- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06532357
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10001
- Pfizer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Classified as Per Responses for Satisfaction of Pain Intensity
Time Frame: 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
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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.
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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
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Number of Participants Classified as Per Responses for Satisfaction With of Attack Duration
Time Frame: 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.
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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
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Number of Participants Classified as Per Responses for Satisfaction With Speed of Action
Time Frame: 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
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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.
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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
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Number of Participants Classified as Per Responses for Satisfaction With Migraine-Induced Cognitive Impact
Time Frame: 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
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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.
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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
|
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Number of Participants Classified as Per Responses for Satisfaction With Relief of Other Symptoms
Time Frame: 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
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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).
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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
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Number of Participants Classified as Per Responses for Satisfaction of Tolerability
Time Frame: 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
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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.
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C4951073
- NCT06532357 (Registry Identifier: ClinicalTrials.gov)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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