Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT03716505
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2018-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-26', 'mcpReleaseN': 15, 'releaseDate': '2025-08-11'}], 'estimatedResultsFirstSubmitDate': '2025-08-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Two parallel groups, gammaCore®-Sapphire (active treatment) and a gammaCore®-Sapphire sham (inactive) treatment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '12 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Responder rate in the nVNS group compared to the sham group', 'timeFrame': 'Last 4 weeks of the 12 week double-blind', 'description': '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'}, {'measure': 'Mean reduction in the number of headache days', 'timeFrame': 'Last 4 weeks of the 12 week double-blind', 'description': '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'}, {'measure': 'Mean reduction in days on which acute migraine medication', 'timeFrame': 'Last 4 weeks of the 12 week double-blind', 'description': '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'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prevention', 'Episodic', 'Chronic'], 'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '35001643', 'type': 'DERIVED', 'citation': 'Najib U, Smith T, Hindiyeh N, Saper J, Nye B, Ashina S, McClure CK, Marmura MJ, Chase S, Liebler E, Lipton RB. Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial. Cephalalgia. 2022 Jun;42(7):560-569. doi: 10.1177/03331024211068813. Epub 2022 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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.\n\nSubjects will dose themselves 3 times per day for 12 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Between the ages of 18 and 75 years\n* Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria\n* Experiences between 8 to 20 headaches days per month (during the last 3 months), with at least 5 of them being migraine days\n* Onset of migraine at age 50 years or younger\n* Agrees to refrain from initiating or changing any prophylactic medications for indications other than migraine\n\nKey Exclusion Criteria:\n\n* Concomitant medical condition that will require oral or injectable steroids during the study\n* Currently on a stable regime of more than 1 migraine preventative therapy\n* Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder)\n* Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)\n* Known or suspected cerebrovascular disease\n* Previous cervical vagotomy\n* Currently implanted with an electrical and/or neurostimulator device\n* Been implanted with metal cervical spine hardware or has a metallic implant near the nVNS stimulation site\n* Known history or suspicion of secondary headache\n* Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 6 months\n* 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\n* Currently takes prescription opioids more than 2 days per month for headaches or body pain\n* Failed an adequate trial (2 months or greater) of at least 3 classes of a drug therapy for migraine prevention\n* Surgery for migraine prevention\n* Undergone nerve block (occipital or other) in the head or neck within the last 3 months\n* Received Botox or CGRP mAb injections within the last 6 months\n* Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control\n* Previously used gammaCore'}, 'identificationModule': {'nctId': 'NCT03716505', 'briefTitle': 'Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines', 'organization': {'class': 'INDUSTRY', 'fullName': 'ElectroCore INC'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)', 'orgStudyIdInfo': {'id': 'GM-US-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gammaCore Sapphire active', 'description': 'Treatment 3 times per day, every day for the 12-week treatment period\n\nEach of the 3 daily treatments comprises 2 consecutive 120-second stimulations on 1 side, ipsilateral (2 stimulations) to the side of predominate pain, upon waking, lunch time (i.e., between 11:00 AM and 2:00 PM), and prior to sleep, for a total of 6 stimulations per day', 'interventionNames': ['Device: gammaCore Sapphire active']}, {'type': 'SHAM_COMPARATOR', 'label': 'gammaCore Sapphire Sham', 'description': 'Treatment 3 times per day, every day for the 12-week treatment period\n\nEach of the 3 daily treatments comprises 2 consecutive 120-second stimulations on 1 side, ipsilateral (2 stimulations) to the side of predominate pain, upon waking, lunch time (i.e., between 11:00 AM and 2:00 PM), and prior to sleep, for a total of 6 stimulations per day', 'interventionNames': ['Device: gammaCore Sapphire Sham']}], 'interventions': [{'name': 'gammaCore Sapphire active', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['gammaCore Sapphire active']}, {'name': 'gammaCore Sapphire Sham', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['gammaCore Sapphire Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'The Research Center of Southern California', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center Hoover Pavilion', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Headache Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Clinic for Headache', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Summit Headache and Neurologic Institute, PC', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Institute for Neurology and Headache', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '06107', 'city': 'West Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford HealthCare Headache Center', 'geoPoint': {'lat': 41.76204, 'lon': -72.74204}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60642', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Diamond Headache Clinic', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore Ambulatory Care Center', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Neurology', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70043', 'city': 'Chalmette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Crescent City Headache and Neurology Center', 'geoPoint': {'lat': 29.94296, 'lon': -89.96537}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner North Shore Medical Center', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '02215-5400', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head Pain & Neurological Institute (MHNI)', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '39157', 'city': 'Ridgeland', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Headache Neurology Research Institute', 'geoPoint': {'lat': 32.42848, 'lon': -90.13231}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'facility': 'StudyMetrix, LLC', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '65810', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest Research', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Dent Neurologic Institute', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Neurology Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Island Neurological Associates', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Headache Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75165', 'city': 'Waxahachie', 'state': 'Texas', 'country': 'United States', 'facility': 'ClinPoint Trials LLC', 'geoPoint': {'lat': 32.38653, 'lon': -96.84833}}, {'zip': '22101', 'city': 'McLean', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medstar Georgetown University Hospital', 'geoPoint': {'lat': 38.93428, 'lon': -77.17748}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Hospitals - Department of Neurology', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Peter Staats, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Medical Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ElectroCore INC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}