Outcomes
NPS, CRPS, pain, treatment-emergent adverse events, cataracts
CATARACTS, ADVERSE EVENT
The primary efficacy endpoint was change in mean 24-hour pain intensity NPS score (mean of three measurements collected during 1 day by electronic pain diary [E-diary]) from baseline to week 15 (end of part A). Secondary efficacy endpoints included the following: percentage change in mean 24-hour pain intensity NPS score from baseline to week 15; percentage of responders (defined as showing ≥ 30% improvement in the 24-hour pain intensity NPS score) at week 15; change and percentage change from baseline to week 15 in mean total Patient-Reported Outcomes Measurement Information System (PROMIS)-29 domain scores; Patient Global Impression of Change (PGI-C) status at week 15; and change and percentage change from baseline to week 15 in mean total CRPS Severity Score (CSS).Safety-related endpoints included the incidence of treatment-emergent adverse events (TEAEs), clinical laboratory test results, vital signs, Columbia-Suicide Severity Rating Scale (C-SSRS), and electrocardiographic parameters. Based on preclinical findings in rats, cataracts were considered an adverse event of special interest. Any participants with cataracts associated with visual acuity changes were immediately withdrawn from the study and were carefully monitored.Exploratory endpoints included responder rate (defined as ≥ 30% improvement from baseline in the 24-hour pain intensity NPS score) during part B, and plasma 24HC levels at baseline and weeks 2, 7, and 29.