NeuroMetrix (NSDQ:NURO) announced a mixed bag of top-line results from its trial of Quell in patients with fibromyalgia.
Woburn, Mass.-based NeuroMetrix’s double-blind, randomized, sham-controlled trial evaluated the treatment of fibromyalgia with Quell, an over-the-counter novel transcutaneous electrical nerve stimulator (TENS) indicated for symptomatic relief and management of chronic lower extremity pain.
Quell, a wearable device that can be used during the day while active and at night while sleeping, offers personalized and manageable therapy through its mobile app and provides health tracking metrics relevant to chronic pain sufferers, according to a news release.
The trial, conducted at the Center for Pain Management at Brigham & Women’s Hospital in Boston, enrolled 119 subjects with fibromyalgia, randomizing the subjects to a standard (active) or modified (sham) Quell device for three months of at-home use. Subjects registered an average age of 50 years old, with most subjects having moderate to severe fibromyalgia with the average duration of chronic pain totaling 18 years. Additionally, 93% of the subjects were female.
Key results include an insignificant treatment difference in the patient global impression of change (PGIC, the primary endpoint) in the intention-to-treat (ITT) patient population. NeuroMetrix did report that, in a pre-specified subgroup analysis of subjects with elevated baseline pain sensitivity, the active treatment group registered a significant and clinically meaningful improvement compared to the sham group.
Additionally, the ITT population delivered positive results with secondary endpoints, reducing the mean FIQR total score in a significant way. The brief pain inventory (BPI) interference subscale and the painDETECT questionnaire also showed significant improvements. The company reported “few TENS-related adverse events,” with all events proving minor and self-limited.
In the ITT population, the FIQR responder rate was 56% for the active device compared to 35% for the sham. In the elevated baseline pain sensitivity subgroup, PGIC responder rate registered 58% (active) against 30% (sham). The pain responder rate was 58% (active) versus 18% (sham).
“I would like to thank Dr. Robert Jamison and his colleagues at Brigham and Women’s Hospital for designing and successfully completing this trial study despite the COVID-19 pandemic. Fibromyalgia is a disabling chronic pain condition with an urgent need for effective treatments without the side effects of drugs currently used to manage the condition. We believe that Quell may be effective in fibromyalgia and the results of this study support this potential,” NeuroMetrix president & CEO Dr. Shai N. Gozani said in the release. “We are particularly pleased that subjects treated with Quell exhibited a significant improvement in FIQR over 3-months compared to sham. FIQR is a comprehensive health-related quality of life assessment specifically designed for fibromyalgia. The 21 clinical items comprising the FIQR have high everyday relevance to individuals with fibromyalgia. We are also pleased with the broad positive results in subjects with elevated pain sensitivity, because these are the patients expected to benefit most from nerve stimulation.”