NCT02378844

A Randomized, Sham-controlled Study of gammaCore ® (nVNS) for Prevention of Episodic Migraine

A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of gammaCore®, a Non-invasive Vagal Nerve Stimulator (nVNS), for Prevention of Episodic Migraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	gammaCore®-R	Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
DEVICE	gammaCore®-R Sham	Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-02-01
• Completion: 2018-08-29
• First posted: 2015-03-04
• Last updated: 2019-08-19
• Results posted: 2019-08-19

Locations

22 sites across 8 countries: Belgium, Denmark, Germany, Greece, Netherlands, Norway, Spain, United Kingdom