114
Participants
Start Date
November 30, 2005
Primary Completion Date
February 28, 2010
Study Completion Date
March 31, 2010
rh IGF-1 (mecasermin)
Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.
Ipsen, Paris
Lead Sponsor
Ipsen
INDUSTRY