89
Participants
Start Date
December 13, 2012
Primary Completion Date
October 21, 2016
Study Completion Date
January 11, 2017
Deferiprone oral solution
Deferiprone 80 mg/mL oral solution will be administered twice daily (b.i.d.) for 18 months. An initial dose of 5 mg/kg b.i.d. will be administered for 6 weeks. The dose will then be escalated to 10 mg/kg b.i.d. and finally to 15 mg/kg b.i.d.
Placebo
A deferiprone matching placebo oral solution will be given twice daily for 18 months.
Foundation Neurological Institute C. Besta, Milan
Klinikum der Universität München, Munich
Children's Hospital & Research Center at Oakland, Oakland
Newcastle University Institute of Human Genetics, Newcastle upon Tyne
Lead Sponsor
Food and Drug Administration (FDA)
FED
ApoPharma
INDUSTRY