ElectroCore - GC 003
Research type
Research Study
Full title
A randomized, multicentre, double-blind, parallel, sham-controlled study of the GammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.
IRAS ID
126255
Contact name
Peter J Goadsby
Contact email
Sponsor organisation
ElectroCore LLC
Research summary
This is study of the GammaCore® medical device, a non-invasive neurostimulator device to compare the pain free rates at 15 minutes following the use of GammaCore® with the sham (inactive) treatment for acute treatment of cluster headache (CH) attacks. The study is a double blind, randomized, sham-controlled, multi-center investigation, designed for comparison of two parallel groups, GammaCore® (active treatment) and a sham treatment. The study period begins with a 1-week run-in period, followed by a 2 week comparative period when the subjects are randomized to either active treatment or sham treatment. The comparative period will be followed by 2 weeks of treatment with GammaCore for both groups. There are four visits during the study over the time of 6 weeks. During the study, patient will undergo different evalutions, like physical examination, vitals and ECGs. Patient will alos complete questionnaire. There is only one site in UK (Royal Free Hopital, London) for this study. There are two sites in Ireland.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/0643
Date of REC Opinion
1 Jul 2013
REC opinion
Further Information Favourable Opinion