Clinical Trial: Safety Study of Flavocoxid in Duchenne Muscular Dystrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open Pilot Trial to Test the Safety and Tolerability of Flavocoxid in Duchenne Muscular Dystrophy

Brief Summary: Objective of this study is to evaluate safety and tolerability of flavocoxid administered at the daily oral dose of 500 or 1000 mg/die for one year in DMD patients, alone or in association with steroids (deflazacort on alternate days) started at least one year before. The investigators will also perform a multidimensional clinical evaluation covering functional and muscle strength and quality of life (QoL)assessments.

Detailed Summary:
Sponsor: University of Messina

Current Primary Outcome: All adverse events and laboratory or ECG abnormalities [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Motor assessments and biochemical evaluation [ Time Frame: 1 year ]

Outcome measures will include:

  • Functional tests: 6- minute walk test, North Star Ambulatory Assessment (NSAA) with timed items
  • Medical Research Council (MRC) score of upper and lower limbs;
  • Maximum voluntary isometric contraction (MVIC)
  • Quality of Life (QoL) evaluation ;
  • Forced vital capacity (FVC) with spirometer . Changes in biomarkers


Original Secondary Outcome: Same as current

Information By: University of Messina

Dates:
Date Received: April 12, 2011
Date Started: March 2011
Date Completion:
Last Updated: January 31, 2014
Last Verified: January 2014