Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04571060
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial in Adult Participants With Acute Migraines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D012001', 'term': 'Hyperacusis'}, {'id': 'D020795', 'term': 'Photophobia'}, {'id': 'D009325', 'term': 'Nausea'}], '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': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biohavenpharma.com', 'phone': '203-404-0410', 'title': 'Chief Medical Officer', 'organization': 'Biohaven Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from study drug dosing up to the end of the study (up to 55 days).', 'description': 'Treated Participants included enrolled participants who took study therapy (zavegepant or placebo).', 'eventGroups': [{'id': 'EG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.', 'otherNumAtRisk': 629, 'deathsNumAtRisk': 629, 'otherNumAffected': 129, 'seriousNumAtRisk': 629, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant-matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.', 'otherNumAtRisk': 653, 'deathsNumAtRisk': 653, 'otherNumAffected': 31, 'seriousNumAtRisk': 653, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 629, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 653, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Freedom From Pain at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '26.9'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '17.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '4.5', 'ciUpperLimit': '13.1', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '43.5'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '27.5', 'upperLimit': '34.7'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '3.4', 'ciUpperLimit': '13.9', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Participants included treated participants who were randomized only once, had moderate to severe pain at the time of dosing, and had non-missing, post-dose efficacy data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '62.6'}, {'value': '49.7', 'groupId': 'OG001', 'lowerLimit': '45.8', 'upperLimit': '53.5'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '3.6', 'ciUpperLimit': '14.5', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '593', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '31.9', 'upperLimit': '39.7'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '29.1'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.2', 'ciLowerLimit': '5.0', 'ciUpperLimit': '15.5', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Participants with functional disability at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000', 'lowerLimit': '36.8', 'upperLimit': '44.5'}, {'value': '33.0', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '36.6'}]}]}], 'analyses': [{'pValue': '0.0048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.6', 'ciLowerLimit': '2.3', 'ciUpperLimit': '12.9', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000', 'lowerLimit': '32.3', 'upperLimit': '39.9'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '26.0', 'upperLimit': '33.1'}]}]}], 'analyses': [{'pValue': '0.0130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.4', 'ciUpperLimit': '11.7', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '17.4'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '12.0'}]}]}], 'analyses': [{'pValue': '0.0076', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '1.3', 'ciUpperLimit': '8.5', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '14.9'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '10.8'}]}]}], 'analyses': [{'pValue': '0.0308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '7.1', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '36.3', 'upperLimit': '45.8'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '37.2'}]}]}], 'analyses': [{'pValue': '0.0123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '1.8', 'ciUpperLimit': '14.9', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Phonophobia (sensitivity to sound) status was measured as absent or present in the eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Participants with symptom of phonophobia present at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000', 'lowerLimit': '33.1', 'upperLimit': '41.1'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '24.9', 'upperLimit': '32.2'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '3.2', 'ciUpperLimit': '14.1', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Photophobia (sensitivity to light) status was measured as absent or present in the eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Participants with symptom of photophobia present at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 60 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '47.2'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '33.6', 'upperLimit': '41.0'}]}]}], 'analyses': [{'pValue': '0.0293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '0.6', 'ciUpperLimit': '11.4', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '60 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '593', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '23.5'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '18.4'}]}]}], 'analyses': [{'pValue': '0.0362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '0.3', 'ciUpperLimit': '9.1', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '60 minutes post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) present at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Participants with normal function at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 30 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '26.9', 'upperLimit': '34.1'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '23.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.2', 'ciLowerLimit': '5.5', 'ciUpperLimit': '15.0', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '593', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '13.0'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '8.0'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '1.3', 'ciUpperLimit': '7.6', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Participants with normal function at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 15 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '18.8'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '10.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '4.2', 'ciUpperLimit': '11.3', 'pValueComment': 'Threshold for significance at 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.'}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '570', 'groupId': 'OG000'}, {'value': '593', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '4.8'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '3.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Participants with normal function at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}, {'value': '643', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '33.3'}, {'value': '35.8', 'groupId': 'OG001', 'lowerLimit': '32.1', 'upperLimit': '39.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 24 hours post-dose', 'description': "Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eCOA handheld device) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin® Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Participants were analyzed. Participants with rescue medication start date less than or equal to (≤) study drug start date + 1 day and missing rescue medication start time were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '57.4'}, {'value': '50.9', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '55.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Nausea status was measured as absent or present in the eCOA handheld device. Freedom from nausea was defined as nausea absent post-dose in the subset of participants with nausea present at on-study migraine attack onset.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Participants with symptom of nausea present at the time of dosing were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '48.8'}, {'value': '35.4', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '45.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Analysis Participants with pain freedom at 2 hours post-dose were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '703'}, {'groupId': 'FG001', 'numSubjects': '702'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '629'}, {'groupId': 'FG001', 'numSubjects': '653'}]}, {'type': 'Efficacy Analysis Set Participants', 'comment': 'Treated participants who were randomized only once, had a migraine of moderate or severe pain intensity at the time of dosing, were treated with study drug, and had post-dose efficacy data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '623'}, {'groupId': 'FG001', 'numSubjects': '646'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who were randomized, received the study drug and completed the study.', 'groupId': 'FG000', 'numSubjects': '622'}, {'comment': 'Participants who were randomized, received the study drug and completed the study.', 'groupId': 'FG001', 'numSubjects': '653'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up from Randomization to Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Never treated migraine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up from Treatment to End of Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 90 sites in the United States.', 'preAssignmentDetails': 'A total of 1978 participants were enrolled, of which 1405 participants were randomized to zavegepant 10 mg dose group or placebo group. The randomization was stratified by the use of prophylactic migraine medication (yes or no). 573 participants were not randomized due to screen failure, lost to follow-up, non-compliance, or other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'BG000'}, {'value': '653', 'groupId': 'BG001'}, {'value': '1282', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zavegepant 10 mg', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'spread': '13.19', 'groupId': 'BG000'}, {'value': '40.7', 'spread': '13.46', 'groupId': 'BG001'}, {'value': '40.8', 'spread': '13.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '508', 'groupId': 'BG000'}, {'value': '551', 'groupId': 'BG001'}, {'value': '1059', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '515', 'groupId': 'BG000'}, {'value': '507', 'groupId': 'BG001'}, {'value': '1022', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '515', 'groupId': 'BG000'}, {'value': '545', 'groupId': 'BG001'}, {'value': '1060', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prophylactic Migraine Medication Use at Randomization', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '541', 'groupId': 'BG000'}, {'value': '570', 'groupId': 'BG001'}, {'value': '1111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated participants included enrolled participants who took the study drug (zavegepant or placebo).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-02', 'size': 749567, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-13T10:41', 'hasProtocol': True}, {'date': '2021-09-15', 'size': 560282, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-13T10:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind to Sponsor, Investigator and Participant.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1978}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'dispFirstSubmitDate': '2022-09-21', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2020-09-11', 'resultsFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2020-09-25', 'dispFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-15', 'studyFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Freedom From Pain at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.'}, {'measure': 'Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia immediately before dosing using the eCOA handheld device. Symptom status (absent, present) was assessed post-dose using the eCOA handheld device separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at on-study migraine attack onset that was absent post-dose.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Pain Relief at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants Who Were Able to Function Normally at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Sustained Pain Relief From 2 Hours to 24 Post-dose', 'timeFrame': 'From 2 to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Pain Relief From 2 Hours to 48 Post-dose', 'timeFrame': 'From 2 to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Pain Freedom From 2 Hours to 24 Post-dose', 'timeFrame': 'From 2 to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Pain Freedom From 2 Hours to 48 Post-dose', 'timeFrame': 'From 2 to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose.'}, {'measure': 'Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Phonophobia (sensitivity to sound) status was measured as absent or present in the eCOA handheld device. Freedom from phonophobia was defined as phonophobia absent post-dose in the subset of participants with phonophobia present at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Photophobia (sensitivity to light) status was measured as absent or present in the eCOA handheld device. Freedom from photophobia was defined as photophobia absent post-dose in the subset of participants with photophobia present at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Pain Relief at 60 Minutes Post-dose', 'timeFrame': '60 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants Who Were Able to Function Normally at 60 Minutes Post-dose', 'timeFrame': '60 minutes post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) present at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Pain Relief at 30 Minutes Post-dose', 'timeFrame': '30 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants Who Were Able to Function Normally at 30 Minutes Post-dose', 'timeFrame': '30 minutes post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Pain Relief at 15 Minutes Post-dose', 'timeFrame': '15 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants Who Were Able to Function Normally at 15 Minutes Post-dose', 'timeFrame': '15 minutes post-dose', 'description': 'Functional disability level was assessed on a 4-point scale (normal function, mildly impaired, severely impaired, requires bedrest) using the eCOA handheld device. Normal function was defined as a functional disability level of normal post-dose in the subset of participants with functional disability (mildly impaired, severely impaired, requires bedrest) at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose', 'timeFrame': 'Through 24 hours post-dose', 'description': "Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eCOA handheld device) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin® Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (for example, metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the site on a case report form."}, {'measure': 'Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Nausea status was measured as absent or present in the eCOA handheld device. Freedom from nausea was defined as nausea absent post-dose in the subset of participants with nausea present at on-study migraine attack onset.'}, {'measure': 'Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose', 'timeFrame': 'From 2 hours to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eCOA handheld device. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose in the subset of participants with pain level of none at 2 hours post-dose.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Migraine', 'Phonophobia', 'Photophobia', 'Nausea'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '36804093', 'type': 'DERIVED', 'citation': 'Lipton RB, Croop R, Stock DA, Madonia J, Forshaw M, Lovegren M, Mosher L, Coric V, Goadsby PJ. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023 Mar;22(3):209-217. doi: 10.1016/S1474-4422(22)00517-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and efficacy of BHV-3500 (zavegepant) versus placebo in the acute treatment of moderate or severe migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant has at least 1-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, including the following:\n\n 1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age\n 2. Migraine attacks, on average, lasting about 4-72 hours if untreated\n 3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months\n 4. At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period\n 5. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.\n 6. Participants on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.\n 7. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.\n2. Male and Female participants ≥18 years of age.\n\nExclusion Criteria:\n\n1. Participant with a history of HIV disease\n2. Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.\n3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however participants can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled).\n4. Participants with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder.\n5. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or participants who have met DSM-V criteria for any significant substance use disorder within the past 12 months.\n6. History of nasal surgery in the 6 months.\n7. Evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g. severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma)\n8. Participation in any other investigational clinical trial while participating in this clinical trial. Participation in a COVID-19 mRNA vaccine study (vaccine must be authorized under FDA emergency use authorization or approval) who are at least 30 days post last dose of the vaccine are permitted to be screened for this study.'}, 'identificationModule': {'nctId': 'NCT04571060', 'briefTitle': 'Randomized Trial in Adult Participants With Acute Migraines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Double-Blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3500 (Zavegepant) Intranasal for the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': 'BHV3500-301'}, 'secondaryIdInfos': [{'id': 'C5301001', 'type': 'OTHER', 'domain': 'Pfizer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zavegepant', 'description': 'Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar Unidose System (UDS) liquid spray device.', 'interventionNames': ['Drug: Zavegepant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants administered a single intranasal dose of zavegepant matching placebo on occurrence of migraine with moderate or severe intensity within 45 days after randomization. The dose was administered using an Aptar UDS liquid spray device.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zavegepant', 'type': 'DRUG', 'otherNames': ['BHV3500'], 'description': 'One dose of zavegepant', 'armGroupLabels': ['Zavegepant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One dose of matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, LLC, An AMR Co.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85286', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'MD First Research', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85710', 'city': 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