Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

NCT06680206 | Completed Results FDA Drug

• 2 other identifiers: C4951076NCT06680206
• Study Type: observational
• Target: 1,395
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

Rimegepant; Triptans; Acute treatment of migraine; Survey; Cross-sectional design; National Health and Wellness Survey (NHWS); Patient-reported outcomes; Treatment satisfaction

Outcome Measures

Primary Outcomes (32)

• 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.

• 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.

Secondary Outcomes (21)

• Research and Development (RAND-36) Physical Component Score, Mental Component Score and Global Health Score - Sensitivity Analysis.

  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

  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

  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

  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

  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

Study Arms (1)

Acute treatment of migraine

Drug: Rimegepant; Drug: Triptans

Interventions

Rimegepant DRUG

Rimegepant for acute treatment of migraine

Acute treatment of migraine

Triptans DRUG

Triptans for acute treatment of migraine

Acute treatment of migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participated in 2023 NHWS in the US
• Consented to the anonymous use of their data for research purpose
• Aged 18 or older
• Self-reported a diagnosis of migraine by physician
• Currently on rimegepant or triptan (via oral route) at the time of the survey

You may not qualify if:

• \- Currently on both rimegepant and triptans at the time of the survey

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Biospecimen

Retention: NONE RETAINED

No biosamples will be collected in this study.

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate; Tryptamines

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 8, 2024
• Study Start: October 10, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)