Duodopa levodopa/carbidopa: Phase III data

A double-blind, international Phase III trial in 71 patients with advanced PD and severe motor fluctuations showed that Duodopa met the primary endpoint of reducing mean daily "off" time in which patients experienced symptoms of their PD from baseline to week 12 vs. immediate-release (IR) carbidopa-levodopa (4.04 vs. 2.14 hours/day, p=0.0015). Duodopa also met the secondary endpoint of increasing daily "on" time in which patients were symptom free without troublesome dyskinesia vs. IR carbidopa-levodopa (4.11 vs. 2.24 hours/day, p=0.0059). Additionally, Duodopa significantly reduced mean PDQ-39 (10.9 vs. 3.9 points, p=0.015) and CGI-I scores from baseline to week 12 vs. IR carbidopa-levodopa (2.3 vs. 3 points, p=0.026). Furthermore, Duodopa significantly reduced UPDRS Part II scores vs. IR carbidopa-levodopa (1.8 points vs. a 1.3 point increase, p=0.009), but non-significantly reduced UPDRS Part III scores (1.5 vs. 2.9 points, p=0.502). Data were presented at the American Academy of Neurology meeting in New Orleans. ...