Reliability of Rimegepant or Triptans for the Acute Treatment of Migraine (Adelphi DSP)

Evaluation of the Reliability of Effect of Rimegepant for the Acute Treatment of Migraine Across Multiple Attacks

This protocol describes the analysis of the Adelphi Real World (ARW) Migraine Disease Specific Programme(TM) 2022, a cross-sectional study which used both physician and patient surveys to assess the perception of the acute treatment for migraine attacks.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders

Detailed Description

This is a retrospective database study that aims to explore the reliability of effect with acute use of Rimegepant or triptans, to evaluate the satisfaction with Rimegepant or triptans, to evaluate willingness to continue using Rimegepant or triptans, and to explore proportion optimized on treatment with Rimegepant or triptans. The data will be extracted from the Adelphi Real World (ARW) Migraine Disease Specific ProgrammeTM (DSP) 2022 database, which was conducted across a number of countries including United States, between May 2022 and November 2022. The DSP was an observational study of clinical practice. Treatment practice data were collected by physicians (physician survey) who were asked to provide information for the next 10 patients consulting for migraine. These patients were then invited to fill out a self-completion form (patient survey) providing their own assessment on the disease and treatments.

• Study Type: Observational
• Enrollment (Actual): 528

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Physician personally responsible for treatment decision of migraine patients were enrolled in the survey. Each physician then enrolled consecutive patients to complete a patient self-completion questionnaire.

Description

Inclusion criteria

• Patients who have episodic and/or chronic migraine
• Patients age > 18
• Currently prescribed rimegepant OR triptans for the acute treatment of migraine

Exclusion criteria

• currently prescribed rimegepant for prevention of migraine or for both the acute treatment & prevention of migraine
• Rimegepant group: currently prescribed an acute treatment for migraine and other than rimegepant
• Triptan Group: currently prescribed an acute treatment for migraine other than triptans

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Rimegepant; Cohort of patients treated with rimegepant
Triptans; Cohort of patients treated with triptans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Failed to Achieve Pain Freedom Within 2 Hours Post Dose (Physician Perspective)	Physicians responded as "Yes" or "No" if participants failed to achieve pain freedom within 2 hours post dose. In this outcome measure, number of participants were reported according to physicians' responses. Participant who failed to achieve pain freedom at 2 hours post dose on more than half of the occasion were reported in this outcome measure.	2 hours post dose (from the data collected retrospectively)
Number of Participants Who Reported Migraine Pain Freedom (Success) Within 2 Hours Post Dose (Participants Perspective)	Number of participants who reported migraine pain freedom within 2 hours post dosing in 0 out of every 5 attacks, 1 out of every 5 attacks, 2 out of every 5 attacks, 3 out of every 5 attacks, 4 out of every 5 attacks, or 5 out of every 5 attacks were recorded. Success was defined as responses to '4 out of every 5 attacks' or '5 out of every 5 attacks' combined. In this outcome measure, number of participants with 'success' were reported as per participants' responses. Participant who reported migraine pain freedom (success) at 2 hours post dose on more than half of occasion were reported in this outcome measure.	2 hours post dose (from the data collected retrospectively)
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)	Physicians' satisfaction with current acute treatment for migraine was recorded and classified as extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied and extremely dissatisfied. In this outcome measure number of participants were reported per each category according to physicians' responses.	Over the last 3 months prior completing the survey
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)	Physicians' reported reasons for lack of satisfaction with current acute treatment. In this outcome measure number of participants were reported per each reason according to physicians' responses. There could be more than 1 reason for lack of satisfaction per participant.	Over the last 3 months prior completing the survey
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)	Participants' satisfaction with current acute treatment for migraine was recorded and classified as extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied and extremely dissatisfied. In this outcome measure number of participants were reported per each category according to participants' responses.	Over the last 3 months prior completing the survey
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)	Participants' reported reasons for lack of satisfaction with current acute treatment. In this outcome measure, number of participants were reported per each reason according to participants' responses. There could be more than 1 reason for lack of satisfaction per participant.	Over the last 3 months prior completing the survey
Number of Participants Willing to Continue Use of Acute Treatment (Participants Perspective)	Participants responded about their willingness to continue use of acute treatment and responses were classified as definitely yes, probably yes, do not know, probably not, definitely not. Willingness to continue was defined as responses to: 'Definitely yes' or 'Probably yes' combined. Unwillingness to continue was defined as responses to 'Probably not' and 'Definitely not' combined. In this outcome measure number of participants were reported according to participants' responses.	Over the last 3 months prior completing the survey
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)	mTOQ6 was participants reported questionnaire and participants had to respond on following 6 items: 1) "Are you able to quickly return to your normal activities (i.e., work, family, leisure, social activities) after taking your migraine medication?"; 2) "After taking your migraine medication, are you pain free within 2 hours for most attacks?"; 3) "Does one dose of your migraine medication usually relieve your headache and keep it away for at least 24 hours?"; 4) "Is your migraine medication well tolerated?"; 5) "Are you comfortable enough with your migraine medication to be able to plan your daily activities?"; and 6) "After taking your migraine medication, do you feel in control of your migraines enough so that you feel there will be no disruption to your daily activities?". Each item had following responses: never, rarely, less than half the time and half the time or more.	Over the last 3 months prior completing the survey
Number of Participants Classified Based on Timing They Took Acute Prescription Treatment	In this outcome measure number of participants were classified based on timing/when they took acute treatment as follows: 1) before any sign of a migraine attack, but in anticipation of one starting; 2) at the first sign of a migraine attack (before the pain started); 3) when the pain started; 4) after the pain had started and participant had an idea of pain's severity.	Over the last 3 months prior completing the survey
Mean of Number of Days Per Month Participants Took Acute Prescription Treatment	In this outcome measure mean of number of days per month participants took acute prescription treatment were recorded.	Over the last 3 months prior completing the survey

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): January 3, 2024
• Study Completion (Actual): January 3, 2024

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: C4951066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.