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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01183767
First received: August 17, 2010
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Duchenne Muscular Dystrophy
Drug: Epigallocatechin-Gallate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • safety and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • efficacy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    changes in the means of the 6 minute walk test (baseline to visit after month 36).


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EGCG
Epigallocatechin-Gallate (EGCG)
Drug: Epigallocatechin-Gallate
EGCG in a dosage of up to 10mg/kg body weight
Placebo Comparator: Placebo Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183767

Contacts
Contact: Friedemann Paul, Dr. +49 30 450 ext 639705 friedemann.paul@charite.de
Contact: Arpad von Moers, Dr. 030 - 3035 57 ext 00 a.moers@drk-kliniken-berlin.de

Locations
Germany
Charité University Berlin Not yet recruiting
Berlin, Germany, 10405
Contact: Friedemann Paul, Dr.    +49 30 450 ext 639705    friedemann.paul@charite.de   
Principal Investigator: Ulrike Grieben, Dr.         
DRK Kliniken Berlin, Westend, Pädiatrie Recruiting
Berlin, Germany, 14050
Contact: Arpad von Moers, Dr.    +49 30 3035 57 ext 00    a.moers@drk-kliniken-berlin.de   
Principal Investigator: Arpad von Moers, Dr.         
Diakonisches Werk Oldenburg SPZ Recruiting
Oldenburg, Germany
Contact: Michael Wagner, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Friedemann Paul, Dr. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Dr. Friedemann Paul, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01183767     History of Changes
Other Study ID Numbers: SUNIMUD
Study First Received: August 17, 2010
Last Updated: September 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Duchenne Muscular Dystrophy
Epigallocatechin-Gallate
Green tea extract

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Muscular Diseases
Muscular Disorders, Atrophic
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Epigallocatechin gallate
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antioxidants
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014