Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03557333
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004087', 'term': 'Dihydroergotamine'}], 'ancestors': [{'id': 'D004879', 'term': 'Ergotamines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kcraig@impelnp.com', 'phone': '206-568-1466', 'title': 'Karen Craig, PhD (Medical Writer)', 'organization': 'Impel NeuroPharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Week 0 to Week 24 (for the 24-Week Treatment Group) and Week 0 to Week 52 (for the 52-Week Treatment Group)', 'eventGroups': [{'id': 'EG000', 'title': '24-Week Treatment Group', 'description': 'Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24 weeks.', 'otherNumAtRisk': 354, 'deathsNumAtRisk': 354, 'otherNumAffected': 241, 'seriousNumAtRisk': 354, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '52-Week Treatment Group', 'description': 'Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 52 weeks. Participants in this treatment group are subset of those included in the 24-Week Treatment Group.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 61, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Product package associated injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Olfactory test abnormal', 'notes': 'Olfactory test abnormal events were asymptomatic decreases of 5 or more points from baseline on UPSIT score.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Product taste abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasal mucosal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Menopause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Status migrainosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ovarian mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-Week Treatment Group', 'description': 'Participants dosed with INP104 as needed for up to 24 weeks of treatment.'}, {'id': 'OG001', 'title': '52-Week Treatment Group', 'description': 'This group is a subset of participants who completed 24 weeks of treatment and continued on study for up to 52 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study enrollment up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group)', 'description': 'Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-Week Treatment Group', 'description': 'Participants dosed with INP104 as needed for up to 24 weeks of treatment.'}, {'id': 'OG001', 'title': '52-Week Treatment Group', 'description': 'This group is a subset of participants who completed 24 weeks of treatment and continued on study for up to 52 weeks of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first use of INP104 up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group)', 'description': 'Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Nasal Mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-Week Treatment Group', 'description': 'Participants dosed with INP104 as needed for up to 24 weeks of treatment.'}, {'id': 'OG001', 'title': '52-Week Treatment Group', 'description': 'This group is a subset of participants who completed 24 weeks of treatment and continued on study for up to 52 weeks of treatment.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)', 'description': 'Mean change from baseline in Quantitative Scoring Scale for Evaluation of the Nasal Mucosa (QSS-NM) score, reported at designated intervals on study. This scale was scored by otolaryngologists during routine endoscopy of the upper nasal cavity of participants. A minimum score of 0 means no issues were detected. A maximum score of 34 indicates severe issues (worse outcome).', 'unitOfMeasure': 'mean change in score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants with assessments at baseline and at the indicated time point have data analyzed in that row.'}, {'type': 'PRIMARY', 'title': 'Change in Olfactory Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24-Week Treatment Group', 'description': 'Participants dosed with INP104 as needed for up to 24 weeks of treatment.'}, {'id': 'OG001', 'title': '52-Week Treatment Group', 'description': 'This group is a subset of participants who completed 24 weeks of treatment and continued on study for up to 52 weeks of treatment.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '2.690', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '2.573', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '2.270', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '2.373', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '2.930', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '2.710', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)', 'description': 'Mean change from baseline in olfactory function score, assessed using the University of Pennsylvania Smell Identification Test (UPSIT), and reported at designated intervals on study. The UPSIT is a 40 question scratch and sniff test of olfactory function. The minimum score of 0 indicates worst olfactory function, and the maximum score of 40 indicates the highest level of olfactory function detectable by the test.', 'unitOfMeasure': 'mean change in score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those subjects with data at baseline and the indicated time point are included in the analysis for that row.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '24-Week Treatment Group', 'description': 'Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24-weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}]}]}], 'preAssignmentDetails': '360 participants were enrolled and were dispensed INP104. Only those participants who dosed at least once with INP104 were included in the 24-Week Treatment Group, which was 354.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '24-Week Treatment Group', 'description': 'Participants in this group dosed at least once with INP104, and treated their migraine headaches as needed up to 2 times in 24 hours or up to 3 times per week with INP104, for up to 24-weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '353', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '304', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '324', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '266', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '354', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean number of migraines in 28-day baseline period', 'classes': [{'categories': [{'measurements': [{'value': '4.60', 'spread': '2.313', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of migraines', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean duration of migraine history', 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '12.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-26', 'size': 1324735, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-26T14:21', 'hasProtocol': True}, {'date': '2020-04-01', 'size': 1575274, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-26T14:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2018-06-04', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-26', 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From study enrollment up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group)', 'description': 'Number of participants with Serious Adverse Events (SAEs) whether or not related to study drug.'}, {'measure': 'Number of Participants With Non-serious Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'From first use of INP104 up to Week 26 (for the 24-Week Treatment Group) and up to Week 54 (for the 52-WeekTreatment Group)', 'description': 'Number of participants with non-serious treatment emergent adverse events (AEs), whether or not related to study drug.'}, {'measure': 'Change in Nasal Mucosa', 'timeFrame': 'Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)', 'description': 'Mean change from baseline in Quantitative Scoring Scale for Evaluation of the Nasal Mucosa (QSS-NM) score, reported at designated intervals on study. This scale was scored by otolaryngologists during routine endoscopy of the upper nasal cavity of participants. A minimum score of 0 means no issues were detected. A maximum score of 34 indicates severe issues (worse outcome).'}, {'measure': 'Change in Olfactory Function', 'timeFrame': 'Baseline up to Week 24 (for the 24-Week Treatment Group) and Baseline up to Week 52 (for the 52-WeekTreatment Group)', 'description': 'Mean change from baseline in olfactory function score, assessed using the University of Pennsylvania Smell Identification Test (UPSIT), and reported at designated intervals on study. The UPSIT is a 40 question scratch and sniff test of olfactory function. The minimum score of 0 indicates worst olfactory function, and the maximum score of 40 indicates the highest level of olfactory function detectable by the test.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Migraine Headache']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/Recalls/', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and a 2-week post-treatment follow-up period.', 'detailedDescription': 'This is an outpatient study in people who currently suffer a minimum of 2 migraines per month. During the study, participants will be instructed to use no more than 2 doses of the study drug INP104 within a 24-hour period, or 3 doses in a 7-day period. Participants will self-administer INP104 nasally and record their migraines in an eDiary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of migraine with or without aura, with at least 2 attacks per month for the previous 6 months.\n* Participants must be in good general health, with no significant medical history (excluding migraine).\n* Participants must have the ability and willingness to attend the necessary visits at the study center.\n* Participants must be able to provide the written informed consent prior to entry into the study.\n* Women of childbearing potential must agree to use adequate contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose fo the study drug.\n* Male participants and their partners must agree to use effective contraception (as defined in the protocol and by study personnel) during the study and for 30 days after the last dose of the study drug. Male participants should also refrain from sperm donation for 30 days after study completion.\n\nExclusion Criteria:\n\n* Subjects with trigeminal autonomic cephalalgias (including cluster headache, hemicrania syndromes and short-lasting unilateral, neuralgiform headache attacks with conjunctival injection and tearing), hemiplegic migraine, or migraine with brainstem aura (previously referred to as basilar migraines).\n* Subjects with chronic migraines, medication overuse headache or other chronic headache syndromes.\n* Subjects with ischemic heart disease or subjects with clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina.\n* Subjects with significant risk factors for coronary artery disease (CAD) including current use of nicotine-containing products, medical history of diabetes, uncontrolled hypertension (high blood pressure), known peripheral arterial disease, Raynaud's phenomenon, sepsis or vascular surgery (within 3 months prior to study start), or severely impaired hepatic or renal (kidney) function.\n* Subjects with recurrent sinusitis or epistaxis.\n* Subjects with a history or presence of alcoholism or drug abuse within 2 years prior to first study drug administration.\n* Women who are pregnant, or planning to get pregnant, or who are lactating while participating in the study.\n* Use of any medications prohibited by protocol.\n* Use of \\>12 days per month of triptan or ergot-based medication in the 2 months prior to screening.\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03557333', 'briefTitle': 'Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Impel Pharmaceuticals'}, 'officialTitle': 'Open-label Study of Safety and Tolerability of Chronic Intermittent Usage for 24 or 52 Weeks of Intranasal Dihydroergotamine Mesylate (DHE) Administered Using the I123 Precision Olfactory Delivery (POD®) Device [INP104, POD-DHE] in Patients With Migraine Headache', 'orgStudyIdInfo': {'id': 'INP104-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INP104', 'description': '24-week treatment period for all participants followed by a 28-week treatment extension period for a subset of participants', 'interventionNames': ['Combination Product: INP104']}], 'interventions': [{'name': 'INP104', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Dihydroergotamine Mesylate (DHE) administered using the I123 Precision Olfactory Delivery (POD) Device', 'INP104, POD-DHE'], 'description': 'No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril.', 'armGroupLabels': ['INP104']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus - Radiant Research, Inc. - Phoenix SE, 2081 West Frye Road', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Synexus - Clinical Research Advantage, Inc., Central Phoenix Medical Clinic, LLC., 7600 North 15th Street, Suite 191', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC., 2600 Redondo Avenue, Suite 415', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research, 3998 Vista Way', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Synexus - Clinical Research Advantage, Inc. - Colorado Springs Family Practice, 2960 North Circle Drive, Suite 200', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc., 5200 Belfort Road, Suite 420', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc., 618 East South Street, Suite 100', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33634', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research - Tampa, 5411 Beaumont Center Boulevard, Suite 760', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT Associates of South Florida, 4631 North Congress Avenue, Suite 200', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of Central Florida, 500 East Central Avenue', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Synexus - 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