Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT03716505
Eligibility Criteria:
Key Inclusion Criteria:
* Between the ages of 18 and 75 years
* Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
* Experiences between 8 to 20 headaches days per month (during the last 3 months), with at least 5 of them being migraine days
* Onset of migraine at age 50 years or younger
* Agrees to refrain from initiating or changing any prophylactic medications for indications other than migraine
Key Exclusion Criteria:
* Concomitant medical condition that will require oral or injectable steroids during the study
* Currently on a stable regime of more than 1 migraine preventative therapy
* Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder)
* Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
* Known or suspected cerebrovascular disease
* Previous cervical vagotomy
* Currently implanted with an electrical and/or neurostimulator device
* Been implanted with metal cervical spine hardware or has a metallic implant near the nVNS stimulation site
* Known history or suspicion of secondary headache
* Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 6 months
* 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
* Currently takes prescription opioids more than 2 days per month for headaches or body pain
* Failed an adequate trial (2 months or greater) of at least 3 classes of a drug therapy for migraine prevention
* Surgery for migraine prevention
* Undergone nerve block (occipital or other) in the head or neck within the last 3 months
* Received Botox or CGRP mAb injections within the last 6 months
* Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
* Previously used gammaCore
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03716505
Study Brief:
Protocol Section:
NCT03716505