Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT03465904
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrial@cefaly.com', 'phone': '+32 4 367 67 22', 'title': 'Clinical Trials Department director', 'organization': 'CEFALY Technology'}, 'certainAgreement': {'otherDetails': "The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted to the sponsor for review. Sponsor may request:\n\n* deletion of any trade secret, proprietary, or confidential information of Sponsor\n* an additional 90 days to take measures to preserve its Intellectual Property rights\n\nSponsor's written consent is required for results communication before trial completion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The data was collected during the 24 hours following the beginning of the treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 298, 'otherNumAffected': 22, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.', 'otherNumAtRisk': 279, 'deathsNumAtRisk': 303, 'otherNumAffected': 8, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Forehead paresthesias, discomfort, or burning', 'notes': 'Expected side effect of the Cefaly® device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea / Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck Stiffness / Muscle tension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsened Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Orodynia - tooth or jaw pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Discomfort or Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness / Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 279, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Appendicitis leading to appendectomy', 'notes': "This Serious Adverse Event was not related to the subject's participation in the study and was not reportable neither to the Institutional Review Board (IRB) nor to the FDA (the subject did not apply the treatment).", 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Freedom at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Most Bothersome Migraine-associated Symptom Freedom at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Medication Between 2 and 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-24 hours', 'description': 'The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Pain Freedom at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Pain Relief at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'OG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'All analyses were performed using SPSS, version 26.0 with two-sided levels of statistical significance established at p \\< 0.05', 'groupDescription': 'Identical statistical analyses were performed for the intent-to-treat (ITT) and the per protocol (PP) populations. The ITT population consisted of all randomized patients, who received any duration of sham or verum treatment and returned completed study materials. The PP population consisted of patients who strictly met inclusion criteria and completed at least 60 min of treatment.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'A Chi-square test of independent proportions was used to compare primary and secondary efficacy outcomes between groups.', 'nonInferiorityComment': 'Our power analysis indicated that a minimum of 239 patients per group was needed to provide 90% power to detect a 13.4% difference in the primary outcome, pain freedom at 2 h. Accounting for an estimated attrition rate of 20%, we aimed to enroll 299 patients per group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2-24 hours', 'description': 'The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'FG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '308'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '279'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Between April 10, 2018 and January 11, 2019, 626 subjects were screened for eligibility, and 607 were enrolled across ten centers in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nVerum Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.'}, {'id': 'BG001', 'title': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack\n\nSham Cefaly® Abortive Program device: The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.22', 'spread': '11.62', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '12.30', 'groupId': 'BG001'}, {'value': '41.14', 'spread': '12.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Migraine type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Migraine with aura', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}, {'title': 'Migraine without aura', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Headache pain severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No Pain', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Mild Pain', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Moderate pain severity', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': 'Severe pain severity', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most Bothersome Symptom', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Nausea as MBS', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Vomiting as MBS', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Sensitivity to light as MBS', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}, {'title': 'Sensitivity to sound as MBS', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Migraine Associated Symptom', 'classes': [{'title': 'Photophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}]}, {'title': 'Phonophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'occurrences reported by subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-26', 'size': 2744236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-23T09:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2018-03-08', 'resultsFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-05', 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Freedom at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.'}, {'measure': 'Most Bothersome Migraine-associated Symptom Freedom at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.'}], 'secondaryOutcomes': [{'measure': 'Pain Relief at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.'}, {'measure': 'Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.'}, {'measure': 'Use of Rescue Medication Between 2 and 24 Hours', 'timeFrame': '2-24 hours', 'description': 'The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.'}, {'measure': 'Sustained Pain Freedom at 24 Hours', 'timeFrame': '24 hours', 'description': 'The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.'}, {'measure': 'Sustained Pain Relief at 24 Hours', 'timeFrame': '2-24 hours', 'description': 'The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '35332216', 'type': 'DERIVED', 'citation': 'Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.', 'detailedDescription': 'The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age from 18 to 65 on the day of signing the informed consent form\n2. ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine\n3. Migraine onset before the age of 50\n4. Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening\n5. Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent\n6. Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events reporting form)\n\nExclusion Criteria:\n\n1. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches\n2. Patient has more than 15 headache days per month\n3. Patient having received supraorbital nerve blocks in the prior 4 months\n4. Patient having received Botox treatment in the prior 4 months\n5. Modification of a migraine prophylaxis treatment in the previous 3 months\n6. Diagnosis of other primary headache disorders, except rare (\\< 4) tension-type headaches per month\n7. Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH)\n8. Patient abusing opioids or user of recreational or illicit drugs or having had a recent history (within the last year) of drug or alcohol abuse or dependence\n9. Implanted metallic or electronic device in the head\n10. Cardiac pacemaker or implanted or wearable defibrillator\n11. Patient having had a previous experience with the Cefaly® device\n12. Migraine Aura without headache\n13. Patient is currently participating or has participated in a study with an investigational compound or device in the last 30 days before the screening visit (Visit 1)\n14. Patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site'}, 'identificationModule': {'nctId': 'NCT03465904', 'acronym': 'TEAM', 'briefTitle': 'A Phase III Trial of e-TNS for the Acute Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cefaly Technology'}, 'officialTitle': 'A Phase III Randomized, Double-blind, Sham-controlled Trial of e-TNS for the Acute Treatment of Migraine (The TEAM Study)', 'orgStudyIdInfo': {'id': '51401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': '2-hour external trigeminal nerve stimulation with the Verum Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack', 'interventionNames': ['Device: Verum Cefaly® Abortive Program device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': '2-hour external trigeminal nerve stimulation with the Sham Cefaly® Abortive Program device, as abortive treatment of an early stage migraine attack', 'interventionNames': ['Device: Sham Cefaly® Abortive Program device']}], 'interventions': [{'name': 'Verum Cefaly® Abortive Program device', 'type': 'DEVICE', 'description': 'The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.', 'armGroupLabels': ['Verum']}, {'name': 'Sham Cefaly® Abortive Program device', 'type': 'DEVICE', 'description': 'The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Consortium', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research (Savannah Neurology)', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '20854', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Meridian Clinical Research (Rockville Neurology)', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Consortium', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rapid Medical Research Inc.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}], 'overallOfficials': [{'name': 'Deena Kuruvilla, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cefaly Technology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}