ElectroCore, a healthcare company dedicated to developing effective, non-invasive Vagal Nerve Stimulation (nVNS) therapies for serious medical conditions including primary headaches, has started enrolling patients in its US FDA approved chronic migraine prevention study using its GammaCore nVNS therapy. The randomised, sham-controlled study is enrolling patients at 10 sites across the US.

The study, which is expected to offer an initial read out during the first half of this year, will include 60 patients who suffer with migraine more than 15 days per month. Participants will use three 180-second GammaCore treatments per day for two months, comparing the frequency, duration, and severity of their migraines against a control group using a sham device, and against their own baseline data gathered prior to the initiation of the treatment protocol. After the study’s initial phases, subjects will be given the opportunity to continue using the prophylactic therapy for six additional months.

“GammaCore is the first non-invasive device capable of stimulating the cervical branches of the vagus nerve, enabling self-administration of therapy without a surgical procedure,” said JP Errico, CEO of ElectroCore. “Positive results from this study will bring us one step closer to providing an important new treatment option to the more than seven million Americans who suffer from chronic migraine.”

Additional ElectroCore activities include:

Initial enrollment has begun in a randomized cluster headache study being conducted by leading neurologists at six sites in Germany with the intent of establishing government reimbursement for nVNS therapy. In the first phases of the study, 90 chronic cluster headache patients are being randomized between GammaCore nVNS therapy and the standard of care. After the first four-week phase, all patients enrolled in the study will be provided GammaCore nVNS therapy during a final phase. In this study, the therapy will be used as both an acute and a prophylactic treatment of their condition. GammaCore nVNS therapy has already been CE marked, and is commercially available in Germany and across the European Union.

ElectroCore received US FDA approval to begin a pivotal study of GammaCore as an acute treatment for cluster headaches. This trial, expected to begin enrolling during the first quarter of 2013, will study the acute benefits of treatment of cluster headache events in 150 chronically suffering subjects at 15 sites across the US. During the initial phase of the study, subjects will be randomized against a sham device for a period when they will treat up to five headache events in a two-week period. At the conclusion of the first phase, all 150 subjects will be provided access to the GammaCore nVNS therapy for a period of six months. This study is expected to read out with an interim analysis in the first half of this year. Based on the results of the study, ElectroCore plans to submit for US FDA approval of GammaCore for the acute treatment of cluster headaches.

GammaCore technology was featured at the 2012 European Headache and Migraine Trust International Congress in London. Fourteen patients attending headache centres in the UK and Ireland were offered non-invasive VNS treatment and questioned during routine follow up about their experience with the device and the perceived impact. Thirteen felt there was an overall improvement in their condition since using the device (the median device use period was 13 weeks), suggesting that GammaCore appears to be well-tolerated and effective in both the acute and preventive treatment of episodic and chronic cluster headache.