electroCore (NASDAQ:ECOR) reported positive topline results from its PREMIUM II study evaluating gammaCore, a non-invasive vagus nerve stimulation (nVNS) device, for the prevention of migraines.
The study was designed to enroll some 300 subjects in the modified-intent-to-treat population, however the company had to terminate the study in April 2020 due to the COVID-19 pandemic. The topline data are based on a modified-intent-to-treat population of 113.
In this population, patients using gammaCore nVNS had 3.1 less migraine days over the final four weeks of the 12-week study period, compared with the four-week run-in period. The sham group reported a decrease of 2.3 migraine days.
“The results of the PREMIUM II study highlight the unique role gammaCore nVNS can play as the only headache treatment that has demonstrated an ability to decrease the number of migraine days a patient experiences while also being able to treat the acute pain of migraines that occur in spite of a preventive regimen,” Eric Liebler, electroCore’s SVP of neurology, said in a statement.
“Although the ongoing COVID-19 pandemic negatively impacted our ability to fully enroll PREMIUM II, our analysis indicates we likely would have reached statistical significance on all of our predefined endpoints had the study reached its original enrollment targets,” he added.
electroCore expects that complete study results will be published in a peer-reviewed journal in early 2021.
