Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 12:12 PM
Study NCT ID:
NCT01016834
Status:
COMPLETED
Last Update Posted:
2011-12-29
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
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': 'D018170', 'term': 'Sumatriptan'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmyers@zogenix.com', 'phone': '510-550-8300', 'title': 'Judith Myers, Senior Director Clinical Operations', 'organization': 'Zogenix'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '60 days', 'description': 'Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.', 'eventGroups': [{'id': 'EG000', 'title': 'Sumavel DosePro', 'description': "The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.", 'otherNumAtRisk': 242, 'otherNumAffected': 136, 'seriousNumAtRisk': 242, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Administrative site conditions', 'notes': 'Inclusive of all single reports of injection site hemorrhage,hematoma, pain, swelling, and erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 99}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizzyness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sumavel DosePro', 'description': "The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'spread': '29.08', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000'], 'groupDescription': "For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After 4 migraines or 60 days', 'description': 'Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject\'s satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)', 'unitOfMeasure': 'Scale of 0-100; 100= very satisfied', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.'}, {'type': 'SECONDARY', 'title': 'Treatment Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sumavel DosePro', 'description': "The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '29.6', 'upperLimit': '40.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 migraines or 60 days', 'description': 'Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Confidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sumavel DosePro', 'description': "The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 4 migraines or 60 days', 'description': 'Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sumavel DosePro', 'description': "The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sumavel DosePro', 'description': "The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject's self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '242', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '242', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2009-11-18', 'resultsFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-28', 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Satisfaction', 'timeFrame': 'After 4 migraines or 60 days', 'description': 'Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject\'s satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)'}], 'secondaryOutcomes': [{'measure': 'Treatment Preference', 'timeFrame': 'After 4 migraines or 60 days', 'description': 'Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).'}, {'measure': 'Treatment Confidence', 'timeFrame': 'After 4 migraines or 60 days', 'description': 'Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['migraine', 'treatment satisfaction'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '21942531', 'type': 'DERIVED', 'citation': 'Rothrock JF, Cady RK, Aurora SK, Brandes JL, Myers JA, Fox AW, Farr SJ. Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence. Curr Med Res Opin. 2011 Nov;27(11):2185-91. doi: 10.1185/03007995.2011.619177. Epub 2011 Sep 26.'}, {'pmid': '21812775', 'type': 'DERIVED', 'citation': 'Cady RK, Aurora SK, Brandes JL, Rothrock JF, Myers JA, Fox AW, Farr SJ. Satisfaction with and confidence in needle-free subcutaneous sumatriptan in patients currently treated with triptans. Headache. 2011 Sep;51(8):1202-11. doi: 10.1111/j.1526-4610.2011.01972.x. Epub 2011 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.', 'detailedDescription': 'Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of 2 to 6 migraine headaches per month\n* Migraines should have been present for at least 1 year with age at onset of migraine less than 50 years\n* History of 24 hours of freedom between migraine attacks\n* Current users of triptan medications\n* Able to distinguish interval or other non-migrainous headaches from typical migraine\n* General good health\n\nExclusion Criteria:\n\n* History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes\n* Significant underlying cardiovascular diseases including uncontrolled hypertension\n* Hemiplegic or basilar migraine\n* History or diagnosis of severe hepatic or renal impairment\n* History of epilepsy or seizure or other serious neurologic condition\n* History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs including sulphonamides\n* History of scleroderma (systemic sclerosis)\n* Pregnant or breastfeeding\n* Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A), selective serotonin reuptake inhibitors, or lithium agents'}, 'identificationModule': {'nctId': 'NCT01016834', 'briefTitle': 'Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zogenix, Inc.'}, 'officialTitle': 'A Multicenter, Open-label Evaluation of Treatment Satisfaction, Tolerability, Safety and Preference for Sumavel DosePro for Treatment of Migraine in Subjects Currently Treated With Triptans', 'orgStudyIdInfo': {'id': 'ZX001-0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sumavel(R) DosePro(R)', 'description': 'Single arm study (Sumavel DosePro)', 'interventionNames': ['Device: Sumavel DosePro', 'Drug: Sumatriptan']}], 'interventions': [{'name': 'Sumavel DosePro', 'type': 'DEVICE', 'description': 'Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration', 'armGroupLabels': ['Sumavel(R) DosePro(R)']}, {'name': 'Sumatriptan', 'type': 'DRUG', 'otherNames': ['Sumavel DosePro (Sumatriptan injection)'], 'description': 'subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period', 'armGroupLabels': ['Sumavel(R) DosePro(R)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Hospital, Dept. of Neurology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': "C. Phillip O'Carroll, MD, Inc", 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Clinic for Headache', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Alpine Clinical Research', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research Inc.', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33716', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Neuroscience Inc', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Comprehensive Neurosciences Inc', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Neurology Specialists of Decatur', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Diamond Headache Clinic', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head, Pain, & Neurological Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest/A Division of Banyan Group, Inc', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Health Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'facility': 'Regional Clinical Research Inc', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Headache Wellness Center', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '33195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic: Neurological Center for Pain', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Headache Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37043', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Neurological Medicine', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville Neuroscience Group', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Pain and Headache Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Roger K Cady, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinvest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zogenix, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Synteract, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}