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

Migraine Clinical Trial

Official 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)

Clinical Trial 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.

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Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03787238
Study type Interventional
Source ElectroCore INC
Contact
Status Withdrawn
Phase N/A
Start date May 15, 2019
Completion date October 1, 2020
View Details
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