Migraine Disorders
Conditions
Keywords
Prevention, Episodic, Chronic
Brief summary
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
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.
Interventions
DEVICEgammaCore 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).
DEVICEgammaCore 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.
Sponsors
ElectroCore INC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Two parallel groups, gammaCore®-Sapphire (active treatment) and a gammaCore®-Sapphire sham (inactive) treatment.
Intervention model description
Two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and effectiveness of gammaCore Sapphire as a treatment for the prevention of a migraine during the double-blind period measured by Incidence of Unexpected Adverse Events. | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate in the nVNS group compared to the sham group | Last 4 weeks of the 12 week double-blind | A subject who reports at least a 50% decrease in the number of migraine days during the last 4 weeks in the 12-week double-blind period |
| Mean reduction in the number of headache days | Last 4 weeks of the 12 week double-blind | Difference between the nVNS and sham treatment groups in mean reduction in the number of headache days during the last 4 weeks of the 12-week double-blind period |
| Mean reduction in days on which acute migraine medication | Last 4 weeks of the 12 week double-blind | Difference between the nVNS and sham treatment groups in the mean reduction in days on which acute migraine medication was taken during the last 4 weeks of the 12 week double-blind period |
Countries
United States
Outcome results
None listed