GM-11: gammaCore nVNS episodic migraine study
Research type
Research Study
Full title
A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®-R, a non-invasive neurostimulator device, for the prevention of episodic migraine
IRAS ID
171813
Contact name
Emma de Launay
Contact email
Sponsor organisation
electroCore LLC
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
The study is a double blind, randomized, sham-controlled, multi-center investigation designed to compare two parallel groups, one treated with the gammaCore®-R (active treatment) and the other treated with a sham (inactive) treatment.
The gammaCore®-R device is a re-chargeable non-invasive neurostimulator device that has been approved for the treatment of primary headaches including migraine. gammaCore®-R is a handheld, rechargeable, non-invasive, low voltage electrical device which delivers treatments which are referred to as ‘stimulation cycles’. A stimulation cycle lasts 120 seconds.The study will begin with a four week run-in period, during which subjects will receive no investigational treatment. The purpose of the run-in period will be observation for baseline comparison.
The run-in period will be followed by a 12 week randomized period when the subjects will be randomized (1:1) to either active treatment or sham (inactive) treatment.
The randomized period will be followed by a 24 week open label period, where the subjects in the sham treatment group will switch in treatment assignment and receive active device. Subjects who received the active device during the randomised period will continue to receive an active treatment.
During the randomised and open label period of the study, subjects will be asked to self-administer two stimulation cycles, one on either side of the neck, three times per day (upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment).
For the duration of the study subjects will be asked to complete an electronic diary to record information including medications, headache and migraine occurrence, treatment compliance and adverse events. Subjects will also complete questionnaires during the study to assess their quality of life and their headache and migraine symptoms.
The primary aim of the study is the investigate the difference between the sham and active groups during the 12 week randomisation period in reduction in number of migraine days, compared to the 4 week run-in period.REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0236
Date of REC Opinion
13 Apr 2015
REC opinion
Further Information Favourable Opinion