A Real-world, Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults.
NCT Number: NCT06467370
Acronym: CONFIDENCE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine
Sponsor: Pfizer
Collaborators: Aptar Digital Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 375
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: Pfizer, New York, New York, 10001, United States

Summary:
This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects:

* Consistency of response to rimegepant across multiple attacks
* Effectiveness of rimegepant in users taking concomitant migraine preventive medications, namely monoclonal antibodies targeting CGRP and onabotulinumtoxinA

Primary Outcome Measures: Satisfaction with prescribed medication, Satisfaction with prescribed medication (rimegepant-treated attacks) as measured by 5 questions with a 7-point rating scale; Distribution analysis and Responder Yes/No. Responder definition: Extremely Satisfied, Satisfied, Slightly Satisfied.", Day 30|Population level consistency, Population level consistency will be determined utilizing the daily diary item 'meaningful pain relief' when rimegepant is used to acutely treat a migraine attack. Those who report meaningful pain relief at \<1 or 1-2 hours after taking rimegepant will be considered a 'responder'. Those who report meaningful pain relief \>2 hours or those who did not achieve meaningful relief/used another acute treatment since taking rimegepant will be considered 'delayed responder' or 'non-responder,' respectively. Population level consistency will be evaluated as the proportion of responders for each attack treated with rimegepant., Day 30|Assessments of meaningful clinical effect, Assessments of meaningful clinical effect will be measured by the rates in achieving meaningful pain relief at other timepoints, rates of improvement of migraine severity and functional disability, satisfaction with treatment and rates of acute treatment optimization. Responder definition: Improvement in functional disability 2 hours after taking rimegepant vs at time of intake (reduction by at least 1 category:e.g., from severely impaired to moderately impaired, from moderately impaired to mildly impaired, from mildly impaired to no disability)., Day 30|meaningful improvement in functioning, Experience of "meaningful improvement in functioning" between 1 and 4 hours after intake., Day 30
Secondary Outcome Measures: Effectiveness of rimegepant in users taking concomitant migraine preventive medications, Percentage of Participants Achieving Meaningful Pain Relief Meaningful relief occurs when the level of headache pain has been reduced to a degree that is meaningful to the participant; this can, but does not necessarily, occur prior to pain freedom. Participants will provide responses for rimegepant-treated migraine attacks about the time to achieve meaningful relief of headache pain. This will result in a binary responder definition coded as "yes" for those achieving meaningful pain relief or "no" for those not satisfying that definition.

Percentage of Participants Who Experience Meaningful improvement in functioning Participants will also rate the ability to perform daily activities at the point when rimegepant was taken using the Functional Disability Scale. This will result in a binary responder definition coded as "yes" for those achieving return to normal function or "no" for those not satisfying that definition., Day 30