Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT03338920
Status:
TERMINATED
Last Update Posted:
2023-07-24
First Post:
2017-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Sponsor:
Organization:
Raw JSON
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'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkyle@curraxpharma.com', 'phone': '708.834.8254', 'title': 'Dr. Michael Kyle', 'organization': 'Currax Pharmaceuticals LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to approximately 28 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Sumatriptan Nasal Powder', 'description': 'Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).\n\nsumatriptan nasal powder: nasal powder administered via nosepiece', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 3, 'seriousNumAtRisk': 79, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.\n\nPlacebo: lactose 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Burning Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sumatriptan Nasal Powder', 'description': 'Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).\n\nsumatriptan nasal powder: nasal powder administered via nosepiece'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.\n\nPlacebo: lactose monohydrate powder administered via nosepiece'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 minutes', 'description': 'Participants will self-report the severity of their headache.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sumatriptan Nasal Powder', 'description': 'Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).\n\nsumatriptan nasal powder: nasal powder administered via nosepiece'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.\n\nPlacebo: lactose monohydrate powder administered via nosepiece'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sumatriptan Nasal Powder', 'description': 'Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).\n\nsumatriptan nasal powder: nasal powder administered via nosepiece'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.\n\nPlacebo: lactose monohydrate powder administered via nosepiece'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '17'}, {'value': '14.4', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '17'}, {'value': '14.4', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-19', 'size': 1295107, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-13T14:13', 'hasProtocol': True}]}}, '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': 159}}, 'statusModule': {'whyStopped': 'eDiary data collected not sufficient to utilize in the analysis of protocol endpoints', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2017-11-07', 'resultsFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-03', 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment', 'timeFrame': '120 minutes', 'description': 'Participants will self-report the severity of their headache.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute migraine', 'aura', 'sumatriptan nasal powder', 'AVP-825', 'adolescents'], 'conditions': ['Acute Migraine With or Without Aura']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age.', 'detailedDescription': 'This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12 to 17 years old).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female participants 12 to 17 years (inclusive) of age at the time of informed consent\n* Have a diagnosis of episodic migraine with or without aura according to International Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or 1.1) criteria, for at least 1 year prior to the screening/enrollment visit\n* Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3 hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the past 6 months prior to the screening/enrollment visit\n* Participant's parent or legal guardian must be willing to sign a copy of the informed consent form as well as documentation for Written Authorization for Use and Release of Health and Research Study Information, after the nature and risks of study participation have been fully explained. Participants must be willing to provide informed assent.\n\nExclusion Criteria:\n\n* Participants with ≥ 15 headache days per month in total (migraine, probable migraine, or tension-type)\n* Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches\n* Participants who have not responded to an adequate dose and appropriate duration of treatment with 2 or more triptans\n* Participants with known nasal obstruction, current uncontrolled nasopharyngeal illness, or known velum insufficiency (i.e., a cleft palate and/or structural abnormalities in the soft palate and nasopharynx) that may interfere with the proper use of study medication\n* Participants whose conditions in the investigator's opinion may put the participant at significant safety risk or confound the study results. This includes participants who in the investigator's opinion should not be enrolled in the study due to the risks described in the Warnings and Precautions or Contraindications sections of the ONZETRA Xsail Prescribing Information."}, 'identificationModule': {'nctId': 'NCT03338920', 'briefTitle': 'Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Currax Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of ONZETRA® Xsail® (Sumatriptan Nasal Powder) for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents', 'orgStudyIdInfo': {'id': '17-AVP-825-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sumatriptan nasal powder', 'description': 'Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).', 'interventionNames': ['Drug: sumatriptan nasal powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'sumatriptan nasal powder', 'type': 'DRUG', 'otherNames': ['AVP-825', 'ONZETRA® Xsail®'], 'description': 'nasal powder administered via nosepiece', 'armGroupLabels': ['Sumatriptan nasal powder']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'lactose monohydrate powder administered via nosepiece', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92805', 'city': 'Anaheim', 'state': 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'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Headache Wellness Center', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45215', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hometown Urgent Care and Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45424', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hometown Urgent Care and Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73034', 'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OK Clinical Research, LLC', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'zip': '73072', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15236', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians, Inc.', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Road Runner Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Olympus Family Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84405', 'city': 'South Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'South Ogden Family Medicine/CCT Research', 'geoPoint': {'lat': 41.19189, 'lon': -111.97133}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Michael Kyle, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Currax Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Currax Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}