Study design
The RESTFUL study was a multicenter, prospective, randomized, double-blind, sham-controlled pivotal trial conducted at 7 sleep clinics in the United States. During stage 1 (Weeks 1–4), participants were randomized 1:1 to active or sham TOMAC treatment. The primary endpoint was assessed at the end of Stage 1. During stage 2 (Weeks 5–8), all participants were assigned to open-label active TOMAC treatment. There was no drug washout; participants were required to maintain a stable dose and schedule of RLS medication for the 30 days prior to study entry and throughout the duration of the study. Upon completion of the RESTFUL study, participants were invited to participate in a separate extension study protocol, the results of which are published separately [