Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
Study NCT ID:
NCT04936061
Status:
TERMINATED
Last Update Posted:
2023-09-29
First Post:
2021-06-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transnasal Cooling for Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D020326', 'term': 'Migraine without Aura'}], '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': 'jholland@cooltechcorp.com', 'phone': '570-228-8140', 'title': 'Clinical Trial Manager', 'organization': 'CoolTech'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burning sensation in nostril', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased head pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], '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 CoolStat treatment session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis was based on a mixed logistic regression model using the variable Pain Relief without rescue medication at 2 hours post treatment as the outcome.'}, {'type': 'PRIMARY', 'title': 'Tolerability of the CoolStat Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 minutes', 'description': 'Number of subjects who fail to complete the full treatment session', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety of the CoolStat Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Number of participants with device-related adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 minutes', '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) immediately after the CoolStat treatment session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 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 24 hours after the CoolStat treatment session without the use of rescue medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], '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 CoolStat treatment session without the use of rescue medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 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 24 hours after the CoolStat treatment session without the use of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Migraine-associated Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction in symptom severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-treatment session without the use of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis'}, {'type': 'SECONDARY', 'title': 'Freedom From Migraine-associated Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the end of the CoolStat treatment session without the use of rescue medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis.'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'OG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 24 hours', 'description': 'The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'FG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'FG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 87 subjects consented, 24 of whom were randomized to a treatment group. 63 subjects did not return to study sites for randomization during an active migraine attack during the 60-day enrollment period. 7 of those subjects reconsented for an additional 60- day enrollment period. Only two subjects who reconsented came to the clinic for randomization. 4 subjects were withdrawn post-consent because they became in eligible (3) or withdrew their consent (1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'BG001', 'title': 'Low Flow Treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.\n\nCoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril.'}, {'id': 'BG002', 'title': 'Sham Flow Ambient Air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.\n\nCoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '47.6', 'spread': '12.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Subjects provided their age at time of enrollment on screening questionnaire.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-02', 'size': 762183, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-25T14:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Recruitment problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-06', 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Relief', '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 CoolStat treatment session.'}, {'measure': 'Tolerability of the CoolStat Device', 'timeFrame': '15 minutes', 'description': 'Number of subjects who fail to complete the full treatment session'}, {'measure': 'Safety of the CoolStat Device', 'timeFrame': '24 hours', 'description': 'Number of participants with device-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Pain Relief', 'timeFrame': '0 minutes', '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) immediately after the CoolStat treatment session.'}, {'measure': 'Pain Relief', 'timeFrame': '24 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 24 hours after the CoolStat treatment session without the use of rescue medication'}, {'measure': 'Pain Freedom', '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 CoolStat treatment session without the use of rescue medication'}, {'measure': 'Pain Freedom', 'timeFrame': '24 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 24 hours after the CoolStat treatment session without the use of rescue medication.'}, {'measure': 'Relief From Migraine-associated Symptoms', 'timeFrame': '2 hours', 'description': 'The percentage of patients having a reduction in symptom severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-treatment session without the use of rescue medication.'}, {'measure': 'Freedom From Migraine-associated Symptoms', 'timeFrame': '2 hours', 'description': 'The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the end of the CoolStat treatment session without the use of rescue medication'}, {'measure': 'Use of Rescue Medication', 'timeFrame': '0 to 24 hours', 'description': 'The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Migraine', 'Episodic Migraine', 'Migraine With Aura', 'Migraine Without Aura']}, 'descriptionModule': {'briefSummary': 'This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).\n2. Patient is between 18 and 80 years of age.\n3. Patient experiences 2 to 8 migraine attacks per month.\n4. Patient is in good reported general health, with no fever (\\<38.3C/101F).\n5. Patient has had diagnosis of migraine with or without aura over at least 1 year.\n6. Migraine onset before 50 years of age.\n7. Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.\n8. Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.\n9. Migraine pain severity of Grade 2 or Grade 3 on day of treatment.\n10. Provision of signed and dated informed consent form.\n11. Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. has difficulty distinguishing his or her migraine attacks from tension-type headaches\n2. Patient has uncontrolled hypertension.\n3. Patient has a fever (≥38.3C / 101F).\n4. Patient has used opioid medication or barbiturates in the past month.\n5. Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).\n6. Patient has 15 or more headache days per month.\n7. Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).\n8. Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.\n9. Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.\n10. Recurrent epistaxis or chronic rhinosinusitis.\n11. Recent facial trauma, sinus or intranasal surgery within the last 4 months.\n12. Known or suspected pregnancy.\n13. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity."}, 'identificationModule': {'nctId': 'NCT04936061', 'briefTitle': 'Transnasal Cooling for Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoolTech LLC'}, 'officialTitle': 'A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': 'P-224011-0040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flow treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.', 'interventionNames': ['Device: CoolStat active device']}, {'type': 'EXPERIMENTAL', 'label': 'Low flow treatment', 'description': '15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.', 'interventionNames': ['Device: CoolStat active device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham flow ambient air', 'description': '15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.', 'interventionNames': ['Device: CoolStat sham device']}], 'interventions': [{'name': 'CoolStat active device', 'type': 'DEVICE', 'description': 'The CoolStat active device will administer a therapeutic flow of dry air into the nostril.', 'armGroupLabels': ['High flow treatment', 'Low flow treatment']}, {'name': 'CoolStat sham device', 'type': 'DEVICE', 'description': 'The CoolStat sham device will administer a sham flow of ambient air into the nostril.', 'armGroupLabels': ['Sham flow ambient air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Neurosciences Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Nauman Tariq, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atrium Health Neurosciences Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoolTech LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}