Study design
ADVERSE EVENTS
This study was a prospective, open-label, single-arm clinical trial conducted at two centers in the US. Active TOMAC treatment was administered throughout the study. The opioid dose was reduced iteratively until each participant completed three consecutive step-downs – lasting 2–3 weeks each – or until RLS symptoms worsened (defined below). The study was conducted in accordance with the International Conference on Harmonization guidelines on good clinical practice and the Declaration of Helsinki. An independent medical monitor was responsible for adjudicating adverse events (AEs). The study protocol and informed consent were approved by a central institutional review board (WCG Institutional Review Board). All participants provided informed consent. The trial was preregistered (ClinicalTrials.gov number NCT04698343 registered on January 6, 2021). Funding for this study was provided by NIH/NINDS R44NS117294.