Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT01183767
• Date of registration: 17/08/2010
• Prospective Registration: Yes
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy SUNIMUD
• Scientific title: Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy
• Date of first enrolment: December 30, 2010
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01183767
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Germany

Contacts

• Name: Friedemann Paul, Dr.
• Affiliation: Charite University, Berlin, Germany

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Intervention(s)

Drug: Placebo

Drug: Epigallocatechin-Gallate

Primary Outcome(s)

safety and tolerability [Time Frame: 12 months]

Secondary Outcome(s)

efficacy [Time Frame: 36 months]

Secondary ID(s)

SUNIMUD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors