Preliminary results of an open-label trial carried in the Journal of Headache and Pain reported that a single treatment with electroCore’s handheld non-invasive vagus nerve stimulation device gammaCore, completely resolved 44.8% of migraines within 30 minutes, with an additional 11.4% experiencing moderate benefits (incomplete resolution of their headaches) by two hours.
This result follows two presentations at the International Headache Meeting in Copenhagen in September showing that patients using gammaCore plus standard of care achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% (p=0.002) in patients treated with the best available standard of care. It also found that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.
This open-label migraine study was carried out at the Headache Centre in the Neurological Institute in Milan. The study involved thirty patients, 18 – 65, who had migraine without aura and suffered from five to nine attacks per month. Patients treated between three and six migraine episodes with gammaCore. Ninety six migraine attacks were treated by a single dose. Forty three attacks were resolved completely within 30 minutes (44.8%); for 42 (43.7%) attacks the application did not show any benefit in the first two hours so patients recurred to rescue medication; in 11 (11.4%) attacks the result was uncertain: no resolution of attack, only a moderate relief of pain. No adverse events were recorded.
Licia Grazzi, lead author, comments: “The results look very promising and patients found the therapy easy to apply and it was well tolerated.”
electroCore had previously reported, at the American Headache Society that a US prevention of chronic migraine study, with a sham control arm, met its primary endpoint of safety, and demonstrated a reduction in the number of headache days per month for patients using the active device. The study suggests that patients who remain on therapy for longer periods of time, enjoy progressively larger decreases in headache days.
electroCore, which is running the broadest headache trial programs in the world, will report shortly on two further sham-controlled clinical studies; a US trial on the acute treatment of episodic and chronic cluster, and a European trial on the acute treatment of episodic and chronic cluster headache.
electroCore chief executive officer and founder JP Errico says: “As the results of our studies continue to demonstrate positive results, we are increasingly optimistic that the extensive investment we have made in both pre-clinical trials and clinical trials was a wise use of our capital and human resources. We believe that this therapy is unique in both its safety and efficacy profiles. With few adverse events reported, non-invasive vagus nerve stimulation appears to be the first therapeutic option that offers both acute and prophylactic benefits for patients who suffer frequent and severe headaches. As such, we believe that gammaCore will ultimately move to a first line treatment for these patients, and will continue to conduct the clinical research necessary to support that conclusion.”