NCT03787238

A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL)

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)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. .

Detailed description

A randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. Eligible subjects will participate in a 4 week run-in period after which they will be randomized (1:1) to either nVNS and standard of care (nVNS group) or standard of care (SOC group) for 12 weeks. The nVNS group will use the nVNS device preventatively and acutely for the treatment of migraine. The SOC group will continue to use their regular standard of care migraine treatment medications for the duration of the 12 week randomized period.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	non-invasive vagus nerve stimulation	non-invasive vagus nerve stimulation using the gammaCore Sapphire device

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-09-01
• Completion: 2020-10-01
• First posted: 2018-12-26
• Last updated: 2019-06-14

Locations

17 sites across 5 countries: Denmark, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study