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

Evaluation of Satisfaction With Rimegepant and Triptans Utilizing Migraine Buddy Retrospective Data

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06532357

Enrollment

1536

Registered

2024-08-01

Start date

2024-06-09

Completion date

2024-06-10

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

acute treatment of migraine, rimegepant, triptans, Migraine Buddy App Users

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Classified as Per Responses for Satisfaction of Pain Intensity	Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day	Participants responded about satisfaction with treatment for pain intensity using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With of Attack Duration	Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day	Participants responded about satisfaction with of attack duration using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With Speed of Action	Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day	Participants responded about satisfaction with speed of action using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With Migraine-Induced Cognitive Impact	Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day	Participants responded about satisfaction with migraine-Induced cognitive impact using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With Relief of Other Symptoms	Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day	Participants responded about satisfaction with relief of other symptoms using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment. Other symptoms included following parameters: photophobia, phonophobia, nausea, vomiting, sensitivity to light/sound/odors).
Number of Participants Classified as Per Responses for Satisfaction of Tolerability	Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day	Participants responded about satisfaction of tolerability using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.

Countries

United States

Participant flow

Recruitment details

In this study, data was gathered between 30 October 2023 to 20 May 2024 from users of the Migraine Buddy application in the US who answered a survey about their acute treatments (rimegepant, or triptans) for migraine, displayed on the home page of the application. For the purpose of this retrospective study, only questions related to treatment satisfaction were analyzed.

Pre-assignment details

As pre-specified, only variables/data collected were the self-reported satisfaction of Migraine Buddy users via a questionnaire accessible from the home screen of the application. Users completed the satisfaction questions only once for each current acute migraine treatment. A total of 1536 participants were enrolled in this study who completed the survey. There were few participants who were not exclusive and completed survey for both rimegepant and triptans.

Participants by arm

Arm	Count
Rimegepant This arm included participants who used Migraine buddy application and answered the survey about satisfaction with rimegepant. No intervention was administered in this study.	0
Triptans This arm included participants who used Migraine buddy application and answered the survey about satisfaction with Triptans. No intervention was administered in this study.	0
Total	0

Baseline characteristics

Characteristic	—
Sex/Gender, Customized Female	— Participants
Sex/Gender, Customized Male	— Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Number of Participants Classified as Per Responses for Satisfaction of Pain Intensity

Participants responded about satisfaction with treatment for pain intensity using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.