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