Episodic cluster headache patients using electroCore’s gammaCore non-invasive vagus nerve stimulation device (nVNS) had a significant and clinically meaningful benefit within 15 minutes of an attack treatment, compared with a sham treatment, with the benefit sustained for over an hour.
The study, which was published in the peer-reviewed journal, Headache, also reported that nVNS is well tolerated, produced no serious side effects, and that the percentage of episodic patients who experienced a successful response to the first attack treated within 15 minutes was triple those using a sham.
The ACT1 study enrolled 150 patients at 20-headache treatment centers. Patients self-administered the therapy by placing a sham or gammaCore on the skin over the vagus nerve in the neck.
“This is one of the largest studies of an acute treatment of cluster headache and provides some very encouraging results for patients, particularly those with episodic cluster, who make up 85% of all cluster patients,” Dr. Stephen Silberstein, an author of the paper and director of the Thomas Jefferson Headache Center in Philadelphia and former president of the American Headache Society, said in a statement.
A similar study is being conducted in the EU and will report soon.
There are limited therapeutic options for the acute treatment of cluster headache, which affects more than 300,000 people in the U.S., where only subcutaneous sumatriptan injections and intravenous dihydroergotamine (DHE) are approved for acute use. However, DHE is limited to hospital use and the FDA approved labeling for sumatriptan allows a maximum of two doses a day.
As a result, there is a significant unmet need for many patients, including those with frequent attacks – three-to-eight a day – who cannot use injectable sumatriptan to treat every attack because of a separate condition known as medication overuse headache, which can be caused by repeated use of triptans.