Neuroscience tech developer ElectroCore today released data from the ACT clinical trials exploring the use of its gammaCore non-invasive vagus nerve stimulator for treating patients with episodic cluster headaches.
Results from the study were presented at the 59th Annual Scientific Meeting of the American Headache Society, the company said.
The 250-patient studies evaluated the safety and efficacy of the gammaCore device as an acute treatment for patients with cluster headaches, the company said. Data from the trial indicated that the proportion for patients who achieved mild or no pain at 15 minutes post treatment was significantly greater in patients treated with the gammaCore versus sham treatment in all but 1 of the trials.
The proportion of all treated attacks that achieved pain-free status at 15 minutes after treatment initiation was significantly greater in gammaCore patients than those in the sham arm at 15% versus 6% in the 1st trial and 35% versus 7% in the 2nd. Pool analysis reported a difference of 24% versus 7%.
Additional results from the ACT2 study found that the proportion of all attacks that achieved pain-free status at 15 minutes with the gammaCore was superior to those in the sham cohort at 47.5% versus 6.2%.
“The findings from this pooled analysis of ACT1 and ACT2 are exciting. The data not only reinforces the safety and efficacy of gammaCore but also highlights some of the important advantages of non-invasive vagus nerve stimulation over existing treatment options, such as ease-of-use and the ability to be employed for multiple attacks a day,” Dr. Peter Goadsby of King’s College London Hospital said in a press release.