Statistical Analyses
sleep stage, cataplexy
SECONDARY, CATAPLEXY
This post hoc analysis assessed the primary and secondary efficacy endpoints in the NT1 and NT2 cohorts separately and was conducted on the modified intent-to-treat population (mITT). The mITT population was composed of all participants with at least 1 efficacy measurement after receiving either 6 g of ON-SXB or placebo. Notably, the trial was not powered for subgroup analyses and enrollment of participants with NT2 was limited by the sample size of the NT1 population required for the cataplexy endpoint.The change from baseline for mean sleep latency on the MWT with ON-SXB vs placebo at weeks 3 (6 g), 8 (7.5 g), and 13 (9 g) was analyzed using a mixed-effects model for repeated measures (MMRM). An MMRM model was also used to analyze changes from baseline with ON-SXB vs placebo at weeks 3 (6 g), 8 (7.5 g), and 13 (9 g) in (1) sleep stage shifts, (2) nocturnal arousals, (3) sleep quality, (4) refreshing nature of sleep, and (5) ESS score. In the model, treatment, visit, treatment by visit, time and treatment by time (ESS only), US or non-US study site, and baseline score were fixed effects; participants were random effects. The MMRM model also included covariate of baseline values and unstructured variance-covariance structure. GLIMMIX model for binomial data was used to analyze CGI-I categorized responses (ie, the proportion of participants who were very much or much improved), and the response variable was the observed values for each CGI-I categorized response [