A Real-world, Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults. (CONFIDENCE)

CONFIDENCE: A Prospective Observational Study With Acute Treatment of Rimegepant ODT on Consistency, Satisfaction and Tolerability of Treatment in the Real World

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

Study Overview

• Status: Completed
• Conditions: Migraine

Detailed Description

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:

1. In adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine, what is the population-level consistency of rimegepant response for pain reduction, meaningful pain relief, performance in daily activities, and return to normal function across multiple attacks in a real-world setting, regardless of prophylactic background?
2. What is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis (specifically, anti-CGRP mAbs or onabotulinumtoxinA (Botox)?
3. What is the efficacy, safety, and tolerability of rimegepant for the acute treatment of migraine, when taken in combination with preventive medications that act on the same pathway?

• Study Type: Observational
• Enrollment (Actual): 342

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

There are 4 subpopulations in this study:

1. participants using rimegepant and no prophylactic
2. participants using rimegepant with background prophylaxis of OMPM
3. participants using rimegepant with background prophylaxis of mAbs
4. participants using rimegepant with background prophylaxis of Botox.

Description

Inclusion Criteria:

• Female or male patients with migraine ≥18 years old
• Having received a prescription for rimegepant for acute treatment
• Experienced between 3 and 14 Headache days in the last 30 days
• Planning to use rimegepant for attacks happening during the next 30 days

Exclusion Criteria:

• Report currently using rimegepant as preventive
• Report currently using concomitantly onabotulinumtoxin and any of the mAbs
• Currently participating in a Migraine-related clinical trial
• Reports a diagnosis from a doctor or other health professional of cluster headache, post-traumatic headache, new daily persistent headache, or hemicrania continua

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Day 30

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Aptar Digital Health
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: acute migraine treatment; real-world setting; rimegepant
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: C4951072; AUDACITY (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No