NeuroMetrix is gearing up to present partial trial results on Quell, the company’s wireless transcutaneous electric nerve stimulation (TENS) device, for treatment of peripheral neuropathy caused by chemotherapy at the American Society of Clinical Oncology (ASCO) in Chicago.
The National Institutes of Health (NIH) funded, multi-site, sham-controlled, subject and assessor blinded randomised trial (NCT04367480) was conducted in conjunction with NCI Community Oncology Research Program (NCORP) to assess the device’s efficacy.
A total of 142 subjects with CIPN were randomised to an active or sham Quell device for 6-weeks. Subjects in both arms were instructed to wear the device for 5 hours each day.
The subjects received stimulation in 1 hour treatment sessions followed by 1 hour rest periods. The placebo Quell was identical, except it delivered only 2.5 mins of stimulation in the treatment period.
Patients with moderate to severe CIPN symptoms of hot/burning pain, sharp/shooting pain or muscle cramping experienced about a 50% reduction in symptoms for active treatment compared to about 30% for sham treatment.
Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN, but less likely to improve numbness and tingling.
The results are consistent with a previous open-label study by NeuroMetrix.
“Quell offers the potential for a safe and effective treatment that can be administered at home," said Neurometrix CEO Shai N. Gozani. "We look forward to obtaining further details on the trial results over the coming months and will correspondingly finalise our regulatory strategy, potentially to include a near term regulatory submission for a Quell CIPN indication. We are also enthusiastic about continuing to support Dr. Gewandter and her colleagues at NCORP as they pursue a confirmatory trial that further investigates the clinical benefits of Quell in CIPN."
In January 2022, Quell received a breakthrough device designation for chronic CIPN by the US Food and Drug Administration (FDA).
Quell had previously received FDA authorisation for fibromyalgia and is currently marketed as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity.
