Clinical trial NCT06532357: A Study to Learn About the Benefit of Rimegepant Versus Triptans in Migraine Buddy App Users.
Official title: Satisfaction With Treatment Outcomes in People With Migraine Receiving Rimegepant or Triptans: a Descriptive Analysis From a Real-world Migraine Tracking App
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: acute treatment of migraine
rimegepant, triptans
Migraine Buddy App Users
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US users of the Migraine Buddy App who use rimegepant or triptans to treat their acute migraine attacks.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate satisfaction in terms of pain intensity after using Nurtec or triptans
timeFrame: Up to 7 months
measure: To evaluate the satisfaction regarding the attack duration after using Nurtec or triptans
timeFrame: Up to 7 months
measure: Evaluation of satisfaction with regard to the speed of action after using Nurtec or triptans
timeFrame: Up to 7 months
measure: To evaluate the satisfaction regarding the migraine-induced cognitive impact after using Nurtec or triptans
timeFrame: Up to 7 months
measure: To assess the satisfaction with regard to the tolarability after using Nurtec or triptans
timeFrame: Up to 7 months
measure: To assess the satisfaction about the relief of other symptoms after using Nurtec or triptans
timeFrame: Up to 7 months
measure: 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 impact
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: