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

NCT ID: NCT06467370

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 342 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-02
• Study Completion Date: 2025-03-11

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?

Conditions

Migraine

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aptar Digital Health

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer

New York, New York, United States

Countries

United States

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4951072

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

Other Identifiers

AUDACITY

Identifier Type: OTHER

Identifier Source: secondary_id

C4951072

Identifier Type: -

Identifier Source: org_study_id