Following the completion of the double-blind period, the ACT 1 trial included a three-month open label phase during which all patients were permitted to use gammaCore. The results for all the episodic patients – those previously on sham and those previously on gammaCore - were in line with the results from the double blind phase, i.e., patients who had previously used the sham device experienced a significant increase (nearly 2.5X) in successful responses.
Patient preference was also measured, and over 90% of the patients found the gammaCore device easy to use and most reported they would recommend it to a family member or friend.
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A similar study is presently being conducted in the EU and will report shortly.
The full paper is available on line in Headache as open source.
www.electrocore.com
About electroCore
electroCore LLC, the New Jersey based bioelectric pharma company, is focused on developing non-invasive vagus nerve stimulation therapies (the gammaCore device) for the treatment of multiple conditions in neurology, psychiatry, gastroenterology, and respiratory fields. The company’s initial target is the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society. In Germany gammaCore is distributed by Desitin.
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