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NCT03716505 · ClinicalTrials.gov registry record · NA
Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
A NA study of Migraine Disorders, sponsored by ElectroCore.
- Completed
- Registry status
- NA
- Development phase
- 231
- Enrollment target
- 20
- Study locations
NCT03716505: Completed NA study of Migraine Disorders, sponsored by ElectroCore.
NCT03716505 is a NA study of Migraine Disorders that has completed, run by ElectroCore. The registered enrollment target is 231 participants, below the 304-participant average among 21 other Migraine Disorders trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03716505, a NA study of Migraine Disorders, has completed, sponsored by ElectroCore.
- COMPLETED
- Registry status
- NA
- Development phase
- 231 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
Primary Outcome
The primary outcome measurement for effectiveness is the difference between the active and sham treatment groups in the mean reduction in number of migraine days during the last 4 weeks of the 12-week double-blind period (versus during the 4-week run-in period).
Conditions Studied
Interventions
- DEVICE gammaCore Sapphire active
- DEVICE gammaCore Sapphire Sham
Study Locations (20)
California
- The Research Center of Southern California - Carlsbad
- Stanford University Medical Center Hoover Pavilion - Palo Alto
- UCSF Headache Center - San Francisco
- California Medical Clinic for Headache - Santa Monica
Connecticut
- New England Institute for Neurology and Headache - Stamford
- Hartford HealthCare Headache Center - West Hartford
Illinois
- Diamond Headache Clinic - Chicago
- NorthShore Ambulatory Care Center - Glenview
Louisiana
- Crescent City Headache and Neurology Center - Chalmette
- Ochsner North Shore Medical Center - Covington
Missouri
- StudyMetrix, LLC - City of Saint Peters
- Clinvest Research - Springfield
Arizona
- Mayo Clinic - Scottsdale
Colorado
- Summit Headache and Neurologic Institute, PC - Englewood
Florida
- University of Miami, Miller School of Medicine - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2018-11-02 |
| Est. Completion | 2020-09-09 |
| Phase | NA |
What the finished NCT03716505 record still lists
NCT03716505 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 21 other Migraine Disorders trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 2 interventions - of which gammaCore Sapphire active is the first listed.
NCT03716505 names 20 study sites across 13 states, led by California, Connecticut, Illinois.
Frequently Asked Questions
What is clinical trial NCT03716505 about?
NCT03716505 is a clinical study titled "Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines". The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
What is the current status of trial NCT03716505?
This trial is currently completed. It is a NA study. The enrollment target is 231 participants. The study started on 2018-11-02. Estimated completion is 2020-09-09.
What conditions does trial NCT03716505 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT03716505?
The interventions under investigation include: gammaCore Sapphire active (DEVICE), gammaCore Sapphire Sham (DEVICE).
Who is sponsoring clinical trial NCT03716505?
This trial is sponsored by ElectroCore, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03716505 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03716505's enrollment target sits among peer trials
231 12th of 21 higher than 10 of 21 other Migraine Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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