A double blind cross-over trial of epigallocatechin gallate to assess safety and effect for patients with dystrophinopathies

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: 1st phase (12w) EGCS 5mg/kg twice/day, washout (2‐4w), 2nd phase (12w) placebo twice/day 1st phase (12w) placebo twice/day, washout (2‐4w), 2nd phase (12wa) EGCS 5mg/kg twice/day CONDITION: Dystrophinopathies (Duchenne/Becker muscular dystrophy) PRIMARY OUTCOME: Safety, motor function, CK, oxidative stress marker (pre and post of each intervention phase) SECONDARY OUTCOME: cTnT, TGF‐beta1, IL‐6 INCLUSION CRITERIA: 1. Genetically or immunologically diagnosed dystrophinopathies 2. Serum CK>1000 U/L 3. Written informed consent
Epistemonikos ID: 0ccecfc736ff85a8e9f93d057f36ace87bad47bf
First added on: Aug 22, 2024