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NCT01792817 · ClinicalTrials.gov registry record · NA

Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache

A NA study of Cluster Headache, sponsored by ElectroCore.

Completed
Registry status
NA
Development phase
150
Enrollment target
20
Study locations

NCT01792817 is a NA study of Cluster Headache that has completed, run by ElectroCore. The registered enrollment target is 150 participants, below the 519-participant average among 3 other Cluster Headache trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01792817, a NA study of Cluster Headache, has completed, sponsored by ElectroCore.

COMPLETED
Registry status
NA
Development phase
150 participants
Enrollment target
20
Study locations

Study Summary

Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatment.

Conditions Studied

Cluster Headache

Interventions

  • DEVICE GammaCore
  • DEVICE Sham GammaCore device

Study Locations (20)

New York

  • Dent Neurologic Institute - Amherst
  • Montefiore Headache Center - New York
  • Center for Headache Care and Research at Island Neurological Associates, PC - Plainview

California

  • California Medical Clinic for Headache - Santa Monica
  • Stanford University Medical Center - Stanford

Colorado

  • Colorado Neurological Institute - Englewood

Connecticut

  • Associated Neurologists of Southern Connecticut - Fairfield

Florida

  • Tampa General Hospital Headache Center - Tampa

Illinois

  • Diamond Headache Clinic - Chicago

Iowa

  • University of Iowa Hospital and Clinics - Iowa City

Kentucky

  • Norton Neurology - Louisville

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2013-02
Est. Completion 2014-10
Phase NA

Sponsor

ElectroCore

6 total trials

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What the Registry Record Tells You About NCT01792817

The ClinicalTrials.gov registry entry for NCT01792817 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 519-participant average among 3 other Cluster Headache trials with a reported enrollment target (71% lower). The listed sponsor is ElectroCore, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cluster Headache appearing as the primary indexed condition, and to 2 interventions - of which GammaCore is the first listed.

NCT01792817 reports 20 study locations spanning 17 distinct geographic areas - top geographies include New York, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01792817 about?

NCT01792817 is a clinical study titled "Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache". Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatme...

What is the current status of trial NCT01792817?

This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2013-02. Estimated completion is 2014-10.

What conditions does trial NCT01792817 study?

This clinical trial studies the following conditions: Cluster Headache.

What interventions are being tested in trial NCT01792817?

The interventions under investigation include: GammaCore (DEVICE), Sham GammaCore device (DEVICE).

Who is sponsoring clinical trial NCT01792817?

This trial is sponsored by ElectroCore, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01792817 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.