Clinical trial NCT06680206: Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey
Official title: Comparing Patient-Reported Outcomes Between Rimegepant and Triptan Users With Migraine in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Rimegepant
Triptans
Acute treatment of migraine
Survey
Cross-sectional design
National Health and Wellness Survey (NHWS)
Patient-reported outcomes
Treatment satisfaction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 1363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Treatment satisfaction
timeFrame: 12 months
measure: Quality of Life (QoL)
timeFrame: 12 months
measure: Qulaity of Life (QoL)
timeFrame: 12 months
measure: Work productivity loss
timeFrame: 12 months
measure: Migraine-specific disability
timeFrame: 12 months
measure: Healthcare Resource Utilization (HCRU)
timeFrame: 12 moths
measure: Healthcare Resource Utilization (HCRU)
timeFrame: 12 months
measure: Healthcare Resource Utilization (HCRU)
timeFrame: 12 months
measure: Healthcare Resource Utilization (HCRU)
timeFrame: 12 months
measure: Healthcare Resource Utilization (HCRU)
timeFrame: 12 months
measure: Healthcare Resource Utilization (HCRU)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: