Complete results of the study are expected to be published in early 2021 in a peer reviewed neurology journal.
electroCore announced that the results from the GM-US-10 (PREMIUM 2) study (NCT03716505) involving non-invasive vagus nerve stimulation (nVNS) met all end points, including several patient-assessed quality of life (QOL) measures in patients with migraine.1
Despite the early termination of the study in April 2020 due to the COVID-19 pandemic, topline results showed benefits from nVNS, including multiple end points achieving a statistically significant improvement compared to sham stimulation. The company noted that the full publication of the results is expected to come sometime in early 2021.
The designated primary analysis population of the study, or the modified intent to treat population (mITT) included 113 patients. Using the gammaCore nVNS, patients had 3.1 less migraine days over the final 4 weeks of the 12-week double-blind study period versus the 4 weeks of the run-in period as compared to a decrease of 2.3 migraine days in the sham group (P = .233).
"The results of the PREMIUM 2 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, senior vice president, Neurology, electoCore, said in a statement.
Within the mITT population, 44.9% of patients using gammaCore nVNS had at least a 50% decrease in the number of migraine days, compared to 26.8% of those who received sham stimulation (P = .048). Additionally, there was a statistically significant decrease in migraine associated disability and an improvement in QOL across all QOL end points in those using the nVNS.
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The study was closed due to the impact of COVID-19 before reaching its original enrollment targets of Q2 in 2020, resulting in intent to treat (ITT) and mITT groups of 228 and 113, respectively.
GammaCore is designed as a portable, easy-to-use technology that can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs, according to electroCore. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which can lead to reduction of pain.
A subgroup that included patients with migraine with aura using nVNS had 5.5 fewer headache days compared to 2.7 fewer headache days in the sham group (P = .041).
Umer Najib, MD, FAHS, director, West Virginia University Headache Center, and investigator in the PREMIUM 2 study said in a statement, "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.”
Safety analysis showed that there was no serious adverse events (AEs), which was consistent with nVNS safety and tolerability profile.
There has been a multitude of previously published data on nVNS prior to the PREMIUM 2 study. In the prospective, double-blind, sham-controlled PREMIUM 1 study (NCT02378844), a 25% reduction in migraine days per month from 8 migraine days for patients with episodic migraine was observed. In addition, therapeutic gains with nVNS were greater for patients with aura (–2.96 days).2
Additional results from PREMIUM 1 showed that 33.6% of patients in the mITT had ≥50% of migraines successfully treated, compared to 23.4% of patients in the sham group (odds ratio, 1.65; P = .074).
Data from the randomized PRESTO study (NCT02686034), which evaluated fast relief from the first treated migraine with nVNS, revealed that 12.7% of patients were pain-free at 30 minutes, 21% at 60 minutes, and 30.4% at 120 minutes, compared to 4.2%, 10%, and 19.7% of patients in the sham group, respectively (P = .012).3
In addition to the improved relief, 75% of patients who were pain-free at 2 hours were also pain-free at 24 hours. While more patients experienced relief with gammaCore at 120 minutes (primary end point), it was not statistically significant.
GammaCore received FDA clearance as an adjunctive medication for the preventive treatment of cluster headaches in adults in November 2018, making it the first and only product FDA cleared for the prevention of cluster headache.4