Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT03461757
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2018-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial in Adult Subjects With Acute Migraines
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578443', 'term': 'rimegepant sulfate'}]}}, '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': 'Serious adverse events (SAEs) were collected from informed consent up to the end of the study, and adverse events (AEs) were collected from randomization up to end of the study (up to 52 days).', 'description': 'The safety population, all enrolled participants who received at least 1 dose of rimegepant or placebo, was used to determine the number of participants at risk for SAEs and Other AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.', 'otherNumAtRisk': 682, 'deathsNumAtRisk': 682, 'otherNumAffected': 0, 'seriousNumAtRisk': 682, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.', 'otherNumAtRisk': 693, 'deathsNumAtRisk': 693, 'otherNumAffected': 0, 'seriousNumAtRisk': 693, 'deathsNumAffected': 0, 'seriousNumAffected': 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': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '24.3'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '13.2'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '6.5', 'ciUpperLimit': '14.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on modified intent to treat (mITT) participants.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '38.7'}, {'value': '26.8', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '30.2'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '3.4', 'ciUpperLimit': '13.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000', 'lowerLimit': '55.6', 'upperLimit': '63.1'}, {'value': '43.3', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '47.0'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.1', 'ciLowerLimit': '10.8', 'ciUpperLimit': '21.3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '34.4', 'upperLimit': '41.8'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '29.1'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '15.1', 'ciUpperLimit': '25.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '51.6'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '31.1'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '15.1', 'ciUpperLimit': '25.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '30.4'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '20.6'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.3', 'ciLowerLimit': '4.9', 'ciUpperLimit': '13.7', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '16.8'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '32.6'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.0', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '-10.7', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '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 eDiary) 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 (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '33.1'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '19.7'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '8.3', 'ciUpperLimit': '17.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '45.9'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '28.5'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.9', 'ciLowerLimit': '12.0', 'ciUpperLimit': '21.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '26.4'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '19.2'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '2.5', 'ciUpperLimit': '11.0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '29.3'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '18.1'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '6.3', 'ciUpperLimit': '14.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}, {'value': '611', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '37.2'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '28.0'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '3.7', 'ciUpperLimit': '13.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants with photophobia present at migraine onset.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '33.7'}, {'value': '21.3', 'groupId': 'OG001', 'lowerLimit': '18.2', 'upperLimit': '24.3'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '4.3', 'ciUpperLimit': '13.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '90 minutes post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 90 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '53.4'}, {'value': '37.2', 'groupId': 'OG001', 'lowerLimit': '33.6', 'upperLimit': '40.9'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.4', 'ciLowerLimit': '7.1', 'ciUpperLimit': '17.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '90 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '18.4'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '7.3'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.1', 'ciLowerLimit': '6.9', 'ciUpperLimit': '13.4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '30.7'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '24.6'}]}]}], 'analyses': [{'pValue': '0.0128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '1.2', 'ciUpperLimit': '10.4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '90 minutes post dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '17.8'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '9.3'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '4.4', 'ciUpperLimit': '11.1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '90 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '46.3'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '34.4'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '5.3', 'ciUpperLimit': '17.7', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants with phonophobia present at migraine onset.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '16.0'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '7.1'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.0', 'ciLowerLimit': '4.9', 'ciUpperLimit': '11.1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 60 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '33.1', 'upperLimit': '40.4'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '34.7'}]}]}], 'analyses': [{'pValue': '0.0314', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '0.5', 'ciUpperLimit': '10.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '25.4'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '18.6'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '2.3', 'ciUpperLimit': '10.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '60 minutes post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '55.9'}, {'value': '45.2', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '49.9'}]}]}], 'analyses': [{'pValue': '0.0898', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '12.7', 'pValueComment': 'P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose', 'description': 'Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on mITT participants with nausea present at migraine onset.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '44.5'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '61.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose for the participants who were pain-free at 2 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was performed on mITT participants with pain freedom at 2 hours post-dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '732'}, {'groupId': 'FG001', 'numSubjects': '734'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '682'}, {'groupId': 'FG001', 'numSubjects': '693'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '679'}, {'groupId': 'FG001', 'numSubjects': '689'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Not Experienced Moderate/Severe Migraine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was conducted at 69 centers in the United States.', 'preAssignmentDetails': 'Total 1811 participants were enrolled, of which 1466 were randomized to rimegepant 75 milligram (mg) orally disintegrating tablet (ODT) or placebo. Total 345 participants failed screening mainly due to failure to meet eligibility criteria. Randomization was stratified in 1:1 ratio based on use of prophylactic migraine medications (yes or no).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'BG000'}, {'value': '682', 'groupId': 'BG001'}, {'value': '1351', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rimegepant 75 mg ODT', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.287', 'spread': '12.0792', 'groupId': 'BG000'}, {'value': '40.030', 'spread': '11.8719', 'groupId': 'BG001'}, {'value': '40.157', 'spread': '11.9713', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '568', 'groupId': 'BG000'}, {'value': '579', 'groupId': 'BG001'}, {'value': '1147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '553', 'groupId': 'BG000'}, {'value': '547', 'groupId': 'BG001'}, {'value': '1100', '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': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '496', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1017', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Migraine Type', 'classes': [{'title': 'Migraine without Aura', 'categories': [{'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '462', 'groupId': 'BG001'}, {'value': '942', 'groupId': 'BG002'}]}]}, {'title': 'Migraine with Aura', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization Strata, Prophylactic Migraine Medication Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '576', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '1164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis was performed on modified intent to treat (mITT) participants, defined as those who were randomized only once, took study medication, had moderate to severe pain level at migraine onset, and who provided at least 1 post-baseline efficacy measurement (i.e., after taking study medication).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-23', 'size': 2221223, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-12T00:49', 'hasProtocol': True}, {'date': '2018-11-15', 'size': 5655095, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-12T00:50', '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', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1811}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'dispFirstSubmitDate': '2019-10-03', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2018-03-06', 'dispFirstSubmitQcDate': '2019-10-03', 'resultsFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2018-03-09', 'dispFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-26', 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-08', '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 diary (eDiary). Pain freedom was defined as pain level of none.'}, {'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 at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at 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 eDiary. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose', 'timeFrame': '2 hours post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.'}, {'measure': 'Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose', 'timeFrame': '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 eDiary) 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 (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary."}, {'measure': 'Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.'}, {'measure': 'Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.'}, {'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 eDiary. Freedom from photophobia was defined as photophobia absent.'}, {'measure': 'Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose', 'timeFrame': '90 minutes post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.'}, {'measure': 'Percentage of Participants With Pain Relief at 90 Minutes Post-dose', 'timeFrame': '90 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose', 'timeFrame': 'From 2 hours up to 24 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose', 'timeFrame': '90 minutes post dose', 'description': 'MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.'}, {'measure': 'Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose', 'timeFrame': '90 minutes post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.'}, {'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 eDiary. Freedom from phonophobia was defined as phonophobia absent.'}, {'measure': 'Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.'}, {'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 eDiary. Pain relief was defined as pain level of none or mild.'}, {'measure': 'Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose', 'timeFrame': '60 minutes post-dose', 'description': 'Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.'}, {'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 eDiary. Freedom from nausea was defined as nausea absent.'}, {'measure': 'Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose', 'timeFrame': 'From 2 hours up to 48 hours post-dose', 'description': 'Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose for the participants who were pain-free at 2 hours post-dose.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine, With or Without Aura']}, 'referencesModule': {'references': [{'pmid': '36739511', 'type': 'DERIVED', 'citation': "Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686."}, {'pmid': '36125279', 'type': 'DERIVED', 'citation': "Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072."}, {'pmid': '31311674', 'type': 'DERIVED', 'citation': 'Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1\\. Subject 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, Beta version \\[1\\] including the following:\n\n1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age\n2. Migraine attacks, on average, lasting about 4-72 hours if untreated\n3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months\n4. Consistent migraine headaches of at least 2 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\n5. 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.\n6. Subjects 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.\n7. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.\n\nKey Exclusion Criteria:\n\n1. Subject with a history of HIV disease\n2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects 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 subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)\n4. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.\n5. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption\n6. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.\n7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.\n8. Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.\n9. Participation in any other investigational clinical trial while participating in this clinical trial"}, 'identificationModule': {'nctId': 'NCT03461757', 'briefTitle': 'Trial in Adult Subjects With Acute Migraines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': 'BHV3000-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Rimegepant 75 mg', 'description': 'Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.', 'interventionNames': ['Drug: Rimegepant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Placebo', 'description': 'Participants were administered a single 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