Efficacy
NPS, Pain, CRPS, pain, depressive, depression
COMPLEX REGIONAL PAIN SYNDROME
For the primary efficacy endpoint, the soticlestat group did not differ from the placebo group, with least-square mean changes from baseline in the 24-hour pain intensity NPS score (95% CI) at week 15 of –0.75 (–1.55, 0.05) and –0.41 (–1.41, 0.59), respectively, resulting in a statistically non-significant placebo-adjusted difference of –0.34 (–1.55, 0.88; Plot of mean change from baseline in weekly averaged daily NPS scores during part A and part B (full analysis set). Data are mean ± SD. NPS = Numeric Pain Scale; SD = standard deviation.Efficacy summaryCI = confidence interval; CRPS = complex regional pain syndrome; CSS = CRPS Severity Score; LS = least-square; NPS = Numeric Pain Scale; PGI-C = Patients’ Global Impression of Change; PROMIS = Patient-Reported Outcomes Measurement Information System; SD = standard deviation.– indicates no data is available.
Defined as ≥ 30% improvement from baseline on the 24-hour pain intensity NPS (n = 24).Higher scores indicate greater CRPS severity, that is, more signs/symptoms (range, 0–16 points) (n = 14).Higher scores indicate more symptoms or function. For example, higher scores on the physical function scale represent better function, whereas higher scores on the depression scale indicate more depressive symptoms. Mean PROMIS-29 scores by visit are summarized in At week 15, four participants (26.7%) in the soticlestat group and two participants (22.2%) in the placebo group were classified as responders (≥ 30% improvement on the 24-hour pain intensity NPS). At week 29, six participants (25.0%) were classified as responders, comprising two participants (22.2%) who had received placebo and four (26.7%) who had received soticlestat during part A (Change from baseline to week 15 in mean CSS total score (SD) was –3.1 (3.12) points with soticlestat and –2.2 (2.48) points with placebo (Minor changes were observed from baseline to week 15 in each of the seven PROMIS-29 domains, which were generally similar between the soticlestat group and the placebo groups (An improvement in PGI-C status (much improved or minimally improved) from baseline to week 15 was reported by seven participants (46.7%) in the soticlestat group and four participants (44.4%) in the placebo group. At week 29, 12 participants (66.7%) reported improvement (very much, much, or minimally improved) (