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| ID | Type | Description | Link |
|---|---|---|---|
| AUDACITY | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Aptar Digital Health | INDUSTRY |
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This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects:
This study will be conducted in a real-world setting in the US using a bespoke interface contained in the Migraine Buddy mobile application. Participants who report using rimegepant for the acute treatment of migraine will be recruited and will be asked to complete a series of questionnaires during the screening and study period. Patient reported outcome measures will be collected at study enrollment, daily during the 28-day observation period, and at the end of the study period.
Research Questions:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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There are 4 subpopulations in this study:
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286469 | Derived | Lipton RB, Abraham L, Urani A, Lambru G, Goadsby PJ, Pozo-Rosich P, Schwedt TJ, Fanning KM, Dai F, Blakeman KH. Consistency of response to rimegepant for the acute treatment of migraine among real-world users - findings from the prospective observational CONFIDENCE study. J Headache Pain. 2026 Jun 12. doi: 10.1186/s10194-026-02421-z. Online ahead of print. |
| 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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| 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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No biosamples will be collected in this study.
| Day 30 |
| D009422 | Nervous System Diseases |