Outcomes
RLS
SECONDARY, BLIND
Efficacy outcome measures were centrally assessed for the intent-to-treat (ITT) population, which comprised all eligible subjects who passed screening and were randomized. The primary endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate at Week 4 (end of stage 1), with responders defined as having been rated by the clinician as “much improved” or “very much improved.” The CGI-I was administered by investigators experienced in the diagnosis and treatment of RLS. Prespecified key secondary endpoints, all completed by the participant and assessed at Week 4 relative to study entry, were ordered as follows: Patient Global Impressions-Improvement (PGI-I) responder rate, change in total IRLS score, change in Medical Outcomes Study Sleep Problem Indices II (MOS-II) and I (MOS-I) scores, mean CGI-I score, and change in IRLS Question #7 score (frequency of RLS symptoms). Change in IRLS question #7 score from baseline to Week 8 was added as a key secondary endpoint before breaking the blind. Descriptive analyses of CGI-I, PGI-I, IRLS, MOS-I, and MOS-II at Week 8 were also prespecified.Adherence to device usage was assessed automatically by the device. Patient satisfaction with treatment was assessed using several questions with yes/no response options.Safety outcome measures were centrally assessed. The count and proportion of participants reporting AEs with new onset or worsening (relative to baseline) were compared between treatment groups and stages. AEs were coded and summarized at the participant level by Medical Dictionary for Regulatory Activities System Organ Class and Preferred Terms and by seriousness, severity, and relationship to the device.Participants self-identified their race and ethnicity on a survey.