NCT01183767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

December 30, 2010

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

7.7 years

First QC Date

August 17, 2010

Last Update Submit

July 28, 2021

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular DystrophyEpigallocatechin-GallateGreen tea extract

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability

    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 Outcomes (1)

  • efficacy

    36 months

Study Arms (2)

EGCG

ACTIVE COMPARATOR

Epigallocatechin-Gallate (EGCG)

Drug: Epigallocatechin-Gallate

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Epigallocatechin-GallateDRUG

EGCG in a dosage of up to 10mg/kg body weight

EGCG
PlaceboDRUG
Placebo

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • another serious organic disease
  • further primary psychiatric or neurological diseases
  • long-term intake of liver-toxic medicines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Charité University Berlin

Berlin, 10405, Germany

Location

DRK Kliniken Berlin, Westend, Pädiatrie

Berlin, 14050, Germany

Location

Diakonisches Werk Oldenburg SPZ

Oldenburg, Germany

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Friedemann Paul, Dr.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Study Start

December 30, 2010

Primary Completion

September 6, 2018

Study Completion

September 6, 2018

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(3)