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Clinical Trial Summary

A prospective, double-blind, randomized, sham-controlled, multicentre investigation.


Clinical Trial Description

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 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 a gammaCore®-R and the gammaCore®-R will continue to receive an active treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02378844
Study type Interventional
Source ElectroCore INC
Contact
Status Completed
Phase N/A
Start date June 2015
Completion date August 29, 2018

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