Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

Migraine Disorders Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716505
• Other study ID #: GM-US-10
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: September 9, 2020

Study information

• Verified date: September 2020
• Source: ElectroCore INC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York
United States	Michigan Head Pain & Neurological Institute (MHNI)	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Montefiore Headache Center	Bronx	New York
United States	The Research Center of Southern California	Carlsbad	California
United States	Crescent City Headache and Neurology Center	Chalmette	Louisiana
United States	Diamond Headache Clinic	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ochsner North Shore Medical Center	Covington	Louisiana
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Summit Headache and Neurologic Institute, PC	Englewood	Colorado
United States	NorthShore Ambulatory Care Center	Glenview	Illinois
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Norton Neurology	Louisville	Kentucky
United States	Medstar Georgetown University Hospital	McLean	Virginia
United States	University of Miami, Miller School of Medicine	Miami	Florida
United States	West Virginia University Hospitals - Department of Neurology	Morgantown	West Virginia
United States	NY Neurology Associates	New York	New York
United States	Stanford University Medical Center Hoover Pavilion	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Island Neurological Associates	Plainview	New York
United States	Headache Neurology Research Institute	Ridgeland	Mississippi
United States	StudyMetrix, LLC	Saint Peters	Missouri
United States	UCSF Headache Center	San Francisco	California
United States	California Medical Clinic for Headache	Santa Monica	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	Clinvest Research	Springfield	Missouri
United States	New England Institute for Neurology and Headache	Stamford	Connecticut
United States	ClinPoint Trials LLC	Waxahachie	Texas
United States	Hartford HealthCare Headache Center	West Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ElectroCore INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	12 weeks
Secondary	Responder rate in the nVNS group compared to the sham group	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	Last 4 weeks of the 12 week double-blind
Secondary	Mean reduction in the number of headache days	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	Last 4 weeks of the 12 week double-blind
Secondary	Mean reduction in days on which acute migraine medication	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	Last 4 weeks of the 12 week double-blind