PLEASANTON, Calif., May 25, 2021 /PRNewswire/ -- Noctrix Health, Inc. today announced that the first patient has been enrolled in a multi-center, randomized controlled clinical trial. The RESTFUL Study (ClinicalTrials.gov Identifier: NCT04874155) 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," said Shri Raghunathan, Ph.D., President and CEO of Noctrix Health.
"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," said one of the principal investigators, Richard Bogan, MD, Associate Clinical Professor at the University of South Carolina School of Medicine and former CMO of SleepMed, Inc., the largest sleep diagnostic company in the United States.
The Company 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, the official, peer-reviewed journal of the American Association of Sleep Medicine (AASM). (Buchfuhrer MJ, Baker FC, Singh H, et al. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021;10.5664/jcsm.9404. doi:10.5664/jcsm.9404)
"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," said the lead author, Dr. Mark Buchfuhrer, MD, a world-renowned expert who has authored numerous books, chapters, and journal articles on the clinical management of RLS.
"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," said Jonathan Charlesworth, Ph.D., Head of Clinical Sciences, Noctrix Health.
About Restless Legs Syndrome (RLS) RLS is the second most common sleep disorder in the world, estimated to impact up to 10% of the adult population in the US alone with nearly a third of RLS patients having moderate-severe symptoms that warrant treatment with medications. There is a large and growing population of patients with refractory RLS, primarily because the most common first-line medications – dopaminergic agents – often lead to progressive worsening of RLS symptoms over time, including the development of significant symptoms earlier the day and symptoms in the upper limbs in addition to the legs.
About Noctrix Health Noctrix Health is a pioneer in the development of wearable therapeutics that employ its proprietary neurostimulation technology to address chronic neurological conditions, with an initial focus on sleep disorders.