Purpose

The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Between the ages of 18 and 75 years
  2. Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
  3. Experiences between 8 to 20 headaches days per month (during the last 3 months), with at least 2 of them being migraine days during which the migraines lasted more than 4 hours
  4. Onset of migraine at age 50 years or younger
  5. Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than migraine that, in the opinion of the clinician may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
  6. Agrees to use nVNS as intended, follow all of the requirements of the study including Follow-up Visit requirements, and record required study data in the subject e-diary
  7. Able to provide written informed consent

Exclusion Criteria

  1. Concomitant medical condition that will require oral or injectable steroids during the study
  2. Currently on a stable regime of more than 1 migraine preventative therapy
  3. History of intracranial aneurysm, intracranial hemorrhage, brain tumor, or significant head trauma
  4. Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
  5. Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
  6. Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that, in the opinion of the Investigator, may confound the study assessments
  7. Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
  8. Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery) or an abnormal baseline electrocardiogram (ECG) within the last year (e.g., second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
  9. Previous cervical vagotomy
  10. Uncontrolled high blood pressure (systolic >160 mm HG, diastolic >100 mm Hg) after 3 measurements within 24 hours
  11. Currently implanted with an electrical and/or neurostimulator device (e.g., cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator, occipital nerve stimulator)
  12. Been implanted with metal cervical spine hardware or has a metallic implant near the nVNS stimulation site
  13. Known history or suspicion of secondary headache
  14. History of syncope (within the last 2 years)
  15. History of seizure (within the last 2 years)
  16. Known history or suspicion of substance abuse or addiction (within the last 5 years)
  17. Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 1 year
  18. Currently takes simple analgesics or NSAIDs >15 days per month or triptans, ergots, or combined analgesics >10 days per month for headaches or other body pain
  19. Currently takes prescription opioids more than 2 days per month for headaches or body pain
  20. Previous diagnosis of medication overuse headache, which has reverted to migraine within the last 3 months
  21. Failed an adequate trial (2 months or greater), or based on the decision of the clinician, of at least 3 classes of a drug therapy for migraine prevention
  22. Surgery for migraine prevention
  23. Undergone nerve block (occipital or other) in the head or neck within the last 3 months
  24. Received Botox or CGRP mAb injections within the last 6 months
  25. Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
  26. Participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
  27. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g., homeless, developmentally disabled, prisoner)
  28. A relative of or an employee of the Investigator or the clinical study site
  29. Psychiatric or cognitive disorder and/or behavioral problems that, in the opinion of the clinician, may interfere with the study
  30. Previously used gammaCore

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Two parallel groups, gammaCore®-Sapphire (active treatment) and a gammaCore®-Sapphire sham (inactive) treatment.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
gammaCore Sapphire active
Treatment 3 times per day, every day for the 12-week treatment period Each of the 3 daily treatments comprises 2 consecutive 120-second stimulations on 1 side, ipsilateral (2 stimulations) to the side of predominate pain, upon waking, lunch time (i.e., between 11:00 AM and 2:00 PM), and prior to sleep, for a total of 6 stimulations per day
  • Device: gammaCore Sapphire active
    GammaCore Sapphire™ is a handheld, non-invasive, low voltage electrical device which stimulates the vagus nerve by producing weak 120 second electrical stimulation cycles that may help reduce, ease, lessen or stop your migraine symptoms. GammaCore Sapphire™ has been approved for the treatment of headache, including migraine by the United States Food and Drug Administration (FDA).
Sham Comparator
gammaCore Sapphire Sham
Treatment 3 times per day, every day for the 12-week treatment period Each of the 3 daily treatments comprises 2 consecutive 120-second stimulations on 1 side, ipsilateral (2 stimulations) to the side of predominate pain, upon waking, lunch time (i.e., between 11:00 AM and 2:00 PM), and prior to sleep, for a total of 6 stimulations per day
  • Device: gammaCore Sapphire Sham
    The sham device is a hand-held portable device that appears identical to gammaCore Sapphire, in look, weight, visual and audible feedback, user application, and control. Like gammaCore Sapphire, the sham device is a multi-use device.

Recruiting Locations

Montefiore Headache Center
Bronx, New York 10461
Contact:
Daniel Sun
929-263-3831
dansun@montefiore.org

More Details

NCT ID
NCT03716505
Status
Recruiting
Sponsor
ElectroCore INC

Study Contact

Rebecca Cadet
1-888-903-2673
rebecca.cadet@electrocore.com

Detailed Description

The study is a prospective randomized, multi-center, double-blind, parallel, sham-controlled study, designed for comparison of two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.

The study period will begin with a four-week run-in period, during which there is no investigational treatment. The purpose of the run-in period will be to establish a baseline of the subject's headache/migraine history for longitudinal comparison.

The run-in period will be followed by a 12-week randomized period when the subjects will be randomized (1:1) to either active treatment or sham (inactive) treatment.

Subjects will dose themselves 3 times per day for 12 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.