In a multicentre, randomised, trial across Europe, electroCore’s non-invasive vagus nerve stimulation therapy was found to meet its primary endpoint of statistical significance in reducing the number of cluster headache attacks when compared with the standard of care. During weeks three and four following the beginning of therapy, the number of cluster headache attacks per week was reduced by 46.3% in patients treated with nVNS compared with 12.5% (p=0.002) in patients treated with the best available standard of care.
Charly Gaul, director of the Migraine and Headache Clinic Königstein, Germany and the principal investigator of the study comments; “This study is one of the few well controlled, randomised studies of any preventative treatment for cluster headache. The ability of electroCore’s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.”
The trial—Preva—which was conducted at ten sites across Europe was investigating both the prevention and acute treatment of chronic cluster headache. Patients delivered the non-invasive vagus nerve stimulation treatment by placing the gammaCore device on the skin over the vagus nerve in the neck prophylacticly twice daily (three stimulations per treatment) and optionally at the onset of a cluster headache.
The trial enrolled 97 patients, and 93 were randomised to participate beyond the initial baseline data collection period. Forty five of the patients were randomly selected to use gammaCore and 48 to the best available standard of care. The baseline data collection period was two weeks, followed by the four week randomised phase. All subjects were permitted to continue on active therapy for an additional four weeks.
The primary efficacy end point was the reduction in number of cluster headache attacks per week during the last two weeks of the randomised phase versus the baseline period. Additional end points included the proportion of subjects with more than 50% reduction in cluster headache attacks per week (response rate).
Device related adverse events were primarily mild and transient. Full data from the randomised and open label portions of the study will be presented at medical meetings later this year.