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

NCT02378844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2019-08-19

Study results available
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Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • ElectroCore INC

    lead INDUSTRY

Principal Investigators

  • Hans-Christoph Diener, Professor · Universtätsklinikum Essen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-02-01
Completion
2018-08-29

Countries

  • Belgium
  • Denmark
  • Germany
  • Greece
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02378844 on ClinicalTrials.gov