Outcomes
RLS
SECONDARY, -11
Outcome measures were listed in prespecified order to first evaluate treatment group Week 24 relative to baseline (primary endpoint and secondary endpoints 1–5) and then evaluate treatment group week 24 relative to control group week 24 (secondary endpoints 6-11). The primary endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate at week 24 for treatment group, with responders defined as “much improved” or “very much improved” relative to baseline (i.e. entry to the RESTFUL study). Key secondary endpoints 1–5 were assessed at week 24 for the treatment group relative to baseline and 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), and change in IRLS Question #7 score (frequency of RLS symptoms). Key secondary endpoints comparing the treatment and control groups at week 24 were assessed in the same order (CGI-I, PGI-I, IRLS, MOS-II, MOS-I, and IRLS Question #7). The primary endpoint and key secondary endpoints comparing week 24 of the treatment group relative to baseline were prespecified in the study protocol; additional key secondary endpoints were prespecified in the statistical analysis plan prior to database lock.