Sample size calculation and non-inferiority margin
parkinsonism, PD, DLB
PARKINSONISM
In previous clinical studies of patients with DLB [In three clinical studies of levodopa in patients with parkinsonism in DLB [For the primary endpoint (change from baseline in MDS-UPDRS Part III total score at 24 weeks), the mean values were assumed to be 6.72 and 5.28 for the zonisamide add-on and levodopa increase groups, respectively, with a common SD of 8.40 for both groups. Regarding the non-inferiority margin, a previous study reported that a clinically important difference in the UPDRS Part III total score change was 2.5 in patients with PD [