ARTICLE | Clinical News

XenoPort starts XP13512 Phase III

March 15, 2006 2:19 AM UTC

XNPT started the double-blind, placebo-controlled U.S. Phase III XP052 trial of XP13512 to treat restless legs syndrome (RLS) in about 200 patients. The co-primary endpoints are change from baseline in International Restless Legs Syndrome rating scale and Clinical Global Impression of Improvement. Secondary endpoints are the onset of efficacy and subjective sleep, pain, mood, and quality of life assessments. XNPT expects top-line results in the first half of 2007. Two additional Phase III trials, studies XP060 and XP053, are planned for this year, and XNPT plans to submit an NDA in the second half of 2008. ...