Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-22 @ 6:17 PM
Study NCT ID:
NCT01529034
Status:
TERMINATED
Last Update Posted:
2023-01-20
First Post:
2012-02-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], '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}, 'limitationsAndCaveats': {'description': 'Open-label, non-comparative design. Potential participation bias due to participants and/or caregiver perceived efficacy/safety in prior study. Seizure data capture in diaries diminished over time in some participants due to length of study.'}}, 'adverseEventsModule': {'timeFrame': 'Original protocol - each participant 2 years from enrollment; Amended protocol - each participant open-ended from enrollment (up to 4 years or longer as approved by Health Authority where study being conducted). Actual individual participant duration 1.0 to 55.7 months.', 'description': 'Adverse events collected at each visit from participant and/or caregiver. Due to intermittent treatment (qualifying seizure clusters), short systemic half-life of active (midazolam), and long participant duration, treatment emergent adverse event within 2 days after each treated seizure cluster are reported. Seizures were not considered adverse events unless worsening from underlying condition.', 'eventGroups': [{'id': 'EG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 33, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 96, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 92, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 27, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Seizure cluster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Safety Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': '5 mg intranasal midazolam\n\nUSL261'}], 'classes': [{'categories': [{'measurements': [{'value': '16.80', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '55.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Duration of participant study participation for collection of long term safety data', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5mg on study'}, {'type': 'PRIMARY', 'title': 'Participants Meeting Predefined Safety Criteria for Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'title': 'SBP <85 mm Hg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SBP change from baseline ≥ 40 mm Hg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'DBP <50 mm Hg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'DBP change from baseline ≥ 30 mm Hg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pulse rate <50 bpm', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pulse rate >120 bpm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pulse rate change from baseline >/= 40 bpm', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Caregiver recorded RR <8 brpm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Caregiver recorded RR >24 brpm', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants meeting predefined safety criteria for vital signs (systolic blood pressure \\[SBP\\] \\<85 mm Hg, SBP change from baseline \\>/= 40 mm Hg, diastolic BP \\[DBP\\] \\<50 mm Hg, DBP change from baseline \\>/=30 mm Hg, pulse rate \\<50 beats per minute (bpm), pulse rate \\>120 bpm, pulse rate change \\>/= 40 bpm at any visit post baseline or for caregiver recorded participant respiration rate \\[RR\\] \\<8 breaths per minute (brpm) or \\>24 brpm) after any USL261 treated seizure cluster episode. Abnormal vital signs were assessed separately by investigator and recorded as adverse events if applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'PRIMARY', 'title': 'Participants With Laboratory Abnormalities Meeting Predefined Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'title': 'ALT >ULN & ≤3xULN', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Albumin <30 g/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ALP >2.5xULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AST >ULN & ≤3xULN', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'AST >5x ULN & <20xULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate <15.9 mmol/L', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol >7.75 mmol/L', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine >1.5xULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine >2x baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'GGT >2.5xULN', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Glucose <3 mmol/L', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Glucose <8.9 mmol/L', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate <0.8 mmol/L', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Potassium >5.5 mmol/L', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Sodium <130 mmol/L', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Sodium >150 mmol/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin <100 g/L', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin decrease 20 g/L', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes <3x10^9/L', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes <0.8x10^9/L', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils <1.5x10^9/L', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal laboratory finding, at any time post baseline, meeting predefined criteria. Abnormal laboratory findings were assessed separately by investigator and recorded as adverse events if applicable. Alanine aminotransferase (ALT); Alkaline phosphatase (ALP); Aspartate aminotransferase (AST); Gamma glutamyl transferase (GGT); upper limit of normal (ULN)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'PRIMARY', 'title': 'Participants With Clinically Significant Abnormalities Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'title': 'Skin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Head/Eyes/Ears/Nose/Throat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neck', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lungs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Heart', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Abdomen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lymph nodes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Extremities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal findings, at any time post baseline, on physical examination considered clinically significant by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'PRIMARY', 'title': 'Participants With Clinically Significant Abnormalities on Neurologic Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'title': 'Mental status', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Cranial nerves II-XII', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Motor strength of limbs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Deep tendon reflexes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Sensory exam', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Station and gait', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hopping', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Romberg test', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Finger-to-nose test', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Heel-to-shin test', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rapid alternating movements', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Nystagmus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Tremor/Other abnormal movements', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal findings, at any time post baseline, on neurologic examination considered clinically significant by the investigator', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'PRIMARY', 'title': 'Participants With Clinically Significant Abnormalities on Nasal Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal findings, at any time post baseline, on nasal examination considered clinically significant by the investigator', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'PRIMARY', 'title': 'Participant Change in B-SIT Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Change in participant Brief Smell Identification Test (B-SIT) score from baseline to last visit with assessment. The B-SIT is a self-administered 12-item test; the score indicates odors correctly identified (0 to 12). The B-SIT was added while the study was already ongoing (Protocol Amendment 4, 20 May 2015) in response to a regulatory request. The test was only implemented at sites in the United States and included only participants considered by the investigator to have adequate cognitive ability to perform the test. Baseline was defined as the latest non-missing value prior to administration of USL261 in the Test Dose Phase of Study P261-401.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study, had a baseline B-SIT in Study P261-401, and a post-baseline B-SIT in Study P261-402.'}, {'type': 'PRIMARY', 'title': 'Participants With Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'title': 'Wish to be dead', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Non-specific active', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Active without specific plan', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Active with specific plan/intent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Any suicidal ideation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with suicidal ideation reported on Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at any post-baseline visit. Responses including: Wish to be Dead; Non-Specific Active Suicidal Thoughts; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; and Any Suicidal Ideation Regardless of Type.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'PRIMARY', 'title': 'Emergency Room/Emergency Medical Service Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': 'USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants requiring emergency room (ER)/emergency medical service (EMS) visit within 24 hours after any USL261 treated seizure cluster (including for continued seizures)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of USL261 5 mg on study'}, {'type': 'SECONDARY', 'title': 'Number of Treated Seizure Clusters Meeting Criteria for Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}, {'units': 'Seizure cluster episodes', 'counts': [{'value': '1998', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'USL261', 'description': '5 mg intranasal midazolam\n\nUSL261'}], 'classes': [{'categories': [{'measurements': [{'value': '1108', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 hours after first dose of USL261 for each treated seizure cluster', 'description': 'Number of Treated Seizure Clusters Meeting Criteria for Treatment Success: Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after administration of first dose of USL261 (intranasal midazolam 5 mg)', 'unitOfMeasure': 'Seizure cluster episodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Seizure cluster episodes', 'denomUnitsSelected': 'Seizure cluster episodes', 'populationDescription': 'Seizure cluster episodes treated with first dose of USL261'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'USL261', 'description': '5 mg intranasal midazolam\n\nUSL261'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Completed Study P261-401 and rolled over to Study P261-402', 'groupId': 'FG000', 'numSubjects': '175'}]}, {'type': 'Exposed', 'achievements': [{'comment': 'Treated at least 1 seizure cluster with USL261', 'groupId': 'FG000', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed under initial protocol duration of 2 years; amended protocol open-ended duration', 'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}]}], 'dropWithdraws': [{'type': 'Discontinued prior to study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'Study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'No treated SCs within protocol window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Caregiver no longer available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Investigator no longer available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Study drug not available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The participant flow refers to the enrolled population and includes participants who did not treat a seizure cluster episode.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'USL261', 'description': '5 mg intranasal midazolam\n\nUSL261'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '153', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.9', 'spread': '11.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '153', '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': '161', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '152', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant in Race unknown category reported race as "Slavic"', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'BG000', 'lowerLimit': '17.7', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m˄2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Height not reported for some participants'}, {'title': 'Seizure cluster episodes in year before Visit 1 in Study P261-401', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '999'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'seizure cluster episodes', 'dispersionType': 'FULL_RANGE'}, {'title': 'Years had seizure cluster episodes prior to Study P261-401', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '48.0'}]}]}], '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': '161', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '170'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'seizures', 'dispersionType': 'FULL_RANGE'}, {'title': 'Typical duration of seizure cluster episode', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Non-numerical duration (eg "several" hours) reported for some participants'}], 'populationDescription': 'Participants exposed to at least 1 dose of USL261'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-20', 'size': 5094451, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-09T13:12', 'hasProtocol': True}, {'date': '2017-05-15', 'size': 873511, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-09T13:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'dispFirstSubmitDate': '2018-03-15', 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2012-02-03', 'dispFirstSubmitQcDate': '2018-03-15', 'resultsFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2012-02-07', 'dispFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-05', 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Safety Observation', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Duration of participant study participation for collection of long term safety data'}, {'measure': 'Participants Meeting Predefined Safety Criteria for Vital Signs', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants meeting predefined safety criteria for vital signs (systolic blood pressure \\[SBP\\] \\<85 mm Hg, SBP change from baseline \\>/= 40 mm Hg, diastolic BP \\[DBP\\] \\<50 mm Hg, DBP change from baseline \\>/=30 mm Hg, pulse rate \\<50 beats per minute (bpm), pulse rate \\>120 bpm, pulse rate change \\>/= 40 bpm at any visit post baseline or for caregiver recorded participant respiration rate \\[RR\\] \\<8 breaths per minute (brpm) or \\>24 brpm) after any USL261 treated seizure cluster episode. Abnormal vital signs were assessed separately by investigator and recorded as adverse events if applicable.'}, {'measure': 'Participants With Laboratory Abnormalities Meeting Predefined Criteria', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal laboratory finding, at any time post baseline, meeting predefined criteria. Abnormal laboratory findings were assessed separately by investigator and recorded as adverse events if applicable. Alanine aminotransferase (ALT); Alkaline phosphatase (ALP); Aspartate aminotransferase (AST); Gamma glutamyl transferase (GGT); upper limit of normal (ULN)'}, {'measure': 'Participants With Clinically Significant Abnormalities Physical Examination', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal findings, at any time post baseline, on physical examination considered clinically significant by the investigator.'}, {'measure': 'Participants With Clinically Significant Abnormalities on Neurologic Examination', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal findings, at any time post baseline, on neurologic examination considered clinically significant by the investigator'}, {'measure': 'Participants With Clinically Significant Abnormalities on Nasal Examination', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with abnormal findings, at any time post baseline, on nasal examination considered clinically significant by the investigator'}, {'measure': 'Participant Change in B-SIT Score', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Change in participant Brief Smell Identification Test (B-SIT) score from baseline to last visit with assessment. The B-SIT is a self-administered 12-item test; the score indicates odors correctly identified (0 to 12). The B-SIT was added while the study was already ongoing (Protocol Amendment 4, 20 May 2015) in response to a regulatory request. The test was only implemented at sites in the United States and included only participants considered by the investigator to have adequate cognitive ability to perform the test. Baseline was defined as the latest non-missing value prior to administration of USL261 in the Test Dose Phase of Study P261-401.'}, {'measure': 'Participants With Suicidal Ideation', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants with suicidal ideation reported on Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at any post-baseline visit. Responses including: Wish to be Dead; Non-Specific Active Suicidal Thoughts; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; and Any Suicidal Ideation Regardless of Type.'}, {'measure': 'Emergency Room/Emergency Medical Service Visits', 'timeFrame': 'From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.', 'description': 'Participants requiring emergency room (ER)/emergency medical service (EMS) visit within 24 hours after any USL261 treated seizure cluster (including for continued seizures)'}], 'secondaryOutcomes': [{'measure': 'Number of Treated Seizure Clusters Meeting Criteria for Treatment Success', 'timeFrame': '6 hours after first dose of USL261 for each treated seizure cluster', 'description': 'Number of Treated Seizure Clusters Meeting Criteria for Treatment Success: Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after administration of first dose of USL261 (intranasal midazolam 5 mg)'}]}, 'conditionsModule': {'keywords': ['Epilepsy', 'seizure clusters', 'acute repetitive seizures', 'rescue treatment'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '36410152', 'type': 'RESULT', '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': '31353457', 'type': 'DERIVED', 'citation': 'Wheless JW, Meng TC, Van Ess PJ, Detyniecki K, Sequeira DJ, Pullman WE. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: An open-label extension trial. Epilepsia. 2019 Sep;60(9):1809-1819. doi: 10.1111/epi.16300. Epub 2019 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.', 'detailedDescription': "Participants who completed study P261-401 (NCT01390220), a randomized double-blind study of USL261 (intranasal midazolam) versus placebo to acutely treat a seizure cluster episode, were eligible to to enroll in this open-label extension study (P261-402). The participant's caregiver administered a USL261 5 milligram (mg) dose for a seizure episode meeting study criteria. A second USL261 5 mg dose could be administered after 10 minutes and up to 6 hours after the first dose for persistent or recurrent seizures, unless the participant met exclusions to administration of the second dose. A participant could have more than 1 seizure cluster episode treated during his/her study participation."}, '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 successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator\n\nExclusion Criteria:\n\n* Has experienced status epilepticus during or since the P261-401 study\n* In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study\n* Has a neurological disorder that is likely to progress in the next year\n* Has a history of acute narrow-angle glaucoma\n* Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy\n* Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen\n* Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study\n* Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history\n* Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401"}, 'identificationModule': {'nctId': 'NCT01529034', 'briefTitle': 'Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters', 'orgStudyIdInfo': {'id': 'P261-402'}, 'secondaryIdInfos': [{'id': '2011-004109-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'USL261', 'description': 'Intranasal midazolam 5 mg', 'interventionNames': ['Drug: USL261']}], 'interventions': [{'name': 'USL261', 'type': 'DRUG', 'armGroupLabels': ['USL261']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'United States, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'United States, Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'United States, Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'United States, Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'United States, California', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'United States, California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'United States, California', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'United States, Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'United States, Connecticut', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'United 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'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'United States, New York', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'United States, North Carolina', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'United States, North Carolina', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'United States, Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'United States, Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'United States, Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'United States, Tennessee', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'United States, Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Greenville', 'state': 'Texas', 'country': 'United States', 'facility': 'United States, Texas', 'geoPoint': {'lat': 33.13845, 'lon': -96.11081}}, {'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Australia, New South Wales', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'Heidelberg West', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Australia, Victoria', 'geoPoint': {'lat': -37.73922, 'lon': 145.04034}}, {'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Australia, Victoria', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Montreal', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canada'}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canada, Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Canada'}, {'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Germany', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'city': 'Marberg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Germany'}, {'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Bielefeld', 'state': 'Westfalen-Lippe', 'country': 'Germany', 'facility': 'Germany', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Petah Tikvah', 'country': 'Israel', 'facility': 'Israel'}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Christchurch', 'state': 'Canterbury', 'country': 'New Zealand', 'facility': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Girona', 'state': 'Cataluyna', 'country': 'Spain', 'facility': 'Spain', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Ukraine', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Ukraine', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Ukraine', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'city': 'Ternopil', 'country': 'Ukraine', 'facility': 'Ukraine', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}, {'city': 'Vinnytsa', 'country': 'Ukraine', 'facility': 'Ukraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma S.P.R.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}