Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy
Cooperative International Neuromuscular Research Group
Phase 1/Phase 2
The purpose of this study is to see if male children with Duchenne muscular dystrophy (DMD)
have changes in strength when given the drug Pentoxifylline as a rescue treatment. A total
of 64 subjects are expected to participate through all other centers of the Cooperative
International Neuromuscular Research Group (CINRG) worldwide.
The primary purpose of this study is to see whether the addition of pentoxifylline to a
steroid regimen is effective in treating deteriorating muscle strength by comparing the
muscle strength of PTX treated subjects and placebo treated subjects.
The present study is designed to assess the natural history in a one year pre-phase of the
trial and evaluate therapeutic efficacy and side effects of deflazacort in LGMD2B/MM
patients in a placebo-controlled trial. Furthermore, long-term development of the disease
under naturalistic conditions will be documented in a 2-year follow-up after the end of the
double-blind treatment phase.
Safety Study of Flavocoxid in Duchenne Muscular Dystrophy
University of Messina
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.
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