Benzinga | Dec 8, 2020 08:01AM EST

electroCore Reports Top-Line Results From PREMIUM II Migraine Prevention Study

electroCore, Inc. (NASDAQ:ECOR), a commercial-stage bioelectronic medicine company, announced today top-line results from its GM-US-10 (PREMIUM II) study. Despite the early termination of the study in April 2020 due to the COVID-19 pandemic, all study endpoints, including several patient-assessed quality of life measures, showed benefit from non-invasive vagus nerve stimulation (nVNS), with many endpoints showing a statistically significant improvement with nVNS compared to sham stimulation.

In the predefined modified intent to treat population (mITT; n=113), which was the designated primary analysis population for the study, patients using gammaCore(tm) nVNS had 3.1 less migraine days over the final four weeks of the 12 week double blind study period versus the four weeks of the run-in period as compared to a decrease of 2.3 migraine days in the sham group (primary endpoint; p=0.233).

Within the mITT population, 44.9% of the subjects using gammaCore(tm) nVNS had at least a 50% decrease in the number of migraine days compared to 26.8% for those receiving sham stimulation (secondary endpoint; p=0.048). Patients using gammaCore also reported a statistically significant decrease in migraine associated disability and improvement in their quality of life across all of the quality of life (QOL) endpoints in the study.

Of particular interest were the results in the predefined sub-population of patients diagnosed as having migraine with aura. In this group, patients using nVNS had 5.5 fewer headache days compared to 2.7 fewer headache days in the sham group (p=0.041). There were no serious adverse effects reported in the study, which is consistent with nVNS' strong safety and tolerability profile.

Complete results of the study are expected to be published in early 2021 in a peer reviewed neurology journal. gammaCore(tm) received 510(k) clearance for the preventative treatment of migraine on March 26, 2020.

Dr. Umer Najib, MD, FAHS, Director of the West Virginia University Headache Center and an investigator in the PREMIUM II study, commented "I am pleased that nVNS continues to demonstrate its ability to effectively decrease the migraine burden in patients who need preventive therapy. The strong benefit seen in patients diagnosed with aura is particularly interesting as those patients can often be particularly difficult to treat."

"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," said Eric Liebler, SVP of Neurology at electroCore, Inc. "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. With FDA clearances for the acute and preventive treatment of both cluster and migraine headache, gammaCore continues to differentiate itself as one of the most effective, safe and flexible treatments available to help patients looking for a way to take control of their headache treatment."

PREMIUM II was a randomized, double-blind, sham-controlled clinical trial of gammaCore(tm) for the prevention of migraine conducted at over 30 sites in the United States (ClinicalTrials.gov identifier NCT03716505). The study was originally designed based on mITT of approximately 300 subjects. The study was closed before reaching its original enrollment targets in Q2 of 2020 due to the impact of COVID-19 on the conduct of clinical trials, resulting in intent to treat (ITT) and mITT groups of 228 and 113, respectively.