Reliability of Rimegepant or Triptans for the Acute Treatment of Migraine

Completed

Conditions: Migraine Disorders

Registration Number: NCT06412965

Lead Sponsor: Pfizer

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 528

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)	Over the last 3 months prior completing the survey	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.
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)	Over the last 3 months prior completing the survey	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.
Number of Participants Classified Based on Timing They Took Acute Prescription Treatment	Over the last 3 months prior completing the survey	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.
Number of Participants Who Failed to Achieve Pain Freedom Within 2 Hours Post Dose (Physician Perspective)	2 hours post dose (from the data collected retrospectively)	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.
Number of Participants Who Reported Migraine Pain Freedom (Success) Within 2 Hours Post Dose (Participants Perspective)	2 hours post dose (from the data collected retrospectively)	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.
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)	Over the last 3 months prior completing the survey	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.
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)	Over the last 3 months prior completing the survey	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.
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)	Over the last 3 months prior completing the survey	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.
Number of Participants Willing to Continue Use of Acute Treatment (Participants Perspective)	Over the last 3 months prior completing the survey	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.
Mean of Number of Days Per Month Participants Took Acute Prescription Treatment	Over the last 3 months prior completing the survey	In this outcome measure mean of number of days per month participants took acute prescription treatment were recorded.