A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily Dosing of Rimegepant in Episodic Migraine Prevention
Phase: PHASE4
Conditions: Migraine, Episodic Migraine, Phonophobia, Photophobia
Sponsor: Pfizer

BHV-3000 (PF-07899801) (Rimegepant)
Protocol BHV3000-405 (C4951011)
Protocol Version 6.0, Amendment 5, 07 August 2023
Page 1 of 86
PFIZER CONFIDENTIAL
DRUG:
BHV-3000 (PF-07899801) (rimegepant)
STUDY NUMBER(S):
BHV3000-405 (C4951011)
PROTOCOL(S) 
TITLE:
A Phase 4, Open-label Study to Evaluate the Safety and 
Tolerability of Daily Dosing of Rimegepant in Episodic Migraine 
Prevention 
IND NUMBER:
109886
SPONSOR:
Pfizer Inc. 
66 Hudson Boulevard East New York, NY 10001 
ORIGINAL 
PROTOCOL DATE:
22 November 2021
VERSION NUMBER:
6.0 
VERSION DATE:
07 August 2023
This amendment incorporates all revisions to date, including amendments made at the request 
of country health authorities and IRBs/ECs and any protocol administrative change letter.
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Protocol BHV3000-405 (C4951011)
Protocol Version 6.0, Amendment 5, 07 August 2023
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PFIZER CONFIDENTIAL
PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Amendment 5 (Protocol Version 6.0) 
Overall Rationale for the Amendment: Change in sponsorship from Biohaven to Pfizer with 
alignment of the protocol template. 
Description of change
Brief Rationale
Section # and Name
Substantial Modification(s)
Referenced study number 
BHV3000-405 to C4951011 and 
compound name BHV-3000 to 
PF-07899801 to reflect 
identification changes by sponsor.
Reflects change in sponsorship 
protocol and compound 
identification numbers
Throughout Document
Headers
Title page
Updated the planned number of 
subjects from 230 to 285.
Increased sample size needs in 
order to account for up to 40% 
drop out rate through 24 weeks
Study Summary (Synopsis)
Section 1.5 Study Rationale
Section 5.1 Number of Subjects
Section 9.1 Sample Size
Clarified the procedure for unused, 
non-expired, and partial wallets 
during Open-label Treatment 
Phase.
Added clarity on study procedures Section 4.3.2 Open-label 
Treatment Phase
Removed criteria pertaining to 
“Signed Written Informed 
Consent”.
Allowed for subjects that were 
unable to read and/or understand 
English or Spanish to be included. 
Removed need to provide all 
demographic information and  
aligned with Pfizer’s standards 
and processes
Section 5.2 Inclusion Criteria 
Removed the exclusion criterion 
for patients with HIV disease.
Aligned with rimegepant 
prescribing information where 
there is no exclusion for use in 
patients with HIV
Section 5.3 Exclusion Criteria #2
Clarified that blood pressure must 
be less than 150/100 mg Hg at the 
screening and baseline visit.
Clarified that BP must be within 
range prior to dosing of IP
Section 5.3 Exclusion Criteria #2b
Removed the exclusion criterion 
for patients with gallstones and 
cholecystectomy.
Aligned with rimegepant 
prescribing information where 
there is no exclusion for use in 
subjects with biliary disorder
Section 5.3 Exclusion Criteria #2
Removed Gilbert's Syndrome from 
the exclusionary criteria.
Aligned with rimegepant 
prescribing information where 
there is no exclusion for use in 
Gilbert’s Syndrome
Section 5.3 Exclusion Criteria #2
Clarified the exclusion criterion of 
narcotics.
Updated for clarity.
Section 5.3 Exclusion Criteria #2j
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Protocol Version 6.0, Amendment 5, 07 August 2023
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PFIZER CONFIDENTIAL
Amended the exclusion criterion 
for body mass index to 
>35.0 kg/m2 from >33.0 kg/m2.
Aligned definition to be inclusive 
of all Class 1 Obesity subjects
Section 5.3 Exclusion Criteria #2n
Updated requirement for duration 
of contraception use after last dose 
of study drug.
Aligned with Pfizer standard and 
processes
Section 5.3 Exclusion Criteria #4a
Amended exclusion criterion for 
HbA1c to > 7.5%.
Allowed inclusion of well 
controlled diabetics aligned with 
rimegepant prescribing 
information where there is no 
exclusion for subjects with 
diabetes
Section 5.3 Exclusion Criteria #5g
Amended the hepatic exclusion 
criteria to allow subjects with 
1.5xULN of ALT, AST and 
1.5xULN of Total Bilirubin.
Allowed for inclusion of subjects 
with mild LFT elevations 
consistent with the prescribing 
information where there is no 
exclusion for subjects with mild 
hepatic disease 
Section 4.3.1 Screening Phase
Section 5.3 Exclusion Criteria #5c
and #5d
Removed specific exclusionary 
ECG criteria.
Allowed for investigator opinion 
on exclusionary ECG findings
Section 5.3 Exclusion Criteria #5b
Changed eGFR from <40 to 
<30 mL/min/1.73m2.
Allowed for subjects with 
moderate renal impairment to be 
included in the trial consistent 
with the prescribing information.
Section 5.3 Exclusion Criteria #5a
Added exclusion criterion for 
involvement in the conduct of the 
clinical trial by staff or family 
members.
Aligned with Pfizer protocol 
template
Section 5.3 Exclusion Criteria #7k
Allowed for re-screening of 
subjects due to prior failed 
eligibility criteria.
Allowed for re-screening of 
subjects who previously were 
screen failed for an amended 
exclusionary criterion
Section 4.3.1 Screening visit
Section 5.3 Exclusion Criteria #7i
Removed “but did not participate 
in any multiple dose rimegepant 
study” from exclusion criteria.
Editorial, redundant sentence
Section 5.3 Exclusion Criteria #7f
Removed “any reason which, in 
opinion of the Investigator, would 
prevent the subject from 
participating in the study” from 
exclusion criteria.
Removed redundant exclusion 
criteria
Section 5.3 Exclusion Criteria #8
Removed tacrolimus from the 
strong CYP3A4 inhibitors list.
Added telithromycin and
troleandomycin to the list of 
strong CYP3A4 inhibitors, and 
avasimibe to the list of strong 
CYP3A4 inducers.
Aligned with nonclinical and 
clinical DDI information available 
on rimegepant
Section 16.2 Appendix 2 Inhibitors 
and Inducers of CYP3A4 and 
Inhibitors of P-glycoprotein (Not 
all-inclusive)
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Protocol Version 6.0, Amendment 5, 07 August 2023
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PFIZER CONFIDENTIAL
Changed term “non-migraine” to 
“non-headache”, and term “acute 
migraine” to “acute headache”.
Clarified to include broader 
definition of headache which 
includes non-migraine and 
migraine headache
Section 5.4 Prohibited and 
Restricted Concomitant 
Medications and Devices
Clarified that in case of DILI the 
PI should determine if the patient 
can safely continue in the study 
and expanded DILI definition to 
include subjects with abnormal 
hepatic function at study entry.
Updated definition to align with 
revised LFT exclusion criteria 
Section 8.4 Potential Drug Induced 
Liver Injury (DILI)
Added Appendix for ECG 
findings of Potential Clinical 
Concern.
Aligned with Pfizer protocol 
template
Section 16.4 Appendix 4 ECG 
Findings of Potential Clinical 
Concern
Added the definition of Sponsor's 
Medically Qualified Individual.
Aligned with Pfizer protocol 
template
Section 10.7 Sponsor’s Medically 
Qualified Individual
Updated benefit risk background 
information, regulatory status, and
clinical development status.
Added benefit risk assessment.
Updated benefit risk information
to include up to date data
Study Summary (Synopsis)
Section 1.3 Product Development 
Background
Section 1.4 Benefit Risk 
Assessment
Updated contraception 
requirement for WOCBP, and 
removed contraception 
requirement for males and sections 
for “Women of Childbearing
Potential” and “Pregnancy”.
Aligned with Pfizer standard and 
processes
Section 5.2 Inclusion Criteria #2b
Section 5.6 Contraception
Section 16.5 Appendix 5 –
Contraceptive and Barrier 
Guidance
Section 5.6 Women of 
Childbearing Potential (Removed)
Section 8.4 Pregnancy (Removed)
Non-substantial Modification(s)
Updated protocol synopsis.
Aligned with Pfizer protocol 
template
Study Summary (Synopsis) 
Removed “Male and female” from 
inclusion criteria #2a.
Aligned with Pfizer protocol 
template
Section 5.2 Inclusion Criteria #2a
Removed the bullet name of 
“Other Inclusion Criteria” for 
previous inclusion criteria #6.
Aligned with Pfizer protocol 
template
Section 5.2 Inclusion Criteria #3
Added galcanezumab and  
eptinezumab as prohibited 
concomitant use of CGRP 
antagonists, updated the generic 
and trade names.
Added comprehensive list of 
CGRP antagonists instead of 
examples for clarity
Section 5.2 Inclusion Criteria #1e, 
ii
Clarified that this amendment 
incorporates all revisions to date, 
including amendments made at the 
request of country health 
authorities and IRBs/ECs and any 
PACL.
Aligned with Pfizer protocol 
template
Title page
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PFIZER CONFIDENTIAL
Added the detail that this is a post 
marketing required study.
Clarified that this is a post 
marketing required study.
Study Summary (Synopsis)
Section 1.5 Study Rationale
Clarified that subjects may start 
study drug on the day of the 
baseline visit or the following day, 
depending on the time of day of 
their visit.
Allowed IP to be started the day 
after the baseline visit if subjects 
have already missed their 
scheduled dosing time, to keep 
dosing around the same time each 
day.
Section 4.3 Schedule of
Assessment, Table 1
Section 4.3.2.1 Baseline Visit
Section 7.2.2 Selection and Timing 
of Dose and Administration
Removed “SAE forms and SAE 
Reporting instructions” and 
“Pregnancy Surveillance Forms” 
form study materials, and added 
“Back-up forms for CT SAE 
report, Exposure During 
Pregnancy and Pregnant Partner 
Release of Information”.
Aligned with Pfizer SAE reporting 
process and applicable study 
materials
Section 6.1 Study Materials
Removed “(and non-
investigational product at the 
discretion of the investigator)”.
Clarified that management of non-
investigational products is not 
protocol driven for early 
discontinuation subjects.
Section 6.5 Early Discontinuation 
from the Study
Updated SAE reporting 
destination and electronic 
reporting system administrative 
changes and clarifications.
Incorporation of non-substantial 
changes described in previous 
PACL dated 28 Apr 2023
Section 8.1.2 Collection and 
Reporting Serious Adverse Events
Updated text for Data Protection.
Aligned with Pfizer protocol 
template
Section 15 Data Protection
Added compliance aim for IP of 
80%.
Defined compliance for clarity
Section 7.4 Treatment 
Compliance
Clarified study drug destruction.
Updated destination for study drug 
destruction
Section 7.5 Destruction and Return 
of Study Drug
Removed Clinical Protocol 
Approval Form.
Aligned with Pfizer protocol 
template
Section 16 Clinical Protocol 
approval form (removed)
Removed CONFIDENTIAL AND 
INVESTIGATOR 
STATEMENT.
Aligned with Pfizer protocol 
template
CONFIDENTIAL AND 
INVESTIGATOR STATEMENT
(removed)
Updated the time for database lock 
and the type of CSR to be 
produced.
Updated for clarity
Section 9.4 Schedule of Analyses
Clarified that acetaminophen 
would be allowed during the study
for acute headache.
Updated for clarity
Section 5.4 Prohibited and 
Restricted Concomitant 
Medications and Devices #5
Added reference to quality 
tolerance limits.
Aligned with Pfizer protocol 
template
Section 9.3 Statistical Methods
Removed Phase 1 study exception
and the statement regarding 
Principal Investigator and the 
Sponsor’s representative 
signatory. Added Sponsor’s 
Aligned with Pfizer protocol 
template
Section 10.1 Good Clinical 
Practice
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PFIZER CONFIDENTIAL
regulatory and ethics 
responsibilities.
Add the section for IRB/IEC.
Aligned with Pfizer protocol 
template
Section 10.3 Institutional Review 
Board/Independent Ethics 
Committee
Added Pfizer standard text for 
Dissemination of Clinical Study 
Data.
Aligned with Pfizer protocol 
template
Section 10.6 Dissemination of 
Clinical Study Data
Added AE information on lack of 
efficacy and medication errors.
Aligned with Pfizer protocol 
template
Section 8.5.4 Lack of Efficacy
Section 8.5.5 Medication Errors
Added Pfizer standard safety 
language for environmental 
exposure, exposure during 
pregnancy, exposure during 
breastfeeding, occupational 
exposure.
Aligned with Pfizer protocol 
template and incorporated changes 
made in PACL dated 28 Apr 2023
Section 8.5 Environmental 
Exposure, Exposure During
Pregnancy or Breastfeeding, and 
Occupational Exposure
Removed “read”, and clarify that 
subjects must sign and date an ICF 
for study participation.
Aligned with Pfizer standard and 
processes
Section 10.4 Informed Consent
Removed Names of Study 
Personnel.
Removed to protect personal 
information
Section 16.1 Appendices Names of 
Study Personnel (removed)
Moved prior Protocol Amendment 
Summary of Changes to 
Appendix.
Editorial
Section 16.1 Appendix 1 Protocol 
Amendment History
Updated List of abbreviations
Editorial
List of Abbreviations
Changed term 
“Non-Investigational Product”, to 
“Concomitant Therapy”, and 
updated the definition for 
concomitant therapy.
Aligned definition with current 
regulations.
Section 7.1.2 Concomitant 
Therapy
Corrected that non-serious AEs 
should be reported from signing of 
consent through Follow up Week 
8 Visit.
Correction
Section 4.3 Schedule of 
Assessment, footnote #10
Section 4.3.3.2 Follow-up Week 8 
Visit
Removed “provided the IRB/IEC 
is notified within 5 days”.
Amended to allow for immediate 
action to be implemented
Section 12 Amendments
Updated Publications Policy.
Updated per investigator’s Clinical 
Research Agreement
Section 13 Publications Policy
Updated details on confidentiality 
and renamed section, Data 
Protection.
Replaced with Pfizer Data 
protection policy
Section 15 Data Protection
Updated the exclusion criterion 
number as 7g in the title.
Editorial update
Section 16.3 Appendix 3 –
Categories of Migraine Prevention 
Medications (Reference for 
Exclusion Criteria 7g)
Removed the subtitle for Clinical 
Adverse Event Profile.
Editorial
Section 1.3.1 Clinical Adverse 
Event Profile
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Updated document header and 
footer.
Updated to align with Pfizer 
protocol template
Header and Footer
Corrected inconsistencies and 
typographical errors throughout 
the protocol.
Corrections to provide clarity and 
consistency throughout the 
protocol. 
Applicable sections of the protocol
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STUDY SUMMARY (SYNOPSIS)
Protocol Title: A Phase 4, Open-label Study to Evaluate the Safety and Tolerability of Daily 
Dosing of Rimegepant in Episodic Migraine Prevention
Brief Title: The purpose of this study is to further evaluate the long-term safety and tolerability 
of daily dosing of rimegepant for the prevention of episodic migraine.
Regulatory Agency Identification Number(s): 
US IND Number:
109886
EudraCT Number:
NA
ClinicalTrials.gov ID:  
NCT05207865
Pediatric Investigational Plan Number:
NA
Protocol Number:
BHV3000-405 (C4951011)
Phase:
4
Rationale: This is a post marketing required study being conducted to further evaluate the long-
term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the 
prevention of episodic migraine. 
Primary Objectives:  
To evaluate the long-term safety and tolerability of rimegepant taken daily for episodic migraine 
prevention.
Primary Endpoint: 
Frequencies of the following safety events and findings on treatment: AEs that occur in at least 
5% of subjects by intensity; serious adverse events (SAEs); AEs leading to study drug 
discontinuation; and grade 3 to 4 laboratory test abnormalities.
Overall Design: 
This is a multicenter, open-label study to assess the safety and tolerability of rimegepant in 
migraine prevention. The Screening Phase is 3-14 days in duration, followed by a Baseline Visit 
at which time eligibility for continued participation in the study will be assessed before study 
drug is dispensed.  Subjects will take 1 tablet (rimegepant 75 mg ODT) each day during the 
Open-Label Treatment Phase. If subjects have a migraine during the Open-label Treatment 
Phase, then they may treat the migraine with permitted acute migraine medication as needed 
while continuing to take the study drug.
Study visits will occur at Screening, Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, 
Week 20, Week 24, and End of Treatment (EOT) for early discontinuation. After the Week 24 or 
EOT Visit, subjects should complete the Follow-up Week 2 and Follow-up Week 8 visits for 
assessment of AEs and laboratory assessments. 
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Number of Subjects: 
A sufficient number of subjects will be screened to treat up to 285 subjects with study drug to 
ensure that at least 170 subjects will complete 24 weeks of treatment.  All subjects will be 
assigned to rimegepant 75 mg ODT dosed daily. 
Study Population:  
The study will recruit subjects 18 years of age or older with at least a one-year history of 
episodic migraine (with or without aura) consistent with a diagnosis according to the 
International Classification of Headache Disorders, 3rd edition. Per their own report, subjects 
must have migraine onset prior to age 50, migraine attacks that last 4-72 hours (if not treated), 
and have had 4-14 migraine attacks per 4 week period within the 12 weeks prior to the 
Screening Visit.
WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to 
avoid pregnancy for the entire study and for 28 days after the last dose of study drug, women 
who are pregnant or breastfeeding, and women with a positive pregnancy test at screening or 
prior to study drug administration will be excluded.  
Subjects with a history of or current evidence of uncontrolled, unstable or recently diagnosed 
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral 
ischemia are excluded. Subjects with myocardial infarction (MI), acute coronary syndrome 
(ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic 
attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit will be excluded. 
Subjects will also be excluded who have uncontrolled hypertension (high blood pressure), 
uncontrolled diabetes, or a history or current evidence of any unstable medical conditions that, in 
the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) 
or interfere with assessments of safety or efficacy during the course of the study
History of use of opioid- (morphine, codeine, oxycodone, hydrocodone) or barbiturate- (e.g. 
butalbital) containing medication for ≥4 days per month during the 3 months (12 weeks) prior to 
the Screening Visit is exclusionary. 
Statistical Methods: 
The frequencies of the following on-treatment safety events and findings will be presented for 
the safety analysis set: AEs by intensity in >5% of subjects (mild, moderate, severe, total); 
SAEs; AEs by relationship to study drug (related, possibly related, unlikely related, not related); 
AEs related to study drug by intensity; AEs leading to study drug discontinuation; hepatic-
related AEs by intensity; hepatic-related AEs leading to study drug discontinuation; laboratory 
test abnormalities by toxicity grade; LFT elevations based on fold change above ULN; and vital 
sign, physical measurement, and ECG abnormalities. Frequencies of safety events will be based 
on the number and percentage of subjects with events.
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Ethical Considerations: 
It is not known if it is safe to take more than 18 doses of rimegepant in 30 days. Taking into 
account the measures to minimize risk to subjects with episodic migraine, the potential risks 
associated with rimegepant are justified by the anticipated benefits that may be afforded to 
subjects with daily dosing regimens. 
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TABLE OF CONTENTS
PROTOCOL AMENDMENT SUMMARY OF CHANGES.....................................................2
STUDY SUMMARY (SYNOPSIS) ..............................................................................................8
TABLE OF CONTENTS ............................................................................................................12
LIST OF TABLES.......................................................................................................................14
LIST OF FIGURES.....................................................................................................................14
LIST OF ABBREVIATIONS .....................................................................................................15
1
INTRODUCTION AND RATIONALE .............................................................................19
1.1
Background ......................................................................................................................19
1.2
CGRP’s Role in Migraine ...............................................................................................19
1.3
Product Development Background ................................................................................20
1.4
Benefit Risk Assessment..................................................................................................20
1.5
Study Rationale................................................................................................................22
1.5.1
Study Design Rationale..............................................................................................22
1.5.2
Dose Selection.............................................................................................................22
1.6
Research Hypothesis........................................................................................................22
2
STUDY OBJECTIVES ........................................................................................................23
2.1
Primary.............................................................................................................................23
2.2
Secondary..........................................................................................................................23
2.3
Exploratory Objectives....................................................................................................23
3
STUDY ENDPOINTS ..........................................................................................................24
3.1
Primary.............................................................................................................................24
3.2
Secondary..........................................................................................................................24
4
STUDY PLAN.......................................................................................................................25
4.1
Study Design and Duration.............................................................................................25
4.2
Study Schematic...............................................................................................................27
4.3
Schedule of Assessments..................................................................................................28
4.3.1
Screening Phase..........................................................................................................33
4.3.2
Open-label Treatment Phase ....................................................................................33
4.3.2.1
Baseline Visit ........................................................................................................34
4.3.2.2
Week 24 or EOT Visit..........................................................................................34
4.3.3
Follow-up Phase .........................................................................................................35
4.3.3.1
Follow-up Week 2 Visit .......................................................................................35
4.3.3.2
Follow-up Week 8 Visit .......................................................................................35
4.4
Post Study Access to Therapy (if applicable) ................................................................35
5
POPULATION......................................................................................................................36
5.1
Number of Subjects..........................................................................................................36
5.2
Inclusion Criteria.............................................................................................................36
5.3
Exclusion Criteria............................................................................................................37
5.4
Prohibited and Restricted Concomitant Medications and Devices.............................42
5.5
Standard of Care Migraine Medications.......................................................................43
5.5.1
Prophylactic Migraine Medications.........................................................................43
5.5.2
Acute Migraine Medications.....................................................................................44
5.6
Contraception...................................................................................................................45
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5.7
Other Restrictions and Precautions (if applicable).......................................................45
5.8
Deviation from Inclusion/Exclusion Criteria and Study Procedures..........................45
6
STUDY CONDUCT AND DESCRIPTION OF STUDY PROCEDURES .....................46
6.1
Study Materials................................................................................................................46
6.2
Safety Assessments...........................................................................................................47
6.2.1
Vital Signs and Physical Measurements (Height and Weight)..............................47
6.2.2
Electrocardiogram (ECG).........................................................................................47
6.2.3
Physical Exam ............................................................................................................47
6.2.4
Laboratory Assessments............................................................................................47
6.2.4.1
Safety Laboratory Testing ..................................................................................48
6.2.4.2
Pregnancy Testing................................................................................................49
6.2.5
Columbia-Suicide Severity Rating Scale (C-SSRS)................................................49
6.3
Efficacy Assessments .......................................................................................................49
6.4
Other Assessments ...........................................................................................................49
6.5
Early Discontinuation from the Study...........................................................................49
6.5.1
Lost to Follow-up .......................................................................................................50
6.6
Clinical Trial Subject Database (CTSdatabase) ...........................................................50
7
STUDY DRUG MANAGEMENT.......................................................................................52
7.1
Description of Study Drug ..............................................................................................52
7.1.1
Investigational Product .............................................................................................52
7.1.2
Concomitant Therapy................................................................................................52
7.1.3
Packaging, Shipment and Storage............................................................................52
7.2
Dose and Administration.................................................................................................53
7.2.1
Method of Assigning Subject Identification ............................................................53
7.2.2
Selection and Timing of Dose and Administration.................................................53
7.2.3
Dose Modification ......................................................................................................53
7.2.4
Dose Interruptions .....................................................................................................54
7.3
Blinding and Unblinding.................................................................................................54
7.4
Treatment Compliance....................................................................................................54
7.5
Destruction and Return of Study Drug..........................................................................55
8
ADVERSE EVENTS ............................................................................................................56
8.1
SERIOUS ADVERSE EVENT.......................................................................................57
8.1.1
Definition of Serious Adverse Event (SAE).............................................................57
8.1.2
Collection and Reporting Serious Adverse Events .................................................59
8.2
Non-serious Adverse Events............................................................................................60
8.2.1
Collection and Reporting of Non-serious Adverse Events .....................................60
8.2.2
Laboratory Test Abnormalities................................................................................60
8.3
Overdose ...........................................................................................................................60
8.4
Potential Drug Induced Liver Injury (DILI) ................................................................60
8.5
Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure ...................................................................................................61
8.5.1
Exposure During Pregnancy.....................................................................................62
8.5.2
Exposure During Breastfeeding................................................................................64
8.5.3
Occupational Exposure .............................................................................................64
8.5.4
Lack of Efficacy..........................................................................................................64
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8.5.5
Medication Errors......................................................................................................64
8.6
Adverse Events of Special Interest.................................................................................65
9
STATISTICS.........................................................................................................................65
9.1
Sample Size.......................................................................................................................65
9.2
Analysis Sets .....................................................................................................................66
9.3
Statistical Methods...........................................................................................................66
9.4
Schedule of Analyses........................................................................................................67
10 ETHICS AND RESPONSIBILITIES.................................................................................68
10.1
Good Clinical Practice.....................................................................................................68
10.2
Data and Safety Monitoring Committee........................................................................68
10.3
Institutional Review Board/Independent Ethics Committee.......................................69
10.4
Informed Consent ............................................................................................................70
10.5
Case Report Forms ..........................................................................................................71
10.6
Dissemination of Clinical Study Data ............................................................................71
10.6.1
Data sharing ...............................................................................................................72
10.7
Sponsor’s Medically Qualified Individual.....................................................................72
11 RECORDS MANAGEMENT AND RETENTION...........................................................73
11.1
Source Documentation.....................................................................................................74
11.2
Study Files and Record Retention..................................................................................74
12 AMENDMENTS...................................................................................................................75
13 PUBLICATIONS POLICY .................................................................................................75
14 STUDY DISCONTINUATION...........................................................................................75
15 DATA PROTECTION.........................................................................................................76
16 APPENDICES.......................................................................................................................77
16.1
Appendix 1 - Protocol Amendment History..................................................................77
16.2
Appendix 2 – Inhibitors and Inducers of CYP3A4 and Inhibitors of  P-
glycoprotein (Not all-inclusive).......................................................................................78
16.3
Appendix 3 – Categories of Migraine Prevention Medications (Reference for 
Exclusion Criteria 7g)......................................................................................................80
16.4
Appendix 4 - ECG Findings of Potential Clinical Concern .........................................81
16.5
Appendix 5 - Contraceptive and Barrier Guidance......................................................83
16.5.1
Male Subject Reproductive Inclusion Criteria .......................................................83
16.5.2
Female Subject Reproductive Inclusion Criteria....................................................83
16.5.3
Woman of Childbearing Potential............................................................................83
16.5.4
Contraceptive Methods .............................................................................................84
17 REFERENCES .....................................................................................................................86
LIST OF TABLES
Table 1
Schedule of Assessments......................................................................................29
LIST OF FIGURES
Figure 1
Study Schematic Up to 24 Weeks of Open-Label Treatment with Daily 
Dosing....................................................................................................................27
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LIST OF ABBREVIATIONS
ACE
Angiotensin Converting Enzyme
ACS
Acute Coronary Syndrome
AD
Anxiety Disorder
ADHD
Attention-Deficit/Hyperactivity Disorder
ADIS
Animal Diseases Information System
AE
Adverse Event
ALT
Alanine Aminotransferase
ARB
Angiotensin Receptor Blocker
AST
Aspartate Aminotransferase
AV
Atrioventricular
BHV
Biohaven
BP
Blood Pressure
bpm
Beats per Minute
BUN
Blood Urea Nitrogen
CBD
Cannabidiol
CGRP
Calcitonin Gene-Related Peptide 
CK
Creatine Kinase
COVID-19
Coronavirus Disease 2019
(e)CRF
(Electronic) Case Report Form
CRO
Clinical Research Organization
CRPS
Complex Regional Pain Syndrome
CSR
Clinical Study Report
C-SSRS
Columbia-Suicide Severity Rating Scale
CT
Clinical Trial
CTCAE
Common Terminology Criteria for Adverse Events
CTIS
Clinical Trial Information System
CTS
Clinical Trial Subject
CV
Cardiovascular
CYP
Cytochrome P450
DAIDS
Division of AIDS
DDI
Drug-Drug Interaction
DILI
Drug-Induced Liver Injury
DSMC
Data and Safety Monitoring Committee
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DSM-V
Diagnostic and Statistical manual of Mental Disorders Fifth edition
DSU
Drug Safety Unit
EC
Ethics Committee
ECC
Emergency Contact Card
ECG
Electrocardiogram
EDB
Exposure During Breastfeeding
EDC
Electronic Data Capture
EDP
Exposure During Pregnancy
eGFR
Estimated Glomerular Filtration Rate
EOD
Every Other Day
EOT
End of Treatment
ET
Early Terminated
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials (European Clinical 
Trials Database)
FDA
Food and Drug Administration
FSH
Follicle Stimulating Hormone
FU
Follow-Up
GCP
Good Clinical Practice
GGT
Gamma-Glutamyl Transferase
GLP
Good Laboratory Practice
HbA1c
Hemoglobin A1C
HCG
Human Chorionic Gonadotropin
HDL 
High Density Lipoprotein
HIV
Human Immunodeficiency Virus
HRT
Hormone Replacement Therapy
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
ID
Identifier
IEC
Independent Ethics Committee
IND
Investigational New Drug
IP
investigational product
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IRB
Institutional Review Board
ISF
Investigator Site File
IV
Intravenous
IWRS
Interactive Web Response System
kg
Kilogram
LBBB
Left Bundle Branch Block
LDH
Lactate Dehydrogenase
LDL
Low-density Lipoprotein
LFTs
Liver Function Tests
MDD
Major Depressive
MDE
Major Depressive Episode
MDMA
3,4-Methyl-enedioxy-methamphetamine
MDRD
Modification of Diet in Renal Disease
MedDRA
Medical Dictionary for Regulatory Activities
mg
Milligram
MI
Myocardial Infarction
min
Minute
mL
Milliliter
MQI
Medically Qualified Individual
mRNA
Messenger Ribonucleic Acid
msec
Millisecond
NA
Not Applicable
NOAEL
No Observed Adverse Effect Level
NSAE
Non-Serious Adverse Event
NSAID
Non-Steroidal Anti-Inflammatory Drug
ODT
Orally disintegrated tablet
OTC
Over-the-Counter
PACL
Protocol Administrative Change Letter
PCI
Percutaneous Coronary Intervention
PCP
Phencyclidine
PE
Physical Examination
P-gp
P-glycoprotein
PI
Principal Investigator
PRN
As Needed
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PSSA
Pfizer SAE Submission Assistant
PVC
Premature Ventricular Contraction
QRS
Ventricular Depolarization
QT
Time to Ventricular Depolarization to Repolarization
QTc
Interval between Q-wave and T-wave in the cardiac cycle
QTcF
QTc corrected using Fridericia’s formula
QTL
Quality Tolerance Limit
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SF
Screen Fail
SOP
Standard Operating Procedure
SRSD
Single Reference Safety Document
TBili
Total Bilirubin
THC
Tetrahydrocannabinol
TIA
Transient Ischemic Attack
(e)TMF
(Electronic) Trial Master File
UK
United Kingdom
uL
Microliter
ULN
Upper Limit of Normal
UNS
United States
US
United States
W#
Week #
WOCBP
Women of Childbearing Potential
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1
INTRODUCTION AND RATIONALE
1.1
Background
Migraine is a common and debilitating neurological disorder that affects approximately 15% of 
the adult population. It is characterized by moderate-to-severe episodic unilateral pulsating 
headaches that last for 4 to 72 hours. Typical characteristics of the headache are unilateral 
location, pulsating quality, moderate or severe intensity, aggravation by routine physical activity, 
and association with nausea and/or photophobia and phonophobia.1
BHV-3000 (PF-07899801) (rimegepant) is a calcitonin gene-related peptide (CGRP) receptor 
antagonist in development for the acute treatment of migraine. The CGRP receptor is located 
within pain-signaling pathways, intracranial arteries and mast cells and its activation is thought 
to play a causal role in migraine pathophysiology. For example, research and clinical studies 
have shown serum levels of CGRP are elevated during migraine attacks, infusion of intravenous 
(IV) CGRP produces persistent pain in migraine sufferers and non-migraine sufferers, and 
treatment with anti-migraine drugs normalize CGRP levels. Additionally, multiple clinical 
studies show that small molecule CGRP receptor antagonists, which inhibit the binding of 
endogenous CGRP to CGRP receptors, are effective in aborting migraine attacks. Treatment with 
a CGRP receptor antagonist is believed to relieve migraine through the possible mechanisms of 
1) blocking neurogenic inflammation, 2) decreasing artery dilation, and 3) inhibiting pain 
transmission. There is widespread agreement that this new approach avoids the cardiovascular 
effects produced by active vasoconstriction associated with the current standard triptan therapy 
(non-selective 5-HT1B/1D agonists [e.g., sumatriptan {Imitrex™}]). 
1.2
CGRP’s Role in Migraine
Rimegepant is a selective, high-affinity, orally administered, small molecule calcitonin gene-
related peptide (CGRP) receptor antagonist.
CGRP is an endogenous 37 amino acid peptide contained within pain-signaling nociceptive 
afferents and is thought to play a causal role in migraine.2,3 Multiple lines of clinical evidence 
point to a role for CGRP in migraine pathophysiology: 1) serum levels of CGRP are elevated 
during migraine;2 2) treatment with anti-migraine drugs returns CGRP levels to normal 
coincident with pain relief;2,3 and 3) intravenous (IV) CGRP infusion produces lasting pain in 
non-migraineurs and migraineurs.4,5
Treatment with a CGRP receptor antagonist is believed to relieve migraine through the following 
possible mechanisms:

Blocking Neurogenic Inflammation: Binding of CGRP receptor antagonists to CGRP 
receptors located on mast cells would inhibit inflammation caused by trigeminal nerve 
release of CGRP onto mast cells within the tough outer covering of the brain, or the 
meninges.
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
Decreasing Artery Dilation: By blocking the CGRP receptors located in smooth muscle 
cells within vessel walls in the meninges, CGRP receptor antagonists would inhibit the 
pathologic dilation of intracranial arteries without the unwanted effect of active 
vasoconstriction.

Inhibiting Pain Transmission: Binding of CGRP receptor antagonists to CGRP receptors 
would suppress the transmission of pain by inhibiting the central relay of pain signals from 
the trigeminal nerve to the caudal trigeminal nucleus.
Rimegepant offers a novel therapeutic mechanism for the acute treatment of migraine with the 
potential to address important unmet needs (e.g., single-dose durable efficacy, efficacy without 
medication overuse headache, and no contraindications or warnings in patients with 
cardiovascular [CV] disease).
1.3
Product Development Background
Details of the clinical and preclinical studies are provided in the most current Investigator 
Brochure (IB). A summary of the relevant data to the study are presented below. 
Rimegepant is approved for acute treatment and prevention of episodic migraine in the US, EU 
and UK and is well tolerated in humans when given as single oral dose of 75 mg to treat acute 
migraine and at a dose of 75 mg EOD for the prevention of episodic migraine. Every other day 
dosing was well tolerated with no signals of hypersensitivity, cardiovascular events or 
hepatotoxicity.6
As of 26 August 2022, more than 8900 unique subjects have participated in Phase 1 studies in 
healthy subjects or Phase 2 and 3 studies in subjects with migraine or refractory trigeminal 
neuralgia, chronic rhinosinusitis, or temporomandibular disorders; of these, approximately 6036 
unique subjects have received rimegepant at any dose. Collectively, the current data 
demonstrates a favorable benefit-risk profile for rimegepant in the acute and preventive treatment 
of migraine.
1.4
Benefit Risk Assessment 
Rimegepant is approved in the US, EU, and UK for the treatment of migraine in adults, including 
both acute treatment of migraine and preventive treatment of episodic migraine. Rimegepant 
appears to be generally safe and well tolerated in humans when given as single oral doses from 
75 mg up to the maximum dose of 1,500 mg and multiple oral doses up to the maximum daily 
dose of 600 mg for 14 days. Rimegepant 75 mg represents an advancement in migraine 
therapeutics, providing the first CGRP antagonist to demonstrate benefit for both the acute 
treatment and prophylaxis of migraine. Dual action therapy for migraine with a single agent 
offers patients the potential for significant clinical advantages including: 1) a simplified 
medication regimen to treat migraine across the spectrum from acute episodes to the prevention 
of future attacks, which are 2 manifestations of the same condition; 2) avoiding polypharmacy 
with concurrent use of multiple medications each with their own side effects; 3) reducing the risk 
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of drug-drug interactions; and 4) cost-effectiveness of a single medication that provides both 
acute and preventive therapy.
Broad and sustained efficacy of rimegepant 75 mg was demonstrated in 3 previously completed 
Phase 3 studies (BHV3000-301, BHV3000-302 and BHV3000-303). Statistically significant 
efficacy was demonstrated on the co-primary endpoints of freedom from pain, and freedom from 
most bothersome symptom at 2 hours post-dose. Also, in all 3 studies, significant results were 
achieved on photophobia freedom, phonophobia freedom and pain relief at 2 hours post-dose. 
Similar results were demonstrated in the BHV3000-310 study recently completed in China and 
Korea. In the Phase 2/3 placebo-controlled study (BHV3000-305) for the preventive treatment of 
migraine, rimegepant at a dose of 75 mg every other day (EOD) demonstrated statistically 
significant superiority to placebo on the primary endpoint of change from the observation period 
in the mean number of migraine days per month on treatment in the last month of the double-
blind treatment phase.
A multicenter open-label, long-term study (BHV3000-201) was conducted to evaluate the safety 
and tolerability of rimegepant 75 mg tablet taken as needed (up to 1 tablet per day upon onset of 
a migraine of mild, moderate, or severe intensity) for the acute treatment of migraine for up to 52 
weeks. This multiple-dose, long-term study of rimegepant 75 mg administered for up to 52 
weeks confirmed the favorable safety profile across a variety of safety endpoints, including AE 
assessments, clinical laboratory testing including LFTs, vital signs and ECGs. Safety data from 
the double-blind treatment and the open-label extension phases of the pivotal Phase 2/3, 
randomized, double-blind, placebo-controlled preventive treatment of migraine study 
(BHV3000-305) support a favorable safety profile of rimegepant 75 mg administered EOD for 
the preventive treatment of migraine. Rimegepant 75 mg administered EOD + PRN for up to 52 
weeks in the open-label phase is well tolerated, with no new safety signals observed in the open-
label-extension phase. It is not known if it is safe to take more than 18 doses of rimegepant in 30 
days. Taking into account the measures to minimize risk to subjects with episodic migraine, the 
potential risks associated with rimegepant are justified by the anticipated benefits that may be 
afforded to subjects with daily dosing regimens.
There are no adequate data on the developmental risk associated with the use of rimegepant in 
pregnant women. Women of childbearing potential (WOCBP) must have a negative pregnancy 
test and WOCBP must use an acceptable method of contraception to avoid pregnancy throughout 
the study in such a manner that the risk of pregnancy is minimized. Subjects undergo regular 
pregnancy testing throughout the duration of the study. Although no safety issues in clinical 
trials of rimegepant were observed, cardiovascular events, cerebrovascular events, hypertensive 
events, and serious gastrointestinal events associated with constipation are reviewed in each 
aggregate report per FDA request. None of these reviews have detected any safety signal 
associated with these events. Subjects are excluded if there is uncontrolled, unstable, or recently 
diagnosed cardiovascular disease or hypertension. Subjects are monitored through multiple 
safety endpoints, including AE assessments, clinical laboratory testing, vital signs and ECGs.
Review of all data available, including post-marketing information, nonclinical, clinical, and 
scientific literature data, demonstrates a favorable benefit-risk profile for the use of rimegepant 
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in this study. More detailed information about the known and expected benefits and risks and 
reasonably expected AEs of rimegepant may be found in the Investigator’s Brochure, which is 
the SRSD for this study.
1.5
Study Rationale
This post marketing required study is being conducted to further evaluate the long-term safety 
and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of 
episodic migraine for up to 24 weeks. Up to 285 subjects will dose with open-label study drug 
every day to ensure that at least 170 subjects will complete 24 weeks of treatment.
1.5.1
Study Design Rationale
This is a 24-week, multicenter, open-label evaluation of the long-term safety of rimegepant 75 
mg taken daily for the prevention of episodic migraine. Subjects will be required to take 1 tablet 
of rimegepant 75 mg ODT every day.  
If subjects have a migraine, they may treat the migraine with permitted acute migraine 
medications as needed (see Section 5.5.2) while continuing to take the study drug.
1.5.2
Dose Selection 
The Phase 2b dose-ranging study CN170003 established that rimegepant 75 mg is the minimum 
effective dose for the acute treatment of migraine. The three Phase 3 studies BHV3000-301, 
BHV3000-302, and BHV3000-303 confirmed this efficacy using the current registrational 
endpoints for acute treatment of migraine. The pivotal Phase 3 Study BHV3000-305 
demonstrated that rimegepant 75 mg EOD is effective and has a favorable safety profile for the 
prevention of migraine headache. The current study will evaluate the safety and tolerability of a 
more frequent daily dosing regimen in episodic migraine prevention.
1.6
Research Hypothesis
Rimegepant 75 mg ODT is well tolerated when taken daily for the prevention of episodic 
migraine.
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2
STUDY OBJECTIVES
2.1
Primary
To evaluate the safety and tolerability of rimegepant taken daily for episodic migraine prevention 
during the Open-label Treatment Phase.
2.2
Secondary
Not applicable.
2.3
Exploratory Objectives
1. To evaluate the frequency of AEs potentially associated with drug abuse during the Open-
label Treatment Phase.
2. To evaluate the frequency and intensity of hepatic-related AEs during the Open-label 
Treatment Phase.
3. To evaluate the frequency of liver function test (LFT) elevations (ALT, AST, alkaline 
phosphatase, and total bilirubin) based on fold changes above ULN during the Open-label 
Treatment Phase.
4. To evaluate the frequency of ALT or AST > 3x ULN concurrent with total bilirubin > 2x 
ULN during the Open-label Treatment Phase.
5. To evaluate the frequency of ALT or AST > 3x ULN in temporal association with nausea, 
vomiting, anorexia, abdominal pain, or fatigue during the Open-label Treatment Phase.
6. To evaluate the Columbia-Suicide Severity Rating Scale (C-SSRS) during the Open-label 
Treatment Phase.
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3
STUDY ENDPOINTS 
3.1
Primary
Frequencies of the following safety events and findings on treatment: AEs that occur in at least 
5% of subjects by intensity; serious adverse events (SAEs); AEs leading to study drug 
discontinuation; and grade 3 to 4 laboratory test abnormalities.
AEs are determined from electronic case report forms (eCRFs). 
Grade 3 to 4 laboratory test abnormalities are determined from laboratory test values graded 
using standardized criteria. Laboratory tests are identified from eCRFs and central laboratory 
data.
3.2
Secondary
Not applicable.
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4
STUDY PLAN
4.1
Study Design and Duration
This is a multicenter, open-label study to assess the safety and tolerability of rimegepant in 
migraine prevention.
The Screening Phase is 3-14 days in duration; subjects should return to the study site as soon 
after screening laboratory results are available, and within 14 days, for the Baseline Visit. For 
subjects to be eligible for the study, they must have reported having had 4-14 migraine attacks
per month in the 3 months prior to the Screening Visit. Subjects will have blood drawn and a 
urinalysis performed for baseline profiles, an ECG performed, and other procedures as noted in 
Table 1 at the Screening Visit. 
Upon the completion of the Screening Visit, subjects will be provided with a concomitant 
medication paper diary to document use of all concomitant medications, including standard of 
care migraine medications (both prophylactic and acute, prescribed and OTC) (see Sections 5.5.1
and 5.5.2). After completing the Screening Phase, subjects will return to the clinic with the paper 
diary for the Baseline Visit. Subjects found to be ineligible will be considered screening failures; 
subjects should return the concomitant medication paper diary which will be maintained as a 
source document.  
At the Baseline Visit, eligibility for continued participation in the study will be assessed before 
study drug is dispensed.  Subjects will be instructed that they must take 1 tablet (rimegepant 75 
mg ODT) each day during the Open-label Treatment Phase. If a dose of study drug for a given 
day is missed, lost, or otherwise unable to be taken, the subject should document that as a missed 
dose on the study drug wallet and should NOT take the following day’s assigned dose until the 
next calendar day at the specified time. If subjects have a migraine during the Open-label 
Treatment Phase, then they may treat the migraine with permitted acute migraine medication as 
needed (see Section 5.5.2) while continuing to take the study drug.
During the Open-label Treatment Phase, subjects will continue to record all concomitant 
medications, including standard of care migraine medications (both prophylactic and acute, 
prescribed and OTC), taken and all study drug taken.  The concomitant medication paper diary 
will continue to be used during the Follow-up Phase.
Assessments and the visit schedule are outlined in the procedural table in Section 4.3. Procedures 
include study personnel review of the concomitant medication paper diary with the subject, 
assessment of study drug compliance, monitoring of tolerability and safety (including vital signs, 
laboratory tests, and electrocardiography).  
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Study visits will occur at Screening, Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, 
Week 20, Week 24, and End of Treatment (EOT) for early discontinuation.  Subjects will return 
to the study site for the Week 24 or EOT Visit. There are follow-up visits approximately 2 weeks 
and 8 weeks after the Week 24 or EOT Visit for assessment of AEs and laboratory assessments.  
Subjects who take study drug and discontinue early from the Open-label Treatment Phase 
should complete the EOT Visit. All subjects who take study drug should complete the Follow-up 
Week 2 and the Follow-up Week 8 Visits, regardless of completing the Open-label Treatment 
Phase.
To closely monitor for potential drug induced liver injury (DILI), guidance on reporting potential 
DILI events is provided in the protocol. Lab results that meet predefined LFT abnormality 
criteria as DILI should be reported as an SAE. See Section 8.4, Potential Drug Induced Liver 
Injury (DILI).
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4.2
Study Schematic
Figure 1
Study Schematic Up to 24 Weeks of Open-Label Treatment with Daily Dosing
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4.3
Schedule of Assessments
Every effort should be made to conduct the study visits as planned. Concerns related to the 
Coronavirus disease 2019 (COVID-19) pandemic, other natural catastrophes (e.g., hurricane), 
and any additional case-by-case situations may be discussed for approval with the Sponsor. 
Following approval, provisions may be implemented to minimize potential hazards to study 
subjects and to maintain compliance with local government and institutional guidance (e.g., 
study center has a policy that a clinical research visit must be delayed).  These provisions may 
allow alternatives to in-person study visits and include, but are not limited to, the following: 
conducting remote study visits via phone/telemedicine video, focusing on safety assessments 
during remote visits, or performing safety labs via local laboratory or professional in-home 
phlebotomy vendors. Any potential issues should be discussed with Sponsor/CRO and will be 
addressed on an individualized basis. The Screening, Pre-Baseline Evaluation, Baseline, and 
Follow-up Week 8 Safety visits must be done in person. Other visits may be conducted under the
provisions mentioned above (remote via phone/telemedicine, local labs, etc.).
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Table 1
Schedule of Assessments
Screening 
Phase
(3-14 days)1
Open-label Treatment Phase2,3
Follow-up 
Phase2
Procedure
Screening 
Visit
Baseline 
Visit (Day 1)
Week 2
(Day 14 +/- 2 
days)
Week 4 (Day 28), 
Week 8 (Day 56), 
Week 12 (Day 84), 
Week 16 (Day 
112), & Week 20 
(Day 140)  (all 
visits +/-2 days)
Week 24 (Day 
168) (+/- 2 days) 
or EOT Visit
FU Week 2 and 
FU Week 8 
Visits (both visits 
+/-2 days) for all 
subjects4
Eligibility Assessments
Informed Consent
X
Duplicate Subject Check (in CTSdatabase)
X
Inclusion/Exclusion Criteria
X
X
Medical History
X
Migraine History (signs/symptoms/prior 
treatment/frequency/intensity)
X
Concomitant medication paper diary5
X
X
X
X
X
X5
Enroll subject / IWRS6
X
Safety Assessments
Physical Examination7
X
X (Week 12 Only)
X
Vital Signs / Physical Measurements8
X
X
X
X
X
X
Clinical Safety Laboratory Testing 9
X
X
X (Weeks 4, 8, 12, 
16 Only)
X
Liver Function Test (LFTs)9
X
X
X
X
X
X
Lipid Panel9
X
X (Week 12 only)
X
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Table 1
Schedule of Assessments
Screening 
Phase
(3-14 days)1
Open-label Treatment Phase2,3
Follow-up 
Phase2
Procedure
Screening 
Visit
Baseline 
Visit (Day 1)
Week 2
(Day 14 +/- 2 
days)
Week 4 (Day 28), 
Week 8 (Day 56), 
Week 12 (Day 84), 
Week 16 (Day 
112), & Week 20 
(Day 140)  (all 
visits +/-2 days)
Week 24 (Day 
168) (+/- 2 days) 
or EOT Visit
FU Week 2 and 
FU Week 8 
Visits (both visits 
+/-2 days) for all 
subjects4
ECG
X
X
X (Week 4, 8, 12 
Only)
X
Urinalysis
X
X
Urine Drug Screen for drugs of abuse
X
FSH, if applicable, to determine WOCBP 
status
X
Pregnancy Test
X (urine, 
serum)
X (urine)
X (urine)
X (urine)
X: FU W2 
(urine) & FU W8 
(serum)
AE, SAE, and Concomitant Procedure 
assessment10
X
X
X
X
X
X
Columbia-Suicide Severity Rating Scale (C-
SSRS)
X
X
X
X
X
X (FU W2 only)
Clinical Drug Supplies / Study Supplies
Dispense study drug11
X
X
Administer study drug, 11,12
X
X
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Table 1
Schedule of Assessments
Screening 
Phase
(3-14 days)1
Open-label Treatment Phase2,3
Follow-up 
Phase2
Procedure
Screening 
Visit
Baseline 
Visit (Day 1)
Week 2
(Day 14 +/- 2 
days)
Week 4 (Day 28), 
Week 8 (Day 56), 
Week 12 (Day 84), 
Week 16 (Day 
112), & Week 20 
(Day 140)  (all 
visits +/-2 days)
Week 24 (Day 
168) (+/- 2 days) 
or EOT Visit
FU Week 2 and 
FU Week 8 
Visits (both visits 
+/-2 days) for all 
subjects4
Return used and unused study drug to site 
for compliance check
X
X
X
1.
The duration between the Screening Visit and the Baseline Visit is 3-14 days.  Every effort should be made to perform the Baseline Visit (or Screening 
Failure Visit, where applicable) as soon as the screening laboratory results are available and within the 14 days.
2.
All subjects who take study drug and discontinue the Open-label Treatment Phase early should complete the EOT Visit. All subjects who take study 
drug should complete the Follow-up Week 2 and Follow-up Week 8 Visits, regardless of completing the Open-label Treatment Phase.
3.
While on-study, all visit windows are used for scheduling purposes and all efforts should be made to return subjects to their original visit schedule by 
calculating the visit window interval from the Baseline Visit.
4.
The follow-up visits should be scheduled based on date of the Week 24 or EOT Visit.  The visit window for the Follow-up Week 2 Visit is 14 days +/- 2 
days.  The visit window for the Follow-up Week 8 Visit is 56 days +/- 2 days; however, in cases of a delayed visit due to restrictions resulting from the 
COVID-19 pandemic, + 14 days may be utilized instead of + 2 days in order to ensure this final visit is completed in person.
5.
Concomitant medications, including standard of care migraine medications (both prophylactic and acute, prescribed and OTC), taken during the Screening 
Phase, Open-label Treatment Phase, or Follow-up Phase should be recorded in the subject’s concomitant medication paper diary, reviewed by study 
personnel at each visit, and a copy made at each study visit to be maintained in source records. At end of study, the concomitant medication paper diary
will be collected at the Follow-up Week 8 Visit.  
6.
The actual baseline visit date should be used for IWRS enrollment date and eligibility date.
7.
Per Section 6.2.3, full PE is required at screening and brief symptom directed PEs are required at all other visits as noted.
8.
Height will be measured at the Screening Visit only.  Weight, body temperature, respiratory rate, blood pressure, and heart rate will be collected at all 
timepoints where indicated.  Sitting arterial systolic and diastolic blood pressure and radial artery pulse rate will be measured.
9.
If possible, subjects should be fasting for a minimum of 8 hours before laboratory tests. However, if a subject is not fasting, the blood draw should still be 
performed, and the non-fasting status should be documented. HbA1c only collected at screening, repeat or UNS. 
10. SAEs, AEs, and Concomitant Procedures must be reported after subject signs informed consent.  SAEs and Concomitant Procedures should be reported 
from signing of consent through the Follow up Week 8 Visit.  Non-serious AEs should be reported from signing of consent through Follow up Week 8 
Visit. 
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Table 1
Schedule of Assessments
Screening 
Phase
(3-14 days)1
Open-label Treatment Phase2,3
Follow-up 
Phase2
Procedure
Screening 
Visit
Baseline 
Visit (Day 1)
Week 2
(Day 14 +/- 2 
days)
Week 4 (Day 28), 
Week 8 (Day 56), 
Week 12 (Day 84), 
Week 16 (Day 
112), & Week 20 
(Day 140)  (all 
visits +/-2 days)
Week 24 (Day 
168) (+/- 2 days) 
or EOT Visit
FU Week 2 and 
FU Week 8 
Visits (both visits 
+/-2 days) for all 
subjects4
11. Subjects should finish a wallet of study drug before starting a new wallet.  Study drug will be dispensed at monthly (every 4 weeks) study visits, as 
needed.  Site staff should mark each wallet with the scheduled date of each dose to be taken when dispensing the study drug.
12. Subjects must take their study drug daily regardless of whether they have a migraine.  Doses are not required to be taken in the office on days of a study 
visit, however dosing requirements and compliance should be discussed with subjects at all visits.  If a dose of study drug for a given day is missed, lost, 
or otherwise unable to be taken, the subject should document that as a missed dose on the study drug wallet and should NOT take the following day’s 
assigned dose until the next calendar day at the specified time.
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4.3.1
Screening Phase
The Screening Phase will be 3-14 days and will have 1 scheduled visit, the Screening Visit, 
which should be completed in person.  Subjects will undergo all screening procedures as detailed 
in Table 1.  
Before any study procedures are performed, subjects must provide documented informed 
consent.  After informed consent, subjects will be enrolled in the IWRS system. The subject’s 
migraine history and medical history will be collected at the Screening Visit.  
All subjects will continue to use their standard of care migraine medications (both prophylactic 
and acute, prescribed and OTC) during the Screening Phase.  Subjects will record all 
concomitant medications, including standard of care migraine medications (both prophylactic 
and acute, prescribed and OTC), in a concomitant medication paper diary. 
The duration between the Screening Visit and the Baseline Visit is 3-14 days.  Every effort 
should be made to perform the Baseline Visit after as soon as the screening laboratory results are 
available and within the 14 days. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
considered for re-screening in select circumstances (e.g., previously pregnant, screening window 
too long). Subjects who were considered screen failures previously may be considered for re-
screening provided the ineligibility was due to one of the eligibility criteria that may have 
changed due to medical intervention or one of the eligibility criteria modified in a protocol 
amendment. Adequate documentation in source records must support the previously failed 
criteria. In all possible re-screening circumstances, the situation must be discussed with
the Sponsor prior to re-screening, with approval in writing from the Sponsor prior to re-
screening.  If a subject is approved for re-screening, a new subject number must be obtained 
from the appropriate study-related system. Re-screening will only be permitted one time.
4.3.2
Open-label Treatment Phase
The Open-label Treatment Phase will be up to 24 weeks from the Baseline Visit through the 
Week 24 or EOT Visit. 
During the Open-label Treatment Phase, subjects will be instructed that they must take 1 tablet of 
study drug (rimegepant 75 mg ODT) daily. If subjects have a migraine during the Open-label 
Treatment Phase, then they may treat the migraine with permitted acute migraine medication as 
needed (see Section 5.5.2) while continuing to take the study drug. 
Subjects will continue to record all concomitant medications, including standard of care migraine 
medications (both prophylactic and acute, prescribed and OTC), taken during the entire Open-
label Treatment Phase on a concomitant medication paper diary.
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After the Baseline Visit, study visits will be approximately every 2 weeks during the first month 
and then every 4 weeks, until the Week 24 or EOT Visit (Table 1). At each visit, the concomitant 
medication paper diary will be reviewed by site staff for completeness and compliance. Study 
drug compliance and concomitant medication use will be reviewed at each visit and subjects will 
be dispensed additional study drug as needed. Unused, non-expired, partial wallets will be 
returned to the subjects for completion prior to starting a new wallet. Additional safety 
assessments (including laboratory tests and ECGs) will be performed per the schedule outlined in
Table 1.
Due to the COVID-19 pandemic, visits may be conducted remotely (ex: telephone, telemedicine) 
unless specified otherwise, and must be documented within the source records as being 
conducted remotely. All procedures not able to be completed due to a visit being conducted 
remotely must be reported as a protocol deviation and can be performed at the next visit, where 
appropriate to do so based on subject presentation.
4.3.2.1
Baseline Visit
Once completing the Screening Phase, subjects will return to the study site for the Baseline Visit, 
which must be completed in person. Subjects who continue to meet all eligibility criteria and 
have been compliant with the concomitant medication paper diary may enter the Open-label 
Treatment Phase.  
At the Baseline Visit, eligibility for continued participation in the study will be assessed before 
study drug is dispensed.  Subjects will be instructed that they must take 1 tablet of study drug 
(rimegepant 75 mg ODT) each day, and dosing should occur around the same time for each 
scheduled dose.  Subjects may start study drug on the day of the Baseline Visit or the following 
day, depending on the time of day of their visit. Subjects must be instructed that they CANNOT 
take more than 1 tablet of study drug daily during the Open-label Treatment Phase.  If a dose of 
study drug for a given day is missed, lost, or otherwise unable to be taken, the subject should 
document that as a missed dose on the study drug wallet and should NOT take the following 
day’s assigned dose until the next calendar day at the specified time. 
4.3.2.2
Week 24 or EOT Visit
Subjects will return to the study site at the Week 24 Visit (Day 168 +/- 2 days), or at the EOT 
Visit for early discontinuation, for review of the concomitant medication paper diary, assessment 
of study drug compliance, and assessment of safety (including vital signs, laboratory tests, and 
electrocardiography) (Table 1).  Subjects must return the unused study drug and concomitant 
paper diary to the study site. 
All subjects who take study drug and discontinue early from the Open-label Treatment Phase 
should complete the EOT Visit. Otherwise, subjects should complete the Week 24 Visit.
In cases where a Week 24 or EOT Visit occurs remotely in order to be completed during the 
protocol required window and due to the COVID-19 pandemic, the subject should return to the 
site for the Follow-up Week 2 Visit (2 weeks after the Week 12 or EOT Visit, -2 to +14 days), to 
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complete all procedures that were not able to be completed remotely.  Procedures completed at 
the Week 24 or EOT Visit occurring remotely do not need to be repeated.  
4.3.3
Follow-up Phase 
The Follow-up Phase will have 2 scheduled visits, Follow-up Week 2, and Follow-up Week 8; 
These visits should occur approximately 2 weeks and 8 weeks after the Week 24 or EOT Visit, 
respectively. All subjects who take study drug should complete both follow-up visits, regardless 
of completing the Open-label Treatment Phase.
Subjects will continue to record all concomitant medications, including standard of care migraine 
medications (both prophylactic and acute, prescribed and OTC), taken during the entire Follow-
up Phase in a concomitant medication paper diary.
4.3.3.1
Follow-up Week 2 Visit
Subjects will return to the study site approximately 2 weeks (14 days +/- 2 days) after the Week 
24 or EOT Visit to collect vital signs, LFTs, assessment of AEs/SAEs, to have the C-SSRS 
performed, and to have a urine pregnancy test performed (WOCBP). 
Investigators should assess subjects for AEs consistent with drug dependency or withdrawal 
effects and report as appropriate (see Section 7.4).
4.3.3.2
Follow-up Week 8 Visit
Subjects will return to the study site approximately 8 weeks (56 days +/- 2 days) after the Week 
24 or EOT Visit to collect vital signs, LFTs, assessment of AE/SAEs, and to have a serum 
pregnancy test performed (WOCBP).  Subjects will return the concomitant medication paper 
diary for documenting concomitant medications. 
The visit window for the Follow-up Week 8 Visit is 56 days +/- 2 days; however, in cases of a 
delayed visit due to restrictions resulting from the COVID-19 pandemic, + 14 days may be 
utilized instead of + 2 days in order to ensure this final visit is completed in person.
4.4
Post Study Access to Therapy (if applicable) 
At the conclusion of this study, subjects or investigators will not have access to the study drug.  
The investigator should ensure that the subject receives appropriate standard of care to treat the 
condition under study.
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5
POPULATION
5.1
Number of Subjects
A sufficient number of subjects will be screened to treat approximately 285 subjects with study 
drug to ensure that at least 170 subjects will complete 24 weeks of treatment.  All subjects will 
be assigned to rimegepant 75 mg ODT dosed daily.
5.2
Inclusion Criteria
1. Target Population
Subject has at least 1 year history of episodic migraine (with or without aura) consistent with 
a diagnosis according to the International Classification of Headache Disorders, 3rd Edition7, 
including the following:
a) Age of onset of migraines prior to 50 years of age.
b) Migraine attacks, on average, lasting 4 - 72 hours if untreated.
c) Per subject report, 4-14 migraine attacks of moderate or severe intensity per month within 
the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the 
purpose of this protocol).
d) Ability to distinguish migraine attacks from tension/cluster headaches.
e) Subjects on prophylactic migraine medication are permitted to remain on therapy if the 
dose has been stable for at least 3 months (12 weeks) prior to the Screening Visit, and the 
dose is not expected to change during the course of the study.
i. Subjects may remain on one (1) medication with possible migraine-
prophylactic effects (see Section 5.4).  
ii. Concomitant use of a CGRP antagonist, such as rimegepant (Nurtec® ODT), 
erenumab (AimovigTM), fremanezumab (AjovyTM), atogepant (QuliptaTM), 
ubrogepant (UbrelvyTM), galcanezumab (EmgalityTM), or eptinezumab 
(VyeptiTM) is prohibited.
iii. Subjects who previously discontinued oral prophylactic migraine medication 
must have done so at least 30 days prior to the Screening Visit.
iv. Subjects who previously discontinued biologic migraine medication must 
have done so at least 3 months (12 weeks) prior to the Screening Visit.
f)
Subjects with contraindications for use of triptans may be included provided they meet all 
other study entry criteria.
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2. Age and Reproductive Status
a) Subjects ≥ 18 years.
b) Subject meets reproductive criteria. Refer to Appendix 5 for reproductive criteria for 
male (Section 16.5.1) and female (Section 16.5.2) subjects. 
c) At the Baseline Visit, WOCBP must have a negative pregnancy test (minimum sensitivity 
25 IU/L or equivalent units of HCG) before dosing with study drug.
3. No clinically significant abnormality identified on the medical or laboratory evaluation. A 
subject with a clinical abnormality or laboratory parameters outside the reference range may 
be included only if the investigator considers the finding not clinically significant, that it will 
not introduce additional risk factors, nor interfere with the study procedures (not including 
exclusion criteria listed in Section 5.3).
5.3
Exclusion Criteria
1. Target Disease Exclusion
a) Subject has a history of basilar migraine, hemiplegic migraine, retinal migraine or 
migraine accompanied by diplopia or decreased level of consciousness as defined by 
International Classification of Headache Disorders, 3rd Edition7.
b) Subjects with headaches occurring 15 or more days per month (migraine or non-
migraine) in any of the 3 months prior to the Screening Visit.
2. Medical History and Concurrent Diseases
a) Subject history with current evidence of uncontrolled, unstable, or recently diagnosed 
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and 
cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome 
(ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke, or transient 
ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit. 
b) Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.  However, 
subjects can be included who have stable hypertension and/or diabetes for 3 months (12 
weeks) prior to the Screening Visit. Blood pressure greater than 150 mm Hg systolic or 
100 mm Hg diastolic after 10 minutes of rest at the screening or baseline visit is 
exclusionary.  Blood pressure measurement may be repeated once at screening visit and 
baseline to confirm reproducibility.
c) Subjects with major depressive (MDD) or any anxiety disorder (AD) which require more 
than 1 daily medication for each disorder or subjects with major depressive episode 
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(MDE) within last 12 months.  Medications to treat major depressive disorder or an 
anxiety disorder must have been at a stable dose for at least 3 months prior to the 
Screening Visit. 
d) Active chronic pain syndromes (such as fibromyalgia, chronic pelvic pain, complex 
regional pain syndrome [CRPS]).
e) Subjects with other pain syndromes (including trigeminal neuralgia), psychiatric 
conditions, dementia, or significant neurological disorders (other than migraine) that, in 
the Investigator’s opinion, might interfere with study assessments of safety or efficacy.
f)
Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, 
Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease or condition 
(e.g., chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption. 
g) Subject has a history or diagnosis of an active hepatic or biliary disorder.
h) The subject has a history or current evidence of any unstable medical conditions (e.g., 
history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis 
B or C, or cancer) that, in the investigator’s opinion, would expose them to undue risk of 
a significant adverse event (AE) or interfere with assessments of safety or efficacy during 
the course of the study.
i)
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months 
(48 weeks) or subjects who have met DSM-V criteria 8 for any significant substance use 
disorder within the past 12 months (48 weeks) from the date of the Screening Visit 
according to PI assessment.
j)
History of use of narcotics such as opioids (morphine, codeine, oxycodone, hydrocodone) 
or barbiturate- (e.g., butalbital) containing medication for >4 days per month during the 3 
months (12 weeks) prior to the Screening Visit. 
k) Subjects should be excluded if the subject has reported current use of, or has tested 
positive at the Screening visit for, drugs of abuse (amphetamines, barbiturates, 
benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA, 
methamphetamines, oxycodone, phencyclidine). In addition:
i.
Detectable levels of cocaine and phencyclidine (PCP) in the drug screen are 
exclusionary. Retesting is not allowed. 
ii.
Subjects who are positive for amphetamines, and who are on a prescribed 
amphetamine medication for an approved indication (e.g., ADHD) will be 
allowed into the study at the Investigator’s discretion.  This determination by the 
Investigator must be well documented in the subject’s source medical records.  
The stimulant dose must be stable from 3 months (12 weeks) prior to the Baseline 
Visit until the Week 24 or EOT Visit occurs.   
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iii.
Detectable levels of marijuana in the drug screen are not exclusionary, if in the 
investigator’s documented opinion the subject does not meet DSM-V  criteria8 for 
substance use disorder, and the positive test does not signal a clinical condition 
that would impact the safety of the subject or interpretation of the study results.  
Subject must agree to refrain from marijuana use during the study.
l)
Hematologic or solid malignancy diagnosis within 5 years prior to the Screening Visit. 
Subjects with a history of localized basal cell or squamous cell skin cancer are eligible 
for the study if they are cancer-free prior to the Screening Visit in this study.
m) Subject has current diagnosis of major depressive disorder requiring treatment with 
atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality 
disorder.
n) Body mass index > 35.0 kg/m2.
3. History of anaphylaxis to any substance or a clinically important reaction to any drug.
4. Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable contraceptive method or 
abstinence to avoid pregnancy for the entire study and 28 days after last dose of study 
drug.
b) Women who are pregnant or breastfeeding. 
c) Women with a positive pregnancy test at screening or prior to study drug administration.
5. ECG and Laboratory Test Findings
a) Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated 
(four-variable) Modification of Diet in Renal Disease (MDRD) Study equation <30
mL/min/1.73m2.
b) Abnormal ECG that in the investigator’s opinion makes the subject unsuitable for a 
clinical trial (e.g. Corrected QT interval > 470 msec).
c) Total bilirubin > 1.5 x ULN (For Gilbert’s syndrome, direct bilirubin >ULN is 
exclusionary).
d) AST or ALT > 1.5 x ULN.
e) Serum albumin <2.8 g/dL.
f)
Neutrophil count ≤ 1000/μL (or equivalent).
g) HbA1c > 7.5%.
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6. Prohibited Medications
a) History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or 
acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the 
Screening Visit.
b) Use of medication accepted for treatment of acute migraine (Section 5.5.2) for a non-
migraine indication on 15 days per month during the 3 months (12 weeks) prior to the 
Screening Visit.
c) Subjects taking a prohibited medication (Refer to Section 5.4). 
7. Other Exclusion Criteria
a) Prisoners or subjects who are involuntarilyincarcerated.
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical 
(e.g., infectious disease) illness.
c) Exposure to non-biological investigational agents (other than rimegepant) within the 30 
days prior to the Screening Visit.
d) Exposure to biological investigational agents within 3 months (12 weeks) prior to the 
Screening Visit.
e) Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5 within the last 12 
months prior to screening, OR subjects who endorse any of the 5 C-SSRS Suicidal 
Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or 
behavior) within the last 10 years prior to the Screening Visit, OR subjects who, in the 
opinion of the investigator, present a serious risk of suicide (See Section 6.2.5).
f)
Previous enrollment in any multiple dose BHV3000 (rimegepant) study, such as 
BHV3000-201, BHV3000-305, or BHV3000-404 regardless of the number of doses 
taken. Subjects may be considered for BHV3000-405 (C4951011) if the subject 
participated in any of the following single dose studies: BHV3000-301, BHV3000-302, 
BHV3000-303. Note that subjects who were considered screen failures in a past 
BHV3000 study may be considered after discussion with the Sponsor and written 
approval is received.  
g) Subjects are excluded if they have had no therapeutic response with > 2 of the 8 
medication categories for prophylactic treatment of migraine listed in Appendix 3 after an 
adequate therapeutic trial.  Additional details can be found in Section 16.3 Appendix 3.
h) Participation in any other investigational clinical study while participating in this clinical 
study. Participation in a COVID-19 mRNA vaccine study (vaccine must be authorized 
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under FDA emergency use authorization or approval) who are at least 30 days post last 
dose of the vaccine are permitted to be screened for this study.
i)
Past participation in a clinical study within 30 days prior to the Screening Visit.  Note: 
Individuals who do not meet the criteria for participation in this study (screen failure) 
may be considered for re-screening in select circumstances (e.g., previously pregnant, 
screening window too long, ineligibility was due to 1 of the eligibility criteria that may 
have changed due to medical intervention or 1 of the eligibility criteria modified in a 
protocol amendment). In all possible re-screening circumstances, the situation must be 
discussed with the Sponsor prior to re-screening, with approval in writing from the 
Sponsor prior to re-screening.
j)
Please see Section 5.4 for prohibited medications and Section 5.5.2 for permitted acute 
migraine medications.
k) Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members.
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5.4
Prohibited and Restricted Concomitant Medications and Devices 
All medications taken by subjects after screening until the last study day will be documented as 
concomitant medications including vaccinations. 
The medications and devices listed below are prohibited starting at the Baseline Visit and during 
the course of this study or as specified. 
1. St. John’s Wort should not be taken 14 days prior to the Baseline Visit and throughout the 
study.
2. Butterbur root or extracts should not be taken 14 days prior to the Baseline Visit and 
throughout the study.
3. History of use of ergotamine medications on 10 days per month on a regular basis for 3
months (12 weeks).  Note that use of ergotamine medication is prohibited throughout the 
entire duration of the study (Screening Visit to Follow-up Week 8 Visit), however reporting 
of any use of ergotamine medication is required for the purpose of defining migraine days.  
4. Use of narcotic medication, such as opioids (e.g., morphine, codeine, oxycodone, and
hydrocodone) or barbiturates is prohibited starting from 2 days prior to the Baseline Visit and 
throughout the study, including the Follow-up Week 8 Visit. 
5. Use of acetaminophen or acetaminophen containing products for non-headache indications 
after the Baseline Visit is prohibited. Any use of acetaminophen or acetaminophen 
containing products for non-headache indications during the Screening Phase must be 
stopped at least 2 days prior to Baseline Visit. Acetaminophen as acute headache medication 
as described in Section 5.5.2 is allowed during the study. 
6. The use of CGRP antagonists (biologic [e.g., Aimovig® or Ajovy®] or small molecule [e.g., 
Nurtec® ODT or UbrelvyTM]) other than rimegepant provided for this clinical study is 
prohibited during the study including through the Follow-up Week 8 Visit.
7. Use of marijuana and all forms of ingested or inhaled cannabidiol (CBD) and THC-
containing products are prohibited during the study. 
8. Concomitant use of moderate to strong CYP3A4 inhibitors is prohibited during the study. If 
use of a moderate or strong CYP3A4 inhibitor is required, such as use of HIV Protease 
Inhibitors, Hepatitis C protease inhibitors, certain azole antifungals, or clarithromycin, dosing 
with rimegepant should be stopped and should not start again until 14 days after the last dose 
of the moderate or strong CYP3A4 inhibitor.  Please see Section 16.2 Appendix 2.
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9. Concomitant use of moderate to strong CYP3A4 inducers is prohibited during the study. If 
use of a moderate or strong CYP3A4 inducer is required, such as use of carbamazepine, 
phenytoin, or rifampin, dosing should be stopped and should not start again until 14 days 
after the last dose of the moderate or strong CYP3A4 inducer. Please see Section 16.2
Appendix 2.
10. Concomitant use of atypical antipsychotics such as Abilify (aripiprazole), Zyprexa 
(olanzapine), Seroquel (quetiapine), Geodon (ziprasidone), or Risperdal (risperidone) or 
Depakote/Depakene (valproic acid/valproate) is prohibited during the study.
11. Concomitant use of LAMICTAL (lamotrigine) is prohibited during the study.
12. Use of analgesics other than acetaminophen for non-migraine use (e.g., nonsteroidal anti-
inflammatory drugs [NSAIDs]) on ≥ 15 days per month is prohibited. during the study. Use 
of acetaminophen or acetaminophen containing products for non-headache indications after 
the Baseline Visit is prohibited.
13. Use of CefalyTM or any other device for migraine treatment within 12 weeks of the Screening 
Visit. 
14. Use of any investigational agent other than rimegepant (provided for the purpose of this 
clinical study) from the Screening Visit through the Follow-up Week 8 Visit.
15. Concomitant use of strong inhibitors of the P-gp transporter with rimegepant is prohibited 
during the study.
5.5
Standard of Care Migraine Medications 
Use of standard of care migraine medication during the Screening Phase and through the Follow-
up Week 8 Visit will be recorded by the subject on the concomitant medication paper diary and 
reported to the site. Migraine medications include both prophylactic and acute migraine 
medications.
5.5.1
Prophylactic Migraine Medications
Subjects may not use more than 1 of the following medications with possible migraine-
prophylactic effects, regardless of indication, if not otherwise prohibited by the protocol.  Doses 
must be stable within 3 months (12 weeks) prior to the Screening Visit and throughout the 
study.  Use of more than 1 of the following medications is prohibited within 3 months (12 
weeks) prior to the Screening Visit and throughout the study.
Prophylactic migraine medications that are permitted during the study include:

Topiramate, gabapentin

Beta blockers (such as: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, 
propranolol, timolol)
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
Tricyclic antidepressants (such as: amitriptyline, nortriptyline, protriptyline)

Venlafaxine, desvenlafaxine, duloxetine, milnacipran

Flunarizine, lomerizine

Lisinopril, candesartan

Clonidine, guanfacine

Cyprohepatdine

Methysergide

Pizotifen

Feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)

Botox®
The above listed medications are the only prophylactic migraine medications allowed.
5.5.2
Acute Migraine Medications
Subjects may use their permitted standard of care medication if needed for acute treatment of a 
migraine throughout the study.  
Acute migraine medications that are permitted during the study include the following: 

triptans, 

aspirin, 

ibuprofen, 

baclofen, 

acetaminophen up to 1000 mg/day for a maximum of 2 consecutive days at a time (this 
includes Excedrin Migraine), 

Naprosyn (or any other type of non-steroidal anti-inflammatory (NSAID)), 

antiemetics (e.g., metoclopramide or promethazine), 

muscle relaxants for rescue during the study. 
The above listed medications are the only acute migraine medications allowed.
If a subject takes a tablet of study drug and experiences a migraine later that day, after dosing 
with study drug for the day, then the subject may take their permitted acute migraine medication
as described in this section of the protocol. During the Open-label Treatment Phase, subjects 
are not allowed to take more than 1 tablet of study drug daily.
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5.6
Contraception
The investigator or their designee, in consultation with the subject, will confirm that the subject 
is utilizing an appropriate method of contraception for the individual subject from the permitted 
list of contraception methods (see Section 16.5.4) and will confirm that the subject has been 
instructed in its consistent and correct use. 
The investigator or designee will inform the subject of the need to use acceptable effective 
contraception consistently and correctly and document the conversation and the subject’s 
affirmation in the subject’s chart. Subjects need to affirm their consistent and correct use of at 
least 1 of the selected methods of contraception, considering that their risk for pregnancy may 
have changed since the last visit. 
The investigator or designee will inform the subject of the need to use acceptable effective 
contraception consistently and correctly and document the conversation and the subject’s 
affirmation in the subject’s chart. Subjects need to affirm their consistent and correct use of at 
least 1 of the selected methods of contraception, considering that their risk for pregnancy may 
have changed since the last visit. 
5.7
Other Restrictions and Precautions (if applicable)
Not Applicable
5.8
Deviation from Inclusion/Exclusion Criteria and Study Procedures
Any significant event that does not comply with the inclusion / exclusion criteria, study conduct, 
or study procedures will be documented as a deviation. Deviations will be documented and 
reported through the clinical monitoring of the study. Deviations will be reported to the IRB/IEC 
at the frequency required by your IRB/IEC. Prospective approval of protocol deviations to 
recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not 
permitted.
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6
STUDY CONDUCT AND DESCRIPTION OF STUDY PROCEDURES
6.1
Study Materials 
The following study materials will be provided at the study start:

Investigator File/Regulatory Binder

Pharmacy Binder

Drug Accountability Logs

Sample source documents, where applicable

Concomitant medication paper diary (take home for subject) 

Investigator Brochure (IB)

Interactive Web-based Response System (IWRS)

Electronic Case Report Form (eCRF) instructions
o
Electronic Case Report Forms (eCRFs) will be prepared for all data collection fields
o
All sites will use an Electronic Data Capture (EDC) tool to submit study data to the CRO. 
Electronic Case Report Forms (eCRFs) will be prepared for all data collection fields 
including Serious Adverse Events (SAE) Reporting. SAE data (including queries) will be 
submitted to the CRO using eCRFs. 

Laboratory Kits and Laboratory Manual
Safety laboratory, plasma, and serum instructions for all specimens collected will be 
provided by a designated central laboratory.

ECG Machine and Instructions
ECG equipment, supplies, instructions, and training materials will be supplied by a 
centralized ECG vendor.

Back-up forms for CT SAE report, Exposure During Pregnancy and Pregnant Partner 
Release of Information

Columbia-Suicide Severity Rating Scale (C-SSRS) forms
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
Study system access:
○
Electronic Data Capture (EDC) tool to submit study data to Sponsor / CRO
○
IWRS
○
Central Laboratory vendor portal
○
Central ECG vendor portal
6.2
Safety Assessments
6.2.1
Vital Signs and Physical Measurements (Height and Weight)
Vital signs, body weight and height will be recorded at the scheduled visits as outlined in 
Table 1.
6.2.2
Electrocardiogram (ECG)
A standard 12-lead ECG will be recorded during the Screening Phase and at all scheduled visits 
as outlined in Table 1. A central ECG service will be utilized for reading all ECGs.  The over 
read from the central ECG vendor should be used to determine eligibility for the study. The 
investigator will determine if any ECG abnormalities are clinically significant or not (see Section
16.4 Appendix 4).
6.2.3
Physical Exam
Subjects will undergo a routine physical examination during the Screening Phase and brief and 
symptom-directed physical exam at all scheduled visits as outlined Table 1. Physical 
examinations to include at minimum examination of heart, abdomen, and lungs, and neurologic 
system with review of any other system to be guided by symptoms.
6.2.4
Laboratory Assessments
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. The 
laboratory reports must be filed with the source documents. Clinically significant abnormal 
laboratory test findings are those which are not associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s condition.
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6.2.4.1
Safety Laboratory Testing
Blood and urine samples will be obtained as outlined in Table 1 for clinical laboratory 
evaluations. A central laboratory vendor will be utilized for this study and a laboratory manual 
will be provided to each site. If possible, subjects should be fasting for a minimum of 8 hours 
before laboratory tests. However, if a subject is not fasting at a given visit, the blood draw 
should still be performed, and the non-fasting status should be documented.
1. Clinical safety labs: 
Hematology: Hemoglobin, hematocrit, red blood cell count, white blood cell count with 
differential, and platelets 
Chemistry: Sodium, potassium, chloride, bicarbonate, calcium; glucose, HbA1c (only 
collecting at screening, repeat, or UNS), BUN (urea), serum creatinine, uric acid, LDH, total 
protein, albumin, CK 
eGFR using the estimated MDRD formula (calculated at central lab)
2. LFTs: AST, ALT, Alkaline Phosphatase and Bilirubin (Total, Direct, Indirect).  Additional 
tests may be obtained to evaluate laboratory abnormalities and/or adverse events; please refer 
to the Laboratory manual.
3. Lipid Panel: Cholesterol, LDL, HDL, triglycerides 
4. Urinalysis: pH, specific gravity, ketones, nitrites, urobilinogen, leukocyte esterase, protein, 
glucose, and blood. If blood, protein, or leukocytes are positive, reflex to microscopic
examination.
5. Urine Drug Screen: For drugs of abuse
6. FSH: At screening in female subjects to confirm postmenopausal status, if applicable.
7. Reflex/add-on tests: 
If ALT or AST ≥ 3 x ULN OR total bilirubin ≥ 2 x ULN at any visit after the Baseline Visit, 
additional reflex or add-on tests may be performed that may include: CK, GGT, and anti-
viral serologies. Subjects may have to return to the study site to provide additional blood 
samples for these laboratory tests. See section on potential Drug Induced Liver Injury 
(Section 8.4).
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Additional tests may be obtained to evaluate laboratory abnormalities and/or adverse 
events; please refer to the Laboratory Manual.
6.2.4.2
Pregnancy Testing
WOCBP will complete pregnancy tests (serum and/or urine) at specified study visits, prior to 
taking study drug, and as outlined in Table 1.
6.2.5
Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide 
Assessment.9  The C-SSRS “Screening version” will be used at the Screening Visit and the 
“Since Last Visit version”10 will be used at subsequent visits in this study.  
The C-SSRS Assessment is intended to help establish a person’s immediate risk of suicide. The 
C-SSRS is a clinician administered scale that should be administered by a certified rater. This 
scale will be collected on site with a paper form.  The C-SSRS should be reviewed by the 
Investigator or designee before the subject is allowed to leave clinic.
At the Screening Visit, the recall period for completing is 12 months for suicidal ideation and 10 
years for suicidal behavior; at all other visits, the recall period for completing the C-SSRS is 
since the last visit (Table 1). 
Any “Yes” responses must be immediately evaluated by the investigator. If the Investigator 
determines that a subject is at risk of suicide, self-harm, appropriate measures to ensure the 
subject’s safety and obtain mental health evaluation must be implemented. In such 
circumstances, the subject must immediately be discontinued from the study. The event should 
be recorded as either an AE or SAE as determined by the Investigator and reported within 24 
hours to the Sponsor.
6.3
Efficacy Assessments
Not applicable.
6.4
Other Assessments 
Not applicable.
6.5
Early Discontinuation from the Study
Subjects MUST discontinue investigational product for any of the following reasons:

Withdrawal of informed consent (subject’s decision to withdraw for any reason)

Any clinical adverse event (AE), laboratory abnormality or intercurrent illness which, in the 
opinion of the investigator, indicates that continued participation in the study is not in the 
best interest of the subject
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
Exclusionary laboratory abnormality identified on the Baseline Laboratory Report.  

Pregnancy

Termination of the study by Pfizer 

Loss of ability to freely provide consent through imprisonment or involuntary incarceration 
for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Poor compliance with study procedures and visits, including poor completion compliance 
with the concomitant medication paper diary. 

See Section 6.2.5 for guidance on study discontinuation based on results from the C-SSRS.

All subjects who discontinue should comply with protocol specified Week 24 or EOT Visit 
procedures as outlined in Table 1. The only exception to this requirement is when a subject 
withdraws consent for all study procedures or loses the ability to consent freely (i.e., is 
imprisoned or involuntarily incarcerated for the treatment of either a psychiatric or physical 
illness).
6.5.1
Lost to Follow-up
A subject will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site.
The following actions must be taken if a subject fails to return to the clinic for a required study 
visit:

The site must attempt to contact the subject and reschedule the missed visit as soon as 
possible and counsel the subject on the importance of maintaining the assigned visit schedule 
and ascertain whether or not the subject wishes to and/or should continue in the study.

Before a subject is deemed lost to follow up, the investigator or designee must make every 
effort to regain contact with the subject (where possible, 3 telephone calls and, if necessary, a 
certified letter to the subject’s last known mailing address or local equivalent methods). 
These contact attempts should be documented in the subject’s medical record.

Should the subject continue to be unreachable, he/she will be considered to have withdrawn 
from the study.
6.6
Clinical Trial Subject Database (CTSdatabase)
CTSdatabase is a clinical trial subject registry that maintains the privacy and security of research 
subjects while providing sponsors and investigators with crucial information about subjects’ 
current and/or previous study participation. 
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CTSdatabase has been shown to reduce the number of duplicate and professional subjects 
entering clinical trials.
The use of this database must be presented to all subjects participating in this protocol.  If 
subjects refuse to provide authorization, the study team should be notified.  At the time of 
providing the Informed Consent for the study, the Investigator or designee will explain the IRB-
approved Subject Database Authorization to the subject and witness the signature.
During screening, site staff that have received training and login information should access 
www.ctsdatabase.com and enter the last 7 digits of the subject study ID and authorized subject 
identifiers.  An immediate report detailing matches is generated and should be printed for source 
documentation. The report will specify either (1) no matches found, (2) a match was found with 
a subject participating in another study within 30 days or (3) the subject matches with a subject 
who has pre-screened at another site.  
At the last subject contact, CTSdatabase staff will automatically close out subjects (SF, ET, or 
Completer) based on IWRS information.
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7
STUDY DRUG MANAGEMENT
7.1
Description of Study Drug
7.1.1
Investigational Product 
An investigational product, also known as investigational medicinal product in some regions, is 
defined as follows:

A pharmaceutical form of an active substance or placebo being tested or used as a reference 
in a clinical study, including products already with a marketing authorization but used or 
assembled (formulated or packaged) in a way different from the authorized form, or used for 
an unauthorized indication, or when used to gain further information about the authorized 
form.

The investigational product should be stored in a secure area according to local regulations. It 
is the responsibility of the investigator to ensure that investigational product is only 
dispensed to study subjects. The investigational product must be dispensed only from official 
study sites by authorized personnel according to local regulations.

In this protocol, investigational product (study drug) is rimegepant ODT (BHV-3000, 
PF-07899801) 75 mg dosed daily.

If a dose of study drug for a given day is missed, lost, or otherwise unable to be taken, the 
subject should document that as a missed dose on the study drug wallet. 
7.1.2
Concomitant Therapy
In this protocol, concomitant therapy is/are standard of care for acute and preventive treatment 
and rescue medication for migraine treatment.
7.1.3
Packaging, Shipment and Storage
The product storage manager should ensure that the study drug is stored in accordance with the 
environmental conditions (temperature and light) as determined by the sponsor. Please see the 
Pharmacy Manual for specific conditions. If concerns regarding the quality or appearance of the 
study drug arise, do not dispense the study drug and contact the sponsor/CRO immediately.
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7.2
Dose and Administration
7.2.1
Method of Assigning Subject Identification
Immediately after written informed consent is obtained and before performing any study-related 
procedures, the site staff must obtain a subject identification by adding a new subject in the 
appropriate study-related system.  In this study, an IWRS system will be utilized for obtaining 
subject identification and as the electronic data capture (EDC) system. Each subject will be 
assigned a unique sequential 8-digit subject number through the appropriate study-related 
system. The subject number will consist of the 3-digit site number, a hyphen, and a unique 4-
digit subject number. This subject number must not be reused for any other subject in the study.  
Subjects will maintain their subject number assigned at screening throughout the study except in 
cases of re-screening, where permitted, in which case a new subject number must be assigned. 
After confirming subject eligibility, registering a subject for Baseline will trigger a container 
number for the study drug. The study drug will be dispensed at the Baseline Visit and as needed 
at other study visits. 
7.2.2
Selection and Timing of Dose and Administration
Study drug (rimegepant ODT) will be assigned via the appropriate study-related system. There 
are no dose adjustments in this study and subjects will receive 8 tablets of rimegepant in a blister 
card heat-sealed into a wallet; subjects will be assigned more than 1 wallet at each visit to ensure 
appropriate supply between visits.  Subjects will be dispensed study drug at the Baseline Visit, 
and the subjects will be instructed that they must take 1 tablet of study drug every day, 
regardless of whether they have a migraine on that day. This is the scheduled dosing regimen 
for the Open-label Treatment Phase.  Site staff should mark each wallet with the scheduled date 
of each dose to be taken when dispensing the study drug. 
Subjects may start study drug on the day of the Baseline Visit or the following day, depending on 
the time of day of their study visit.  Dosing should occur around the same time for each 
scheduled dose.  It is preferred that subjects dose in the morning; however, it is more important 
that the subject consistently dose at approximately the same time for each scheduled dose.  The 
time of dosing should be consistent throughout the study.  If the subject has a migraine on a day 
when they already took study drug, the subject can take permitted acute migraine medication as 
needed (see Section 5.5.2).  Subjects must be instructed that they CANNOT take more than 1 
tablet of study drug daily during the Open-label Treatment Phase.  
If a dose of study drug for a given day is missed, lost, or otherwise unable to be taken, the 
subject should document that as a missed dose on the study drug wallet. 
7.2.3
Dose Modification
There will be no dose adjustments in this study.
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7.2.4
Dose Interruptions
If a subject experiences an AE that requires interruption in study drug, the investigator should 
consult with the Sponsor medical monitor to evaluate the need for any additional tests prior to re-
starting study drug. 
7.3
Blinding and Unblinding 
Not applicable to this protocol.
7.4
Treatment Compliance
Responsible study personnel will dispense the study drug.  Subjects should finish a wallet of 
study drug before starting a new wallet. Accountability and compliance verification should be 
documented in the subject’s study records.  Subjects must be counseled on the importance of 
taking the study drug as directed. Treatment compliance and review of study drug doses through 
review of returned study drug, should be assessed by site staff at each study visit. Discrepancies 
between review of study drug and information provided by subject must be documented in the 
source record. 
Investigators should inform subjects that involuntary termination from the study will occur in 
cases where non-compliance is identified. Study staff should contact a subject between the 
monthly study visits if the subject demonstrates non-compliance and document the contact in the 
source, to identify potential lost to follow-up subjects as early as possible. 
Compliance with study intervention will be defined as:

≥80% (and ideally, up to 100%) of study-supplied intervention from Day 1 through the 
Treatment Phase are expected to be consumed.

at each dispensation visit (refer to SoA-Table 1), subjects who are <80% compliant must 
be re-educated on the importance of daily self administration of study drug;

Overall aim: maintain ≥80% compliance over the duration of dosing.
Investigators must monitor subjects for possible cases of abuse of study drug (subjects taking 
study drug for non-therapeutic purposes, e.g., for psychoactive effects such as high or euphoria). 
Investigators should also assess study drug accountability discrepancies (e.g., missing study 
drug, loss of study drug, or non-compliance cases in which more study drug was used, as 
compared to expected). Investigators should obtain more information and explanation from 
subjects when there are study drug accountability discrepancies. See Section 8.1.1.
Cases of potential study drug abuse or overdose (including cases of non-compliance with study 
drug dosing instructions or subjects who discontinue without returning study drug) should be 
documented in the source record and reported as an AE or SAE as appropriate. Dosing errors 
(e.g., accidentally taking 2 tablets on 1 calendar day) should be reported as deviations. 
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7.5
Destruction and Return of Study Drug
All unused and/or partially used study drug can be sent to the predetermined drug destruction 
facility only after being inspected and reconciled by the responsible Study monitor or the 
sponsor’s designee.  If it is site policy to destroy study drug on site, it is the Investigator’s 
responsibility to ensure that arrangements have been made for the disposal, procedures for proper 
disposal have been established according to the applicable regulations, guidelines and 
institutional procedures, and appropriate records of the disposal have been documented. 
Destruction at a study site may only occur after being inspected and reconciled by the 
responsible Study monitor or the sponsor’s designee.
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8
ADVERSE EVENTS
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a 
pre-existing medical condition in a subject or clinical investigation subject administered an 
investigational (medicinal) product and that does not necessarily have a causal relationship with 
this treatment.  An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding for example) symptom, or disease temporally associated with the 
use of the investigational product, whether or not considered relate to the investigational product. 
Adverse events can be spontaneously reported or elicited during an open-ended questioning, 
examination, or evaluation of a subject.  In order to prevent reporting bias, subjects should not be 
questioned regarding the specific occurrence of one or more AEs.
If a specific diagnosis or syndrome is identified by the Investigator, this should be recorded as 
the AE, rather than recording (as separate AEs) the individual signs/symptoms or clinically 
significant laboratory abnormalities known to be associated with and considered by the 
Investigator to be a component of, the disease/syndrome.
Definition of terms related to all AEs (serious and non-serious):
Mild: Is usually transient and may require only minimal treatment or therapeutic 
intervention. The event does not generally interfere with usual activities of daily living.
Moderate: Is usually alleviated with additional specific therapeutic intervention. The event 
interferes with usual activities of daily living, causing discomfort but poses no significant or 
permanent risk of harm to the subject.
Severe: Interrupts usual activities of daily living, significantly affects clinical status, or may 
require intensive therapeutic intervention.
Life threatening: An AE is life threatening if the subject was at immediate risk of death from the 
event as it occurred, i.e., it does not include a reaction that if it had occurred in a more serious 
form might have caused death. For example, drug induced hepatitis that resolved without 
evidence of hepatic failure would not be considered life threatening even though drug induced 
hepatitis can be fatal.
Hospitalization: AEs requiring hospitalization should be considered SAEs. Hospitalization for 
elective surgery or routine clinical procedures that are not the result of AE (e.g., elective surgery 
for a pre-existing condition that has not worsened) need not be considered AEs or SAEs. If 
anything untoward is reported during the procedure, that occurrence must be reported as an AE, 
either 'serious' or 'non-serious' according to the usual criteria.
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Assessment for Determining Relationship of AE to Study Drug:
The relatedness of each AE to study drug must be classified based on medical judgement and 
according to the following categories. The definitions are as follows:
Related: This category applies to AEs that are considered, with a high degree of certainty, to be 
related to the study drug. An AE may be considered related when it follows a temporal sequence 
from the administration of study drug, it cannot reasonably be explained by the known 
characteristics of the subject’s clinical state, environment, or toxic factors, or other modes of 
therapy administered to the subject. An AE may be considered related when it follows a known 
pattern of response to the study drug, or if the AE reappears upon re-challenge.
Possibly related (non-serious AEs only): This category applies to AEs that are considered to have 
an unlikely connection to study drug, but a relationship cannot be ruled out with certainty.
Unlikely related (non-serious AEs only): This category applies to AEs that do not follow a 
reasonable temporal sequence from the administration of the study drug. The AE may readily 
have been produced by the subject’s clinical state, environmental or toxic factors, or other modes 
of therapy administered to the subject.
Unrelated: This category applies to AEs that are considered with a high degree of certainty to be 
due only to extraneous causes (e.g., subject’s clinical state, environment, toxic factors, disease 
under study, etc.) and does not meet the criteria of other categories above.
There are two types of adverse events, Serious Adverse Events (SAE) and Non-serious Adverse 
Events (AEs).
8.1
SERIOUS ADVERSE EVENT
8.1.1
Definition of Serious Adverse Event (SAE)
An SAE is any event that meets any of the following criteria at any dose:

Death

Life-threatening

Inpatient hospitalization or prolongation of existing hospitalization

Persistent or significant disability/incapacity

Congenital anomaly/birth defect in the offspring of a subject who received rimegepant

Other: Important medical events that may not result in death, be life-threatening, or require 
hospitalization, may be considered an SAE when, based upon appropriate medical judgment, 
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they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such events are (but not limited to):
○
Intensive treatment in an emergency room or at home for allergic bronchospasm
○
Blood dyscrasias or convulsions that do not result in inpatient hospitalization
○
Development of drug dependency or drug abuse
○
Potential drug induced liver injury (see Section 8.4)
○
Abuse or overdose of study drug
▪
Potential study drug abuse (including cases of excessive non-compliance with study 
drug dosing instructions or subjects who discontinue treatment without returning 
study drug) should be documented in the source record and reported as an AE or SAE 
as appropriate. Investigators must monitor subjects for possible cases of abuse of 
study drug (subjects taking study drug for non-therapeutic purposes, e.g., for 
psychoactive effects such as high or euphoria). Investigators should obtain more 
information and explanation from subjects when there are study drug accountability 
discrepancies
▪
Potential study drug overdose is defined in Section 8.3
In general, hospitalization signifies that the subject has been detained (usually involving at least 
an overnight stay) at the hospital or emergency ward for observation and/or treatment that would 
not have been appropriate in the physician's office or outpatient setting. When in doubt as to 
whether 'hospitalization' occurred or was necessary, the AE should be considered serious.
The following hospitalizations are not considered SAEs in Pfizer clinical studies (but may be 
considered non-serious AEs):
1. A visit to the emergency room or other hospital department <24 hours that does not result in 
an admission (unless considered “important medical event” or event that is life threatening);
2. Elective surgery planned prior to signing consent;
3. Admissions as per protocol for a planned medical/surgical procedure;
4. Routine health assessment requiring admission (i.e., routine colonoscopy);
5. Admission encountered for another life circumstance that carries no bearing on health and 
requires no medical intervention (i.e., lack of housing, care-giver respite, family 
circumstances).
Disability/incapacitating: An AE is incapacitating or disabling if the experience results in a 
substantial and/or permanent disruption of the subject's ability to carry out normal life functions.
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8.1.2
Collection and Reporting Serious Adverse Events
Following the subject’s written consent to participate in the study, all SAEs, whether related or 
not related to study drug, must be collected, including those thought to be associated with 
protocol-specific procedures.   All SAEs must be collected that occur at the Screening Visit and 
up to and including the Follow-up Week 8 Visit. The investigator should report any SAE 
occurring after this time period that is believed to be related to study drug or protocol-specific 
procedures.  
All SAEs should be followed to resolution or stabilization.
An SAE report should be completed for any event where doubt exists regarding its status of 
seriousness.  
If the investigator believes that an SAE is not related to the study drug but is potentially related 
to the conditions of the study (such as a withdrawal of previous therapy or a complication related 
to study procedure), the relationship should be specified in the narrative section of the SAE 
Report. 
SAEs, whether related or not related to study drug, overdose (see Section 8.3), potential drug 
induced liver injury (see Section 8.4) and pregnancies (see Section 8.5.1) must be reported 
within 24 hours of the Investigator becoming aware of the event. For this study we will be 
capturing SAEs through electronic data capture (EDC) and on the SAE form.
The Investigator is responsible for submitting all applicable events to the Independent Review 
Board (IRB) as per the IRB’s reporting requirements. Additionally, the Investigator, or 
designated staff, is responsible for entering the SAE information into the Case Report Form 
(CRF) and safety reporting system (i.e., event term, start/stop dates, causality, and intensity).
Any serious adverse event must be reported immediately or no later than 24 hours after 
awareness of the event to Pfizer DSU either via the Pfizer SAE Submission Assistant (PSSA) 
tool or as a written description using the Pfizer CT SAE report form, that must be sent to by 
facsimile (fax or eFax) to the Pfizer DSU at 1-866-997-8322. 
If only limited information is initially available, follow-up reports are required. If an ongoing 
SAE changes in its intensity or relationship to study drug or if new information becomes 
available, a follow-up SAE report should be sent within 24 hours of the Investigator becoming 
aware of the updated information using the same procedure used for the transmission of the 
initial SAE and the same event term should be used.
The minimum information required for an initial SAE report is:

Sender of report (Site number, Investigator name)

Subject identification (subject number)
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
Protocol number

SAE term (if an SAE is being reported)
8.2
Non-serious Adverse Events
A non-serious adverse event is an AE not classified as serious. 
8.2.1
Collection and Reporting of Non-serious Adverse Events
All non-serious AEs must be collected that occur following written consent through the Follow-
up Week 8 Visit. 
Non-serious AEs should be followed until conclusion or stabilization or reported as SAEs if they 
become serious.  Follow-up is also required for non-serious AEs that cause interruption or 
discontinuation of study drug or those that are present at the end of study treatment. 
8.2.2
Laboratory Test Abnormalities
The following laboratory test abnormalities should be captured on the Non-serious AE CRF page 
or SAE Report Form (paper or electronic) as appropriate:
1. Any laboratory test result that is clinically significant or meets the definition of an SAE;
2. Any laboratory abnormality that required the subject to have the study drug discontinued or 
interrupted;
3. Any laboratory abnormality that required the subject to receive specific corrective therapy.
8.3
Overdose
An overdose is defined as the accidental or intentional administration of any dose of a
product that is considered both excessive and medically important.  
All occurrences of overdose (suspected or confirmed) must be communicated to Pfizer or a 
specified designee within 24 hours and be fully documented as an SAE. Details of any signs or 
symptoms and their management should be recorded including details of any treatments 
administered.
Asymptomatic dosing errors (e.g., accidentally taking 2 tablets on 1 calendar day) should be 
reported as deviations.
8.4
Potential Drug Induced Liver Injury (DILI)
Wherever possible, timely confirmation of the initial liver-related laboratory abnormalities 
should occur prior to the reporting of a potential DILI event.  All occurrences of potential DILIs, 
meeting the defined criteria, must be reported as SAEs as per Section 8.1.2. 
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The threshold of laboratory abnormalities for a potential DILI case depends on the subject’s 
individual baseline values and underlying conditions. Subjects who present with the following 
laboratory abnormalities should be evaluated further as potential DILI (Hy’s law) cases to 
definitively determine the etiology of the abnormal laboratory values.
Potential drug induced liver injury is defined as: 
1. ALT or AST elevation > 3 times the upper limit of normal (ULN)
AND
2. Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase)
AND
3. No other immediately apparent possible causes of ALT or AST elevation and 
hyperbilirubinemia, including but not limited to, viral hepatitis, pre-existing chronic or acute 
liver disease, or the administration of other drug(s) known to be hepatotoxic. 
For subjects with baseline AST OR ALT OR T bili values above the ULN, the following 
threshold values are used in the definition mentioned above, as needed, depending on which 
values are above the ULN at baseline:

Preexisting AST or ALT baseline values above the normal range: AST or ALT values 
≥2 times the baseline values AND ≥3 × ULN; or ≥8 × ULN (whichever is smaller).

Preexisting values of T bili  above the normal range: T bili level increased from baseline 
value by an amount of ≥1 × ULN or if the value reaches ≥3 × ULN (whichever is smaller).
If any potential DILI is identified and meets the criteria above, the Pfizer Medical Monitor (or 
designee) should immediately be contacted for further instruction and whether the subject must 
discontinue from the study and appropriate follow up requirements. 
Process for abnormal liver function tests: If at any visit after initiation of study drug the AST or 
ALT is > 3x ULN, the following steps should be taken as soon as the investigator is aware: 1. 
The subject must be informed of the results and instructed to stop study drug, 2. The subject 
must be instructed to return to the clinic within 3-5 days for Unscheduled visit for repeat LFT 
panel and further clinical evaluation and testing as appropriate (with consultation with the 
Medical Monitor, and 3. The Medical Monitor and Pfizer Medical Monitor (if separate) should 
immediately be contacted. Guidance will be provided to augment management as appropriate.
8.5
Environmental Exposure, Exposure During Pregnancy or Breastfeeding, 
and Occupational Exposure
Environmental exposure occurs when a person not enrolled in the study as a subject receives
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unplanned direct contact with or exposure to the study drug. Such exposure may or may
not lead to the occurrence of an AE or SAE. Persons at risk for environmental exposure include
healthcare providers, family members, and others who may be exposed. An environmental
exposure may include EDP, EDB, and occupational exposure.
Any such exposures to the study drug under study are reportable to Pfizer Safety within
24 hours of investigator awareness.
8.5.1
Exposure During Pregnancy
If, following the Baseline Visit it is subsequently discovered that a study subject is pregnant or 
may have been pregnant at the time of the investigational produce exposure, including during at 
least 6 half-lives after the product administration, the investigational product will be permanently 
discontinued in an appropriate manner (i.e., dose tapering if necessary for subject safety).  
Protocol-required procedures for the study discontinued and the follow-up must be performed on 
the subject unless contraindicated by the pregnancy (i.e., x-ray studies).  Other appropriate 
pregnancy follow-up procedures should be considered if indicated.  The investigator must 
immediately notify the Pfizer (or designee) Medical Monitor and report the event by either using 
the PSSA tool and by completing an Exposure During Pregnancy (EDP) Supplemental Form 
following the SAE reporting procedures as described in Section 8.1.2. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable offspring information must be reported on an EDP Supplemental 
Form.
Any pregnancy that occurs in a female partner of a male study subject should be reported to 
Pfizer DSU.  Information on this pregnancy will be collected on an EDP Supplemental Form, as 
appropriate.   
An EDP occurs if: A female subjects found to be pregnant while receiving or after discontinuing 
study drug. 

A male subject who is receiving or has discontinued study drug inseminates a female 
partner. A female nonsubject is found to be pregnant while being exposed or having 
been exposed to study drug because of environmental exposure. Below are examples 
of environmental EDP:  
o
A female family member or healthcare provider reports that she is pregnant 
after having been exposed to the study drug by ingestion or skin contact.
o
A male family member or healthcare provider who has been exposed to the 
study drug by ingestion or skin contact then inseminates his female partner 
prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
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should include the anticipated date of delivery (see below for information related to termination 
of pregnancy). 
If EDP occurs in a subject/subject’s partner, the investigator must report this information to 
Pfizer Safety using the CT SAE Form and EDP supplemental form or via PSSA, regardless of 
whether an SAE has occurred. Details of the pregnancy will be collected after the start of study 
drug and until 66 hours after the last dose. 
If EDP occurs in the setting of environmental exposure, the investigator must report information 
to Pfizer Safety using the CT SAE Form and EDP supplemental form or via PSSA. Since the 
exposure information does not pertain to the subject enrolled in the study, the information is not 
recorded on a CRF; however, a copy of the completed report is maintained in the investigator 
site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for all 
EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial report. In the case of a live birth, the structural integrity of the neonate 
can be assessed at the time of birth. In the event of a termination, the reason(s) for termination 
should be specified and, if clinically possible, the structural integrity of the terminated fetus 
should be assessed by gross visual inspection (unless pre-procedure test findings are conclusive 
for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets the 
criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal demise, 
neonatal death, or congenital anomaly [in a live-born baby, a terminated fetus, an intrauterine 
fetal demise, or a neonatal death]), the investigator should follow the procedures for reporting 
SAEs. Additional information about pregnancy outcomes that are reported to Pfizer Safety as 
SAEs follows: 

Spontaneous abortion including miscarriage and missed abortion should be reported as an 
SAE;

Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs 
when the investigator assesses the infant death as related or possibly related to exposure 
to the study drug. 
Additional information regarding the EDP may be requested by the sponsor. Further followup of 
birth outcomes will be handled on a case by case basis (eg, followup on preterm infants to 
identify developmental delays). In the case of paternal exposure, the investigator will provide the 
subject with the Pregnant Partner Release of Information Form to deliver to his partner. The 
investigator must document in the source documents that the subject was given the Pregnant 
Partner Release of Information Form to provide to his partner.
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8.5.2
Exposure During Breastfeeding
An EDB occurs if:.A female subject is found to be breastfeeding while receiving or after 
discontinuing study drug. 

A female nonsubject is found to be breastfeeding while being exposed or having been 
exposed to study drug (ie, environmental exposure). An example of environmental 
EDB is a female family member or healthcare provider who reports that she is 
breastfeeding after having been exposed to the study drug by ingestion or skin 
contact.  
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported using 
the CT SAE Report Form. When EDB occurs in the setting of environmental exposure, the 
exposure information does not pertain to the subject enrolled in the study, so the information is 
not recorded on a CRF. However, a copy of the completed report is maintained in the 
investigator site file.
An EDB report is not created when a Pfizer drug specifically approved for use in breastfeeding 
women (eg, vitamins) is administered in accordance with authorized use. However, if the infant 
experiences an SAE associated with such a drug, the SAE is reported together with the EDB.
8.5.3
Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 24 
hours of the investigator’s awareness using the CT SAE Report Form or PSSA, regardless of 
whether there is an associated SAE. Since the information about the occupational exposure does 
not pertain to a subject enrolled in the study, the information is not recorded on a CRF; however, 
a copy of the completed report is maintained in the investigator site file.
8.5.4
Lack of Efficacy
The investigator must report signs, symptoms, and/or clinical sequelae resulting from lack of 
efficacy. Lack of efficacy or failure of expected pharmacological action is reportable to Pfizer 
Safety only if associated with an SAE.  
8.5.5
Medication Errors
Medication errors may result from the administration or consumption of the study drug by the 
wrong subject, or at the wrong time, or at the wrong dosage strength. Medication errors are 
recorded and reported as follows:
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Recorded on the 
Medication Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the CT SAE 
Report Form or PSSA to 
Pfizer Safety Within 24 
Hours of Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the medication error
Only if associated with an 
SAE
Medication errors include:

Medication errors involving subject exposure to the study drug.

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study subject.
Whether or not the medication error is accompanied by an AE, as determined by the investigator, 
such medication errors occurring to a study subject are recorded on the medication error page of 
the CRF, which is a specific version of the AE page and, if applicable, any associated serious and 
nonserious AE(s) are recorded on the AE page of the CRF.
In the event of a medication dosing error, the sponsor should be notified within 24 hours. 
Medication errors should be reported to Pfizer Safety within 24 hours via PSSA tool or by 
completing the CT SAE Report Form only when associated with an SAE.
8.6
Adverse Events of Special Interest
Not applicable for this study.
9
STATISTICS
Complete details on the statistical methods for this study may be found in the Statistical Analysis 
Plan (SAP).
9.1
Sample Size
With a target sample size of 285 subjects in the safety analysis set and no events observed, the 
upper bound of a one-sided 95% confidence interval for zero observations is 0.01. Hence this 
sample size is large enough to rule out events that occur at rates greater than 1 case per 100 
subjects.
In BHV3000-305 (C4951025) migraine-prevention study with EOD dosing, 73% of subjects in 
the rimegepant treatment group had ≥ 6 months (defined as ≥23 weeks) of double-blind or open-
label rimegepant (i.e., 27% non-completion rate). In this study, it is expected that the 24-week 
non-completion rate will be higher due to early termination from baseline laboratory test 
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elevations. Assuming a 40% non-completion rate, approximately 170 subjects in the safety 
analysis set are expected to complete 24 weeks of treatment.
9.2
Analysis Sets

Enrolled: Subjects who sign the informed consent form and are assigned a subject 
identification number.

Safety: Subjects in the enrolled analysis set who take 1 dose of study drug (rimegepant).
9.3
Statistical Methods
Deaths will be listed without regard to onset for the enrolled analysis set.
The frequencies of the following on-treatment safety events and findings will be presented for 
the safety analysis set: AEs by intensity in 5% of subjects (mild, moderate, severe, total); 
SAEs; AEs by relationship to study drug (related, possibly related, unlikely related, not related); 
AEs related to study drug by intensity; AEs leading to study drug discontinuation; hepatic-
related AEs by intensity; hepatic-related AEs leading to study drug discontinuation; laboratory 
test abnormalities by toxicity grade; LFT elevations based on fold change above ULN; and vital 
sign, physical measurement, and ECG abnormalities. Frequencies of safety events will be based 
on the number and percentage of subjects with events.
The investigators will determine the intensity of AEs and the relationship of AEs to study drug. 
The investigators’ terms will be coded using the latest version of the Medical Dictionary for 
Regulatory Activities (MedDRA). AEs will be presented by system organ class and preferred 
term. In tables by intensity, if a subject has an AE with different intensities over time, then only 
the greatest intensity will be reported. In tables by relationship to study drug, if a subject has an 
AE with different relationships over time, then the highest degree of relatedness to study drug 
will be reported.
Laboratory test results will be graded according to numeric laboratory test criteria in Common 
Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (2017), if available. Otherwise, 
if CTCAE grades are not available, then results will be graded according to numeric laboratory 
test criteria in Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric 
Adverse Events Corrected Version 2.1 (2017). If a subject has a laboratory test abnormality with 
different toxicity grades over time, then only the highest toxicity grade will be reported.
In addition, Quality Tolerance Limits (QTLs) are predefined parameters that are monitored 
during the study. Important deviations from the QTLs and any remedial actions taken will be 
summarized.
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9.4
Schedule of Analyses
There is 1 planned database lock which will occur after the last subject completes the Follow-up 
Week 8 Visit. The final clinical study report (CSR) will be produced to support regulatory 
requirements after the final database lock.
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10 ETHICS AND RESPONSIBILITIES
10.1
Good Clinical Practice
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), 
Good Laboratory Practice (GLP), International Conference on Harmonization guidelines, and all 
applicable regulations, including the Federal Food, Drug and Cosmetic Act, U.S. applicable 
Code of Federal Regulations (title 21), any Independent Ethics Committee (IEC) requirements 
relative to clinical studies. The study will also be conducted in compliance with the 
recommendations laid down in the most recent version of the Declaration of Helsinki.
This study will be conducted in compliance with the protocol. The protocol and any amendments 
and the subject informed consent will receive Institutional Review Board/Independent Ethics 
Committee (IRB/IEC) approval/favorable opinion prior to initiation of the study.   
The Sponsor is responsible for ensuring that all updated relevant information related to the 
protocol be submitted to regulatory authorities and Independent Ethics Committees in 
accordance with local laws and regulations. This includes expedited reporting of suspected 
unexpected serious adverse reactions per regulatory guidelines.
All serious breaches must be reported to Pfizer (or designee) immediately.  A Serious breach is a 
breach of the conditions and principles of GCP in connection with the study or protocol, which is 
likely to affect, to a significant degree, the safety or physical or mental integrity of the subjects 
of the study or the scientific value of the study. 
Study personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective task(s). 
This study will not use the services of study personnel where sanctions have been invoked or 
where there has been scientific misconduct or fraud (e.g., loss of medical licensure, debarment).
It is the Sponsor’s responsibility to submit the protocol and its amendments (if any), and the 
ICFs to regulatory authorities when necessary. 
10.2
Data and Safety Monitoring Committee
This study will not make use of a Data Safety Monitoring Committee (DSMC). The study drug 
rimegepant has been tested and found to be well tolerated.  Safety will be closely monitored via 
oversight by the investigators, Sponsor and CRO/designee and an Institutional Review 
Board/Independent Ethics Committee.
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10.3
Institutional Review Board/Independent Ethics Committee
The Investigators agree to provide the IRB/IEC with all appropriate documents, including a copy 
of the protocol/amendments, ICFs, advertising text (if any), Investigator’s brochure (if any) and 
any other written information provided to study subjects. The trial will not begin until the 
Investigators have obtained the IRB/IEC favorable written approvals for the above-mentioned 
study documents.  
In the event that the protocol is amended, the revised protocol must be approved by the IRB/IEC 
prior to its implementation, unless the changes involve only logistical or administrative aspects 
of the trial.
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10.4
Informed Consent
Investigators must ensure that subjects, or, in those situations where consent cannot be given by 
subjects, their legally acceptable representatives, are clearly and fully informed about the 
purpose, potential risks, and other critical issues regarding clinical studies in which they 
volunteer to participate. 
Pfizer (or designee) will provide the investigator with an appropriate (i.e., Global or Local) 
sample informed consent form which will include all elements required by ICH, GCP and 
applicable regulatory requirements.  The sample informed consent form will adhere to the ethical 
principles that have their origin in the Declaration of Helsinki.
Before the potential subject has undergone any study-related screening procedures, the nature of 
the study and the potential risks associated with it will be explained to the subject, and the 
subject will be given an opportunity to ask questions to his or her satisfaction. After the 
questions are answered, but before proceeding further, if the subject has not opted out of the 
CTSdatabase portion of the study, they must sign and date an IRB/IEC approved written 
informed consent form for study participation and CTSdatabase participation. The signed and 
dated ICF will be retained at the Investigator’s site, with a copy provided to the study subject and 
date will be entered in his or her CRF or appropriate system. The IRB/IEC must review and 
approve all protocol versions and informed consent form versions and a copy of each version of 
the IRB/IEC approved protocol and informed consent form is to be retained in the Study Master 
file. Any revisions to the protocol or ICF will be reviewed and approved by the IRB/IEC and 
subjects will be informed of ICF changes and document continuing consent by signing and 
dating the revised version of the ICF.
If a revised ICF is introduced during the study, each subject’s further consent must be obtained. 
The new version of the ICF must be approved by the IRB/IEC, prior to subsequently obtaining 
each subject’s consent. 
If informed consent is initially given by a subject’s legal guardian or legally acceptable 
representative, and the subject subsequently becomes capable of making and communicating 
their informed consent during the study, then the consent must additionally be obtained from the 
subject. 
The informed consent form must also include a statement that Pfizer and its representatives and 
regulatory authorities may have direct access to subject records.  
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10.5
Case Report Forms
An Investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation of each study subject. Data 
reported on the CRF that are derived from source documents must be consistent with the source 
documents or the discrepancies must be explained.
Electronic CRFs will be prepared for all data collections fields when electronic data capture 
(EDC) is being used.   
The confidentiality of records that could identify subjects must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 
The Investigator must retain a copy of the CRFs including records of changes and corrections.   
If EDC is being used, signatures will be obtained electronically and a copy of the electronic 
CRFs will be provided (or the data from the CRFs) for future reference. 
10.6
Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries and websites in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and complete 
manner and are reported regardless of the outcome of the study or the country in which the study 
was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, regardless of 
the geographical location in which the study is conducted. These results are submitted for 
posting in accordance with the format and timelines set forth by US law.
EudraCT/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com for 
Pfizer sponsored interventional studies at the same time the corresponding study results are 
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posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable information 
anonymized.
Documents within marketing applications
Pfizer complies with applicable local laws/regulations to publish clinical documents included in 
marketing applications. Clinical documents include summary documents and CSRs including the 
protocol and protocol amendments, sample CRFs, and SAPs. Clinical documents will have 
personally identifiable information anonymized.
10.6.1
Data sharing
Pfizer provides researchers secure access to subject level data or full CSRs for the purposes of 
“bonafide scientific research” that contributes to the scientific understanding of the disease, 
target, or compound class. Pfizer will make data from these trials available 18 months after study
completion. Subject level data will be anonymized in accordance with applicable privacy laws 
and regulations. CSRs will have personally identifiable information anonymized.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not be 
provided to applicants with significant conflicts of interest, including individuals requesting 
access for commercial/competitive or legal purposes.
10.7
Sponsor’s Medically Qualified Individual 
The contact information for the sponsor’s MQI for the study is documented in the study contact 
list located in the principal investigator ISF.
To facilitate access to their investigator and the sponsor’s MQI for study related medical 
questions or problems from non-study healthcare professionals, subjects are provided with an 
ECC at the time of informed consent. The ECC contains, at a minimum, (a) protocol and study 
drug identifiers, (b) subject’s study identification number, (c) site emergency phone number 
active 24 hours/day, 7 days per week, and (d) Pfizer Call Center number. 
The ECC is intended to augment, not replace, the established communication pathways between 
the subject and their investigator and site staff, and between the investigator and sponsor study 
team. The ECC is only to be used by healthcare professionals not involved in the research study, 
as a means of reaching the investigator or site staff related to the care of a subject. The Pfizer 
Call Center number is to be used when the investigator and site staff are unavailable. The Pfizer 
Call Center number is not for use by the subject directly; if a subject calls that number directly, 
they will be directed back to the investigator site.
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11 RECORDS MANAGEMENT AND RETENTION
In accordance with the principles of GCP and GLP, the study may be inspected by regulatory 
authorities, the Sponsor and CRO. The Sponsor is entitled to access information about the status 
of the study and to review the original documents of the study.
The Investigator must retain all study records and source documents for the maximum required 
by the applicable regulations and guidelines, or institution procedures or for the period of time 
specified by the sponsor, whichever is longer.  The Investigator must contact the Sponsor prior to 
destroying any records associated with this study. 
Pfizer will notify the Investigators when the study files for this study are no longer needed. 
If the Investigator withdraws from the study (i.e., retirement, relocation), the records shall be 
transferred to a mutually agreed upon designee.  Notice of such transfer will be given in writing 
to Pfizer. 
It is the responsibility of the Investigator to ensure that the current disposition record of 
investigational product (those supplied by the sponsor) is maintained at each study site where the 
study drug is inventoried and dispensed.  Records or logs must comply with applicable 
regulations and guidelines and should include:
1. amount of study drug received and placed in storage area
2. label ID number or batch number or Kit number as specified for the protocol
3. amount dispensed to and returned from each subject
4. amount transferred to another area or site for dispensing or storage if applicable
5. amount of drug lost or wasted
6. amount destroyed at the site, if applicable
7. amount returned to sponsor, if applicable
8. retain sampled for bioavailability/bioequivalence, if applicable
9. record of dates and initials of personnel responsible for IM dispensing and accountability  
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11.1
Source Documentation
An Investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent for all subjects on study.  
If source documents are created to support the collection of study information, this must be 
retained with the other pertinent medical records for each subject for verification of data points, 
unless otherwise instructed by the Sponsor or designee to enter data directly on the eCRF.
Study monitors will perform ongoing source data verification to confirm that data entered into 
the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of subjects are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study agreements, 
ICH GCP, and all applicable regulatory requirements.
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents.
11.2
Study Files and Record Retention
The Sponsor does not require original documents that have already been scanned and entered 
into the eTMF system to be forwarded to the Sponsor. Any original documents (i.e. 1572, signed 
financial disclosure, signed ICF, etc.) will be retained in the regulatory binder at the study site. 
The CRO will conduct a final TMF reconciliation to ensure all study files and regulatory 
documents have been correctly uploaded to the TMF prior to the close or termination of the 
study. Any materials or documents to support the clinical study outside of the eTMF (i.e., rater 
training tapes) should be maintained by the CRO. The Sponsor will be contacted to determine 
whether the study documents/materials that are retained outside of the TMF will be forwarded to 
the Sponsor, destroyed, or kept at the CRO or at another facility for a longer period of time at the 
Sponsor's expense.
The CRO will maintain adequate study records after completion or termination of study. After 
that period, the Sponsor will be contacted to determine whether the study records will be 
forwarded to the Sponsor, destroyed, or kept at CRO or at another facility for a longer period of 
time at the Sponsor's expense. 
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12 AMENDMENTS
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by Pfizer. A protocol change intended to eliminate an apparent immediate hazard to 
subjects may be implemented immediately.
Any permanent change to the protocol must be handled as a protocol amendment. The written 
amendment must be submitted to the IRB/IEC and the investigator must await approval before 
implementing the changes. Pfizer will submit protocol amendments to the appropriate regulatory 
authorities for approval.
If in the judgment of the IRB/IEC, the investigator, and/or Pfizer, the amendment to the protocol 
substantially changes the study design and/or increases the potential risk to the subject and/or has 
an impact on the subject's involvement as a study subject, the currently approved written 
informed consent form will require similar modification. In such cases, informed consent will be 
renewed for subjects enrolled in the study before continued participation.
13 PUBLICATIONS POLICY
The publication policy of Pfizer is discussed in the investigator's Clinical Research Agreement.
14 STUDY DISCONTINUATION 
Both Pfizer and the Principal Investigator reserve the right to terminate the study at the 
investigator’s site at any time. Should this be necessary, Pfizer or a specified designee will 
inform the appropriate regulatory authorities of the termination of the study if needed and the 
reasons for its termination, and the Principal Investigator will inform the IRB/IEC of the same. 
In terminating the study, Pfizer and the Principal Investigator will assure that adequate 
consideration is given to the protection of the subjects’ interests.
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15 DATA PROTECTION
All parties will comply with all applicable laws, including laws regarding the implementation of 
organizational and technical measures to ensure protection of subject data.
Subjects’ personal data will be stored at the study site in encrypted electronic and/or paper form 
and will be password protected or secured in a locked room to ensure that only authorized study 
staff have access. The study site will implement appropriate technical and organizational 
measures to ensure that the personal data can be recovered in the event of disaster. In the event 
of a potential personal data breach, the study site will be responsible for determining whether a 
personal data breach has in fact occurred and, if so, providing breach notifications as required by 
law.
To protect the rights and freedoms of subjects with regard to the processing of personal data, 
subjects will be assigned a single, subject specific numerical code. Any subject records or data 
sets that are transferred to the sponsor will contain the numerical code; subject names will not be 
transferred. All other identifiable data transferred to the sponsor will be identified by this single, 
subject specific code. The study site will maintain a confidential list of subjects who participated 
in the study, linking each subject’s numerical code to their actual identity and medical record ID. 
In case of data transfer, the sponsor will protect the confidentiality of subjects’ personal data 
consistent with the clinical study agreement and applicable privacy laws.
Information technology systems used to collect, process, and store study-related data are secured 
by technical and organizational security measures designed to protect such data against 
accidental or unlawful loss, alteration, or unauthorized disclosure or access.
The sponsor maintains SOPs on how to respond in the event of unauthorized access, use, or 
disclosure of sponsor information or systems.
When subject data are to be deleted, the investigator will ensure that all copies of such data are 
promptly and irrevocably deleted from all systems.
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16 APPENDICES
16.1
Appendix 1 - Protocol Amendment History
Change
Section(s) Affected
Summary (changes are noted 
in bold)
Not Applicable
Not Applicable
Original Protocol
V2.0
Table 1
Typographical Errors and 
Addition of Physical 
Measurements. 
V2.0
Inclusion Criteria 4e.i. 
Removed reference to CGRP 
and added referral to section 5.4
V2.0
Exclusion Criteria 5h.
Removal of equals sign
V2.0
Section 5.4 and 
Appendix 17.2
Removal of P-gp restrictions
V2.0
Section 6.2.4.1 
Chemistry
Clarified timing of HbA1C 
testing
V2.0
Correction of other minor 
typographical errors throughout 
protocol
V3.0
Section 5.4 and 
Appendix 17.2
Retraction of removal of P-gp 
restrictions
V3.0
Section 5.4.12
Clarification of analgesic usage
V4.0
Appendix 17.1
Update to Signatories
V4.0
Synopsis, Sections 1.4, 
5.1, 9.1
Update to number of expected 
screened and enrolled
V4.0
Section 8.2.1
Correction to NSAE reporting
V4.0
Added Exclusion 
Criteria 8.
Criteria added for any subjects 
in PI opinion do not qualify
V4.0
Exclusion Criteria 2m
Clarified wording around drugs 
of abuse
V4.0
Appendix 17.2
Removal of Grapefruit and 
Seville Orange as moderate 
CYP3A4 inhibitors
V5.0
Synopsis, Section 5.1, 
Section 9.1
Update to number of subjects 
and samples size.
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16.2
Appendix 2 – Inhibitors and Inducers of CYP3A4 and Inhibitors of 
P-glycoprotein (Not all-inclusive)
The following medications and medication combinations are moderate to strong inhibitors of 
CYP3A4. This list should not be considered all-inclusive. As described in the study protocol, 
concomitant use of moderate to strong CYP3A4 inhibitors is prohibited. Individual drug labels 
should be reviewed for specific information on propensity to cause moderate to strong inhibition 
of the CYP3A4 enzyme or for a specific compound.
Strong CYP3A4 inhibitors
Boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, 
indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and 
ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, 
telaprevir, tipranavir and ritonavir, troleandomycin, voriconazole, clarithromycin, 
nefazodone, nelfinavir, , mifepristone, mibefradil, telithromycin, troleandomycin
Moderate CYP3A4 inhibitors
Amprenavir, aprepitant, casopitant, cimetidine, ciprofloxacin, diltiazem, dronedarone, 
erythromycin, fluconazole, isavuconazole, lefamulin, letermovir, netupitant, ravuconazole, 
verapamil
The following medications and supplements are moderate to strong inducers of CYP3A4. As 
described in the study protocol, concomitant use of moderate to strong CYP3A4 inducers is 
prohibited. This list should not be considered all-inclusive. Individual product labels should be 
reviewed for specific information on propensity to cause moderate to strong induction of the 
CYP3A4 enzyme for a specific compound.
Moderate CYP3A4 inducers
Bosentan, rifabutin, modafinil, nafcillin, efavirenz, etravirine, lopinavir
The following medications are strong P-glycoprotein (P-gp) inhibitors as described in the study 
protocol; concomitant use of strong P-gp inhibitors is prohibited. This list should not be considered 
all-inclusive. Individual product labels should be reviewed for specific information on propensity to 
strongly inhibit P-gp for a specific compound.
Strong P-gp Inhibitors
Amiodarone, clarithromycin, cyclosporine, dronedarone, itraconazole, lapatinib, propafenone, 
quinidine, ritonavir, verapamil
Strong CYP3A4 inducers
Carbamazepine, phenytoin, rifampin, St. John’s Wort, rifapentine, phenytoin, phenobarbital, 
apalutamide, avasimibe
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Resources: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti
onsLabeling/ucm093664.htm#table3-2
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteracti
onsLabeling/ucm093664.htm#table3-3
Hachad H, Ragueneau-Majlessi I, Levy RH. A useful tool for drug interaction evaluation: the 
University of Washington Metabolism and Transport Drug Interaction Database. Hum 
Genomics. 2010 Oct;5(1):61-72. 
University of Washington Metabolism and Transport Drug Interaction Database accessible at 
https://www.druginteractioninfo.org/
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16.3
Appendix 3 – Categories of Migraine Prevention Medications (Reference for 
Exclusion Criteria 7g)
No therapeutic response with > 2 of the following 8 medication categories for prophylactic 
treatment of migraine after an adequate therapeutic trial. These medication categories are:

Category 1: Antiepileptics (for example: divalproex sodium, sodium valproate)

Category 2: Antiepileptics (for example: topiramate, carbamazepine, gabapentin)

Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, 
pindolol, propranolol, timolol)

Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, 
protriptyline)

Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, 
desvenlafaxine, duloxetine, milnacipran)

Category 6: Calcium channel blockers (for example: flunarizine, verapamil)

Category 7: Angiotensin converting enzyme (ACE) inhibitor/angiotensin receptor blocker 
(ARB): (for example: lisinopril, candesartan)

Category 8: Neuromuscular blocker: (Botox®)
No therapeutic response is defined as no reduction in headache frequency, duration, or intensity 
after administration of the medication for at least 6 weeks at the generally accepted therapeutic 
dose(s) based on the investigator’s assessment.
The following scenarios do not constitute lack of therapeutic response:

Lack of sustained response to a medication

Failure to tolerate a therapeutic dose
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16.4
Appendix 4 - ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as AEs

Marked sinus bradycardia (rate <40 bpm) lasting minutes.

New PR interval prolongation >280 ms.

New prolongation of QTcF to >480 ms (absolute).

New prolongation of QTcF by >60 ms from baseline.

New‑onset atrial flutter or fibrillation, with controlled ventricular response rate: ie, 
rate <120 bpm.

New‑onset type I second‑degree (Wenckebach) AV block of >30-second duration.

Frequent PVCs, triplets, or short intervals (<30 seconds) of consecutive ventricular 
complexes.
ECG Findings That May Qualify as SAEs

QTcF prolongation >500 ms.

Absolute value of QTcF >450 ms AND QTcF change from baseline >60 ms.

New ST‑T changes suggestive of myocardial ischemia.

New‑onset LBBB (QRS complex >120 ms).

New‑onset right bundle branch block (QRS complex >120 ms).

Symptomatic bradycardia. 

Asystole

In awake, symptom‑free subjects in sinus rhythm, with documented asystolic pauses 
≥3 seconds or any escape rate <40 bpm, or with an escape rhythm that is below the 
AV node;

In awake, symptom‑free subjects with atrial fibrillation and bradycardia with 1 or 
more asystolic pauses of at least 5 seconds or longer. 

Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate >120 
bpm.

Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short duration 
with relevant symptoms or lasting >1 minute).

Ventricular rhythms >30 second duration, including idioventricular rhythm (HR <40 
bpm), accelerated idioventricular rhythm (HR 40 bpm to <100 bpm), and 
monomorphic/polymorphic ventricular tachycardia (HR >100 bpm [such as torsades 
de pointes]).

Type II second‑degree (Mobitz II) AV block.

Complete (third‑degree) heart block.
ECG Findings That Qualify as SAEs

Change in pattern suggestive of new myocardial infarction. 

Sustained ventricular tachyarrhythmias (>30-second duration).

Second‑ or third‑degree AV block requiring pacemaker placement.
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
Asystolic pauses requiring pacemaker placement.

Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.

Ventricular fibrillation/flutter.

At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The major events of potential clinical concern listed above are recommended as “alerts” or notifications from 
the core ECG laboratory to the investigator and Pfizer study team, and not to be considered as all-inclusive of 
what is to be reported as AEs/SAEs.
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16.5
Appendix 5 - Contraceptive and Barrier Guidance
16.5.1
Male Subject Reproductive Inclusion Criteria
No contraception methods are required for male subjects in this study, as the calculated safety 
margin is ≥100 fold between the estimated maternal exposure due to seminal transfer and the 
NOAEL for serious manifestations of developmental toxicity in nonclinical studies.
16.5.2
Female Subject Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criterion 2.b (Age and Sex; Section 5.2) and specify the 
reproductive requirements for including female subjects. Refer to Section 16.5.4 for a complete 
list of contraceptive methods permitted in the study. 
A female subject is eligible to participate if she is not pregnant or breastfeeding and at least 1 of 
the following conditions applies:
·         Is not a WOCBP (see definitions below in Section 16.5.3). 
OR
·         Is a WOCBP and agrees to use an acceptable contraceptive method during the intervention 
period (for a minimum of 28 days after the last dose of study drug).  The investigator should 
evaluate the effectiveness of the contraceptive method in relationship to the first dose of study 
drug.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
16.5.3
Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below).
If fertility is unclear (eg, amenorrhea or oligomenorrhea) and a menstrual cycle cannot be 
confirmed before the first dose of study drug, additional evaluation should be considered.
Women in the following categories are not considered WOCBP:
1.      Premenarchal.
2.      Premenopausal female with 1 of the following:
·         Documented hysterectomy
·         Documented bilateral salpingectomy
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·         Documented bilateral oophorectomy
For individuals with permanent infertility due to a medical cause other than the above (eg, 
mullerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s review 
of the subject’s medical records, medical examination, or medical history interview. The method 
of documentation should be recorded in the subject’s medical record for the study.
1.      Postmenopausal female:
·         A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition:
·         A high FSH level in the postmenopausal range must be used to confirm a postmenopausal 
state in women under 60 years of age and not using hormonal contraception or HRT. 
·         A female on HRT and whose menopausal status is in doubt will be required to use one of 
the highly effective nonestrogen hormonal contraception methods if she wishes to continue her 
HRT during the study. Otherwise, she must discontinue HRT to allow confirmation of 
postmenopausal status before study enrollment.
16.5.4
Contraceptive Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency 
1.      Implantable progestogen‑only hormone contraception associated with inhibition of 
ovulation.
2.      Intrauterine device.
3.      Intrauterine hormone‑releasing system.
4.      Bilateral tubal occlusion.
5.      Vasectomized partner:
·         Vasectomized partner is a highly effective contraceptive method provided that the partner 
is the sole sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used. The spermatogenesis cycle is 
approximately 90 days.
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Highly Effective Methods That Are User Dependent 
6.      Combined (estrogen‑ and progestogen‑containing) hormonal contraception associated with 
inhibition of ovulation:
·         Oral
·         Intravaginal
·         Transdermal
7.      Progestogen‑only hormone contraception associated with inhibition of ovulation:
·         Oral
·         Injectable
8.      Sexual Abstinence
·         Sexual abstinence is considered a highly effective method only if defined as refraining 
from heterosexual intercourse during the entire period of risk associated with the study drug. The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and 
the preferred and usual lifestyle of the subject.
Other Effective Methods
9.      Progestogen‑only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
10.  Male or female condom, with or without spermicide.
11.  Cervical cap, diaphragm, or sponge with spermicide.
12.  A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double‑barrier methods).
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