Reliability of Rimegepant 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, to evaluate the satisfaction with Rimegepant, to evaluate willingness to continue using Rimegepant, and to explore proportion optimized on treatment with Rimegepant. 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): 91

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 for the acute treatment of migraine

Exclusion criteria

• currently prescribed rimegepant for prevention of migraine or for both the acute treatment & prevention of migraine
• Currently prescribed an acute treatment for migraine other than rimegepant

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Physician Survey; Physicians who were enrolled in the Adelphi Migraine Disease Specific Programme (DSP)™
Patient survey; Patients who were enrolled in the Adelphi Migraine Disease Specific Programme (DSP)™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure to achieve pain freedom within 2 hours post dose (physician perspective)	Frequency of patients for which the physician reports that fail to achieve pain freedom at 2 hours post dose on more than half of occasions measured by using answers on the physician survey	2 hours post dose
Number of migraine attacks acute treatment achieves pain freedom within 2 hours post dose (patient perspective)	Frequency of patients 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 measured by using answers on the patient survey	2 hours post dose
Reason for choice of current acute treatment - 'consistency of response after repeated use' (physician perspective)	Description of the reasons why the physician chooses the acute treatment considering the following domains: type of control and effects; formulation/dosage; quality of life; side effects and safety; patient types; and general attributes measured by using answers on the physician survey	Over the last 3 months prior completing the survey
Satisfaction with current acute treatment (physician perspective)	Frequency with which the physician is extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the patient´s acute treatment prescription measured by using answers on the physician survey	Over the last 3 months prior completing the survey
Drivers for lack of satisfaction with current acute treatment (physician perspective)	Description of the reasons why the physician is not satisfied with patient´s treatment prescription measured by using answers on the physician survey	Over the last 3 months prior completing the survey
Satisfaction with current acute treatment (patient perspective)	Frequency of patients who reported being extremely satisfied, satisfied, slightly satisfied, neither satisfied not dissatisfied, slightly dissatisfied, or extremely dissatisfied with the treatment for their migraine attacks measured by using answers on the patient survey	Over the last 3 months prior completing the survey
Drivers for lack of satisfaction with current acute treatment (patient perspective)	Description of the reasons why the patients are not satisfied or extremely satisfied with their acute treatment measured by using answers on the patient survey	Over the last 3 months prior completing the survey
Patient willingness to continue use of acute treatment (patient perspective)	Frequency of patients who reported willingness to continue using their acute treatment, categorized into definitely yes, probably yes, do not know, probably not, or definitely not measured by using answers on the patient survey	Over the last 3 months prior completing the survey
Migraine treatment optimization questionnaire (mTOQ6)	Mean and median of total scores. The mTOQ-6 score is calculated by summing individual question scores (score range of 6-24), with higher scores indicating better acute treatment optimization	Over the last 3 months prior completing the survey
Migraine Treatment Optimization Questionnaire (m-TOQ6)	Frequency of each item with the response options (never, rarely, less than half of the time, or half of the time or more)	Over the last 3 months prior completing the survey
When patients takes acute prescription treatment	Frequency of patients who usually take their acute treatment: before any sign of a migraine attack, but in anticipation of one starting; or at the first sign of a migraine attack (before the pain starts); or when the pain starts; or after the pain has started and have an idea of how severe it is measured by using answers on the patient survey	Over the last 3 months prior completing the survey
How many days per month patient takes acute prescription treatment	Average number of days per month the patient takes the acute treatment measured by using answers on the patient survey	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): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 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.