Post hoc exploratory analysis of the effect of foslevodopa/foscarbidopa continuous subcutaneous infusion on nocturia in patients with Parkinson's disease.

3.2.2 Nocturia correlation with QoL Both the open-label and active-controlled trials’ primary results suggested LDp/CDp treatment improved overall QoL in PwP, as indicated by a significant reduction in the PDQ-39 Summary Index score from baseline to all time points in the open-label trial and a PDQ-39 Summary Index score improvement in LDp/CDp-treated patients (which did not reach statistical significance due to the active-controlled trial’s hierarchical testing procedure) [7] , [8] .

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A subsequent post hoc analysis indicated that the LDp/CDp-treated patients PDSS-2 total score within-group improvement from baseline in the active-controlled trial was clinically meaningful and nominally statistically significant, as well as showed the between-group PDSS-2 total score was nominally significant versus oral-treated patients [ 16 ].

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