ElectroCore Announces Initial Activities in its Chronic Migraine Prevention and Cluster Headaches Studies Utilizing its GammaCore Therapy
- Company has enrolled first U.S. patients for its FDA approved chronic migraine prophylaxis study
- ElectroCore received FDA approval to begin enrollment of an acute cluster headache study
- Initial enrollment of a cluster headache acute and prophylaxis study has begun in Germany
- 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 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 U.S. 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 U.S. Food & Drug Administration approval of GammaCore for the acute treatment of cluster headaches.
- GammaCore technology was featured in a poster session at the 2012 European Headache and Migraine Trust International Congress in London. Fourteen patients attending headache centers in the U.K. 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.
For more information, visit: http://www.electrocoremedical.com/.
SOURCE ElectroCore Medical