Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01390220
Status:
TERMINATED
Last Update Posted:
2019-10-10
First Post:
2011-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'C537589', 'term': 'Severe combined immunodeficiency with sensitivity to ionizing radiation'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsequeira@proximagen.com', 'phone': '952-658-7438', 'title': 'David Sequeira', 'organization': 'Proximagen, LLC'}, 'certainAgreement': {'otherDetails': 'A manuscript or abstract should not be submitted by investigator(s) for publication or presentation until a New Drug Application is approved by the US FDA or permission is granted in writing by sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events (TEAEs) collected from administration of first open-label dose of USL261 5 mg in Test Dose Phase (TDP) until completion of the final study visit or 7 days after the last administration of study drug, whichever was later. The duration of individual participant participation was variable as administration of the double-blind dose in the Comparative Phase (CP) was dependent on occurrence of a seizure cluster episode meeting trial criteria after randomization.', 'description': 'Adverse events collected at each visit from participant and/or caregiver. TEAEs presented for TDP and CP separately. Due to the short systemic half-life of active (midazolam), TEAEs within 2 days after administration of first open-label USL261 5 mg dose presented for TDP, and within 2 days after administration of double-blind dose for CP.', 'eventGroups': [{'id': 'EG000', 'title': 'USL261 TDP', 'description': 'Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP)', 'otherNumAtRisk': 292, 'deathsNumAtRisk': 292, 'otherNumAffected': 78, 'seriousNumAtRisk': 292, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'USL261 CP, USL261 5 mg Only', 'description': 'Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 17, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'USL261 CP, USL261 5 mg + 5 mg', 'description': 'Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode and received an open-label USL261 5 mg dose in the Comparative Phase (CP)', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 10, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo CP, Placebo Only', 'description': 'Participants completing TDP who received Placebo as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo CP, Placebo + USL261 5 mg', 'description': 'Participants completing TDP who received Placebo as randomized dose to treat a seizure cluster episode and received an open-label USL261 5 mg dose in the Comparative Phase (CP)', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 7, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 61, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Product taste abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Seizure cluster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261 CP', 'description': '5 mg intranasal midazolam\n\nUSL261'}, {'id': 'OG001', 'title': 'Placebo CP', 'description': 'Intranasal placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0109', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2-sided'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours', 'description': 'Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received the double-blind dose in the CP.'}, {'type': 'SECONDARY', 'title': 'Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261 CP', 'description': '5 mg intranasal midazolam\n\nUSL261'}, {'id': 'OG001', 'title': 'Placebo CP', 'description': 'Intranasal placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0043', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2-sided'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Participants with recurrence of seizure(s) \\>10 minutes and up to 4 hours after administration of the double-blind dose in the CP. Participants who received the open-label second dose within 4 hours of administration of the double-blind dose were analyzed as having had a seizure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received the double-blind dose in the CP.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261 CP', 'description': '5 mg intranasal midazolam\n\nUSL261'}, {'id': 'OG001', 'title': 'Placebo CP', 'description': 'Intranasal placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Occurrence of next seizure with a start time \\>10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received the double-blind dose in the CP.'}, {'type': 'SECONDARY', 'title': 'Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261 CP', 'description': '5 mg intranasal midazolam\n\nUSL261'}, {'id': 'OG001', 'title': 'Placebo CP', 'description': 'Intranasal placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimable as probability of no seizures through 24 hours was above 50%. Upper bound of 95% CI was not estimable.', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': 'NA'}, {'value': '12.1', 'comment': 'Upper bound of 95% CI was not estimable.', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Kaplan-Meier estimates.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Time to next seizure with a start time \\>10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received the double-blind dose in the CP'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'USL261 TDP', 'description': 'Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP)'}, {'id': 'FG001', 'title': 'USL261 CP', 'description': 'Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)'}, {'id': 'FG002', 'title': 'Placebo CP', 'description': 'Participants completing TDP who received placebo as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP)'}], 'periods': [{'title': 'Test Dose Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'comment': 'This arm not applicable in TDP.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'This arm not applicable in TDP.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No treated seizure cluster episode', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study/Site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Caregiver no longer available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Logistical', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Comparative Phase', 'milestones': [{'type': 'STARTED', 'comment': 'Patients completing TDP, were randomized, and received double-blind dose in CP', 'achievements': [{'comment': 'This arm not applicable in CP', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This arm not applicable in CP', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '133'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants underwent in-clinic administration of open-label USL261 5 mg followed by USL261 5 mg 10 minutes in absence of a seizure (Test Dose Phase \\[TDP\\]). Participants were then randomized to double-blind USL261 5 mg or Placebo to be administered by caregiver to treat a seizure cluster in Comparative Phase (CP) in the outpatient setting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'USL261 Test Dose', 'description': 'Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '272', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '270', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '275', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self reported. Unknown or not reported includes Other, eg. "Slavic".', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}, {'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.69', 'groupId': 'BG000', 'lowerLimit': '15.8', 'upperLimit': '48.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Height not measurable in some patients'}, {'title': 'Seizure cluster episodes in year before Visit 1 of study', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '999'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'seizure cluster episodes', 'dispersionType': 'FULL_RANGE'}, {'title': 'Years had seizure cluster episodes prior to study', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '62.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Unknown or data entered as indefinite (eg \\>3) for some participants'}, {'title': 'Typical number of seizures in seizure cluster episode', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '200.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'seizures', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Not reported for 1 subject'}, {'title': 'Typical duration of seizure cluster episode', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '4320.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Non-numerical duration (eg "several" hours reported for some participants'}], 'populationDescription': 'USL261 Test Dose: All patients receiving at least 1 dose of USL261 5 mg in TDP.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-20', 'size': 2941434, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-09T11:54', 'hasProtocol': True}, {'date': '2017-04-14', 'size': 2917701, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-09T11:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2018-03-15', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-08', 'studyFirstSubmitDate': '2011-07-06', 'dispFirstSubmitQcDate': '2018-03-15', 'resultsFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2011-07-07', 'dispFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-09', 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)', 'timeFrame': '6 hours', 'description': 'Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.'}], 'secondaryOutcomes': [{'measure': 'Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose', 'timeFrame': '4 hours', 'description': 'Participants with recurrence of seizure(s) \\>10 minutes and up to 4 hours after administration of the double-blind dose in the CP. Participants who received the open-label second dose within 4 hours of administration of the double-blind dose were analyzed as having had a seizure.'}, {'measure': 'Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose', 'timeFrame': '24 hours', 'description': 'Occurrence of next seizure with a start time \\>10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.'}, {'measure': 'Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose', 'timeFrame': '24 hours', 'description': 'Time to next seizure with a start time \\>10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epilepsy', 'seizure clusters', 'acute repetitive seizures', 'rescue treatment', 'ARTEMIS'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '36410152', 'type': 'DERIVED', 'citation': 'Meng TC, Szaflarski JP, Chen L, Brunnert M, Campos R, Van Ess P, Pullman WE, Fakhoury T. Psychosocial outcomes of repeated treatment of seizure clusters with midazolam nasal spray: Results of a phase 3, open-label extension trial. Epilepsy Behav. 2023 Jan;138:108989. doi: 10.1016/j.yebeh.2022.108989. Epub 2022 Nov 18.'}, {'pmid': '31140596', 'type': 'DERIVED', 'citation': 'Detyniecki K, Van Ess PJ, Sequeira DJ, Wheless JW, Meng TC, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters-a randomized, double-blind, placebo-controlled trial. Epilepsia. 2019 Sep;60(9):1797-1808. doi: 10.1111/epi.15159. Epub 2019 May 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.', 'detailedDescription': "Qualifying participants underwent an in-clinic administration (Test Dose Phase \\[TDP\\]) of two doses of USL261 (intranasal midazolam 5 mg), separated by 10 minutes, in the absence of seizures. Eligible participants were then randomized to USL261 versus Placebo in an outpatient Comparative Phase (CP). When the participant had a qualifying seizure cluster episode, as described in an individualized patient management plan, the participant's caregiver administered the double-blind dose. An open-label USL261 dose could be administered after 10 minutes and up to 6 hours after the double-blind dose, if the participant had persistent or recurrent seizures. Initial participants could not proceed to CP until an independent data safety monitoring board (DSMB) reviewed safety data from at least the first 25 participants in TDP; the DSMB performed additional safety reviews at pre-set intervals based on enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes\n* Has an established diagnosis of partial or generalized epilepsy that includes the following:\n\n * A documented history of seizure clusters lasting a minimum of 10 minutes\n * Seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)\n * A second seizure in the seizure cluster typically occurring within 6 hours from the time of cluster recognition\n * A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures\n * A seizure cluster pattern established \\> 3 months before Visit 1\n * A frequency of ≥ 3 seizure clusters during the year before Visit 1\n * At least 1 seizure cluster occurring ≤ 4 months before Visit 1\n * Seizure cluster pattern is confirmed by a central reviewer\n* Currently on a stable regimen of anti-epileptic drugs (AEDs) with no changes in type of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose\n* Weight is 40 kg to 125 kg, inclusive\n\nExclusion Criteria:\n\n* Has a neurological disorder that is likely to progress in the next year\n* Has severe chronic cardio-respiratory disease\n* Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1\n* Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1\n* Has a history of acute narrow-angle glaucoma.\n* Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years\n* Currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1"}, 'identificationModule': {'nctId': 'NCT01390220', 'acronym': 'ARTEMIS1', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters. ARTEMIS-1: Acute Rescue Therapy in Epilepsy With Midazolam Intranasal Spray-1', 'orgStudyIdInfo': {'id': 'P261-401'}, 'secondaryIdInfos': [{'id': '2011-001318-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'USL261', 'description': 'intranasal midazolam 5mg', 'interventionNames': ['Drug: USL261']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Intranasal placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'USL261', 'type': 'DRUG', 'otherNames': ['Midazolam nasal spray (MDZ NS)'], 'armGroupLabels': ['USL261']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'United States, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'United States, Arizona', 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