Patient Global Impression of Change

Based on the prespecified statistical hierarchy in the pivotal phase 3 clinical trial, patient global impression of change (PGIC) and OFF time were not eligible to be evaluated for statistical significance; however, analysis was conducted and nominal P values are provided for descriptive purposes, but conclusions cannot be drawn.1,21

More INBRIJA patients reported improvement in PGIC compared with placebo at week 121,22

chart

*

P<0.001; the nominal P value was not statistically significant per the prespecified hierarchy.1

 

Percentage of responses to survey question: “How has the addition of study drug changed your Parkinson’s disease?”22

Change in total daily OFF time1,22

Patients’ self-reported accounting of Parkinson's disease symptoms completed at home over 3 days showed no differences in the reduction in mean total daily OFF time from baseline (P=0.975).
• INBRIJA -0.47 hours (n=114) vs placebo -0.48 hours (n=112)
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