GM-18: Open Label nVNS for prevention and acute treatment of migraine
Research type
Research Study
Full title
GM-18: A Randomized, multicenter, study for the prEvention and Acute treatment of migraine using open Label non-invasive vagal nerve stimulation, versus standard of care (REAL)
IRAS ID
259054
Contact name
Alexandra Sinclair
Contact email
Sponsor organisation
electrocore Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The study is a randomized, multi-centre investigation using non-invasive vagal nerve stimulation both preventatively and acutely for the treatment of migraine. The study is designed to compare treatment of migraine headache using nVNS (in addition to standard of care) against standard care alone (SOC); standard of care = study participants’ regular headache medications. The nVNS device is the gammaCore SapphireTM, the device has been approved for the treatment of primary headaches including migraine. gammaCore SapphireTM is a handheld, non-invasive, low voltage electrical device which delivers treatments which are referred to as ‘stimulation cycles’. A stimulation cycle lasts 120 seconds.
Participants, identified in hospital headache clinics, who experience at least 6 and no more than 24 headache days per month and a minimum of 4 migraines over the last month will be eligible to be enrolled. The study will begin with a 4 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 the nVNS treatment group or the SOC group.
During the randomised period the nVNS treatment group will be asked to self-administer two stimulation cycles, one on either side of the neck, two times per day (upon waking and before bedtime) (preventative treatment). In addition these subjects will also use the device to treat migraine attacks when they occur (acute treatment).
The purpose of the study is to compare the difference in reduction of migraine days in the two groups during the last 4 weeks of the randomised period and the 4 week run-in period.
For the duration of the study all 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.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0140
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion