NeuroMetrix's Nerve Stimulator Shows Mixed Outcomes In Fibromyalgia Trial

NeuroMetrix Inc NURO has reported that top-line results from a randomized controlled trial of Quell for fibromyalgia will be presented at two upcoming pain medicine conferences.
Quell is a transcutaneous electrical nerve stimulator indicated for symptomatic relief and management of chronic lower extremity pain and is available over-the-counter.
A total of 119 fibromyalgia subjects were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use.
In the intention-to-treat population, the treatment difference in the Patient Global Impression of Change (PGIC, primary endpoint) was not significant. PGIC reflects a patient's belief about the efficacy of treatment.
However, in a pre-specified subgroup analysis of subjects with elevated baseline pain sensitivity, the active treatment group exhibited significant and clinically meaningful improvements compared to sham.
The PGIC responder rate was 58% (active) versus 30% (sham). The pain responder rate (over 30% reduction) was 58% (active) versus 18% (sham).
The health-related quality of life assessment responder rate (over 15% reduction) was 56% for the active device compared to 35% for sham.
There were few adverse events, and all were minor and self-limited.
The use of Quell for fibromyalgia is investigational.
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