NCT06467370

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 342 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Migraine

Timeline

• Start date: 2024-07-02
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2024-06-21
• Last updated: 2025-03-30

Locations

1 site across 1 country: United States