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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06680206 | Registry Identifier | ClinicalTrials.gov |
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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).
All 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.
This 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.
Inverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.
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).
All 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.
This 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.
Inverse probability of treatment weighting (IPTW) will be used to adjust for differences that may exist between rimegepant and triptan users prior to comparing outcomes.
Additional information is provided in the study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute treatment of migraine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant for acute treatment of migraine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to Migraine Medication Type (Prescription Drug or Over the Counter [OTC]) | Number of participants according to migraine medication type: 1) as prescription drug only, 2) as OTC only or 3) as both prescription drug and OTC based on the use of migraine medication classes is reported in this outcome measure. Analysis was performed using inverse probability treatment weighting (IPTW) method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to Migraine Treatment Type (Acute or Prevention) | Number of participants according to migraine treatment type: 1) acute use only, 2) prevention use only, or 3) both acute and prevention use based on the use of migraine medication classes is reported in this outcome measure. Acute treatments included: triptans, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, barbiturates, ergots, gepants [acute; including Nurtec], ditan, combination analgesics, and other acute treatment; preventive treatment included: anticonvulsants, beta blocker, antidepressant, calcitonin gene-related peptide antibodies monoclonal antibodies (CGRP mAb), botox, and gepant [prevention treatment including Nurtec]). Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Total Number of Acute Migraine Agent Drug Classes Used | Total number of distinct acute migraine agent drug classes used by participants is reported as mean in this outcome measure. Acute migraine agents included: triptans, NSAIDs, opioids, barbiturates, ergots, gepants [acute; including Nurtec], ditan, combination analgesics, and other acute treatment. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Measure | Description | Time Frame |
|---|---|---|
| Research and Development (RAND-36) Physical Component Score, Mental Component Score and Global Health Score - Sensitivity Analysis. | RAND-36=standardized survey evaluating 8 domains of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 domains were scaled from 0=worst condition to 100=best condition, higher scores indicated better health status. These 8 domains were summarized as summary scores: physical component scores (derived from physical functioning, role physical, bodily pain, general health), mental component scores (derived from social functioning, role emotional mental health and vitality) and global health composite score (derived from physical and mental component scores). Each of the summary scores were standardized to a T-score with mean=50 and SD=10. Scores ranged from 0 to 100, where 0 (worst condition) to 100 (best condition), where higher scores represent better health status. Analysis was performed using IPTW method to adjust for confounding by the covariates. |
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Inclusion Criteria:
Exclusion Criteria:
- Currently on both rimegepant and triptans at the time of the survey
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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.
This study will focus on NHWS respondents who report a physician diagnosis of migraine.
This 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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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In this retrospective observational study, data of participants who used rimegepant or triptans for migraine (diagnosed by physician) in Year 2023, was retrieved from United States National Health and Wellness Survey (NHWS). Retrieved retrospective data was evaluated in approximately 1.41 months (from study start date: 10-Oct-2024 to study completion date: 20-Nov-2024) per objectives of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimegepant | Participants with self-reported diagnosis of migraine currently on rimegepant use at the time of survey (NHWS in year 2023) were included. No intervention was administered as part of this study. |
| FG001 | Triptans | Participants with self-reported diagnosis of migraine currently on triptan use at the time of survey (NHWS in year 2023) were included. No intervention was administered as part of this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were retrieved and observed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant | Participants with self-reported diagnosis of migraine currently on rimegepant use at the time of survey (NHWS in year 2023) were included. No intervention was administered as part of this study. |
| BG001 | Triptans |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants According to Migraine Medication Type (Prescription Drug or Over the Counter [OTC]) | Number of participants according to migraine medication type: 1) as prescription drug only, 2) as OTC only or 3) as both prescription drug and OTC based on the use of migraine medication classes is reported in this outcome measure. Analysis was performed using inverse probability treatment weighting (IPTW) method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
|
Not applicable as adverse events and all-cause mortality were not planned to be evaluated/ monitored for the study.
Due to non-interventional nature of the study and nature of data sources, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met, hence adverse events and all-cause mortality were not planned to be assessed or monitored (thus at risk appears "0").
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimegepant | Participants with self-reported diagnosis of migraine currently on rimegepant use at the time of survey completion (NHWS in year 2023) were included. No intervention was administerred as part of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2024 | Nov 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
| D014363 | Tryptamines |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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No biosamples will be collected in this study.
| Triptans |
| Drug |
Triptans for acute treatment of migraine |
|
| Number of Participants According to Number of Acute Migraine Agent Drug Classes Used | Number of participants categorized by the number of distinct acute migraine agent drug classes used is reported in this outcome measure. Categories included 1 drug class, 2 or more drug classes, and 3 or more drug classes. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Total Number of Prevention Migraine Agent Drug Classes Used | Preventive migraine agents included: anticonvulsants, beta blocker, antidepressant, CGRP mAb, botox, and gepant [prevention treatment including Nurtec]. Total number of distinct preventive migraine agent drug classes used by participants is reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to Number of Prevention Migraine Agent Drug Classes Used | Number of participants categorized by the number of distinct prescription preventive migraine agent drug classes used reported in this outcome measure. Categories included use of 1 drug class, 2 or more drug classes, and 3 or more drug classes. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to Current Migraine Treatments | Number of participants according to current migraine treatments on drug classes including: Nurtec (rimegepant) only, acute agents, triptans, NSAIDs, opioids, barbiturates, ergots, gepants [acute; including Nurtec], ditan, combination analgesics, and other acute treatment (aspirin lysine/metoclopramide hydrochloride monohydrate or indometacin/caffeine/prochlorperazine), prevention agents (anticonvulsants, beta-blocker, antidepressant, CGRP mAb, botox, and gepant) are reported in this outcome measure. One participant could receive more than one migraine treatment. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to Treatment Satisfaction of Migraine Drug Class | Number of participants according to treatment satisfaction for the migraine drug classes including: acute agents, NSAIDs, opioids, barbiturates, ergots, gepants (acute), ditans, combination analgesics, other, prevention agents, anticonvulsants, beta blockers, antidepressants, CGRPs mAb, botox, and gepant reported in this outcome measure. Treatment satisfaction for each of the migraine drug class was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to Current Migraine Treatments on OTC Class | Participants were categorized based on current use of OTC migraine treatments, including analgesics (acetaminophen only), analgesics (combination), NSAIDs, and other OTCs. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to Treatment Satisfaction of Analgesics (Acetaminophen Only) | Number of participants according to treatment satisfaction for analgesics (acetaminophen only) is reported in this outcome measure. Treatment satisfaction was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Number of Participants According to Treatment Satisfaction to Rimegepant or Triptans | Number of participants according to treatment satisfaction for rimegepant or triptans is reported in this outcome measure. Treatment satisfaction was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Research and Development (RAND-36) Physical Component Score, Mental Component Score and Global Health Score - Primary Analysis | RAND-36=standardized survey evaluating 8 domains of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 domains were scaled from 0=worst condition to 100=best condition, higher scores indicated better health status. These 8 domains were summarized as summary scores: physical component scores (derived from physical functioning, role physical, bodily pain, general health), mental component scores (derived from social functioning, role emotional mental health and vitality) and global health composite score (derived from physical and mental component scores). Each of the summary scores were standardized to a T-score with mean=50 and SD=10. Scores ranged from 0 to 100, where 0 (worst condition) to 100 (best condition), where higher scores represent better health status. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Index Score - Primary Analysis | EQ-5D-5L is participant completed questionnaire that consisted of two components: a five-item health state profile and visual analog scale (VAS). EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised health state/a single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had unique predefined utility index value assigned to it per US value sets, by EuroQol. Index scores ranged from -0.59 to 1; where 1 =best possible health state. Negative values= health states perceived as worse than dead, (death=0). Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| EQ-5D-5L Visual Analog Scale (VAS) Score - Primary Analysis | The EQ-5D-5L is a participant completed questionnaire that consisted of two components: a five-item health state profile and a VAS. EQ-5D VAS was used to record participant's rating for his/her current health state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Percentage of Work Time Missed in Past 7 Days Based on Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire- Primary Analysis | The WPAI is a standardized Patient reported outcome (PRO) that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of work time missed ranged from 0 (no impairment/high productivity) to-100% (total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Percentage Impairment Experienced While at Work in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage impairment experienced ranged from 0 (no impairment/high productivity/high impairment) to 100% (total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Percentage Overall Work Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage overall work impairment experienced ranged from 0 (no impairment/high productivity/high impairment) to 100% (total loss of work productivity/high impairment) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Percentage Total Activity Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of total activity impairment ranged from 0 (no impairment/high productivity) to 100% (total loss of work productivity/high impairment) with higher score indicating greater impairment and less productivity. In this outcome measure, percentage total activity impairment among total population, employed, unemployed and disabled is reported. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Migraine Disability Assessment Scale (MIDAS) Total Score and Individual Item Scores- Primary Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provided the number of missed work or school days (MIDAS Item 1); missed household chores days (MIDAS Item 2); missed social or leisure activity days (MIDAS Item 3); and days with productivity loss at work or school (MIDAS Item 4), days with productivity loss in household work (MIDAS Item 5), frequency of headaches (MIDAS Item 6) and the intensity of the headache pain (MIDAS Item 7). The score ranged from 0 (no disability) to 90 (maximum disability) for each of individual item scores. The 5 item scores (Item 1 to Item 5) were summed to compute the MIDAS total score ranging from 0 (no disability) to 450 (maximum disability). Lower scores indicate less headache-related disability. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants According to MIDAS Grade- Primary Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as days with lost time or productivity due to headache from paid work or school, household work, and non-work activities. Participants were categorized according to MIDAS scores as Grade I = Little or No Disability (Score: 0-5), Grade II= Mild Disability (Score: 6-10), Grade III = Moderate Disability (Score: 11-20), Grade IV =severe disability (Score: >=21). Analysis was performed using IPTW method to adjust for confounding by the covariates. | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Emergency Room (ER) Visits in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of ER Visits in Past 6 Months- Primary Analysis | Number of ER visits within the last six months due to any cause among those who had at least 1 ER visit reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Hospitalizations in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Hospitalizations in Past 6 Months - Primary Analysis | Mean number of hospitalizations within the last six months due to any cause among those who had at least 1 hospitalization is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Family Practitioner Visits in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Family Practitioner Visits in Past 6 Months- Primary Analysis | Mean number of family practitioner visits within the last six months due to any cause among those who had at least 1 family practitioner visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Cardiologist Visits in Past 6 Month- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Cardiologist Visits in Past 6 Months- Primary Analysis | Mean number of cardiologist visits within the last six months due to any cause among those who had at least 1 cardiologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Neurologist Visits in Past 6 Months - Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 month of this observational study. |
| Mean Number of Neurologist Visits in Past 6 Months- Primary Analysis | Mean number of neurologist visits within the last six months due to any cause among those who had at least 1 neurologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Traditional Healthcare Provider Visits in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Traditional Healthcare Provider Visits in Past 6 Months- Primary Analysis | Mean number of traditional healthcare provider visits within the last six months due to due to any cause among those who had at least 1 healthcare provider visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariate. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Index Score- Sensitivity Analysis | EQ-5D-5L is participant completed questionnaire that consisted of two components: a five-item health state profile and visual analog scale (VAS). EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised health state/a single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had unique predefined utility index value assigned to it per US value sets, by EuroQol. Index scores ranged from -0.59 to 1; where 1 =best possible health state. Negative values= health states perceived as worse than dead, (death=0). Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| EQ-5D-5L Visual Analog Scale (VAS) Score- Sensitivity Analysis | The EQ-5D-5L is a participant completed questionnaire that consisted of two components: a five-item health state profile and a VAS. EQ-5D VAS was used to record participant's rating for his/her current health state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Analysis was performed using IPTW method to adjust for confounding by the covariates. | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Percentage of Work Time Missed in Past 7 Days Based on Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire- Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of work time missed ranged from 0 (no impairment/high productivity) to 100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Percentage Impairment Experienced While at Work in Past 7 Days Based on WPAI-GH Questionnaire-Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage impairment experienced ranged from 0 (no impairment/high productivity) to 100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Percentage Overall Work Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage overall work impairment experienced ranged from 0 (no impairment/high productivity) to 100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Percentage Total Activity Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of total activity impairment ranged from 0 (no impairment/high productivity) to100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. In this outcome measure, percentage total activity impairment among total population, employed, unemployed and disabled is reported. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Migraine Disability Assessment Scale (MIDAS) Total Score and Individual Item Scores- Sensitivity Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provided the number of missed work or school days (MIDAS Item 1); missed household chores days (MIDAS Item 2); missed social or leisure activity days (MIDAS Item 3); and days with productivity loss at work or school (MIDAS Item 4), days with productivity loss in household work (MIDAS Item 5), frequency of headaches (MIDAS Item 6) and the intensity of the headache pain (MIDAS Item 7). The score ranged from 0 (no disability) to 90 (maximum disability) for each of individual item scores. The 5 item scores (Item 1 to Item 5) were summed to compute the MIDAS total score ranging from 0 (no disability) to 450 (maximum disability). Lower scores indicate less headache-related disability. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Number of Participants According to MIDAS Grade - Sensitivity Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as days with lost time or productivity due to headache from paid work or school, household work, and non-work activities. Participants were categorized according to MIDAS scores as Grade I = Little or No Disability (Score: 0-5), Grade II= Mild Disability (Score: 6-10), Grade III = Moderate Disability (Score: 11-20), Grade IV =severe disability (Score: >=21). Analysis was performed using IPTW method to adjust for confounding by the covariates. | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Emergency Room (ER) Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of ER Visits in Past 6 Months- Sensitivity Analysis | Number of ER visits within the last six months due to any cause among those who had at least 1 ER visit reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Number of Participants With Hospitalizations in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Hospitalizations in Past 6 Months- Sensitivity Analysis | Mean number of hospitalizations within the last six months due to any cause among those who had at least 1 hospitalization is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Family Practitioner Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Family Practitioner Visits in Past 6 Months- Sensitivity Analysis | Mean number of family practitioner visits within the last six months due to any cause among those who had at least 1 family practitioner visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Number of Participants With Cardiologist Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Mean Number of Cardiologist Visits in Past 6 Months- Sensitivity Analysis | Mean number of cardiologist visits within the last six months due to any cause among those who had at least 1 cardiologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Number of Participants With Neurologist Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 month of this observational study. |
| Mean Number of Neurologist Visits in Past 6 Months- Sensitivity Analysis | Mean number of neurologist visits within the last six months due to any cause among those who had at least 1 neurologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
| Number of Participants With Traditional Healthcare Provider Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
| Mean Number of Traditional Healthcare Provider Visits in Past 6 Months- Sensitivity Analysis | Mean number of traditional healthcare provider visits within the last six months due to due to any cause among those who had at least 1 healthcare provider visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariate. | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
Participants with self-reported diagnosis of migraine currently on triptan use at the time of survey (NHWS in year 2023) were included. No intervention was administered as part of this study.
| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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Participants with self-reported diagnosis of migraine currently on rimegepant use at the time of survey (NHWS in year 2023) were included. No intervention was administered as part of this study. |
| OG001 | Triptans | Participants with self-reported diagnosis of migraine currently on triptan use at the time of survey (NHWS in year 2023) were included. No intervention was administered as part of this study. |
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| Primary | Number of Participants According to Migraine Treatment Type (Acute or Prevention) | Number of participants according to migraine treatment type: 1) acute use only, 2) prevention use only, or 3) both acute and prevention use based on the use of migraine medication classes is reported in this outcome measure. Acute treatments included: triptans, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, barbiturates, ergots, gepants [acute; including Nurtec], ditan, combination analgesics, and other acute treatment; preventive treatment included: anticonvulsants, beta blocker, antidepressant, calcitonin gene-related peptide antibodies monoclonal antibodies (CGRP mAb), botox, and gepant [prevention treatment including Nurtec]). Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Total Number of Acute Migraine Agent Drug Classes Used | Total number of distinct acute migraine agent drug classes used by participants is reported as mean in this outcome measure. Acute migraine agents included: triptans, NSAIDs, opioids, barbiturates, ergots, gepants [acute; including Nurtec], ditan, combination analgesics, and other acute treatment. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Drug classes per participant | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to Number of Acute Migraine Agent Drug Classes Used | Number of participants categorized by the number of distinct acute migraine agent drug classes used is reported in this outcome measure. Categories included 1 drug class, 2 or more drug classes, and 3 or more drug classes. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Total Number of Prevention Migraine Agent Drug Classes Used | Preventive migraine agents included: anticonvulsants, beta blocker, antidepressant, CGRP mAb, botox, and gepant [prevention treatment including Nurtec]. Total number of distinct preventive migraine agent drug classes used by participants is reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. The analysis was performed on all participants reported under Overall Number of Participants Analyzed. | Posted | Mean | Standard Deviation | Drug classes per participant | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to Number of Prevention Migraine Agent Drug Classes Used | Number of participants categorized by the number of distinct prescription preventive migraine agent drug classes used reported in this outcome measure. Categories included use of 1 drug class, 2 or more drug classes, and 3 or more drug classes. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. The analysis was performed on all participants reported under Overall Number of Participants Analyzed. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to Current Migraine Treatments | Number of participants according to current migraine treatments on drug classes including: Nurtec (rimegepant) only, acute agents, triptans, NSAIDs, opioids, barbiturates, ergots, gepants [acute; including Nurtec], ditan, combination analgesics, and other acute treatment (aspirin lysine/metoclopramide hydrochloride monohydrate or indometacin/caffeine/prochlorperazine), prevention agents (anticonvulsants, beta-blocker, antidepressant, CGRP mAb, botox, and gepant) are reported in this outcome measure. One participant could receive more than one migraine treatment. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to Treatment Satisfaction of Migraine Drug Class | Number of participants according to treatment satisfaction for the migraine drug classes including: acute agents, NSAIDs, opioids, barbiturates, ergots, gepants (acute), ditans, combination analgesics, other, prevention agents, anticonvulsants, beta blockers, antidepressants, CGRPs mAb, botox, and gepant reported in this outcome measure. Treatment satisfaction for each of the migraine drug class was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to Current Migraine Treatments on OTC Class | Participants were categorized based on current use of OTC migraine treatments, including analgesics (acetaminophen only), analgesics (combination), NSAIDs, and other OTCs. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Analysis was performed on all participants reported under "Overall Number of Participants Analyzed". | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to Treatment Satisfaction of Analgesics (Acetaminophen Only) | Number of participants according to treatment satisfaction for analgesics (acetaminophen only) is reported in this outcome measure. Treatment satisfaction was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Primary | Number of Participants According to Treatment Satisfaction to Rimegepant or Triptans | Number of participants according to treatment satisfaction for rimegepant or triptans is reported in this outcome measure. Treatment satisfaction was categorized as: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither dissatisfied nor satisfied, somewhat satisfied, very satisfied, extremely satisfied. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Primary | Research and Development (RAND-36) Physical Component Score, Mental Component Score and Global Health Score - Primary Analysis | RAND-36=standardized survey evaluating 8 domains of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 domains were scaled from 0=worst condition to 100=best condition, higher scores indicated better health status. These 8 domains were summarized as summary scores: physical component scores (derived from physical functioning, role physical, bodily pain, general health), mental component scores (derived from social functioning, role emotional mental health and vitality) and global health composite score (derived from physical and mental component scores). Each of the summary scores were standardized to a T-score with mean=50 and SD=10. Scores ranged from 0 to 100, where 0 (worst condition) to 100 (best condition), where higher scores represent better health status. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Units on a scale | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Index Score - Primary Analysis | EQ-5D-5L is participant completed questionnaire that consisted of two components: a five-item health state profile and visual analog scale (VAS). EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised health state/a single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had unique predefined utility index value assigned to it per US value sets, by EuroQol. Index scores ranged from -0.59 to 1; where 1 =best possible health state. Negative values= health states perceived as worse than dead, (death=0). Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Units on a scale | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | EQ-5D-5L Visual Analog Scale (VAS) Score - Primary Analysis | The EQ-5D-5L is a participant completed questionnaire that consisted of two components: a five-item health state profile and a VAS. EQ-5D VAS was used to record participant's rating for his/her current health state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Units on a scale | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Percentage of Work Time Missed in Past 7 Days Based on Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire- Primary Analysis | The WPAI is a standardized Patient reported outcome (PRO) that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of work time missed ranged from 0 (no impairment/high productivity) to-100% (total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Percentage work time missed | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Percentage Impairment Experienced While at Work in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage impairment experienced ranged from 0 (no impairment/high productivity/high impairment) to 100% (total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Percentage impairment | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Percentage Overall Work Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage overall work impairment experienced ranged from 0 (no impairment/high productivity/high impairment) to 100% (total loss of work productivity/high impairment) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Percentage work impairment | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Primary | Percentage Total Activity Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Primary Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of total activity impairment ranged from 0 (no impairment/high productivity) to 100% (total loss of work productivity/high impairment) with higher score indicating greater impairment and less productivity. In this outcome measure, percentage total activity impairment among total population, employed, unemployed and disabled is reported. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Percentage activity impairment | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Migraine Disability Assessment Scale (MIDAS) Total Score and Individual Item Scores- Primary Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provided the number of missed work or school days (MIDAS Item 1); missed household chores days (MIDAS Item 2); missed social or leisure activity days (MIDAS Item 3); and days with productivity loss at work or school (MIDAS Item 4), days with productivity loss in household work (MIDAS Item 5), frequency of headaches (MIDAS Item 6) and the intensity of the headache pain (MIDAS Item 7). The score ranged from 0 (no disability) to 90 (maximum disability) for each of individual item scores. The 5 item scores (Item 1 to Item 5) were summed to compute the MIDAS total score ranging from 0 (no disability) to 450 (maximum disability). Lower scores indicate less headache-related disability. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Mean | Standard Deviation | Units on a scale | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants According to MIDAS Grade- Primary Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as days with lost time or productivity due to headache from paid work or school, household work, and non-work activities. Participants were categorized according to MIDAS scores as Grade I = Little or No Disability (Score: 0-5), Grade II= Mild Disability (Score: 6-10), Grade III = Moderate Disability (Score: 11-20), Grade IV =severe disability (Score: >=21). Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants With Emergency Room (ER) Visits in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of ER Visits in Past 6 Months- Primary Analysis | Number of ER visits within the last six months due to any cause among those who had at least 1 ER visit reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ER visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants With Hospitalizations in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Mean Number of Hospitalizations in Past 6 Months - Primary Analysis | Mean number of hospitalizations within the last six months due to any cause among those who had at least 1 hospitalization is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hospitalizations | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants With Family Practitioner Visits in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Mean Number of Family Practitioner Visits in Past 6 Months- Primary Analysis | Mean number of family practitioner visits within the last six months due to any cause among those who had at least 1 family practitioner visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Family Practitioner Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants With Cardiologist Visits in Past 6 Month- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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|
| Primary | Mean Number of Cardiologist Visits in Past 6 Months- Primary Analysis | Mean number of cardiologist visits within the last six months due to any cause among those who had at least 1 cardiologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Cardiologist Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants With Neurologist Visits in Past 6 Months - Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 month of this observational study. |
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| Primary | Mean Number of Neurologist Visits in Past 6 Months- Primary Analysis | Mean number of neurologist visits within the last six months due to any cause among those who had at least 1 neurologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Neurologist Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Number of Participants With Traditional Healthcare Provider Visits in Past 6 Months- Primary Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Primary | Mean Number of Traditional Healthcare Provider Visits in Past 6 Months- Primary Analysis | Mean number of traditional healthcare provider visits within the last six months due to due to any cause among those who had at least 1 healthcare provider visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariate. | Analysis population included all eligible participants whose data were retrieved and observed in the study and were adjusted using IPTW method (pseudo-set); hence, numbers of participants are different here from those presented in participant flow and baseline section. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Traditional Healthcare Provider Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Research and Development (RAND-36) Physical Component Score, Mental Component Score and Global Health Score - Sensitivity Analysis. | RAND-36=standardized survey evaluating 8 domains of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 domains were scaled from 0=worst condition to 100=best condition, higher scores indicated better health status. These 8 domains were summarized as summary scores: physical component scores (derived from physical functioning, role physical, bodily pain, general health), mental component scores (derived from social functioning, role emotional mental health and vitality) and global health composite score (derived from physical and mental component scores). Each of the summary scores were standardized to a T-score with mean=50 and SD=10. Scores ranged from 0 to 100, where 0 (worst condition) to 100 (best condition), where higher scores represent better health status. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Units on a scale | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Index Score- Sensitivity Analysis | EQ-5D-5L is participant completed questionnaire that consisted of two components: a five-item health state profile and visual analog scale (VAS). EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised health state/a single utility index value. E.g. if a participant responds "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses) had unique predefined utility index value assigned to it per US value sets, by EuroQol. Index scores ranged from -0.59 to 1; where 1 =best possible health state. Negative values= health states perceived as worse than dead, (death=0). Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Units on a scale | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | EQ-5D-5L Visual Analog Scale (VAS) Score- Sensitivity Analysis | The EQ-5D-5L is a participant completed questionnaire that consisted of two components: a five-item health state profile and a VAS. EQ-5D VAS was used to record participant's rating for his/her current health state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Units on a scale | At the time of survey during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Percentage of Work Time Missed in Past 7 Days Based on Work Productivity and Activity Impairment - General Health (WPAI-GH) Questionnaire- Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of work time missed ranged from 0 (no impairment/high productivity) to 100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Percentage work time missed | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Percentage Impairment Experienced While at Work in Past 7 Days Based on WPAI-GH Questionnaire-Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage impairment experienced ranged from 0 (no impairment/high productivity) to 100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Percentage impairment | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Percentage Overall Work Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage overall work impairment experienced ranged from 0 (no impairment/high productivity) to 100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Percentage work impairment | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Percentage Total Activity Impairment in Past 7 Days Based on WPAI-GH Questionnaire- Sensitivity Analysis | The WPAI is a standardized PRO that assessed the previous 7 days of completing the questionnaire. WPAI:GH is a self-reported measure of work productivity and impairment, which had four scores: absenteeism (work time missed); presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism plus presenteeism); and total activity impairment. The scores for percentage of total activity impairment ranged from 0 (no impairment/high productivity) to100% (high impairment/total loss of work productivity) with higher score indicating greater impairment and less productivity. In this outcome measure, percentage total activity impairment among total population, employed, unemployed and disabled is reported. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percentage activity impairment | 7 days before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Migraine Disability Assessment Scale (MIDAS) Total Score and Individual Item Scores- Sensitivity Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provided the number of missed work or school days (MIDAS Item 1); missed household chores days (MIDAS Item 2); missed social or leisure activity days (MIDAS Item 3); and days with productivity loss at work or school (MIDAS Item 4), days with productivity loss in household work (MIDAS Item 5), frequency of headaches (MIDAS Item 6) and the intensity of the headache pain (MIDAS Item 7). The score ranged from 0 (no disability) to 90 (maximum disability) for each of individual item scores. The 5 item scores (Item 1 to Item 5) were summed to compute the MIDAS total score ranging from 0 (no disability) to 450 (maximum disability). Lower scores indicate less headache-related disability. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Mean | Standard Deviation | Units on a scale | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Number of Participants According to MIDAS Grade - Sensitivity Analysis | MIDAS is a retrospective, self-administered, 7-item questionnaire that measured headache-related disability as days with lost time or productivity due to headache from paid work or school, household work, and non-work activities. Participants were categorized according to MIDAS scores as Grade I = Little or No Disability (Score: 0-5), Grade II= Mild Disability (Score: 6-10), Grade III = Moderate Disability (Score: 11-20), Grade IV =severe disability (Score: >=21). Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 3 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Number of Participants With Emergency Room (ER) Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Number of ER Visits in Past 6 Months- Sensitivity Analysis | Number of ER visits within the last six months due to any cause among those who had at least 1 ER visit reported as mean in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ER visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Number of Participants With Hospitalizations in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Mean Number of Hospitalizations in Past 6 Months- Sensitivity Analysis | Mean number of hospitalizations within the last six months due to any cause among those who had at least 1 hospitalization is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hospitalizations | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Number of Participants With Family Practitioner Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Mean Number of Family Practitioner Visits in Past 6 Months- Sensitivity Analysis | Mean number of family practitioner visits within the last six months due to any cause among those who had at least 1 family practitioner visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Family Practitioner Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Number of Participants With Cardiologist Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Mean Number of Cardiologist Visits in Past 6 Months- Sensitivity Analysis | Mean number of cardiologist visits within the last six months due to any cause among those who had at least 1 cardiologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Cardiologist Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Number of Participants With Neurologist Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 month of this observational study. |
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| Secondary | Mean Number of Neurologist Visits in Past 6 Months- Sensitivity Analysis | Mean number of neurologist visits within the last six months due to any cause among those who had at least 1 neurologist visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Neurologist Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
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| Secondary | Number of Participants With Traditional Healthcare Provider Visits in Past 6 Months- Sensitivity Analysis | Analysis was performed using IPTW method to adjust for confounding by the covariates. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. | Posted | Count of Participants | Participants | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study |
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| Secondary | Mean Number of Traditional Healthcare Provider Visits in Past 6 Months- Sensitivity Analysis | Mean number of traditional healthcare provider visits within the last six months due to due to any cause among those who had at least 1 healthcare provider visit is reported in this outcome measure. Analysis was performed using IPTW method to adjust for confounding by the covariate. | Analysis population included all eligible participants whose data were retrieved and observed in the study. For sensitivity analysis a subset of rimegepant users with less than 12 days of rimegepant use per month were included and the numbers were adjusted using IPTW method, which created pseudo population, leading to difference from the sample sizes before IPTW. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Traditional Healthcare Provider Visits | 6 months before the survey was taken, during 1 year of data identification (Year 2023); available retrospective data was evaluated over approximately 1.41 months of this observational study. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Triptans | Participants with self-reported diagnosis of migraine currently on triptan use at the time of survey completion (NHWS in year 2023) were included. No intervention was administerred as part of this study. | 0 | 0 | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009422 | Nervous System Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Both Acute and Prevention use |
|
| 3 or more drug classes |
|
| =0.463 |
| Other |
| 3 or more drug classes | Chi-squared | =0.644 | Other |
| 3 or more drug classes |
|
| <0.001 |
| Other |
| 3 or more drug classes | Chi-squared | <0.001 | Other |
| Triptans |
|
| NSAIDs |
|
| Opioids |
|
| Barbiturates |
|
| Ergots |
|
| Gepants (acute; including Nurtec) |
|
| Ditan |
|
| Combination analgesics |
|
| Other (acute treatment) |
|
| Prevention agents |
|
| Anticonvulsants |
|
| Beta blocker |
|
| Antidepressant |
|
| CGRP mAb |
|
| Botox |
|
| Gepant (prevention treatment including Nurtec) |
|
| <0.001 |
| Other |
| NSAIDs | Chi-squared | =0.746 | Other |
| Opioids | Chi-squared | =0.319 | Other |
| Barbiturates | Fisher Exact | =0.223 | Other |
| Ergots | Fisher Exact | =0.791 | Other |
| Gepants (acute; including Nurtec) | Chi-squared | <0.001 | Other |
| Ditan | Fisher Exact | =1.000 | Other |
| Combination analgesics | Chi-squared | =0.447 | Other |
| Other (acute treatment) | Fisher Exact | =1.000 | Other |
| Prevention agents | Chi-squared | <0.001 | Other |
| Anticonvulsants | Chi-squared | =0.661 | Other |
| Beta blocker | Fisher Exact | =0.315 | Other |
| Antidepressant | Chi-squared | =0.377 | Other |
| CGRP mAb | Chi-squared | =0.093 | Other |
| Botox | Chi-squared | =0.041 | Other |
| Gepant (prevention treatment including Nurtec) | Chi-squared | <0.001 | Other |
| Very dissatisfied |
|
| Somewhat dissatisfied |
|
| Neither dissatisfied nor satisfied |
|
| Somewhat satisfied |
|
| Very satisfied |
|
| Extremely satisfied |
|
| Current migraine satisfactions - NSAIDs |
|
|
| Current migraine satisfactions - Opioids |
|
|
| Current migraine satisfactions - Barbiturates |
|
|
| Current migraine satisfactions - Ergots |
|
|
| Current migraine satisfactions - Gepants (acute; including Nurtec) |
|
|
| Current migraine satisfactions - Ditans |
|
|
| Current migraine satisfactions - Combination Analgesics |
|
|
| Current migraine satisfactions - Other (Acute treatment) |
|
|
| Current migraine satisfactions - Prevention agents |
|
|
| Current migraine satisfactions - Anticonvulsants |
|
|
| Current migraine satisfactions - Beta-blockers |
|
|
| Current migraine satisfactions - Antidepressants |
|
|
| Current migraine satisfactions - CGRPs mAb |
|
|
| Current migraine satisfactions - Botox |
|
|
| Current migraine satisfactions - Gepant (prevention treatment including Nurtec) |
|
|
| =0.518 |
| Other |
| Current migraine satisfactions - Opioids | Fisher Exact | =0.184 | Other |
| Current migraine satisfactions - Barbiturates | Fisher Exact | =0.333 | Other |
| Current migraine satisfactions - Ergots | Fisher Exact | <0.001 | Other |
| Current migraine satisfactions - Gepants (acute; including Nurtec) | Fisher Exact | <0.001 | Other |
| Current migraine satisfactions - Combination Analgesics | Fisher Exact | =0.680 | Other |
| Current migraine satisfactions - Other (Acute treatment) | Fisher Exact | =0.011 | Other |
| Current migraine satisfactions - Prevention agents | Fisher Exact | <0.001 | Other |
| Current migraine satisfactions - Anticonvulsants | Fisher Exact | =0.314 | Other |
| Current migraine satisfactions - Beta-blockers | Fisher Exact | =0.890 | Other |
| Current migraine satisfactions - Antidepressants | Fisher Exact | =0.055 | Other |
| Current migraine satisfactions - CGRPs mAb | Fisher Exact | =0.016 | Other |
| Current migraine satisfactions - Botox | Fisher Exact | =0.079 | Other |
| Current migraine satisfactions - Gepant (prevention treatment including Nurtec) | Fisher Exact | =0.079 | Other |
| NSAIDs |
|
| Other |
|
| =0.421 |
| Other |
| NSAIDs | Chi-squared | =0.636 | Other |
| Other | Fisher Exact | =1.000 | Other |
| Somewhat dissatisfied |
|
| Neither dissatisfied nor satisfied |
|
| Somewhat satisfied |
|
| Very satisfied |
|
| Extremely satisfied |
|
| Somewhat dissatisfied |
|
| Neither dissatisfied nor satisfied |
|
| Somewhat satisfied |
|
| Very satisfied |
|
| Extremely satisfied |
|
| Global health composite T score |
|
| =0.781 |
| Other |
| Global health composite T score | t-test, 2 sided | =0.637 | Other |
| Activity impairment among employed |
|
|
| Activity impairment among unemployed |
|
|
| Activity impairment among disabled |
|
|
| =0.825 |
| Other |
| Activity impairment among unemployed | t-test, 2 sided | 0.117 | Other |
| Activity impairment among disabled | t-test, 2 sided | =0.921 | Other |
| MIDAS Item 2 (MGMIDAS2) |
|
| MIDAS Item 3 (MGMIDAS3) |
|
| MIDAS Item 4 (MGMIDAS4) |
|
| MIDAS Item 5 (MGMIDAS5) |
|
| MIDAS Item 6 (MGMIDAS6) |
|
| MIDAS Item 7 (MGMIDAS7) |
|
| =0.741 |
| Other |
| MIDAS Item 2 (MGMIDAS2) | t-test, 2 sided | =0.080 | Other |
| MIDAS Item 3 (MGMIDAS3) | t-test, 2 sided | =0.026 | Other |
| MIDAS Item 4 (MGMIDAS4) | t-test, 2 sided | =0.254 | Other |
| MIDAS Item 5 (MGMIDAS5) | t-test, 2 sided | =0.723 | Other |
| MIDAS Item 6 (MGMIDAS6) | t-test, 2 sided | =0.012 | Other |
| MIDAS Item 7 (MGMIDAS7) | t-test, 2 sided | =0.807 | Other |
| MIDAS Grade III |
|
| MIDAS Grade IV |
|
| Global health composite T score |
|
| =0.602 |
| Other |
| Global health composite T score | t-test, 2 sided | =0.815 | Other |
| Activity impairment among employed |
|
|
| Activity impairment among unemployed |
|
|
| Activity impairment among disabled |
|
|
| =0.496 |
| Other |
| Activity impairment among unemployed | t-test, 2 sided | =0.268 | Other |
| Activity impairment among disabled | t-test, 2 sided | =0.57 | Other |
| MIDAS Item 2 (MGMIDAS2) |
|
| MIDAS Item 3 (MGMIDAS3) |
|
| MIDAS Item 4 (MGMIDAS4) |
|
| MIDAS Item 5 (MGMIDAS5) |
|
| MIDAS Item 6 (MGMIDAS6) |
|
| MIDAS Item 7 (MGMIDAS7) |
|
| =0.884 |
| Other |
| MIDAS Item 2 (MGMIDAS2) | t-test, 2 sided | =0.373 | Other |
| MIDAS Item 3 (MGMIDAS3) | t-test, 2 sided | =0.109 | Other |
| MIDAS Item 4 (MGMIDAS4) | t-test, 2 sided | =0.368 | Other |
| MIDAS Item 5 (MGMIDAS5) | t-test, 2 sided | =0.714 | Other |
| MIDAS Item 6 (MGMIDAS6) | t-test, 2 sided | =0.020 | Other |
| MIDAS Item 7 (MGMIDAS7) | t-test, 2 sided | =0.889 | Other |
| MIDAS Grade III |
|
| MIDAS Grade IV |
|