Noctrix Health announces publication of landmark results from randomized clinical trial and long-term extension study of its revolutionary Tonic Motor Activation (TOMAC) therapy for Restless Legs Syndrome (RLS) in Sleep

• Dual feature in the prestigious, peer-reviewed journal, Sleep show that TOMAC therapy was safe and effective in adults with RLS refractory to medications, with all primary and secondary endpoints successfully met with no serious or severe device-related adverse events.
• Mean change in International RLS Rating Scale (IRLS) of -11.3 points and a mean responder rate (CGI-I) of 72.7% at week 24 for patients on TOMAC therapy.
• Long-term TOMAC treatment led to a substantial reduction in frequency of RLS symptoms from 5.9 nights to 3.2 days per week and a mean reduction of -17.2 points on the MOS-II sleep scale.

Excerpt from the Press Release:

PLEASANTON, Calif., July 26, 2023 /PRNewswire/ — Noctrix Health, Inc. announced a double feature in the renowned peer-reviewed journal, Sleep, showcasing the outcomes of two major clinical trials that assessed TOMAC therapy for the treatment of RLS. The two papers feature the results from the RESTFUL study (NCT04874155), a multi-center, randomized, sham-controlled clinical trial, and a subsequent 24-week extension study (NCT05196828). This major accomplishment comes after the FDA-granted the technology a “Breakthrough Device Designation” in May 2020 and subsequent market authorization in April 2023. The prescription therapy includes a pair of neuromodulation devices worn on the lower legs that electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation, and suppress symptoms of RLS. The mechanism of action behind this therapy was also published earlier this month in the Journal of Clinical Sleep Medicine, the official journal of the American Association of Sleep Medicine (AASM).

The RESTFUL study enrolled a total of 133 adult participants with medication-refractory, moderate-to-severe, primary RLS and reported statistical significance for all seven efficacy outcomes. The therapy was well-tolerated by patients and did not result in any significant adverse events. These data were taken into consideration by the US FDA to grant a De Novo authorization, making the NTX100 TOMAC System the first and only therapy of its kind for patients with moderate-severe, drug-refractory RLS.

The extension study reinforced and further improved on these results to demonstrate that long-term use of TOMAC therapy provides robust and durable benefits at very low risk to patients. Mean responder rates (CGI-I) and mean change in the International RLS Rating Scale (IRLS) improved from 63.6% and -7.4 points at 8 weeks (end of RESTFUL RCT) to 72.7% and -11.3 points at 24 weeks, respectively. Significant sleep quality improvements were also seen, as measured by a mean change of -17.2 points on the MOS-II sleep scale at 24 weeks from baseline.

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