Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-03 @ 12:27 AM
Study NCT ID:
NCT02856802
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}], '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': 'D018170', 'term': 'Sumatriptan'}, {'id': 'D059085', 'term': 'Nasal Sprays'}], 'ancestors': [{'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'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000336', 'term': 'Aerosols'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uslinfo@upsher-smith.com', 'phone': '(763) 315-2000', 'title': 'Clinical Operations', 'organization': 'Upsher-Smith Laboratories, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were assessed from the initial dose of study medication up to 5 days after the last dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'DFN-02 (DB1)', 'description': 'DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Active in Double-blind Treatment Period 1', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 5, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (DB1)', 'description': 'DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Placebo in Double-blind Treatment Period 1', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DFN-02 (DB2)', 'description': 'DFN-02 Active Nasal Sumatriptan 10-mg spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Active in Double-blind Treatment Period 2', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 5, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo (DB2)', 'description': 'DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Placebo in Double-blind Treatment Period 2', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFN-02 (DB1)', 'description': 'DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02'}, {'id': 'OG001', 'title': 'Placebo (DB1)', 'description': 'DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '1.05', 'ciUpperLimit': '6.83', 'groupDescription': 'Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the statistical analysis system (SAS)® software package (version 9.3).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Assumption that 15% of placebo and 42% of DFN 02 10 mg (treated) subjects would be pain-free at 2 hours. A sample size of 50 subjects in each DB1 dosing arm provided 86% power to detect this assumed difference between placebo and DFN-02 10 mg at a 5% (2-sided) level of significance.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours after study medication administration', 'description': "Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \\[Grade 2\\] or severe \\[Grade 3\\] predose and reduced to none \\[Grade 0\\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population. Last observation carried forward (LOCF) imputation method. The FAS included all randomized subjects who took at least one dose of study medication during the DB treatment period (1) and had at least one post-baseline efficacy time point assessment in DB treatment period (1).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFN-02 (DB1)', 'description': 'DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02'}, {'id': 'OG001', 'title': 'Placebo (DB1)', 'description': 'DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority conducted as specified in the statistical analysis plan (SAP).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours after study medication administration', 'description': "Number of participants with their MBS among nausea, photophobia and phonophobia absent at 10, 15, 20, 30, 60, 90, and 120 minutes after the first dose of study medication taken for a migraine attack during DB1 treatment period are summarized by treatment group and time point for the full analysis set (FAS1). The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups. Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFN-02 (DB2)', 'description': 'Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode.\n\nSumatriptan 10 MG Nasal Spray: 100 μL nasal spray once'}, {'id': 'OG001', 'title': 'Placebo (DB2)', 'description': 'Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode.\n\nSumatriptan Placebo Nasal Spray: 100 μL nasal spray once'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.52', 'ciUpperLimit': '3.30', 'groupDescription': 'Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the SAS® software package (version 9.3).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'No assumptions made.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours after study medication administration', 'description': 'In Double-blind Treatment Period 2 (DB2), freedom from headache pain 2 hours after the first dose of study medication taken within one hour of experiencing a migraine attack for any headache pain level, e.g., mild \\[Grade 1\\], moderate \\[Grade 2\\], or severe \\[Grade 3\\] and reduced to none \\[Grade 0\\] after study medication administration. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Last observation carried forward (LOCF) imputation method. Analysis included all randomized subjects who took at least one dose of study medication during the second DB treatment period (2) and had at least one post-baseline efficacy time point assessment in DB treatment period (2).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DFN-02', 'description': 'DFN-02 Active Nasal Sumatriptan 10mg spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'DFN-02 Placebo spray upon onset of acute migraine pain during each acute migraine episode\n\nDFN-02 Placebo'}], 'periods': [{'title': 'Double-Blind Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '4 of 54 randomized subjects did not start; 2 had no migraines, 1 withdrew, 1 lost to follow-up.', 'groupId': 'FG000', 'numSubjects': '50'}, {'comment': '10 of 53 randomized subjects did not start; 6 had no migraines, 3 withdrew, 1 sponsor terminated.', 'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of diary compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Double-Blind Treatment Period 2', 'milestones': [{'type': 'STARTED', 'comment': '86 subjects completing double-blind treatment period 1, and still eligible, were re-randomized into double-blind treatment period 2', 'achievements': [{'comment': '6 of 43 re-randomized subjects did not start; 5 had no migraines, for 1 protocol deviation.', 'groupId': 'FG000', 'numSubjects': '37'}, {'comment': '5 of 43 re-randomized subjects did not start; 4 had no migraines, for 1 prohibited drug use.', 'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in the United States. At least 1 subject was enrolled at 9 study centers.', 'preAssignmentDetails': 'Subjects had to have an average of 2 to 8 migraine attacks per month for at least the prior 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DFN-02 (Double-Blind Treatment Period 1)', 'description': '50 of 54 randomized subjects started and were dosed; 2 subjects had no migraine attack, 1 subject withdrew and 1 subject was lost to follow-up. Per protocol these 4 subjects are excluded from analysis.'}, {'id': 'BG001', 'title': 'Placebo (Double-Blind Treatment Period 1)', 'description': '43 of 53 randomized subjects started and were dosed; 6 subjects had no migraine attack, 3 subjects withdrew and 1 subject was terminated by the sponsor. Per protocol these 10 subjects are excluded from analysis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '68'}, {'value': '41.0', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '63'}, {'value': '42.3', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '68'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.70', 'spread': '6.441', 'groupId': 'BG000'}, {'value': '28.80', 'spread': '7.500', 'groupId': 'BG001'}, {'value': '28.21', 'spread': '6.933', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A maximum 21 day screening period was conducted to evaluate whether a subject met the migraine inclusion criteria pursuant to ICHD-3, and did not exhibit medication overuse. If eligible and randomized, subjects in the DB1 treatment period were instructed to use the study medication for their first migraine attack as soon as (and no more than 1 hour after) experiencing moderate to severe migraine pain. If the subject was missed dosing the first migraine, they were to dose the next attack.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-01', 'size': 837601, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-03T13:09', 'hasProtocol': True}, {'date': '2016-09-16', 'size': 14344140, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-03T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'dispFirstSubmitDate': '2018-03-18', 'completionDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2016-07-29', 'dispFirstSubmitQcDate': '2018-03-18', 'resultsFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2016-08-02', 'dispFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-03', 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1).', 'timeFrame': '2 hours after study medication administration', 'description': "Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \\[Grade 2\\] or severe \\[Grade 3\\] predose and reduced to none \\[Grade 0\\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1)', 'timeFrame': '2 hours after study medication administration', 'description': "Number of participants with their MBS among nausea, photophobia and phonophobia absent at 10, 15, 20, 30, 60, 90, and 120 minutes after the first dose of study medication taken for a migraine attack during DB1 treatment period are summarized by treatment group and time point for the full analysis set (FAS1). The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups. Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed."}, {'measure': 'Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2)', 'timeFrame': '2 hours after study medication administration', 'description': 'In Double-blind Treatment Period 2 (DB2), freedom from headache pain 2 hours after the first dose of study medication taken within one hour of experiencing a migraine attack for any headache pain level, e.g., mild \\[Grade 1\\], moderate \\[Grade 2\\], or severe \\[Grade 3\\] and reduced to none \\[Grade 0\\] after study medication administration. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aura'], 'conditions': ['Migraine Headaches']}, 'referencesModule': {'references': [{'pmid': '30877622', 'type': 'DERIVED', 'citation': 'Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment. CNS Drugs. 2019 Apr;33(4):375-382. doi: 10.1007/s40263-019-00614-6.'}, {'pmid': '29878341', 'type': 'DERIVED', 'citation': 'Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02 (Sumatriptan 10 mg With a Permeation Enhancer) Nasal Spray vs Placebo in the Acute Treatment of Migraine: A Double-Blind, Placebo-Controlled Study. Headache. 2018 May;58(5):676-687. doi: 10.1111/head.13309.'}]}, 'descriptionModule': {'briefSummary': 'A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.', 'detailedDescription': "This was a randomized, two double-blind (DB) treatment period dosing study.\n\nPreviously diagnosed subjects with a history of episodic migraine (as defined by International Classification of Headache Disorders (ICHD), 3rd edition \\[beta version\\] \\[ICHD 3\\]) who experienced an average of 2 to 8 migraine attacks per month for at least the prior 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine, were randomized in a 1:1 ratio in both DB periods to receive either DFN-02 (sumatriptan nasal spray 10 mg) or a matching placebo.\n\nSubjects treated one moderate to severe migraine attack in the first double-blind treatment period (DB1) and, if eligible, were re-randomized into the second double-blind treatment period (DB2) to treat another migraine attack at any pain level.\n\nThere was a screening period of up to 21 days to evaluate whether subjects fit the migraine inclusion criteria pursuant to ICHD-3, and did not have medication overuse. Subjects with at least a 12 month medical history of acute migraine were eligible for enrollment in the treatment period. Subjects continued to take their normal migraine medication during this screening period.\n\nIf eligible and randomized, subjects in the DB1 treatment period were instructed to use the study medication in one migraine attack as soon as (and no more than within one hour after) experiencing moderate to severe migraine pain (defined as headache pain rating of Grade 2 \\[moderate\\] or Grade 3 \\[severe\\] on a pain severity scale of 0 to 3). If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. Those subjects who did not experience a migraine attack, and/or did not treat any migraine attack with study medication or record diary data, were not allowed to continue into the DB2 treatment period, and were discontinued.\n\nAfter treating a migraine attack with study medication, subjects were instructed to contact the site within 24 hours of the treated migraine (or the next working day) to schedule their next visit.\n\nSubjects returned to the study site within 2 to 7 days in the DB1 treatment period and, if continuing to be eligible, were re-randomized into a DB2 treatment period to treat one migraine attack at any pain level, and return to the study site within 2 to 7 days of the second treatment.\n\nOnce randomized, the total duration of each subject's participation in the study was up to 10 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A history of episodic migraine who experience an average of 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine headaches\n2. Patients who have migraine with or without aura. If migraine with aura, the aura cannot last longer than 60 minutes.\n3. Patients who are willing and able to:\n\n 1. Evaluate and record pain, migraine symptoms, and study medication effectiveness information in real-time using a diary for the duration of the study;\n 2. Record each instance of the use of study medication and rescue medication in a patient diary in real-time for the duration of the study;\n 3. Comply with all other study procedures and scheduling requirements.\n\nExclusion Criteria:\n\n1. Minors, even if they are in the specified study age range\n2. Medication overuse:\n\n 1. Opioids ≥ 10 days during the 90 days prior to screening\n 2. Combination medications (e.g., Fiorinal®) ≥ 10 days during the 90 days prior to screening (only applies if combination medication contains an opioid and/or barbiturate)\n 3. Nonsteroidal Anti-inflammatory Drugs or other simple medications ˃ 14 days a month during the 90 days prior to screening\n 4. Triptans or ergots ≥ 10 days a month during the 90 days prior to screening\n3. Treated with onabotulinumtoxinA (Botox®) or other botulinum toxin treatment within 4 months prior to screening for migraine prophylaxis (patients who were treated with same for cosmetic purposes may be allowed on a case-by-case basis after approval from the Medical Monitor)\n4. A history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the Investigator, would compromise data collection\n5. Use of antipsychotics at least 15 days prior to randomization\n6. Patients who received treatment with an investigational drug or device within 30 days prior to randomization, or within 3 months if associated with central nervous system\n7. Patients who participated in a central nervous system clinical trial within 3 months prior to randomization\n8. Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody serology testing\n9. Patients who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical study research site'}, 'identificationModule': {'nctId': 'NCT02856802', 'briefTitle': 'An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Upsher-Smith Laboratories'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of DFN-02 in Episodic Migraine With or Without Aura', 'orgStudyIdInfo': {'id': 'DFN-02-CD-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DFN-02', 'description': 'Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode.', 'interventionNames': ['Drug: Sumatriptan 10 mg Nasal Spray']}, {'type': 'OTHER', 'label': 'Placebo', 'description': 'Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode.', 'interventionNames': ['Other: Sumatriptan Placebo Nasal Spray']}], 'interventions': [{'name': 'Sumatriptan 10 mg Nasal Spray', 'type': 'DRUG', 'otherNames': ['Sumatriptan'], 'description': '100 μL nasal spray once', 'armGroupLabels': ['DFN-02']}, {'name': 'Sumatriptan Placebo Nasal Spray', 'type': 'OTHER', 'description': '100 μL nasal spray once', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Site 30', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Site 11', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site 31', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 18', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Site 02', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Site 29', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Site 25', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Site 33', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Site 28', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Sagar Munjal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Dr. Reddy's Laboratories, LLC"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Upsher-Smith Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}