Clinical trial NCT06467370: A Real-world, Prospective Observational Study of Rimegepant ODT for the Acute Treatment of Migraine Attacks in Adults.
Official title: CONFIDENCE: A Prospective Observational Study With Acute Treatment of Rimegepant ODT on Consistency, Satisfaction and Tolerability of Treatment in the Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: rimegepant
acute migraine treatment
real-world setting
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Aptar Digital Health
First posted: 2024-06-21
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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

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?

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction with prescribed medication
timeFrame: Day 30
measure: Population level consistency
timeFrame: Day 30
measure: Assessments of meaningful clinical effect
timeFrame: Day 30
measure: meaningful improvement in functioning
timeFrame: Day 30
Secondary outcomes:
measure: Effectiveness of rimegepant in users taking concomitant migraine preventive medications
timeFrame: Day 30
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: