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

NCT06467370 | Completed

• 2 other identifiers: C4951072AUDACITY
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

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

Conditions

Migraine

Keywords

rimegepant; acute migraine treatment; real-world setting

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Effectiveness of rimegepant in users taking concomitant migraine preventive medications

  Day 30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Aptar Digital Health: collaborator

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

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

Biospecimen

Retention: NONE RETAINED

No biosamples will be collected in this study.

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: July 2, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)