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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: Completed NA study of Cluster Headache, sponsored by ElectroCore.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group. A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-10 |
| Phase | NA |
What the finished NCT01792817 record still lists
NCT01792817 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 519-participant average among 3 other Cluster Headache trials with a reported enrollment target (71% lower).
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 names 20 study sites across 17 states, led by 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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