Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT06680206
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-02', 'releaseDate': '2025-11-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-19'}}, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biosamples will be collected in this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1363}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-27', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment satisfaction', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents to rate their satisfaction with treatment on a 7-point Likert scale (from 1=extremely dissatisfied to 7=extremely satisfied).\n\nRespondents will be stratified into 3 groups based on their answer:\n\n1. Dissatisfied (1=extremely dissatisfied to 2=very dissatisfied)\n2. Neutral (3=somewhat dissatisfied, 4=neither dissatisfied nor satisfied, 5=somewhat satisfied)\n3. Satisfied (6=very satisfied to 7=extremely satisfied)'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents to complete the validated questionnaire that report on general health-related QoL:\n\nEuroQoL5 dimension (EQ-5D) - Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.'}, {'measure': 'Qulaity of Life (QoL)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents to complete the validated questionnaire that report on general health-related QoL:\n\nShort form 36 (SF-36) - The higher the score, the less disability i.e., a score of zero (minimum) is equivalent to maximum disability and a score of 100 (maximum) is equivalent to no disability.'}, {'measure': 'Work productivity loss', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents about:\n\n1\\. Employment status 2. Absenteeism 3. Presenteeism 4. Work productivity loss 5. Activity impairment.\n\nWork productivity loss: WPAI (Work productivity and activity impairment) scores are based on 1-item (presenteeism, activity impairment), 2-items (absenteeism) and multiple items (overall work productivity). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.'}, {'measure': 'Migraine-specific disability', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents to complete the Migraine Disability Assessment Scale (MIDAS), a validated instrument that assesses disability related to migraine for:\n\n1. School work or work for pay\n2. Household work or chores\n3. Family, social, and leisure activities\n\nRespondents are stratified by MIDAS scores (from Grade 1 indicating little or no disability to grade 4 indicating severe disability)'}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': '12 moths', 'description': 'Measured in NHWS by asking respondents about:\n\nNumber of ER visits (within the last six months; any cause)'}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents about:\n\nNumber of hospitalizations (within the last six months; any cause)'}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents about:\n\nNumber of family practitioner visits (within the last six months; any cause)'}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents about:\n\nNumber of cardiologist visits (within the last six months; any cause)'}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents about:\n\nNumber of neurologist visits (within the last six months; any cause)'}, {'measure': 'Healthcare Resource Utilization (HCRU)', 'timeFrame': '12 months', 'description': 'Measured in NHWS by asking respondents about:\n\nNumber of traditional healthcare provider visits (within the last six months; any cause)'}]}, 'conditionsModule': {'keywords': ['Rimegepant', 'Triptans', 'Acute treatment of migraine', 'Survey', 'Cross-sectional design', 'National Health and Wellness Survey (NHWS)', 'Patient-reported outcomes', 'Treatment satisfaction'], 'conditions': ['Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4951076', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional study using the cross-sectional 2023 National Health and Wellness Survey (NHWS) data from the US, with a large and nationally representative population (N=75,007).\n\nAll data from the NHWS are reported by respondents, who are recruited through an existing, general-purpose, web-based, consumer panel via opt-in e-mails, co-registration with panel partners, e-newsletter campaigns, banner placements, and affiliate networks. All respondents explicitly agree to be a panel member, register with the panel through a unique e-mail address, and complete an in-depth demographic registration profile.\n\nThis analysis will focus on respondents who self-report having migraine diagnosed by a physician. Individuals who use rimegepant for acute treatment of migraine will be compared with those who use triptans for acute treatment of migraine. Outcomes of interest include treatment satisfaction, healthcare resource utilization (HCRU), quality of life (QoL), work productivity loss, and migraine-specific disability outcomes.\n\nInverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.', 'detailedDescription': 'This is a cross-sectional study using the cross-sectional 2023 National Health and Wellness Survey (NHWS) data from the US, with a large and nationally representative population (N=75,007).\n\nAll data from the NHWS are reported by respondents, who are recruited through an existing, general-purpose, web-based, consumer panel via opt-in e-mails, co-registration with panel partners, e-newsletter campaigns, banner placements, and affiliate networks. All respondents explicitly agree to be a panel member, register with the panel through a unique e-mail address, and complete an in-depth demographic registration profile.\n\nThis analysis will focus on respondents who self-report having migraine diagnosed by a physician. Individuals who use rimegepant for acute treatment of migraine will be compared with those who use triptans for acute treatment of migraine. Outcomes of interest include treatment satisfaction, healthcare resource utilization (HCRU), quality of life (QoL), work productivity loss, and migraine-specific disability outcomes.\n\nInverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.\n\nAdditional information is provided in the study protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will analyze data from 2023 National Health and Wellness Survey (NHWS) in the US. The NHWS is a cross-sectional study intended to be representative of the US population in terms of age, sex, race, and ethnicity.\n\nThis study will focus on NHWS respondents who report a physician diagnosis of migraine.\n\nThis analysis will compare those who report taking rimegepant for acute treatment of migraine and those who report taking triptans for acute treatment of migraine at the time of the survey.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in 2023 NHWS in the US\n* Consented to the anonymous use of their data for research purpose\n* Aged 18 or older\n* Self-reported a diagnosis of migraine by physician\n* Currently on rimegepant or triptan (via oral route) at the time of the survey\n\nExclusion Criteria:\n\n\\- Currently on both rimegepant and triptans at the time of the survey'}, 'identificationModule': {'nctId': 'NCT06680206', 'briefTitle': 'Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Comparing Patient-Reported Outcomes Between Rimegepant and Triptan Users With Migraine in the United States', 'orgStudyIdInfo': {'id': 'C4951076'}}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-19', 'type': 'RELEASE'}, {'date': '2025-12-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Pfizer'}}}}