A clinical trial was administered to test the efficacy and safety of restiffic. The Principal Investigator of the clinical trial was Daniel J. Olson, DPM; Sub-Investigators were John P. Sullivan, MD and Frederick J. Tomassi, DPM. It was a single arm, open label clinical trial with a repeated measures design. The study population consisted of 30 otherwise healthy adults, mean age 51.5 years (range 30 to 75 years), diagnosed with moderate to severe primary RLS.
Efficacy was measured using the International RLS Study Group (IRLSS) Rating Scale, with scores ranging from 0 to 30 (30 being the most severe), and the physician-generated Clinical Global Impression (CGI) Scale, measuring severity, improvement, and Efficacy Index (EI). Safety was assessed by recording adverse events, analyzing the severity, and the relationship to the restiffic device.
During the study, patients recorded their RLS symptoms over 8 weeks. After one week of observation without treatment, patients were given a pair of restiffic devices for Weeks 2 through 4. The devices were removed for Week 5, and returned to the patients for Weeks 6 through 8.