Evaluation of Satisfaction With Rimegepant and Triptans Utilizing Migraine Buddy Retrospective Data
Conditions: Migraine
Sponsor: Pfizer

Rimegepant
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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
Evaluation of satisfaction with rimegepant and triptans utilizing 
Migraine Buddy retrospective data
Protocol number
C4951073
Protocol version 
identifier
V1.0
Date
04 June 2024
Active substance
Analgesics, calcitonin gene-related peptide (CGRP) antagonists. 
ATC code: N02CD06
Medicinal product
Rimegepant (Nurtec 75mg ODT)
Research question 
and objectives
Primary objective: This study aims 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.
Research questions:
1. How does satisfaction with pain intensity compare between 
adults diagnosed with migraine who are using Nurtec or 
triptans as an acute treatment for migraine?
2. How does satisfaction with attack duration compare between 
adults diagnosed with migraine who are using Nurtec or 
triptans as an acute treatment for migraine?
3. 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?
4. 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?
5. How does satisfaction with tolerability compare between 
adults diagnosed with migraine who are using Nurtec or 
triptans as an acute treatment for migraine?
6. How does satisfaction with relief of other symptoms compare 
between adults diagnosed with migraine who are using 
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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................3
2. LIST OF ABBREVIATIONS................................................................................................4
3. RESPONSIBLE PARTIES....................................................................................................6
4. AMENDMENTS AND UPDATES.......................................................................................7
5. MILESTONES.......................................................................................................................8
6. RATIONALE AND BACKGROUND..................................................................................8
7. RESEARCH QUESTION AND OBJECTIVES ...................................................................9
8. RESEARCH METHODS ....................................................................................................10
8.1. Study Design ...........................................................................................................10
8.2. Setting......................................................................................................................10
8.2.1. Inclusion Criteria ........................................................................................11
8.2.2. Exclusion Criteria.......................................................................................11
8.3. Variables..................................................................................................................11
8.4. Data Sources............................................................................................................12
8.5. Study Size................................................................................................................12
8.6. Data Management ...................................................................................................12
8.7. Data Analysis ..........................................................................................................13
8.8. Quality Control........................................................................................................13
8.9. Limitations of the Research Methods......................................................................13
8.10. Other Aspects ........................................................................................................14
9. PROTECTION OF HUMAN PARTICIPANTS .................................................................14
9.1. Patient Information..................................................................................................14
9.2. Patient Consent........................................................................................................14
9.3. Institutional Review Board (IRB)/ Ethics Committee (EC)....................................14
9.4. Ethical Conduct of the Study ..................................................................................14
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................14
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........15
12. REFERENCES ..................................................................................................................16
13. LIST OF TABLES.............................................................................................................17
14. LIST OF FIGURES ...........................................................................................................17
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2. LIST OF ABBREVIATIONS
Abbreviation
Definition
ADH
Aptar Digital Health
AE
Adverse Event
CGRP
Calcitonin Gene-related Peptide
CM
Chronic Migraine
CV
Cardiovascular
EM
Episodic Migraine
EMA
European Medicines Agency
HCP
Healthcare Professional
HIPPA
Health Insurance Portability and Accountability Act
HT
Hydroxytryptamine
ICJME
International Committee of Medical Journal Editors
IRB
Institutional Review Board
ISPOR
International Society for Pharmacoeconomics and 
Outcomes Research
MHD
Monthly Headache Day
MMD
Monthly Migraine Day
NRDL
National Reimbursement Drugs List
ODT
Orally Disintegrating Tablet
QoL
Quality of Life
RCT
Randomized control trial
SD
Standard Deviation
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Abbreviation
Definition
US
United States of America
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4. AMENDMENTS AND UPDATES
None.
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5. MILESTONES
Milestone
Planned Date
Initiation of data analysis
09 June 2024
Completion of data analysis
10 June 2024
Abstract
14 June 2024
6. RATIONALE AND BACKGROUND
Migraine is a common, often disabling neurologic disease characterized by recurrent attacks 
of head pain that are typically unilateral, throbbing, and associated with a range of symptoms 
that may include photophobia, phonophobia, nausea, and vomiting.1-3 Migraine can be 
classified as episodic or chronic based on the frequency of the migraine or headache: 
episodic migraine (EM) is characterized by one to 14 monthly headache days (MHDs) or 
monthly migraine days (MMDs), while chronic migraine (CM) is characterized by 15 or 
more MHDs for at least three months, with at least eight days a month on which the 
headaches and associated symptoms meet diagnostic criteria for migraine.1,3,4 Migraine is a 
clinically complex disorder, and in addition to its direct clinical burden, patients experience a 
greater number of comorbidities compared to those without migraine.5
While treatment goals vary by region, guidelines from both the US and France (the most 
recently published treatment goals in Europe) for acute migraine treatment suggest these are 
rapid and sustained freedom from pain, improvement in other migraine symptoms, and 
minimal or no adverse events (AEs).6,7 There is significant need for effective and tolerable 
treatments for migraine sufferers, especially those who experience at least four migraine days 
per month. In these patients, preventive treatment is recommended to reduce migraine-related 
disability and the overuse of acute therapies and rescue medication.6 Both US and European 
guidelines note the importance of reduced attack frequency, reduction or maintenance (no 
escalation) of acute treatment use, and an improvement in quality of life (QoL).6,7 Current 
migraine treatments leave millions of people who have migraine with unmet needs due to 
lack of and/or insufficient efficacy, AEs, and contraindications.8,9
Treatment strategies aim to abort episodic symptoms and reduce the frequency of attacks, 
with "triptans" (5-hydroxytryptamine [5-HT]1b/1d receptor agonists) being the most 
commonly used prescription medications for acute treatment.10 However, their effectiveness 
is not universal, and due to vasoconstrictive effects, they are contraindicated in patients with 
known cardiovascular disease (CV). Recent advancements have introduced 2 novel classes of 
acute migraine medications: selective 5-HT1F agonists ("ditans") and CGRP antagonists 
("gepants"), with the U.S. Food and Drug Administration approving Lasmiditan, Ubrogepant, 
and rimegepant for the acute treatment of migraine in adults.
Rimegepant (VYDURA®/NURTEC® ODT), a next-generation, small molecule oral 
selective and potent calcitonin gene-related peptide (CGRP) receptor antagonist, is the first 
and only migraine treatment approved for both the acute treatment of migraine with or 
without aura in adults and for the preventive treatment of EM in adults who have at least four 
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migraine attacks per month. Prior to rimegepant, there was no single medication proven to be 
safe and effective for both acute and preventive treatment of migraine. Rimegepant was 
approved in the US for the acute treatment of migraine in February 2020, and for preventive 
treatment of episodic migraine in adults who have at least 4 migraine attacks per month in 
May 2021. It was approved by the EMA for both indications in April 2022.
There is a lack of published studies comparing directly triptans which are the most 
commonly used prescription medications for acute treatment with rimegepant. Existing 
indirect comparisons between the randomized controlled trials (RCTs) of rimegepant and 
triptans are confounded by high levels of heterogeneity leading to biased results.
This study will utilize retrospective data collected with the Migraine Buddy Mobile 
application to evaluate satisfaction of treatment with rimegepant and triptans. The primary 
motivation for the study is to generate evidence to support a submission to the National 
Reimbursement Drugs List (NRDL) in China, but it is anticipated that results will also be of 
relevance to health care providers and payers outside of China.
7. RESEARCH QUESTION AND OBJECTIVES
Primary objective: The objective of this study is 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.
Research questions:
1. How does satisfaction with pain intensity compare between adults diagnosed with 
migraine who are using Nurtec or triptans as an acute treatment for migraine?
2. How does satisfaction with attack duration compare between adults diagnosed with 
migraine who are using Nurtec or triptans as an acute treatment for migraine?
3. 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?
4. 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?
5. How does satisfaction with tolerability compare between adults diagnosed with 
migraine who are using Nurtec or triptans as an acute treatment for migraine?
6. 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?
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7. How do clinical characteristics (for eg, 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.
8. RESEARCH METHODS 
8.1. Study Design 
This is a retrospective analysis of cross-sectional data collected in the Migraine Buddy app 
between 20 October 2023 and 20 May 2024 from US users. 
Migraine Buddy users reporting current use of an acute treatment for their migraine attacks 
completed a survey assessing their satisfaction with the acute migraine drugs being used. 
Data from users reporting use of Nurtec and/or a triptan (and Rizatriptan in particular) will be 
extracted for analysis.
The primary endpoint is the level of satisfaction on several dimensions of migraine 
characteristics. Survey questions ask specifically about satisfaction with Nurtec or the triptan. 
The level of satisfaction with Nurtec will be compared to the level of satisfaction with 
triptans.
The strength of this design is the real-life setting of the data collected. Users were using the 
Migraine Buddy app for tracking their migraines in real life.
8.2. Setting
Migraine Buddy is an app available on iOS and Android. It’s used by people interested in 
tracking their headaches and other symptoms. It generates reports that users are able to share
with their doctors to help them establish a diagnosis and/or optimize treatment. The app has 
been downloaded more than 3.7 million times across 190 countries.
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. For the purpose 
of 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. The survey becomes visible on the home page after users have recorded in the app 
at least one migraine attack treated with that specific acute treatment (via a survey about this 
medication in particular eg, “Are you satisfied with Nurtec?”). Once completed, the survey is 
removed from the home page unless the user switches or initiates a new 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 particular acute treatment eg, 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
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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 30 October 2023 & 20 May 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 in order to 
perform the analysis described in this protocol.
8.2.1. 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).
Patients must meet all of the following inclusion criteria to be eligible for the study:
1. Male or female participants with migraine
2. Having consented to the anonymous use of their data for research 
3. Currently using Nurtec and/or triptans to treat migraine attacks
8.2.2. Exclusion Criteria
Patients meeting any of the following criteria will not be included in the study:
1. Users who did not report using either medication for which they complete the survey 
within 60 days prior to the survey.
8.3. Variables
For this retrospective study, the only variables collected are the self-reported satisfaction of 
Migraine Buddy users via a questionnaire accessible from the home screen of the app.
Satisfaction with Nurtec or triptans was asked in relation to several dimensions: pain
intensity, attack duration, speed of action, cognitive impact of Migraine, tolerability, and 
other symptoms. 
Variable
Role
Current acute treatment (s)
Patient treatments
Current prevention treatment (s)
Patient treatments
Monthly migraine Days
Clinical Characteristics
Satisfaction with treating pain
Outcome
Satisfaction with reducing attack duration
Outcome
Satisfaction with speed of pain relief
Outcome
Satisfaction with reduction of migraine-
Outcome
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Variable
Role
cognitive impact 
Satisfaction with tolerability
Outcome
Satisfaction with relief of other symptoms
Outcome
8.4. Data Sources 
Data source is the Migraine Buddy app responses to questions in the satisfaction survey. The 
Migraine buddy app and its database is owned by ADH, after the acquisition of Healint. The 
satisfaction levels refer to the medication in general. They are not tied to specific attacks. To 
avoid a recall bias, data from users answering the survey more than 60 days after the last time 
they reported using Nurtec or a triptan will be discarded.
This questionnaire 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. 
Data will be reported for the overall cohort, no individual data will be shared.
8.5. Study Size
The available number of patients (sample size) for this study is approx. 700 for the Nurtec 
group and 800 for the triptan group. By definition some users may have responded to both 
satisfaction surveys, ie, both groups of patients may overlap. Descriptive statistics will be 
used to summarize the study variables.
8.6. Data Management 
This retrospective observational study involves the use of real-world data that exists in 
anonymized structured format and does not contain patient personal information. If 
identifiable information is available, this will be removed by ADH in accordance with 
HIPPA standards to protect participants privacy.
ADH is the developer and distributor of the Migraine Buddy app. This app is used by people 
who wish to track their migraine attacks for their own usage and/or share reports with their 
doctor. Occasionally, users answers surveys to improve their journey with the app. The 
source of data for this retrospective study is the Migraine Buddy app. The data used for this 
study was collected independently from the protocol. There is no CRF. The survey data are 
simply extracted as csv files via a python code.
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8.7. Data Analysis 
The study analysis population will include patients who received Nurtec and/or triptans as an 
acute treatment currently for their migraine. 
The feasibility of subgroup analyses will be explored (eg, by migraine severity, currently 
using prophylactic treatment). Feasibility will evaluate if there is sufficient sample size for 
meaningful comparisons. All outcomes will remain blinded for the feasibility assessment.
The mean, standard deviation (SD), median, 25th and 75th percentiles and minimum and 
maximum values will be reported for numeric variables, whilst relative frequencies and 
percentages will be reported for categorical variables.
To compare the outcome measures (Section 7) between adults diagnosed with migraine who 
are using either Nurtec or triptans as an acute treatment for migraine, appropriate tests 
(eg, t-test, chi-square test) will be used based on the distribution of the measure. The alpha 
level will be 0.05, 2-sided.  No adjustments for multiple comparisons will be made.
The real-world nature of the Migraine Buddy app means variables may contain different 
proportions of missing data. We would expect the non-missing observations (the ‘base’) of 
patients to vary from variable to variable. The base relevant to each analysis will be reported 
in any data tables provided. This study will use a ‘complete case analysis’ approach to handle 
missing values, ie, there will be no imputation of missing data. Where missing values are 
found in a particular variable, any patients with missing values will be removed from all 
pieces of analysis where that variable is used. However, patients removed from one piece of 
analysis are still eligible for inclusion in other analyses.11
8.8. Quality Control
As this is a retrospective study, issues of quality control at study sites, eg, data queries, do 
not apply. Analysis is programmed according to the specifications in this protocol.
Data will be cleaned to address missing values, outliers and inconsistencies.
No open field questions are used in the survey, participants simply check boxes. 
Programming prevented users from selected multiple answers to single-choice questions. The 
number of variables is low. No specific encoding (C-DISC etc) is needed.
8.9. Limitations of the Research Methods
While Migraine Buddy users self-report as having migraine has been shown to be reliable, it 
is possible that they have been misdiagnosed or are currently receiving a triptan to assist an 
HCP with determining a diagnosis of migraine.12 This would potentially reduce the response 
to migraine-specific drugs such as triptans or rimegepant.
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The answers from users can be recorded at different time in relation to a migraine attacks: 
before, during, just after or up to 60 days after an attack. Those timings can impact the 
perception of relief/outcome. Therefore, the results presented should only be considered in 
the scope of a comparison between 2 drugs and not as absolute values expressing a 
proportion of attacks on which the said drug will provide a positive outcome.
8.10. Other Aspects
Not applicable.
9. PROTECTION OF HUMAN PARTICIPANTS
9.1. Patient Information 
This study involves data that exist in deidentified/anonymized structured format and contains
no patient personal information. 
9.2. Patient Consent
As this study involves deidentified/anonymized structured data, which according to 
applicable legal requirements do not contain data subject to privacy laws, obtaining informed 
consent from patients by Pfizer is not required.
9.3. Institutional Review Board (IRB)/ Ethics Committee (EC)
It is the responsibility of ADH to obtain an IRB-approved waiver which provides legal 
protection and institutional endorsement of the study. All correspondence with the IRB/EC 
should be retained by ADH. Copies of IRB/EC waivers should be forwarded to Pfizer.
9.4. Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as 
with scientific purpose, value, and rigor and follow generally accepted research practices 
described in Good Pharmacoepidemiology Practices issued by the International Society for 
Pharmacoepidemiology, the Good Outcomes Research Practices issued by ISPOR (formerly 
known as the International Society for Pharmacoeconomics and Outcomes Research) and the 
International Ethical Guidelines for Epidemiological Research issued by the Council for
International Organizations of Medical Sciences.
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS 
This study involves data that already exist as structured data by the time of study start. In 
these data sources, it is not possible to link (ie, identify a potential association between) a 
particular product and medical event for any individual. Thus, the minimum criteria for 
reporting an adverse event (AE) (ie, identifiable patient, identifiable reporter, a suspect 
product, and event) cannot be met.
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11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
Data will be analyzed to produce an abstract to be submitted for a presentation at the 
PAINWeek meeting in September 2024. Authorship of any publications resulting from this 
study will be determined on the basis of the International Committee of Medical Journal 
Editors (ICJME) Recommendations for the Conduct, Reporting, Editing and Publication of 
Scholarly Work in Medical Journals. 13
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
competent authority in any area of the world, or if the party responsible for collecting data 
from the participant is aware of any new information which might influence the evaluation of 
the benefits and risks of a Pfizer product, Pfizer should be informed immediately.  
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12. REFERENCES
1.
Headache Classification Committee of the International Headache Society (IHS). The 
International Classification of Headache Disorders, 3rd edition. Cephalalgia. 
2018;38(1):1-211.
2.
Mayans L, Walling A. Acute Migraine Headache: Treatment Strategies. American 
Family Physician. 2018;97(4):243-251.
3.
Ailani j, Burch R, Robbins M, Directors ABo. The American Headache Society 
Consensus Statement: Update on Integrating New Migraine Treatments Into Clinical 
Practice. Headache: The Journal of Head and Face Pain. 2021;61(7):1021-1039.
4.
Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between 
episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16(1):86-92.
5.
Bonafede M, Cai Q, Cappell K, et al. Factors associated with direct health care costs 
among patients with Migraine. Journal of Managed Care and Specialty Pharmacy. 
2017;23(11):1169-1176.
6.
Ailani j, Burch R, Robbins M, Directors ABo. The American Headache Society 
Consensus Statement: Update on Integrating New Migraine Treatments Into Clinical 
Practice. Headache: The Journal of Head and Face Pain. 2021;61(7):1021-1039.
7.
Ducros A, de Gaalon S, Roos C, et al. Revised guidelines of the French headache 
society for the diagnosis and management of migraine in adults. Part 2: 
Pharmacological treatment. Revue neurologique. 2021;177(7):734-752.
8.
Marmura MJ, Silberstein SD, Schwedt TJ. The Acute Treatment of Migraine in Adults: 
The A merican H eadache Society Evidence Assessment of Migraine 
Pharmacotherapies. Headache: The Journal of Head and Face Pain. 2015;55(1):3-20.
9.
Moreno-Ajona D, Chan C, Villar-Martínez MD, Goadsby PJ. Targeting CGRP and 5-
HT(1F) Receptors for the Acute Therapy of Migraine: A Literature Review. Headache: 
The Journal of Head and Face Pain. 2019;59 (Suppl 2):3-19.
10.
Loder E. Triptan therapy in migraine. New Engl J Med. 2010;363(1):63-70.
11.
Ross RK, Breskin A, Westreich D. When Is a Complete-Case Approach to Missing 
Data Valid? The Importance of Effect-Measure Modification. Am J Epidemiol. 2020 
Dec 1;189(12):1583-1589. 
12.
Ezzati A, Fanning K, Urani A, Cadiou F, Lipton RB. A comparison of Headache 
Assessment via Digital Platform in the United States (HeAD-US) and AMPP studies. 
2024; 102 (17 suppl 1)-6686.
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13.
Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly 
Work in Medication Journals, 2019.
13. LIST OF TABLES 
None.
14. LIST OF FIGURES
None.
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PFIZER CONFIDENTIAL 
CT24-WI-GL02-RF02 6.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 
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Appendix 1. Screenshots of the Survey as Seen by the Participants
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Rimegepant
C4951073 NON-INTERVENTIONAL STUDY PROTOCOL
V1.0, 04 June 2024
PFIZER CONFIDENTIAL 
CT24-WI-GL02-RF02 6.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 
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090177e1a10c93c9\Approved\Approved On: 27-Jun-2024 17:43 (GMT)

Rimegepant
C4951073 NON-INTERVENTIONAL STUDY PROTOCOL
V1.0, 04 June 2024
PFIZER CONFIDENTIAL 
CT24-WI-GL02-RF02 6.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 
Page 20 of 20
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