CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 477 enrolled
Drug / intervention
gammaCore®-R +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02378844
NCT02378844N/ACompleted
CompareCT.gov

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

ElectroCore INC·interventional·Posted Mar 4, 2015·Updated Aug 19, 2019

In Brief

A clinical study evaluating gammaCore®-R and gammaCore®-R Sham for Migraine. Completed, enrolled 477 participants across 22 sites in 8 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesBelgium, Denmark, Germany, Greece, Netherlands, Norway, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 4, 2015
Enrollment StartJun 1, 2015
Primary CompletionFeb 1, 2018
Study CompletionAug 29, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.3 years ago

Interventions

gammaCore®-Rdevice

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).

gammaCore®-R Shamdevice

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).