Noctrix Health Inc has enrolled the first patient in a multi-center, randomized controlled clinical trial. The RESTFUL Study is a first of its kind two-phase, randomized, double-blind, sham-controlled clinical trial to evaluate the company’s proprietary wearable NTX100 Neuromodulation System in patients with moderate-severe primary RLS who remain refractory to medications.
“Enrolling our first patient in this multi-center study represents an important milestone in our efforts to advance a potentially game-changing wearable therapeutic for patients who struggle to find symptomatic relief with medications due to side effects or insufficient efficacy,” says Shri Raghunathan, PhD, president and CEO of Noctrix Health, in a release.
“There are a large number of patients that would benefit tremendously from this potential alternative to dopaminergic treatments, and I am excited to partner with the Noctrix Health team in studying its effectiveness in the medication-refractory RLS population,” says one of the principal investigators, Richard Bogan, MD, associate clinical professor at the University of South Carolina School of Medicine and former chief medical officer of SleepMed Inc, in a release.
Noctrix also announced positive results from an earlier pilot study exploring the efficacy of its noninvasive neurostimulation platform in patients with moderate-severe RLS that have been accepted for publication in the Journal of Clinical Sleep Medicine.
“Noninvasive neuromodulation shows great promise in reducing symptoms of moderate-severe RLS and has the potential to become an alternative to pharmacologic treatments for many patients. There is a large and growing population of RLS patients who are unable to find sufficient benefits from existing RLS medications, largely due to augmentation, a long-term worsening of RLS symptoms caused by commonly prescribed dopaminergic medications,” says the lead author, Mark Buchfuhrer, MD, in a release.
Jonathan Charlesworth, PhD, head of clinical sciences at Noctrix Health, says in a release, “We look forward to advancing our clinical program by building a strong body of evidence to support the use of this breakthrough technology in the treatment of RLS and are grateful for the support of our clinical collaborators in support of this mission.”