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Clinical Trial Summary

The purpose of the study is to investigate if the use of gammaCore Sapphireâ„¢ device reduces the number of migraines preventatively.


Clinical Trial Description

The study is a prospective randomized, multi-center, double-blind, parallel, sham-controlled study, designed for comparison of two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.

The study period will begin with a four-week run-in period, during which there is no investigational treatment. The purpose of the run-in period will be to establish a baseline of the subject's headache/migraine history for longitudinal 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.

Subjects will dose themselves 3 times per day for 12 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03716505
Study type Interventional
Source ElectroCore INC
Contact
Status Completed
Phase N/A
Start date November 2, 2018
Completion date September 9, 2020

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