The noninvasive vagus nerve stimulation device showed results consistent with what had been previously observed in the literature, with a particular benefit observed for those who have migraine with aura.
Findings from the double-blind, sham-controlled PREMIUM II trial (NCT03716505) further reinforced the efficacy and safety of gammaCore (electrocore), a noninvasive vagus nerve stimulation (nVNS) device designed as a portable, easy-to-use technology, for the prevention of migraine, and in particular, those who have migraine with aura.1,2
The newly published data in Cephalagia continued to build on the growing efficacy profile of gammaCore since its FDA approval for the treatment of cluster headache in 2018. The study was originally powered to be randomized to 400 patients with migraine, but was closed early due to COVID-19 after enrolling 231 individuals.
Those included in the study completed a 4-week diary run-in period, followed by a 12-week double-blind period where they were randomized to gammaCore nVNS. At the end of the study period, patients who were treated with the device recorded a decrease of 4.6 monthly headache days, whereas those on sham showed an increase of 3.0 days per month (P = .05). Furthermore, 44.87% of those on gammaCore demonstrated at least a 50% reduction in these days, compared with 26.81% of those in the sham group (P = .05).
Lead author Umer Najib, MD, associate professor, and program director, Headache Medicine Fellowship Program, West Virginia University, said in a statement, "We are pleased to have added to the data that helps suggest the types of migraine patients who could likely benefit most from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or adjunctive treatment, depending on the needs of the patient, and its flexibility allows health care providers to consider it for many of their patients."1
The mean reduction in monthly migraine days, the primary end point, was 3.12 for the active group and 2.29 days for the sham group (difference, –0.83; P = .2329). Investigators observed improvements of –4.9 points in quality of life, as measured by the Headache Impact scale (HIT-6), compared to –2.3 for those in the sham group (P <.05).
A secondary analysis that included only those diagnosed with migraine with aura showed a decrease of 5.5 headache days on gammaCore nVNS compared to just 2.7 days (P <.05) for those on sham, a more than 100% therapeutic gain. The safety and tolerability profile was consistent to what had been previously observed, with no serious device-related adverse events reported.
"We congratulate and thank all of the investigators, site staff, and subjects who conducted this study throughout the United States despite the challenges that arrived with COVID-19,” Eric Liebler, senior vice president, Neurology, electroCore, said in a statement.1 "With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the findings of this study highlighting the potential benefits in patients who have migraine with aura are particularly compelling."
Placed on a patient’s neck over the vagus nerve, the gammaCore device aims to stimulate the nerve’s different fibers. When it received its original FDA greenlight, it became the first noninvasive hand-held medical therapy applied at the neck to treat migraine and cluster headache. Since then, it has gained expanded indications to acutely treat pain associated with episodic cluster headache, and the acute and preventative treatment of migraine in adolescents (ages 12 years and older).
In September 2021, the device received FDA approval to treat patients with paroxysmal hemicrania and hemicrania continue in adult patients, making it the first treatment–drug or device–to be approved for these patient populations.3 Data from multiple clinical audits and case series/case reports, including one which found more than three-fourths of the cohort to benefit from the device, were the basis for that decision.