34
Participants
Start Date
May 31, 2012
Primary Completion Date
January 31, 2016
Study Completion Date
March 31, 2016
Repository Corticotropin Injection
H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups \[8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)\].
Placebo
Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.
Questcor Investigational Site, The Bronx
Questcor Investigational Site, Bethlehem
Questcor Investigational Site, Cooper City
Questcor Investigational Site, Miami Springs
Questcor Investigational Site, Chattanooga
Questcor Investigational Site, Columbus
Questcor Investigational Site, Greenville
Questcor Investigational Site, Houston
Questcor Investigational Site, San Antonio
Questcor Investigational Site, Roseville
Lead Sponsor
Mallinckrodt
INDUSTRY