Abstract

Objective: Describe the impact of baseline factors on response to apomorphine sublingual film (APL-130277; APL) among patients with Parkinson's disease (PD) and “OFF” episodes in a pivotal controlled trial. APL was efficacious and generally well tolerated for the on-demand treatment of “OFF” episodes; the study met its primary endpoint of change in MDS-UPDRS Part III score at 30 minutes postdose at week 12 (least squares mean difference from placebo, -7.6 points; P=0.0002) and its key secondary endpoint of self-rated FULL “ON” response rate within 30 minutes postdose at week 12 (P=0.0426).

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