MedPath

A Study to Learn About the Benefit of Rimegepant Versus Triptans in Migraine Buddy App Users.

Completed
Conditions
Migraine
Registration Number
NCT06532357
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to collect information of the US users from the Migraine Buddy app between 20 October 2023 and 20 May 2024. Patients who used Nurtec and/or triptans as an acute treatment for migraine, with or without a background of preventive treatment (anti-CGRP, Botox or oral migraine preventive medications) and completed a survey were eligible for this study. Acute treatment is a short-term treatment. The aim of this retrospective analysis was to learn about the user´s satisfaction with Nurtec or the triptan. The level of satisfaction with Nurtec will be compared to the level of satisfaction with triptans. The benefit of this study is the real-life setting of the information collected. This means that the users were using the Migraine Buddy app for tracking their migraines in real life.

Detailed Description

This study will utilize retrospective data collected with the Migraine Buddy Mobile application to evaluate satisfaction of treatment with rimegepant and triptans. The study population for this study is Migraine Buddy users in the US who answered a survey about their acute treatments, displayed on the home page of the app. It generates reports that users can share with their doctors to help them establish a diagnosis and/or optimize treatment. For this retrospective study, only questions related to treatment satisfaction will be analyzed.

Users complete the satisfaction questions only once for each current acute migraine treatment. If a patient is using more than one acute treatment, they will be able to complete satisfaction questions for each acute treatment. Approximately two-thirds of the app users are currently using both rimegepant and triptans to acutely treat their migraine attacks. Questions are worded such that they ask specifically about the acute treatment e.g., Nurtec. For the surveys used in the 7-month time frame of this retrospective study, feasibility assessment showed that participants answered the satisfaction questions for a specific acute medication only once, in 97% of the cases. For the few users who responded to 2 or more waves of identical surveys, the most recent answer will be used for the analysis.

Data was gathered between October 20, 2023 \& May 20, 2024, from users of the Migraine Buddy app through the "diary tracking" and the satisfaction questions were administered via survey and via the interactive data collection tool named "Taylor". All the data will be extracted from the Aptar Digital Health (ADH) platform existing database to perform the analysis described in this protocol.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Patients who used Nurtec and/or triptans as an acute treatment for migraine, with or without a background of preventive treatment (anti-CGRP, Botox or oral migraine preventive medications).
  • Male or female participants with migraine
  • Having consented to the anonymous use of their data for research
  • Currently using Nurtec and/or triptans to treat migraine attacks
Exclusion Criteria
  • Users who did not report using either medication for which they complete the survey within 60 days prior to the survey.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the satisfaction about the relief of other symptoms after using Nurtec or triptansUp to 7 months

How does satisfaction with relief of other symptoms compare between adults diagnosed with migraine who are using Nurtec or triptans as an acute treatment for migraine? Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment

To assess the holistic benefit of rimegepant as compared to triptans, particularly in relation to patients' satisfaction with regards to medication efficacy, tolerability, and migraine-induced cognitive impactUp to 7 months

How do clinical characteristics (for e.g., migraine severity, current migraine prophylactic treatment use) impact patients' satisfaction with regards to medication efficacy, tolerability, and migraine-induced cognitive impact in those who are using Nurtec or triptans as an acute treatment for migraine. Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment

Evaluation of satisfaction with regard to the speed of action after using Nurtec or triptansUp to 7 months

How does satisfaction with speed of action compare between adults diagnosed with migraine who are using Nurtec or triptans as an acute treatment for migraine? Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment

To assess the satisfaction with regard to the tolarability after using Nurtec or triptansUp to 7 months

How does satisfaction with tolerability compare between adults diagnosed with migraine who are using Nurtec or triptans as an acute treatment for migraine? Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment

To evaluate the satisfaction regarding the attack duration after using Nurtec or triptansUp to 7 months

How does satisfaction with attack duration compare between adults diagnosed with migraine who are using Nurtec or triptans as an acute treatment for migraine? Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment

To evaluate the satisfaction regarding the migraine-induced cognitive impact after using Nurtec or triptansUp to 7 months

How does satisfaction with migraine-induced cognitive impact compare between adults diagnosed with migraine who are using Nurtec or triptans as an acute treatment for migraine? Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment

To evaluate satisfaction in terms of pain intensity after using Nurtec or triptansUp to 7 months

How does satisfaction with pain intensity compare between adults diagnosed with migraine who are using Nurtec or triptans as an acute treatment for migraine? Satisfaction is measured using a questionnaire. This questionnaire was developed internally specifically for this study and asked the level of satisfaction with their treatment on a 7-levels Lickert scale. (1 = extremely dissatisfied to 7 = extremely satisfied). Based on their responses, the respondents will be stratified into those who were dissatisfied (reporting 1 = extremely dissatisfied to 3 = somewhat dissatisfied), neutral (4=neither dissatisfied nor satisfied) or satisfied (reporting 5 = somewhat satisfied to 7 = extremely satisfied) with the treatment.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Pfizer

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath