A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ElectroCore INC
- Enrollment
- 231
- Locations
- 59
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Mean reduction in the number of headache days(Last 4 weeks of the 12 week double-blind)
- Mean reduction in days on which acute migraine medication(Last 4 weeks of the 12 week double-blind)
- Responder rate in the nVNS group compared to the sham group(Last 4 weeks of the 12 week double-blind)