A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore® Non-invasive Vagus Nerve Stimulator (nVNS), for the Acute Treatment of Migraine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- ElectroCore INC
- Enrollment
- 285
- Locations
- 10
- Primary Endpoint
- Number of Participants With Treatment Response - No Pain
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine attacks
Detailed Description
Period 1: 4-week observational run-in period; no stimulation treatment. Subjects use standard of care (SoC) medication to treat their migraine attacks, according to their individual prescriptions. Period 2: 4-week randomized/controlled period. After the run-in period, subjects are randomized (1:1) to receive either an nVNS device or a sham device to treat up to 5 migraine attacks. Period 3: 4-week open-label (active treatment) period. After the randomized period, subjects continue to the open-label period where all subjects receive an active gammaCore device to treat up to 5 migraine attacks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is 18-75 years old.
- •Has been previously diagnosed with migraine (with or without aura) in accordance with the ICHD-3 Beta classification criteria.
- •Age of onset of migraines \< 50 years old.
- •Experiences between 3-8 migraine attacks per month of moderate or severe intensity, and less than 15 headache days per month over the last 6 months.
- •Is able to distinguish migraine headaches from other headaches (e.g. tension type headache).
- •Agrees to withhold usual acute migraine medications until 2 hours after stimulation treatment with the study device.
- •Agrees not to initiate new or change existing migraine prophylaxis medication for the duration of the study, or receive nerve blocks or injections.
- •Agrees not to initiate new or change existing prophylactic medication for indications other than migraine that in the opinion of the Investigator may interfere with the study objectives (e.g. antidepressant, anti-convulsant, beta blockers, etc).
- •Has internet/web access for web-based e-Diary completion.
- •Agrees to use the study device as intended, comply with all study requirements including treatment, follow-up visits, record required study data in the subject diary, and complete study self-assessment questionnaires.
Exclusion Criteria
- •Experiences ≥ 15 headache days per month, including migraine, tension type headache, medication overuse headache, and other types of headache as defined in the ICHD-3 Beta classification.
- •Has a known history or suspicion of secondary headache.
- •Has previous diagnosis of medication overuse headache (MoH), which has reverted to episodic migraine within the last 6 months.
- •Has had surgical intervention for migraine prevention.
- •Has had a cervical vagotomy.
- •Has a structural abnormality (e.g. lymphadenopathy, neoplasm, previous surgery or abnormal anatomy), or pain (e.g. dysesthesia, neuralgia and/or cervicalgia) at the stimulation treatment site.
- •Has other significant pain problem (e.g. cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the Investigator may confound the study assessments.
- •Is 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, or occipital nerve stimulator).
- •Has been implanted with metal cervical spine hardware or has a metallic implant near the stimulation treatment site.
- •Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for acute treatment of migraine.
Outcomes
Primary Outcomes
Number of Participants With Treatment Response - No Pain
Time Frame: 2 hours post-treatment
The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment.
Secondary Outcomes
- Number of Participants With Treatment Response - No Pain or Mild Pain(2 hours post-treatment)
- Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia(2 hours post-treatment study - period 2 (each study period was 4 weeks))
- Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks(30, 60, 120 minutes; Study Period 2 (each study period was 4 weeks))
- Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours.(24 and 48 hours post-treatment)