Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy (SUNIMUD)

July 28, 2021 updated by: Friedemann Paul, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10405
        • Charite University Berlin
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin, Westend, Pädiatrie
      • Oldenburg, Germany
        • Diakonisches Werk Oldenburg SPZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: EGCG
Epigallocatechin-Gallate (EGCG)
Drug: Epigallocatechin-Gallate
EGCG in a dosage of up to 10mg/kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy
Time Frame: 36 months
changes in the means of the 6 minute walk test (baseline to visit after month 36).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Friedemann Paul, Dr., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2010

Primary Completion (Actual)

September 6, 2018

Study Completion (Actual)

September 6, 2018

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNIMUD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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