Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01183767 |
| Other study ID # |
SUNIMUD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2010 |
| Est. completion date |
September 6, 2018 |
Study information
| Verified date |
July 2021 |
| Source |
Charite University, Berlin, Germany |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
