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

Migraine Clinical Trial

— CONFIDENCE  

Official title:

A prospeCtive ObservatioNal Study With Acute Treatment oF rImegepant ODT on consistENcy, satisfaCtion and Tolerability of trEatment in the Real World

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467370
• Other study ID #: C4951072
• Secondary ID: CONFIDENCEAUDACI
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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. 1. In adult patients having received a prescription for Nurtec ODT (rimegepant) for acute treatment, 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 the real world, regardless of their prophylactic background? 2. In those patients, and in particular in subgroups of patients receiving migraine preventives anti-CGRP mAbs or onabotulinumtoxinA, what are the satisfaction and the tolerability of rimegepant? 3. What is the efficacy, safety, and tolerability of oral rimegepant in acute migraine treatment, when taken in combination with these preventives that act on the same pathway?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 468
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Aptar Digital Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	meaningful improvement in functioning	Experience of "meaningful improvement in functioning" between 1 and 4 hours after intake.	Day 30
Secondary	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