Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-23 @ 9:28 AM
Study NCT ID:
NCT01807234
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D018170', 'term': 'Sumatriptan'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hnitchi1@jhmi.edu', 'phone': '410-550-9550', 'title': 'Dr. B. Lee Peterlin', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small study size (n=54)'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected at the 10 minute, 15 minute, 20 minute, 30 minute, 60 minute, 2 hour, 24 hour and 72 hour mark.', 'description': 'At each of the time intervals listed above, participants were instructed to document any adverse effects from drug that occured.', 'eventGroups': [{'id': 'EG000', 'title': 'Sprix/Placebo', 'description': 'Sprix 31.5 mg single dose nasal spray and Placebo\n\nSPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.\n\nThe most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%).', 'otherNumAtRisk': 52, 'otherNumAffected': 43, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sumatriptan/Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.\n\nFor those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%).', 'otherNumAtRisk': 50, 'otherNumAffected': 39, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SRIX Placebo/Sumatriptan Placebo', 'description': 'single dose SPRIX placebo, single dose Sumatriptan placebo\n\nPlacebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.\n\nThe most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%).', 'otherNumAtRisk': 50, 'otherNumAffected': 11, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild burning of nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'moderate burning of nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'severe burning of nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'mild unusual taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'moderate unusual taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'severe unusual taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'burning of throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedWatch'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '2- Hour Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '59.9', 'upperLimit': '85.2'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '82.8'}, {'value': '38.8', 'groupId': 'OG002', 'lowerLimit': '24.6', 'upperLimit': '52.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '57.2'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '50.7'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '29.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-hours', 'description': '1\\) Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absence of Photophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000', 'lowerLimit': '56.1', 'upperLimit': '74.7'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '54.4', 'upperLimit': '73.6'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '36.1', 'upperLimit': '55.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-hours', 'description': '2\\) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absence of Phonophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '83.4'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '56.5', 'upperLimit': '75.4'}, {'value': '56.0', 'groupId': 'OG002', 'lowerLimit': '46.1', 'upperLimit': '65.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-hours', 'description': '3\\) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absence of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '90.0'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '65.2', 'upperLimit': '82.7'}, {'value': '66.0', 'groupId': 'OG002', 'lowerLimit': '56.5', 'upperLimit': '75.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-hours', 'description': '4\\) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absence of Allodynia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000', 'lowerLimit': '57.6', 'upperLimit': '83.5'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '87.9'}, {'value': '69.0', 'groupId': 'OG002', 'lowerLimit': '57.6', 'upperLimit': '83.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-hours', 'description': '5\\) Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '13.1'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '20.1'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '22.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-hours', 'description': "Participants' self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. .", 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Pain Relief (SPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'title': '24 hour sustained pain relief', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '63.2'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '55.1'}, {'value': '20.4', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '32.1'}]}]}, {'title': '48 hour sustained pain relief', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '63.2'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '43.9'}, {'value': '20.4', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '32.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 and 48 hours', 'description': '7\\) 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Pain Freedom (SPF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'title': '24 hour sustained pain freedom', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '21.7', 'upperLimit': '48.9'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '34.5'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '21.7'}]}]}, {'title': '48 hour sustained pain freedom', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '19.9', 'upperLimit': '46.7'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '29.6'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '21.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 and 48 hours', 'description': '8\\) 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketorolac/ Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo\n\nKetorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG001', 'title': 'Sumatriptan/ Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo\n\nSumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}, {'id': 'OG002', 'title': 'Ketorolac Placebo/ Sumatriptan Placebo', 'description': 'Single dose Ketorolac placebo, single dose Sumatriptan placebo\n\nPlacebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray.'}], 'classes': [{'title': '10 minutes', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '26.0'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '24.4'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '21.7'}]}]}, {'title': '15 minutes', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '21.7', 'upperLimit': '48.8'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '49.7'}, {'value': '14.3', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '24.4'}]}]}, {'title': '20 minutes', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '57.2'}, {'value': '44.9', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '59.3'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '10.3', 'upperLimit': '34.5'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '69.0'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '67.5'}, {'value': '26.5', 'groupId': 'OG002', 'lowerLimit': '13.7', 'upperLimit': '39.3'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000', 'lowerLimit': '44.8', 'upperLimit': '72.8'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '71.5'}, {'value': '32.6', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '46.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'following each treated migraine attack', 'description': '9\\) The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketorolac Then Sumatriptan Then Placebo', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.'}, {'id': 'FG001', 'title': 'Kerorolac Then Placebo Then Sumatriptan', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.'}, {'id': 'FG002', 'title': 'Sumatriptan Then Ketorolac Then Placebo', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.'}, {'id': 'FG003', 'title': 'Sumatriptan Then Placebo Then Ketorolac', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.'}, {'id': 'FG004', 'title': 'Placebo Then Ketorolac Then Sumatriptan', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.'}, {'id': 'FG005', 'title': 'Placebo Then Sumatriptan Then Ketorolac', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'Randomized, But Did Not Take Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Completed Only 1 Attack', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketorolac Then Sumatriptan Then Placebo', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.'}, {'id': 'BG001', 'title': 'Ketorolac Then Placebo Then Sumatriptan', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.'}, {'id': 'BG002', 'title': 'Sumatriptan Then Ketorolac Then Placebo', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.'}, {'id': 'BG003', 'title': 'Sumatriptan Then Placebo Then Ketorolac', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.'}, {'id': 'BG004', 'title': 'Placebo Then Ketorolac Then Sumatriptan', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.\n\nAttack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.'}, {'id': 'BG005', 'title': 'Placebo Then Sumatriptan Then Ketorolac', 'description': 'Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo\n\nAttack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.\n\nAttack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.\n\nAttack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '36.3', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '9.8', 'groupId': 'BG003'}, {'value': '36.3', 'spread': '9.8', 'groupId': 'BG004'}, {'value': '36.3', 'spread': '9.8', 'groupId': 'BG005'}, {'value': '36.3', 'spread': '9.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Average age of participants', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Of the 72 randomized participants, 54 (75%) treated at least one attack and 49 (68%) completed all three treatments, for a total of 152 treated migraine attacks.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2013-03-06', 'resultsFirstSubmitDate': '2016-01-27', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-10', 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2- Hour Pain Relief', 'timeFrame': '2 hours', 'description': 'The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)'}], 'secondaryOutcomes': [{'measure': 'Pain Freedom', 'timeFrame': '2-hours', 'description': '1\\) Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).'}, {'measure': 'Absence of Photophobia', 'timeFrame': '2-hours', 'description': '2\\) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)'}, {'measure': 'Absence of Phonophobia', 'timeFrame': '2-hours', 'description': '3\\) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)'}, {'measure': 'Absence of Nausea', 'timeFrame': '2-hours', 'description': '4\\) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)'}, {'measure': 'Absence of Allodynia', 'timeFrame': '2-hours', 'description': '5\\) Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.'}, {'measure': 'Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability', 'timeFrame': '2-hours', 'description': "Participants' self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. ."}, {'measure': 'Sustained Pain Relief (SPR)', 'timeFrame': '24 and 48 hours', 'description': '7\\) 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).'}, {'measure': 'Sustained Pain Freedom (SPF)', 'timeFrame': '24 and 48 hours', 'description': '8\\) 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).'}, {'measure': 'Time to Pain Relief', 'timeFrame': 'following each treated migraine attack', 'description': '9\\) The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraines']}, 'referencesModule': {'references': [{'pmid': '26840902', 'type': 'DERIVED', 'citation': 'Rao AS, Gelaye B, Kurth T, Dash PD, Nitchie H, Peterlin BL. A Randomized Trial of Ketorolac vs. Sumatripan vs. Placebo Nasal Spray (KSPN) for Acute Migraine. Headache. 2016 Feb;56(2):331-40. doi: 10.1111/head.12767. Epub 2016 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for migraine associated symptoms including nausea and allodynia.', 'detailedDescription': 'Participants are randomized to Ketorolac NS 31.5 mg, Sumatriptan NS 20 mg or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack so that they received each treatment only once.\n\nFor each treated attack (moderate to severe migraine attack), participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.\n\nRandomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion/Exclusion Criteria\n\nAt the Screening Visit, a subject must meet the following criteria to participate in this study:\n\n1.18-65 years of age 2.Fulfills International Classification of Headache Disorders (ICHD)-II Criteria of migraine as noted below in Table 1 3.History of migraines for at least one year 4.Migraine onset prior to the age of 50 years of age 5.Headache frequency (of any headaches, migraine or non-migraine) \\< 9 days per month 6.At visit 2, participants must report two or more headache days during the 28-day run-in period on the headache diary. 7.At least 48 hours of freedom from headache between treated migraine attacks. 8.If currently using headache preventive medications, must be on a stable dose for at least 3 months prior to enrollment and throughout the study period and be on no more than one prophylactic agent. 9.Able to complete all study procedures, including the questionnaire (assessing demographics, headache characteristics, headache comorbidities and medical history at the initial visit and headache characteristics) and the required headache calendars, and all study visits; 10.Able to understand, read and sign an informed consent (English).\n\nExclusion Criteria:\n\n1. Any condition (history or presence of) which contraindicates the use of triptans or NSAIDs including:\n\n * Known hypersensitivity or intolerance to triptans or NSAIDs\n * Contraindications to triptan use (uncontrolled hypertension, ischemic heart disease, prinz-metal angina, cardiac arrhythmias, multiple risk factors for atherosclerotic vascular disease, primary vasculopathies, and basilar and hemiplegic migraine)\n * Cerebrovascular disease except for mild non-specific white matter disease\n * Peripheral vascular disease or any other ischemic disease including myocardial infarction\n * Uncontrolled hypertension (systolic BP 160 mmHg or diastolic BP 95 mmHg or (both)\n * Migraine aura fulfilling ICHD-II criteria for hemiplegic or basilar-type migraine\n * Any history of chronic renal or hepatic impairment\n * Use of an ergotamine-containing medication or monamine oxidase inhibitor\n * Known or suspected pregnancy, negative pregnancy test\n * Lactation\n * Bleeding dsycrasias including gastritis, peptic ulcer disease,gastrointestinal bleeding\n2. Physician diagnosis of any pain syndrome other than migraine\n3. Classification as treatment resistant by investigator\n4. Known drug or substance abuse\n5. Any opioid use in past 2 months\n6. Use of any medication, which could interfere with study assessments\n7. History of noncompliance with taking medication;\n8. Use of any experimental drug or device within 30 days prior to the Screening Visit (Visit 1);\n9. Any abnormal finding or condition deemed clinically significant by the investigator on history, screening, or physical exam that contraindicates the use of triptans or NSAIDs or that might interfere with the patient's safety, study participation, or which might confound the interpretation of the study results.\n10. Any history of chronic renal or hepatic disease already excluded above under number 1; plus see exclusion 9.\n11. History of chronic pulmonary disorder including nasal polyps (see 1) and asthma.\n12. History of upper respiratory infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with assessment of AEs including rhinitis medicamentosa (chronic daily use of topical decongestants).\n13. History of nasal surgery."}, 'identificationModule': {'nctId': 'NCT01807234', 'acronym': 'KSPN', 'briefTitle': 'Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (The KSPN Migraine Study)', 'orgStudyIdInfo': {'id': 'NA00075486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketorolac/Placebo', 'description': 'Ketorolac 31.5 mg single dose nasal spray and Placebo', 'interventionNames': ['Drug: Ketorolac', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sumatriptan/Placebo', 'description': 'Sumatriptan 20 mg single dose nasal spray and placebo', 'interventionNames': ['Drug: Sumatriptan', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ketorolac Placebo/Sumatriptan placebo', 'description': 'single dose Ketorolac placebo, single dose Sumatriptan placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Sprix'], 'description': 'Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.', 'armGroupLabels': ['Ketorolac/Placebo']}, {'name': 'Sumatriptan', 'type': 'DRUG', 'otherNames': ['Imitrex'], 'description': 'Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack.', 'armGroupLabels': ['Sumatriptan/Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo one spray in each nostril and placebo one nasal spray.', 'armGroupLabels': ['Ketorolac Placebo/Sumatriptan placebo', 'Ketorolac/Placebo', 'Sumatriptan/Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Bayview Headache Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, The Johns Hopkins Bayview Headache Research', 'investigatorFullName': 'Drs Barbara Peterlin', 'investigatorAffiliation': 'Johns Hopkins University'}}}}