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Following the announcement last month that it had fully enrolled its pilot FDA chronic migraine study electroCore has announced that its European randomized controlled trial, GC - 002, for the prevention and acute treatment of chronic cluster headache has been found by the external statistical team to require no changes based on the planned interim sizing analysis.
This study, which is a multicentre trial with sites in Germany -5, UK -3, Belgium -1, Italy -1, has as its primary outcome the reduction in the number of cluster headache attacks per week. The trial is a randomized controlled study involving parallel groups. One arm receiving the standard of care while the other arm is receiving the standard of care plus treatment with gammaCore - electroCore's non invasive vagus nerve stimulation (nVNS) therapy. The trial, which is due to finish at the end of the second quarter next year, has already enrolled 58 patients with a target total of 90 patients.
electroCore's extensive clinical trials program is continuing to explore the potential of its revolutionary non invasive vagus nerve stimulation therapy across a number of conditions. Surgically invasive vagus nerve stimulation therapy has proven to be very effective in epilepsy and depression but because of its very high cost is not used except as a last resort. Its high cost has also deterred research into the many conditions where it is reported to have been effective.
Several other key electroCore headache trials are also underway.
A European acute treatment of cluster headache trial has just started recruitment.
This randomized controlled study has two parallel groups one using gammaCore, the other a sham device. The trial is being run across eight sites - UK - 4, Germany 2, Denmark -1 and Netherlands 1. The results are expected in the third quarter of next year.
A pivotal FDA trial into the acute relief of cluster headaches is being carried out across nineteen sites in the US with 78 patients already enrolled. The final number of patients required, between 150 and 300, will be determined by an interim analysis by an outside statistical team based on the first 75 completed patients by the end of the year. This trial is measuring the level of pain on a five point scale 15 minutes after patients have self treated an acute cluster headache attack with the gammaCore device. The results are expected at the end of next year.
An epilepsy trial using electroCore's nVNS therapy, the first clinical study of nVNS in this indication, is now being run at two sites in Australia. The randomized controlled, parallel-group, crossover trial using a sham device will measure the reduction of seizures in patients with epilepsy. Four out of 30 patients have already been enrolled and the results will be available at the end of quarter three next year.
JP Errico CEO of electroCore commented "We are delighted with the progress we are making. The open label trials we have run were very encouraging and we are confident that next year these randomized controlled trials will confirm that our non invasive vagus nerve stimulation VNS offers a significant benefit to patients with many types of serious headaches."
Article adapted by Medical News Today from original press release. Source:
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13 Dec. 2013. <http://www.medicalnewstoday.com/releases/268270>
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