease
  • further primary psychiatric or neurological diseases
  • long-term intake of liver-toxic medicines
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01183767
Other Study ID Numbers  ICMJE SUNIMUD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Friedemann Paul, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Friedemann Paul, Dr. Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date April 2020

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