Statistical analysis
NPS, pain
Assuming a standard deviation (SD) of 2 and a 12% drop-out rate, a sample size of 24 participants (with a randomization ratio of 2:1 for soticlestat: placebo) was judged to be sufficient to achieve at least 65% power to detect a 2-point difference between soticlestat and placebo on the change from baseline to week 15 in mean 24-hour pain intensity NPS score at a two-sided significance level (two-sample Efficacy analyses were based on the full analysis set, which included all participants who were randomized, received at least one dose of the study drug, and had at least one valid post-baseline value for the assessment of mean 24-hour pain intensity score in part A or part B. The safety analysis set included all participants who received at least one dose of the study drug.Observed values, change from baseline, and percentage change from baseline were summarized with descriptive statistics. Throughout the study, “baseline” was defined as the baseline in part A. For the primary efficacy endpoint, the average 24-hour pain intensity was calculated as the mean of three measurements collected by E-diary during 1 day. Data from the last 7 days before screening, week 15 (or last dose in part A, whichever was earlier), and week 29 (or last dose in part B, whichever was earlier) were used to derive the mean 24-hour pain intensity scores for baseline, week 15, and week 29, respectively. Linear mixed models for repeated measurements were used to evaluate the effect of soticlestat on mean 24-hour pain intensity in part A. Estimates for least-square means, least-square mean differences, 95% confidence intervals (CIs), and Statistical analyses were performed using SAS