BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Phase: PHASE4
Conditions: Migraine
Sponsor: Pfizer

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DRUG:
Rimegepant (BHV-3000) (PF-07899801)
STUDY NUMBER(S):
BHV3000-406 (C4951004)
PROTOCOL TITLE:
BHV3000-406 (C4951004): A Phase 4, Randomized, 
Double-blind Placebo-Controlled, Efficacy and 
Tolerability Trial of Rimegepant for the Acute 
Treatment of Migraine in Adults Unsuitable for 
Triptan Use
US IND NUMBER:
109886 
EU CT NUMBER: 
2024-513269-37-00
ClinicalTrials.gov ID:  
NCT05509400
SPONSOR:
Pfizer Inc. 
66 Hudson Boulevard East
New York, NY 10001
ORIGINAL PROTOCOL 
DATE:
14-July-2022
VERSION NUMBER:
Version 6.0 
VERSION DATE:
29-August-2024
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(s).
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SUMMARY OF CHANGES
Amendment Version 6.0 
Overall Rationale for the Amendment: Alignment with the Clinical Trials Regulation EU 
No 536/2014 (CTR).  Amendment also includes protocol administrative change letters (dated 
06 Dec 2023; 07 Mar 2024) and edits to align with the SAP and Pfizer protocol template
Description of change
Brief Rationale
Section # and Name
Non Substantial Modification(s)
Addition of various sponsor 
reporting responsibilities per 
EU CTR 
Alignment with EU CTR 
requirements
16.7.3 European Union
Clarification of procedures 
relative to Urgent Safety 
Measures and Serious 
Breaches
Alignment with EU CTR 
requirements
10.1 Good Clinical Practice
Procedures relative to 
collection of data regarding 
withdrawn subjects clarified
Alignment with EU CTR 
requirements
6.6 Subject Early Discontinuation 
Criteria
Clarification regarding 
timelines for clinical trial 
results publication on CTIS
Alignment with EU CTR 
requirements
10.7 Dissemination of Clinical 
Study Data
Handling of SAP deviations 
from protocol-specified 
analyses added
Alignment with EU CTR 
requirements
9 Statistics
Handling of missing, unused, 
and spurious data added
Alignment with EU CTR 
requirements
9.3 Statistical Methods
IOL=F algorithm added
Alignment with Statistical 
Analysis Plan
9.3.1 Efficacy Analyses
Reliability of rimegepant 
effect in the OLE Phase 
endpoint definition modified
Alignment with Statistical 
Analysis Plan
3.2.2 Other Secondary Endpoints
9.3.1.2 Secondary Endpoints
Section header renamed to 
‘Statistical hypotheses’ and 
text added to describe the 
null hypothesis for primary 
and secondary endpoints
Alignment with Statistical 
Analysis Plan
9.3.1.3 Statistical Hypotheses
AEs by relationship to study 
drug replaced with AEs 
related to study drug
Alignment with Statistical 
Analysis Plan
9.3.2 Safety Analyses
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Description of change
Brief Rationale
Section # and Name
FDA laboratory test toxicity 
grading scale added
Alignment with Statistical 
Analysis Plan and FDA 
request
9.3.2 Safety Analyses
“ALT and AST > 2xULN” 
replaced by “ALT or AST 
>2xULN” in exclusion 
criterion 5d
Alignment with rimegepant 
program-level exclusion 
criteria
5.3 Exclusion criteria
“Non-migraine” indication 
replaced with “Non 
headache” indication in 
exclusion criterion 6g
For consistency with 
exclusion criterion 6a 
5.3 Exclusion criteria
Addition of muscle relaxants
Inclusion of an updated list 
of CYP3A4 inhibitors/
inducers and P-gp inhibitors, 
and specification of the 
washout period in case of 
concomitant use of CYP3A4 
inhibitors/inducers or P-gp 
inhibitors.
Alignment with updated 
product-level DDI Master 
List and Sponsor’s standard 
approach
16.1 Prohibited and Restricted 
Concomitant Medications and 
Devices
Addition of FSH post 
menopausal range (>35 
mIU/mL)
Reinstatement of FSH 
menopausal range deleted by 
mistake in prior amendment
16.5.2 Woman of Childbearing 
Potential
Study intervention table 
added
To align with Pfizer’s 
protocol template 
7.1.1 Investigational product
Definition of rescue 
medications clarified
Clarification that rescue 
medications are concomitant 
medications used per 
standard of care to treat 
persistent migraine 
symptoms
6.4.4 Rescue medication
Primary and Secondary 
Endpoints added in the 
synopsis
To align with Pfizer’s 
protocol template
Synopsis
Study drug dosing regimen 
and treatment duration 
clarified
To align with Pfizer’s 
protocol template
Synopsis
Main exclusion criteria 
added
To align with Pfizer’s 
protocol template
Synopsis
Statistical paragraph 
removed
To align with Pfizer’s 
protocol template
Synopsis
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Description of change
Brief Rationale
Section # and Name
Ethical considerations 
regarding placebo use 
rationale; treatment duration 
and burden for subjects 
clarified
To align with Pfizer’s 
protocol template
Synopsis
Clarification that rimegepant 
dose, population and 
indication in the study are 
covered by Marketing 
Authorization
Alignment with EU CTR 
requirements
1.1.2 Product Development 
Background
Number of subjects involved 
in rimegepant clinical 
development updated
Alignment with 
Investigator's Brochure v3.0, 
April 2024
1.1.2 Product Development 
Background
Reference to European 
directive 2001/20/EC 
replaced by reference to EU 
CTR No 536/2014
Alignment with EU CTR 
requirements
8.1.2 Collection and Reporting 
Serious Adverse Events
Eudra CT number replaced 
by EU CT number
Alignment with EU CTR 
requirements
Cover page, synopsis
Reference to 24h dosing 
interval in the OLE phase 
deleted
Incorporation of 
nonsubstantial changes 
described in previous PACL 
dated 06 Dec 2023
Synopsis
4.1 Study design and duration
7.1.5.2 Open-label Extension 
phase
MQOL collection clarified
Incorporation of 
nonsubstantial changes 
described in previous PACL 
dated 06 Dec 2023
4.1 Study design and duration
4.3 Schedule of Assessments
4.3.3.3 OLE Week 12/OLE EOT 
visit
6.5.2 Migraine Quality of Life 
Questionnaire (MQOL)
Clarification regarding 
Medication Errors reporting
Incorporation of 
nonsubstantial changes 
described in previous PACL 
dated 06 Dec 2023
8.5.5 Medications Errors
Change to the process for 
contacting a medically 
qualified individual from a 
medical escalation process 
via a Pfizer Call Center to 
direct clinical team contact 
using a Study Team 
Incorporation of 
nonsubstantial changes 
described in previous PACL 
dated 07 Mar 2024
10.8 Sponsor’s Medically 
Qualified Individual
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Description of change
Brief Rationale
Section # and Name
Contact List. Emergency 
Contact Card replaced by a 
study information card
Addition that the CT SAE 
Report Form should only be 
used as a backup in the event 
PSSA is not operational
Incorporation of 
nonsubstantial changes 
described in previous PACL 
dated 06 Dec 2023
8.1.2 Collection and Reporting 
Serious Adverse Events
List of references updated
Ensuring complete 
alignment with protocol 
updates
17 References
List of Abbreviations 
updated
Ensuring complete 
alignment with protocol 
List of abbreviations
Minor typographic and
spelling corrections
Corrections
Throughout the document
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STUDY SUMMARY (SYNOPSIS)
PROTOCOL SUMMARY 
Synopsis 
Protocol Title: A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and 
Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable 
for Triptan Use.
Brief Title: A Phase 4 Study Evaluating Efficacy and Tolerability of Rimegepant for the 
Treatment of Migraine in Adults Unsuitable for Triptan Use.
Regulatory Agency Identification Number(s):
US IND Number:
109886
EU CT Number:
2024-513269-37-00
ClinicalTrials.gov ID: 
NCT05509400
Pediatric Investigational Plan Number:
N/A
Protocol Number:
BHV3000-406 (C4951004)
Phase:
4
Rationale:
Rimegepant is approved for the acute treatment and prevention of episodic migraine in the 
United States (US), United Kingdom (UK), and European Union (EU). Effectiveness for the 
acute treatment of migraine was initially demonstrated in a Phase 2b double-blind, 
randomized, placebo-controlled, dose-ranging study where rimegepant at 75 mg showed 
efficacy on all four traditional endpoints: pain, nausea, photophobia and phonophobia. 
Efficacy was confirmed for the acute treatment of migraine in three pivotal single attack 
Phase 3 trials using the registrational co-primary endpoints of pain freedom and freedom 
from most bothersome symptom at 2 hours postdose. Rimegepant effectiveness for the 
preventive treatment of migraine was also demonstrated in a Phase 2/3 double-blind, 
randomized, placebo-controlled study of rimegepant 75 mg dosed every other day (EOD). 
EOD dosing was also well tolerated with no signals of Medication-Overuse Headache 
(MOH), abuse potential, cardiovascular events, or hepatotoxicity. 
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a 
population of adult subjects that are unsuitable for triptan medications due to previous 
intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant 
cardiovascular disease). Rimegepant (75mg once daily as needed) will be further evaluated in 
this population during the trial’s 12-week open-label extension phase.
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Objectives and Endpoints:
Objectives
Endpoints
Primary objective: 
Primary endpoint:
To compare the efficacy of rimegepant with placebo in the acute treatment of 
migraine, as measured by migraine headache pain relief at 2 hours postdose 
during the Double Blind Treatment (DBT) Phase
Percentage of subjects with a headache pain intensity of none or mild at 2 
hours postdose in the DBT Phase. Migraine headache pain intensity will be 
measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 
3=severe).
Key secondary objectives: 
Key secondary endpoints
To compare rimegepant with placebo for migraine headache pain freedom at 2 
hours postdose during the DBT Phase.
Percentage of subjects with a headache pain intensity of none at 2 hours 
postdose in the DBT Phase
To compare rimegepant with placebo for rescue medication use within 24 hours 
postdose during the DBT Phase
Percentage of subjects who take rescue medication within 24 hours after 
taking study drug in the DBT Phase. Rescue medication is defined in the 
protocol.
To compare rimegepant with placebo for return to normal function, as measured 
by the functional disability scale, at 2 hours postdose during the DBT Phase
Percentage of subjects with a functional disability level of normal at 2 hours 
postdose in the DBT Phase in the subset of subjects with functional disability 
at the time of dosing. Functional disability level will be measured on a 4-
point numeric rating scale (0=normal, 1=mildly impaired, 2=severely 
impaired, 3=requires bedrest).
To compare rimegepant with placebo for sustained return to normal function, as 
measured by the functional disability scale, from 2 to 24 hours postdose during 
the DBT Phase
Percentage of subjects with functional disability levels of normal at all time 
points from 2 to 24 hours postdose in the DBT Phase in the subset of 
subjects with functional disability at the time of dosing
To compare rimegepant with placebo for sustained return to normal function, as 
measured by the functional disability scale, from 2 to 48 hours postdose during 
the DBT Phase
Percentage of subjects with functional disability levels of normal at all time 
points from 2 to 48 hours postdose in the DBT Phase in the subset of 
subjects with functional disability at the time of dosing
To compare rimegepant with placebo for sustained migraine headache pain relief 
from 2 to 24 hours postdose during the DBT Phase
Percentage of subjects with headache pain intensities of none or mild at all 
time points from 2 to 24 hours postdose in the DBT Phase
To compare rimegepant with placebo on sustained migraine headache pain relief 
from 2 to 48 hours postdose during the DBT Phase
Percentage of subjects with headache pain intensities of none or mild at all 
time points from 2 to 48 hours postdose in the DBT Phase
To compare rimegepant with placebo for sustained migraine headache pain 
freedom from 2 to 24 hours postdose during the DBT Phase
Percentage of subjects with headache pain intensities of none at all time 
points from 2 to 24 hours postdose in the DBT Phase
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Objectives
Endpoints
To compare rimegepant with placebo for sustained migraine headache pain 
freedom from 2 to 48 hours postdose during the DBT Phase
Percentage of subjects with headache pain intensities of none at all time 
points from 2 to 48 hours postdose in the DBT Phase
To compare rimegepant with placebo for freedom from the most bothersome 
symptom (MBS) associated with migraine at 2 hours postdose during the DBT 
Phase
Percentage of subjects with an MBS that is reported on study before dosing 
and is absent at 2 hours postdose in the DBT Phase. The MBS on study 
before dosing will be reported as nausea, phonophobia, or photophobia. 
Symptom status will be reported postdose as present or absent for each 
symptom (nausea, phonophobia, and photophobia).
Other secondary objectives
Other secondary endpoints
To evaluate reliability of rimegepant effect in the Open-label extension (OLE) 
Phase, as measured by Migraine Quality of Life Questionnaire (MQoL) Question 
16 (overall change in migraine symptoms since taking study medication) at 24 
hours postdose in the DBT Phase and after each of the first 5 qualifying migraine 
attacks in the OLE Phase
Percentages of subjects achieving response after (1) the single evaluable 
qualifying migraine attack in the DBT Phase for those randomized to 
rimegepant, and (2) each of the first 5 evaluable qualifying migraine attacks 
≥23 hours apart in the OLE Phase. Reliability of rimegepant effect during the 
OLE Phase is defined as percentages for at least 4 of the first 5 evaluable 
qualifying migraine attacks ≥23 hours apart in the OLE Phase being no more 
than 7% less than the percentage in the DBT Phase. Response is defined as a 
category of “moderately better” or “very much better” for MQoL Question 
16 (overall change in migraine symptoms since taking study medication) at 
24 hours postdose. Evaluable qualifying migraine attacks are defined in the 
protocol
To evaluate the mean change from historical baseline in the number of migraine 
days per month by headache pain intensity (total; moderate or severe) in each 
month and over the entire OLE Phase
Mean change from historical baseline in the number of migraine days per 
month by headache pain intensity (total; moderate or severe) in each month 
and over the entire OLE Phase
To evaluate the proportions of subjects with ≥ 50% reduction from historical 
baseline in the number of migraine days per month by headache pain intensity 
(total; moderate or severe) in each month and over the entire OLE Phase
Percentages of subjects with ≥50% reduction from historical baseline in the 
number of migraine days per month by headache pain intensity (total; 
moderate or severe) in each month and over the entire OLE Phase
To evaluate the frequencies of adverse events by intensity, serious adverse 
events, adverse events leading to study drug discontinuation, and grade 3 to 4 
laboratory test abnormalities during the DBT and OLE Phases. 
Number and percentage of subjects with AEs by intensity (mild, moderate, 
severe, total), SAEs, AEs leading to study drug discontinuation, and grade 3 
to 4 laboratory test abnormalities on treatment during the DBT and OLE 
Phases
To evaluate the mean change from baseline in the Migraine Interictal Burden 
Scale (MIBS) score over time during the OLE Phase
Mean changes from baseline in the MIBS score at Weeks 4, 8, and 12 of the 
OLE Phase
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Overall Design:
This is a multicenter, phase 4, randomized, double-blind placebo-controlled study, with an 
OLE phase to assess the efficacy and tolerability of rimegepant for the acute treatment of 
migraine in a population of adult subjects that are unsuitable for the use of triptan 
medications due to previous intolerance, lack of efficacy, or contraindication (including a 
history of clinically significant cardiovascular disease)
The total study duration for each subject will be up to !24 weeks. 
∀
In the DBT Phase, subjects will be dispensed one single blister card containing one 
tablet of blinded study drug consisting of rimegepant 75 mg oral disintegrating tablet
(ODT) or matching placebo. The DBT Phase will last approximately 11 weeks 
(including a 3 to 28-day screening period, a treatment phase that can last up to 45-
days or until the subject experiences a qualifying migraine attack [whichever comes 
first], and an end-of-treatment visit ~7 days after the administration of study drug). 
Subjects will take blinded study drug as the first treatment for a migraine attack of 
moderate or severe headache pain intensity, and are not to take permitted acute 
migraine medication before taking blinded study drug.
∀
In the OLE Phase, lasting up to 12 weeks, subjects will be able to take up to 1 tablet 
of open-label study drug (75 mg ODT rimegepant) per calendar day as needed for 
acute treatment of migraine for a maximum of 18 doses per month (month is 28 
days). 
o
During the OLE Phase 
∀
Subjects are to use open-label study drug as the first treatment of migraine 
attacks of moderate or severe headache pain intensity, and should not take 
acute migraine medication before taking open-label study drug 
∀
In association with each of the First 5 Qualifying Migraine Attacks , subjects 
are required to complete the MQoL Questionnaire within the eDiary at 24 
hours after dosing with open-label study drug 
∀
If migraine-associated symptoms persist beyond 2 hours after dosing with 
open-label study drug, subjects may use permitted acute migraine medication 
for the purposes of rescue, as needed and in accordance with the standard of 
care. All dosing of rescue medication (permitted or exclusionary), is to be 
recorded on the Rescue Medication paper diary.
Number of Subjects:
Approximately 600 subjects will be randomized in a 1:1 ratio to blinded rimegepant or 
matching placebo in the DBT Phase. Randomization will be stratified by history of clinically 
relevant cardiovascular (CV ) disease (yes, no). In addition, randomization of subjects in the 
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CV subgroup (“yes” category) will be capped at 15%. In the OLE Phase, the study drug will 
be 75 mg ODT of open label rimegepant as needed, up to once per calendar day.
Study Population: 
The study will recruit subjects ≥18 years of age with a minimum 1 year documented history 
of migraine attacks (with or without aura) consistent with a diagnosis according to the 
International Classification of Headache Disorders, 3rd Edition. 
Per self-report, with confirmation from Investigator/ supporting medical record, subjects 
must have:
1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of
age.
2. Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
3. 4 to 14 migraine days per month on average across the 3 months prior to the Screening 
Visit (month is defined as 28 days for the purpose of this protocol).
4. Less than 15 headache days (migraine or non-migraine) per month in each of the 3 
months prior to the Screening Visit and throughout the Screening Phase
5. Less than 7 non-migraine headache days per month, on-average, across the 3-months 
prior to the Screening Visit 
6. Subjects must be able to distinguish migraine attacks from tension headaches.
7. Subjects on prophylactic migraine medication (excluding calcitonin gene-related peptide 
[CGRP] antagonists) are permitted to remain on therapy if they have been on a stable 
dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not 
expected to change during the course of the study. 
8. Be Triptan unsuitable.
Moreover, subjects must not have: 
9. History of cluster headache, basilar migraine (migraine with brainstem aura), or
hemiplegic migraine 
10. Current Medication-overuse headaches 
Ethical Considerations:
Rimegepant is being developed for the treatment of migraine. Effectiveness for the acute 
treatment of migraine was initially demonstrated in a Phase 2b double-blind, randomized, 
placebo-controlled, dose-ranging study where rimegepant at 75 mg showed efficacy on all 
four traditional endpoints: pain, nausea, photophobia and phonophobia. Efficacy was 
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confirmed for the acute treatment of migraine in three pivotal Phase 3 trials using the current 
registrational co-primary endpoints of Pain Freedom and Freedom from Most Bothersome 
Symptom at 2 hours after dosing. Effectiveness for the preventive treatment of episodic 
migraine was demonstrated in a Phase 2/3 double-blind, randomized, placebo-controlled 
study of rimegepant 75 mg dosed EOD. Every other day dosing was also well tolerated with 
no signals of hypersensitivity, cardiovascular events, or hepatotoxicity. Every other day 
scheduled dosing with as needed dosing was shown to be well tolerated with a favorable 
safety profile. 
The randomized, double-blind, placebo-controlled study design takes into consideration all 
potential influences such as the placebo effect and variability in pain intensity, whilst 
minimizing bias. The design of the study, including the use of a placebo control, is in
accordance with the most current International Headache Society (IHS) guidelines on the 
conduct of controlled trials in the acute treatment of migraine attacks in adults. Specifically, 
the document states, “Drugs intended for the acute treatment of migraine attacks can only be 
reliably evaluated in randomized, double-blind, placebo-controlled trials”.
During the DBT phase, subjects randomized to placebo are not expected to obtain any 
specific benefit beyond close monitoring of their medical condition and safety. Subjects 
continuing to the OLE phase will have the opportunity to receive open-label rimegepant for 
12 weeks (regardless whether they received placebo or rimegepant in the DBT phase) and 
may potentially derive benefit from the pharmacological effects of rimegepant in regards to 
the acute treatment of migraine.
Additionally, during both phases of the study, subjects may use their permitted acute 
migraine medication (prescribed or over-the-counter [OTC] agents) for the management of 
acute attacks, as needed, and in accordance with the standard of care.
During the study, subjects will undergo electrocardiograms (ECG), blood and urine sampling 
and will be asked to complete electronic and paper diaries and to attend visits.
The results of previous studies of rimegepant support the investigation of rimegepant in acute 
migraine prevention with multiple dosing regimens, and there is a favorable benefit-risk 
profile to support the rationale for this study. Taking into account the measures to minimize 
risk to subjects, the potential risks associated with rimegepant are justified by the anticipated 
benefits that may be afforded to subjects with acute migraine.
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STUDY SCHEMATIC
Screening 
Visit 
Baseline 
Visit 
(Random-
ization)
Randomized 1:1 ratio
Total study subject duration 24 weeks
Blinded study drug administered for 
acute treatment of a qualifying 
migraine, in accordance with the 
protocol
Blinded 
Rimegepant 
75 mg ODT
Matching 
placebo
DBT EOT Visit:
7 (+2) days after 
dosing with 
blinded study 
drug or the 
conclusion of the 
45-day DBT 
phase (in the 
absence of a 
qualifying 
migraine attack)
OLE Week 12 
Visit or EOT 
Visit (in the 
case of early 
d/c)
2-weeks (+/- 2 
days) from last 
OLE visit
Open-label 
Rimegepant 
administered for 
acute treatment 
of migraine in 
accordance with 
the protocol 
Screening Phase
(3-28 days)
Double-blind Treatment Phase (DBT)
(up to 45 days)
Follow-up
(2 weeks)
Open-label Extension Phase (OLE)
(up to 12 weeks)
With the first 5 qualifying 
migraine attacks to occur 
during the OLE Phase, the 
MQoL scale is to be 
completed within the eDiary 
at 24 hours after dosing with 
open-label study drug, in 
accordance with the protocol
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TABLE OF CONTENTS
SUMMARY OF CHANGES.....................................................................................................2
STUDY SUMMARY (SYNOPSIS)..........................................................................................6
PROTOCOL SUMMARY.........................................................................................................6
Synopsis ...........................................................................................................................6
STUDY SCHEMATIC ............................................................................................................12
TABLE OF CONTENTS.........................................................................................................13
LIST OF TABLES...................................................................................................................18
LIST OF ABBREVIATIONS..................................................................................................19
1. INTRODUCTION AND RATIONALE..............................................................................24
1.1. Background .............................................................................................................24
1.1.1. Clinical Experience.....................................................................................24
1.1.2. Product Development Background.............................................................24
1.2. Benefit/Risk Assessment.........................................................................................25
1.3. Study Rationale .......................................................................................................26
1.3.1. Study Design Rationale ..............................................................................27
1.3.2. Dose Selection Rationale............................................................................27
1.3.3. Research Hypothesis...................................................................................27
2. STUDY OBJECTIVES........................................................................................................28
2.1. Primary Objectives..................................................................................................28
2.2. Secondary Objectives..............................................................................................28
2.2.1. Key Secondary Objectives..........................................................................28
2.2.2. Other Secondary Objectives .......................................................................28
2.3. Exploratory Objectives............................................................................................29
3. STUDY ENDPOINTS.........................................................................................................30
3.1. Primary Endpoints...................................................................................................31
3.2. Secondary Endpoints...............................................................................................31
3.2.1. Key Secondary Endpoints...........................................................................31
3.2.2. Other Secondary Endpoints........................................................................32
4. STUDY PLAN.....................................................................................................................32
4.1. Study Design and Duration .....................................................................................32
4.2. Study Schematic......................................................................................................35
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4.3. Schedule of Assessments ........................................................................................36
4.3.1. Screening Phase..........................................................................................45
4.3.2. Double-blind Treatment Phase ...................................................................46
4.3.2.1. Baseline (Randomization) Visit ................................................47
4.3.2.2. DBT EOT Visit .........................................................................47
4.3.3. Open-label Extension Phase .......................................................................47
4.3.3.1. OLE Eligibility Confirmation Phone Visit................................47
4.3.3.2. OLE Day 1 ................................................................................47
4.3.3.3. OLE Week 12 / OLE EOT Visit ...............................................47
4.3.4. Follow-up Phase .........................................................................................49
4.4. Post Study Access to Therapy.................................................................................49
5. POPULATION ....................................................................................................................49
5.1. Number of Subjects.................................................................................................49
5.2. Inclusion Criteria.....................................................................................................50
5.3. Exclusion Criteria....................................................................................................51
5.4. Prohibited and Restricted Concomitant Medications and Devices .........................55
5.5. Permitted Non-study Standard of Care Migraine Medications...............................56
5.5.1. Prophylactic Migraine Medications............................................................56
5.5.2. Acute Migraine Medications ......................................................................56
5.5.2.1. Acute Migraine Medications in the DBT Phase........................56
5.5.2.2. Acute Migraine Medications in the OLE Phase........................57
5.5.2.3. Migraine Medications in the Follow-up Phase .........................57
5.6. Contraception ..........................................................................................................58
5.7. Deviation from Inclusion/ Exclusion Criteria .........................................................58
6. STUDY CONDUCT AND DESCRIPTION OF STUDY PROCEDURES........................58
6.1. Study Materials .......................................................................................................58
6.2. Eligibility Assessments ...........................................................................................60
6.3. Safety Assessments .................................................................................................60
6.3.1. Vital Signs and Physical Measurements (Height and Weight)...................60
6.3.2. Electrocardiogram (ECG)...........................................................................60
6.3.3. Physical Exam ............................................................................................60
6.3.4. Laboratory Assessments.............................................................................60
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6.3.4.1. Safety Laboratory Testing.........................................................61
6.3.4.2. Pregnancy Testing.....................................................................62
6.3.5. Columbia-Suicide Severity Rating Scale (C-SSRS)...................................62
6.4. Efficacy Assessments..............................................................................................62
6.4.1. Pain .............................................................................................................62
6.4.2. Nausea, Phonophobia and Photophobia .....................................................62
6.4.3. Functional Disability ..................................................................................63
6.4.4. Rescue Medication......................................................................................63
6.4.5. Migraine Days ............................................................................................64
6.4.6. Headache Days ...........................................................................................64
6.5. Other Assessments ..................................................................................................64
6.5.1. Migraine-Specific Quality-of-Life Questionnaire (MSQ) v 2.1.................64
6.5.2. Migraine Quality of Life Questionnaire (MQoL).......................................65
6.5.3. Migraine Interictal Burden Scale (MIBS) ..................................................65
6.6. Subject Early Discontinuation Criteria ...................................................................65
6.6.1. Lost to Follow-up .......................................................................................66
6.7. Study Early Discontinuation Criteria ......................................................................67
7. STUDY DRUG MANAGEMENT......................................................................................67
7.1. Description of Study Drug ......................................................................................67
7.1.1. Investigational Product ...............................................................................67
7.1.2. Concomitant Therapy .................................................................................68
7.1.3. Formulation.................................................................................................68
7.1.4. Packaging, Shipment and Storage ..............................................................68
7.1.5. Dose and Administration............................................................................69
7.1.5.1. Double-blind Treatment Phase..................................................69
7.1.5.2. Open-label Extension Phase......................................................69
7.1.6. Method of Assigning Subject Identification...............................................69
7.1.7. Selection and Timing of Dose and Administration ....................................70
7.1.8. Dose Modifications.....................................................................................70
7.2. Blinding and Unblinding.........................................................................................70
7.3. Treatment Compliance ............................................................................................71
7.4. Destruction and Return of Study Drug....................................................................72
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8. ADVERSE EVENTS...........................................................................................................72
8.1. Serious Adverse Events...........................................................................................74
8.1.1. Definition of Serious Adverse Event (SAE)...............................................74
8.1.2. Collection and Reporting Serious Adverse Events.....................................75
8.2. Non-serious Adverse Events ...................................................................................77
8.2.1. Collection and Reporting of Non-serious Adverse Events.........................77
8.2.2. Laboratory Test Abnormalities...................................................................77
8.3. Overdose..................................................................................................................78
8.4. Potential Drug Induced Liver Injury (DILI) ...........................................................78
8.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure..............................................................................................80
8.5.1. Exposure During Pregnancy.......................................................................80
8.5.2. Exposure During Breastfeeding..................................................................82
8.5.3. Occupational Exposure...............................................................................83
8.5.4. Lack of Efficacy .........................................................................................83
8.5.5. Medication Errors .......................................................................................83
8.6. Adverse Events of Special Interest..........................................................................84
9. STATISTICS .......................................................................................................................84
9.1. Sample Size.............................................................................................................84
9.2. Analysis Sets ...........................................................................................................84
9.3. Statistical Methods ..................................................................................................85
9.3.1. Efficacy Analyses .......................................................................................85
9.3.1.1. Primary Endpoint ......................................................................85
9.3.1.2. Secondary Endpoints.................................................................86
9.3.1.3. Statistical Hypotheses ...............................................................87
9.3.2. Safety Analyses ..........................................................................................87
9.4. Schedule of Analyses ..............................................................................................88
10. ETHICS AND RESPONSIBILITIES................................................................................88
10.1. Good Clinical Practice ..........................................................................................88
10.2. Data and Safety Monitoring Committee ...............................................................89
10.3. Steering Committee...............................................................................................89
10.4. Institutional Review Board/Independent Ethics Committee.................................89
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10.5. Informed Consent..................................................................................................89
10.6. Case Report Forms................................................................................................90
10.7. Dissemination of Clinical Study Data...................................................................90
10.7.1. Data sharing..............................................................................................91
10.8. Sponsor’s Medically Qualified Individual ............................................................92
11. RECORDS MANAGEMENT ...........................................................................................92
11.1. Source Documentation ..........................................................................................93
11.2. Study Files and Record Retention.........................................................................93
12. AMENDMENTS ...............................................................................................................94
13. STUDY REPORT AND PUBLICATIONS ......................................................................94
14. STUDY DISCONTINUATION ........................................................................................94
15. DATA PROTECTION.......................................................................................................94
16. APPENDICES ...................................................................................................................96
16.1. APPENDIX 1 – Prohibited and Restricted Concomitant Medications and 
Devices ......................................................................................................................96
16.2. APPENDIX 2 – Permitted Prophylactic Migraine Medication ............................99
16.3. APPENDIX 3 – Permitted Acute Migraine (Rescue) Medications ....................100
16.4. APPENDIX 4 – Triptan-unsuitable Criteria .......................................................101
16.5. Appendix 5: Contraceptive and Barrier Guidance ..............................................104
16.5.1. Female Participant Reproductive Inclusion Criteria...............................104
16.5.2. Woman of Childbearing Potential ..........................................................104
16.5.3. Contraception Methods...........................................................................105
16.6. APPENDIX 6 - ECG Findings of Potential Clinical Concern............................107
16.7. Appendix 7: Country-Specific Requirements .....................................................109
16.7.1. France .....................................................................................................109
16.7.2. Germany .................................................................................................110
16.7.3. European Union......................................................................................111
16.8. APPENDIX 8– Protocol Amendment History....................................................112
17. REFERENCES ................................................................................................................123
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LIST OF TABLES
Table 1.
Screening Phase and DBT Phase Schedule of Assessments ....................36
Table 2.
OLE Phase and Follow-up Phase Schedule of Assessments....................41
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LIST OF ABBREVIATIONS
ACE
Angiotensin-converting enzyme
ACS
acute coronary syndrome
AD
anxiety disorder
ADHD
Attention-deficit/hyperactivity disorder
AE
Adverse event
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
AV
atrioventricular
AxMP
Auxiliary Medicinal Product
BHV
Biohaven
BUN
Blood urea nitrogen
CABG
Coronary artery bypass grafting
CAD
coronary artery disease
CBD
cannabidiol
CFR
Code of Federal Regulations
CGRP
calcitonin gene-related peptide
CI
Confidence interval
CK
Creatine kinase
COVID-19
coronavirus disease of 2019
CRF
Case report form
CRO
Contracted Research Organization
CRPS
complex regional pain syndrome
CRS
chronic rhinosinusitis
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
CV
Cardiovascular
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CVA
Cerebrovascular accident
CYP
cytochrome P450
DAIDS
Division of AIDS
DBT
Double-blind Treatment
DDI
drug-drug interaction
DILI
Drug Induced Liver Injury
DMC
Data Safety Monitoring Committee
DSM-V
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
DSU
Drug Safety Unit
EC
Ethics Committee
ECG
Electrocardiogram
eCRF
Electronic Case report form
EDB
Exposure During Breastfeeding
EDC
Electronic Data Capture
eDiary
Electronic Diary
EDP
Exposure During Pregnancy
EFD
embryo-fetal development
eGFR
Estimated glomerular filtration rate
EOD
Every Other Day
EOT
End of Treatment
eTMF
electronic Trial Master File
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials (European 
Clinical Trials Database)
FDA
Food and Drug Administration
FSH
Follicle stimulating hormone
GCP
Good clinical practice
GGT
gamma-glutamyl transferase
GLP
Good Laboratory Practice
HbA1c
glycated haemoglobin
HCG
Human chorionic gonadotropin
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HR
Heart rate
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
identification
IEC
Independent Ethics Committee
IHS
International Headache Society
IMP
Investigational Medicinal Product
IND
Investigational New Drug
IOL=F
Intervening OL Rimegepant = Failure
IP
Investigational product
IRB
Institutional Review Board
IRT
Interactive Response Technology
IU/L
International Units Per Liter
kg
Kilogram
L
Liters
LBBB
Left Bundle Branch Block
LFT
Liver function test
LSLV
Last Subject Last Visit
MBS
Most bothersome symptom
MDD
Major depressive disorder
MDE
major depressive episode
MDRD
Modification of Diet in Renal Disease
MedDRA
Medical Dictionary for Regulatory Activities
mg
Milligram
MI
myocardial infarction
MIBS
The Migraine Interictal Burden Scale 
min
Minute
mL
millilitres
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mmHg
Millimeters mercury
MOH
Medication Overuse Headache
MQI
Medically Qualified Individual
MQoL
Migraine Quality of Life Questionnaire
MSQ
Migraine-Specific Quality-of-Life Questionnaire
NC=F
Non-completer = Failure
NIMP
Non Investigational Medicinal Product
NOAEL
No Observed Adverse Event Level
NSAID
Non-steroidal anti-inflammatory drug
ODT
Oral disintegrating tablet 
OL
Open-label
OLE
Open-label Extension
OTC
Over-the-Counter
PACL
Protocol Administrative Clarification Letter
PCD
Primary Completion Date
PCI
percutaneous coronary intervention
PCP
phencyclidine
P-gp
P-glycoprotein
PI
Principal investigator
PRN
as needed
PSSA
Pfizer SAE Submission Assistant
PVC
Premature Ventricular Contraction
QTcF
QTc corrected using Fridericia’s formula
QTL
Quality Tolerance Limit
RM=F
Rescue Medication = Failure
RTSM
Randomization and Trial Supply Management
SAE
Serious adverse event
SAP
Statistical Analysis Plan
SOP
standard operating procedure
SRSD
Single Reference Safety Document
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SUSAR
Suspected Unexpected Serious Adverse Reaction
T Bili
Total bilirubin
THC
Tetrahydrocannabinol
TIA
transient ischemic attack
TMD
temporomandibular disorders
TMF
Trial Master File
UK
United Kingdom
ULN
Upper limit of normal
US
United States
WOCBP
Woman/women of childbearing potential
WPW
Wolff-Parkinson-White
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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 headache pain intensity, aggravation by 
routine physical activity, and association with nausea and/or photophobia and phonophobia.1
BHV-3000 (rimegepant) (PF-07899801) 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 key role in migraine pathophysiology. For example, research and clinical 
studies have shown: serum levels of CGRP are elevated during migraine attacks, infusion of 
intravenous 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™]).
1.1.1. Clinical Experience
Rimegepant (Nurtec® ODT, Vydura, BHV-3000 [PF-07899801]) is an oral, small molecule, 
calcitonin gene-related peptide (CGRP) receptor antagonist approved in the United States 
(US) and the European Union (EU) for the acute treatment of migraine and the preventive 
treatment of episodic migraine in adults.2,3 Rimegepant is currently in development for the 
acute and preventive treatment of migraine in pediatric subjects, as well as for the treatment 
of refractory trigeminal neuralgia, the acute treatment of chronic rhinosinusitis (CRS), and 
temporomandibular disorders (TMD)
Please refer to the most up to date Investigator’s Brochure for additional safety information. 
1.1.2. Product Development Background
Details of the clinical and preclinical studies are provided in the current Investigator 
Brochure. A summary of the relevant data to the study are presented below.4
Rimegepant is approved for the acute treatment and prevention of episodic migraine in the 
United States (US), United Kingdom (UK), and European Union (EU) and is well tolerated 
when given as a single oral dose of 75 mg for the acute treatment of migraine and at a dose of 
75 mg every other day (EOD) for the prevention of episodic migraine. The efficacy and 
tolerability of rimegepant for the acute and preventive treatment of migraine in the pediatric 
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population is currently being evaluated. In this study, rimegepant is used in adults at the dose 
(75 mg) and in the indication (acute treatment of migraine) which are covered by the 
Marketing Authorization.
As of 26 February 2024, it is estimated that 12,135 participants have been involved in 
rimegepant clinical development studies and approximately 6630 participants 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. 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.
1.2. Benefit/Risk Assessment 
Rimegepant represents an advancement in migraine therapeutics, providing the first CGRP 
antagonist to demonstrate benefit for both the acute treatment and prophylaxis of migraine.
Rimegepant appears to be generally safe and well tolerated when given as single oral doses 
from 75 mg up to the maximum dose of 1500 mg and multiple oral doses up to the maximum 
daily dose of 600 mg for 14 days.
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 one 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 was well tolerated, with 
no new safety signals observed in the open-label-extension phase.
Across the rimegepant clinical development program, low frequency of events of 
hypersensitivity (including urticaria, angioedema, anaphylactic reaction, and rash) were 
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observed. No AEs representing serious cutaneous manifestation of hypersensitivity (e.g, 
Stevens-Johnson syndrome) were observed.
Across the rimegepant clinical development program, no cases of Hy’s Law were identified, 
and there was no signal of DILI due to rimegepant when administered up to once daily PRN 
for up to 52 weeks of treatment. 
There are no adequate data on the developmental risk associated with the use of rimegepant 
in pregnant women. Both women of childbearing potential, as well as those who are of non 
childbearing potential, may be enrolled given the availability of embryo-fetal development 
(EFD) nonclinical toxicity studies with rimegepant. Contraception method is required, and 
measures will be taken to limit the risk of pregnancy in the female population of childbearing 
potential enrolled (See Appendix 5). The potential risk of exposure to rimegepant in a sexual 
partner of a male subject in this study via ejaculate is low, and therefore no contraception 
(condom) use in male subjects is warranted. The calculated safety margin is ≥100-fold 
between the estimated partner exposure due to seminal transfer and the NOAEL for serious 
manifestations of developmental toxicity in nonclinical studies. The safety margin of 100-
fold is based on applying a 10-fold safety factor for interspecies extrapolation and a 10-fold 
safety factor for susceptible populations.5
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 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 
Brochure, which is the SRSD for this study.
1.3. Study Rationale
Rimegepant is approved medication for the acute treatment of migraine attacks and 
preventive treatment of episodic migraine. Effectiveness for the acute treatment of migraine 
was initially demonstrated in a Phase 2b double-blind, randomized, placebo-controlled, dose-
ranging study where rimegepant at 75 mg showed efficacy on all four traditional endpoints: 
pain, nausea, photophobia, and phonophobia.1
Efficacy was confirmed for the acute treatment of migraine in three pivotal single-attack 
Phase 3 trials using the current registrational co-primary endpoints of migraine headache pain 
freedom and freedom from most bothersome symptom at 2 hours postdose. Rimegepant 
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effectiveness for the preventive treatment of episodic migraine was demonstrated in a Phase 
2/3 double-blind, randomized, placebo-controlled study of rimegepant 75 mg dosed every 
other day (EOD).6 EOD dosing was also well tolerated with no signals of medication-overuse 
headache, abuse potential, cardiovascular events, or hepatotoxicity. 
Rimegepant represents an alternative treatment option for migraine sufferers who are not 
well served by existing standard of care (e.g., triptans), due to either a poor or inconsistent 
therapeutic response, prior intolerance, or due to the presence of contraindications. Subgroup 
analysis of subjects enrolled in Phase 3 pivotal trials who were identified having 
discontinued one or more triptans indicated that rimegepant demonstrated a similar degree of 
efficacy as for the general study population. Therefore, the primary aim of this study is to 
confirm the efficacy of rimegepant in a population deemed unsuitable for triptan use and in 
whom an alternative treatment option would be most advantageous.
1.3.1. Study Design Rationale
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for the 
acute treatment of migraine among adults considered unsuitable for triptan use because of 
prior intolerance, lack of efficacy or contraindication (including a history of clinically 
relevant cardiovascular disease). The double-blind, placebo-controlled, parallel group design 
to assess the efficacy and tolerability of rimegepant in this population in a primary migraine 
attack is in accordance with international guidelines for such an evaluation.7 Additional 
information on the effectiveness and safety of rimegepant will also be obtained across 
additional attacks when used as needed in the 12-week open-label extension. The inclusion of 
the 12-week OLE Phase allows for the evaluation of safety and tolerability of rimegepant 
across multiple migraine attacks in a population of triptan-unsuitable adults. In addition, the 
OLE Phase allows for the potential to evaluate consistency of effect (as measured by 
improvement in quality of life [MQoL Question 16]), at the population level, among adults in 
need of effective alternative treatments for the management of acute migraine.
1.3.2. Dose Selection Rationale
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 current study will evaluate the 
efficacy and tolerability of the acute treatment of multiple migraine attacks in adults 
unsuitable for triptan use. 
1.3.3. Research Hypothesis
Rimegepant is a safe and effective treatment for acute treatment of migraine in adults who 
are unsuitable for triptan use because of prior intolerance, lack of efficacy, or 
contraindication (including a history of clinically relevant cardiovascular disease).
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2. STUDY OBJECTIVES
2.1. Primary Objectives
To compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as 
measured by migraine headache pain relief at 2 hours postdose during the DBT Phase. 
2.2. Secondary Objectives
2.2.1. Key Secondary Objectives
1. To compare rimegepant with placebo for migraine headache pain freedom at 2 hours 
postdose during the DBT Phase.
2. To compare rimegepant with placebo for rescue medication use within 24 hours postdose 
during the DBT Phase.
3. To compare rimegepant with placebo for return to normal function, as measured by the 
functional disability scale, at 2 hours postdose during the DBT Phase.
4. To compare rimegepant with placebo for sustained return to normal function, as 
measured by the functional disability scale, from 2 to 24 hours postdose during the DBT 
Phase.
5. To compare rimegepant with placebo for sustained return to normal function, as 
measured by the functional disability scale, from 2 to 48 hours postdose during the DBT 
Phase.
6. To compare rimegepant with placebo for sustained migraine headache pain relief from 2 
to 24 hours postdose during the DBT Phase. 
7. To compare rimegepant with placebo on sustained migraine headache pain relief from 2 
to 48 hours postdose during the DBT Phase.
8. To compare rimegepant with placebo for sustained migraine headache pain freedom from 
2 to 24 hours postdose during the DBT Phase. 
9. To compare rimegepant with placebo for sustained migraine headache pain freedom from 
2 to 48 hours postdose during the DBT Phase. 
10. To compare rimegepant with placebo for freedom from the most bothersome symptom 
(MBS) associated with migraine at 2 hours postdose during the DBT Phase. 
2.2.2. Other Secondary Objectives
1. To evaluate reliability of rimegepant effect in the OLE Phase, as measured by Migraine 
Quality of Life Questionnaire (MQoL) Question 16 (overall change in migraine 
symptoms since taking study medication) at 24 hours postdose in the DBT Phase and 
after each of the first 5 qualifying migraine attacks in the OLE Phase.
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2. To evaluate the mean change from historical baseline in the number of migraine days per 
month by headache pain intensity (total; moderate or severe) in each month and over the 
entire OLE Phase.
3. To evaluate the proportions of subjects with ≥50% reduction from historical baseline in 
the number of migraine days per month by headache pain intensity (total; moderate or 
severe) in each month and over the entire OLE Phase.
4. To evaluate the frequencies of adverse events by intensity, serious adverse events, 
adverse events leading to study drug discontinuation, and grade 3 to 4 laboratory test 
abnormalities during the DBT and OLE Phases.
5. To evaluate the mean change from baseline in the Migraine Interictal Burden Scale 
(MIBS) score over time during the OLE Phase.
2.3. Exploratory Objectives
1. To evaluate the Migraine Quality of Life Questionnaire (MQoL) at 24 hours postdose 
during the DBT Phase 
2. To evaluate the Migraine Quality of Life Questionnaire (MQoL) at 24 hours postdose 
after each of the first 5 qualifying migraine attacks during the OLE Phase. 
3. To evaluate migraine headache pain relief at all scheduled time points postdose during 
the DBT Phase.
4. To evaluate migraine headache pain freedom at all scheduled time points postdose during 
the DBT Phase.
5. To evaluate MBS freedom at all scheduled time points postdose during the DBT Phase.
6. To evaluate return to normal function, as measured by the functional disability scale, at 
all scheduled time points postdose during the DBT Phase.
7. To evaluate photophobia freedom at all scheduled time points postdose during the DBT 
Phase.
8. To evaluate phonophobia freedom at all scheduled time points postdose during the DBT 
Phase.
9. To evaluate nausea freedom at all scheduled time points postdose during the DBT Phase.
10. To evaluate pain relapse from 2 to 48 hours postdose during the DBT Phase. 
11. To evaluate time to migraine headache pain relief through 48 hours postdose during the 
DBT Phase.
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12. To evaluate the mean number of acute migraine medication (rescue or non-rescue) days 
per month in each month and over the entire OLE Phase.
13. To evaluate the proportion of subjects who use rescue medication after each of the first 5 
qualifying migraine attacks during the OLE Phase. 
14. To evaluate the frequencies of hepatic-related adverse events and hepatic-related adverse 
events leading to study drug discontinuation in subjects treated with rimegepant during 
the DBT and OLE Phases.
15. To evaluate the mean changes from baseline in the Migraine-Specific Quality-of-Life 
Questionnaire v2.1 (MSQ) domain scores at Week 12 of the OLE Phase.
16. To evaluate the frequency of liver function test (LFT) elevations (AST, ALT, or total 
bilirubin) based on fold changes above ULN in subjects treated with rimegepant during 
the DBT and OLE Phases.
17. To evaluate primary and key secondary efficacy endpoints during the DBT Phase and 
high-level safety endpoints during the DBT and OLE Phases by history of clinically 
relevant CV disease (yes, no).
18. To evaluate primary and key secondary efficacy endpoints during the DBT Phase by 
history of documented failure to ≥ 2 triptan medications with ≥ 1 failure due to lack of 
efficacy (yes, no).
3. STUDY ENDPOINTS 
Efficacy endpoints based on scales (migraine headache; presence or absence of nausea, 
phonophobia, or photophobia; functional disability level), and MQoL scores during the DBT 
and OLE Phases are derived from the eDiary.
Adverse events (AEs) and acute migraine medication use are determined from CRFs.
Grade 3 to 4 laboratory test abnormalities are determined from laboratory test values graded 
using standardized criteria. Laboratory tests are identified from CRFs and central laboratory 
data.
During the DBT Phase, the intercurrent event of rescue medication use will be handled using 
Rescue Medication = Failure (RM=F), i.e., subjects who take rescue medication (see 
Section 6.4.4) will be classified as failures for all efficacy assessments that are reported at or 
after taking acute migraine medication as rescue.
The RM=F method will apply to all binary efficacy endpoints listed below 
(including reliability of rimegepant effect) except the key secondary endpoint of rescue 
medication use within 24 hours postdose. 
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3.1. Primary Endpoints
Percentage of subjects with a headache pain intensity of none or mild at 2 hours postdose in 
the DBT Phase. Migraine headache pain intensity will be measured on a 4-point numeric 
rating scale (0=none, 1=mild, 2=moderate, 3=severe).
3.2. Secondary Endpoints
3.2.1. Key Secondary Endpoints
1. Percentage of subjects with a headache pain intensity of none at 2 hours postdose in the 
DBT Phase.
2. Percentage of subjects who take rescue medication within 24 hours after taking study 
drug in the DBT Phase. Rescue medication is defined in Section 6.4.4.
3. Percentage of subjects with a functional disability level of normal at 2 hours postdose in 
the DBT Phase in the subset of subjects with functional disability at the time of dosing. 
Functional disability level will be measured on a 4-point numeric rating scale (0=normal, 
1=mildly impaired, 2=severely impaired, 3=requires bedrest).
4. Percentage of subjects with functional disability levels of normal at all time points from 2 
to 24 hours postdose in the DBT Phase in the subset of subjects with functional disability 
at the time of dosing.
5. Percentage of subjects with functional disability levels of normal at all time points from 2 
to 48 hours postdose in the DBT Phase in the subset of subjects with functional disability 
at the time of dosing.
6. Percentage of subjects with headache pain intensities of none or mild at all time points 
from 2 to 24 hours postdose in the DBT Phase.
7. Percentage of subjects with headache pain intensities of none or mild at all time points 
from 2 to 48 hours postdose in the DBT Phase.
8. Percentage of subjects with headache pain intensities of none at all time points from 2 to 
24 hours postdose in the DBT Phase.
9. Percentage of subjects with headache pain intensities of none at all time points from 2 to 
48 hours postdose in the DBT Phase.
10. Percentage of subjects with an MBS that is reported on study before dosing and is absent 
at 2 hours postdose in the DBT Phase. The MBS on study before dosing will be reported 
as nausea, phonophobia, or photophobia. Symptom status will be reported postdose as 
present or absent for each symptom (nausea, phonophobia, and photophobia).
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3.2.2. Other Secondary Endpoints
1.
Percentages of subjects achieving response after (1) the single evaluable qualifying 
migraine attack in the DBT Phase for those randomized to rimegepant, and (2) each of 
the first 5 evaluable qualifying migraine attacks ≥23 hours apart in the OLE Phase. 
Reliability of rimegepant effect during the OLE Phase is defined as percentages for at 
least 4 of the first 5 evaluable qualifying migraine attacks ≥23 hours apart in the OLE 
Phase being no more than 7% less than the percentage in the DBT Phase. Response is 
defined as a category of “moderately better” or “very much better” for MQoL Question 
16 (overall change in migraine symptoms since taking study medication) at 24 hours 
postdose. Evaluable qualifying migraine attacks are defined in Section 9.3.1.2.
2. Mean change from historical baseline in the number of migraine days per month by 
headache pain intensity (total; moderate or severe) in each month and over the entire 
OLE Phase.
3. Percentages of subjects with ≥50% reduction from historical baseline in the number of 
migraine days per month by headache pain intensity (total; moderate or severe) in each 
month and over the entire OLE Phase.
4. Number and percentage of subjects with AEs by intensity (mild, moderate, severe, total), 
SAEs, AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test 
abnormalities on treatment during the DBT and OLE Phases.
5. Mean changes from baseline in the MIBS score at Weeks 4, 8, and 12 of the OLE Phase.
4. STUDY PLAN
4.1. Study Design and Duration
This is a multicenter, phase 4, randomized, double-blind placebo-controlled study, with an 
open label extension (OLE) phase to assess the efficacy and tolerability of rimegepant for the 
acute treatment of migraine in subjects who are unsuitable for triptan use (see Section 16.4, 
Appendix 4, for triptan unsuitable). 
The total study duration for each subject will be up to ~24 weeks. The end of the study is 
defined as the last visit of the last subject. 
∀
In the DBT Phase, subjects will be dispensed 1 blister card and instructed to take 1 tablet 
(75 mg ODT) of blinded rimegepant or matching placebo when they have a migraine 
attack of moderate or severe headache pain intensity that they have not already treated 
with acute migraine medication (see Section 16.3 Appendix 3).
∀
The DBT Phase will last approximately 11 weeks (including a 3 to 28-day screening 
period, a treatment phase that can last up to 45 days or until the subject experiences a 
qualifying migraine attack (see definition below) [whichever comes first], and an end-
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of-treatment visit that is to occur ~7-days after the administration of blinded study 
drug). 
∀
A qualifying migraine attack in the DBT Phase is defined as a migraine attack of 
moderate or severe headache pain intensity that is first treated with blinded 
study drug, i.e., acute migraine medication is not taken before taking blinded 
study drug.
∀
Subjects who do not have a qualifying migraine attack (see above for definition) 
during the 45-day DBT Phase will not be eligible for the OLE Phase.
∀
In association with a qualifying migraine attack, subjects are required to use the 
eDiary to complete (1) efficacy-related questions though 48 hours after dosing with 
blinded study drug, and (2) the MQoL Questionnaire at 24 hours after dosing with 
blinded study drug.
∀
In the OLE Phase, subjects will be able to take up to 1 tablet of open-label study drug 
(75 mg ODT rimegepant) per calendar day as needed for acute treatment of migraine for 
a maximum of 18 doses per month (month is 28 days). 
o
During the OLE Phase, 
∀
Subjects are to use open-label study drug as the first treatment for migraine 
attacks of moderate or severe headache pain intensity, and should not take acute 
migraine medication before taking open-label study drug (see Section 16.3 
Appendix 3). 
∀
A qualifying migraine attack in the OLE Phase is defined as a migraine 
attack of moderate or severe headache pain intensity that is first treated with 
open-label study drug, i.e., acute migraine medication is not taken before 
taking open-label study drug. 
∀
In association with each of the First 5 Qualifying Migraine Attacks, subjects are 
required to use the eDiary to complete the MQoL Questionnaire at 24 hours after 
dosing with open-label study drug. In the event an MQoL Questionnaire is not 
completed for any of the first 5 qualifying migraine attacks (eg, inadvertently 
missed), MQoL Questionnaires will be collected for subsequent qualifying 
migraine attacks until a total of 5 MQoL Questionnaires are completed.
∀
If migraine-associated symptoms persist beyond 2 hours after dosing with open-
label study drug, subjects may use permitted acute migraine medication (see 
Section 16.3, Appendix 3) for the purposes of rescue, as needed and in accordance 
with the standard of care. All dosing of rescue medication (permitted or 
exclusionary), as defined in Section 6.4.4, is to be recorded on the Rescue 
Medication paper diary.
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In the DBT Phase, the study drug will be blinded 75 mg ODT of rimegepant or matching 
placebo. The study will randomize approximately 600 subjects in a 1:1 ratio to blinded 
rimegepant or matching placebo in the DBT Phase. Randomization will be stratified by 
history of clinically relevant CV disease (yes or no; see Section 7.1.6). In addition, 
randomization of subjects in the CV subgroup (“yes” category) will be capped at 15%. In the 
OLE Phase, the study drug will be 75 mg ODT of open-label rimegepant.
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4.2. Study Schematic
Total study subject duration 24 weeks
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4.3. Schedule of Assessments
Table 1.
Screening Phase and DBT Phase Schedule of Assessments
Screening Phase
(3-28 days)
DBT Phase (up to 45 days in duration)
Procedure 
Screening Visit 
Baseline/ 
Randomization 
(Day 1)1
Moderate or Severe 
Migraine Before 
Study Drug 
Post Study Drug: 
Administration 15, 30, 
45, 60, 90 minutes 
2, 3, 4, 6, 8, 24 and 48 
hours 
End of Treatment –
(DBT Phase) 
(7 days +2 days 
after dosing)2
Notes
Eligibility Assessments
Informed consent
X
Subject must be entered in 
the RTSM after informed 
consent is collected to 
obtain their study subject 
identification number.
Inclusion/ Exclusion 
criteria assessed 
X
X
Medical history 
X
Migraine history 
assessment (signs/ 
symptoms/ prior 
treatment/ frequency/ 
intensity) 
X
Concomitant 
medication paper 
diary 
X
X
X
X
See Section 5.4 for 
additional details
Rescue Medication 
paper diary 
X
X
X
1 The Baseline Visit may only occur after all screening procedures are completed and the subject meets all inclusion/exclusion criteria. If the subject does not meet all 
eligibility requirements, the subject is to be counted as a Screen Failed within the RTSM system.
2 All subjects will return to the site (after assessments in the eDiary are completed) within 7 (+2) days after dosing with study drug in this phase. The “+2” day window is 
included for scheduling purposes only. Every effort should be made to conduct the DBT EOT Visit and maintain the 7 (+2) day window. However, due to concerns related to 
the COVID-19 pandemic, or any natural catastrophe, the DBT EOT Visit window may be modified beyond the 7 (+2) day window. Any potential issues should be discussed 
with Sponsor/CRO and will be addressed on an individualized basis.
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Screening Phase
(3-28 days)
DBT Phase (up to 45 days in duration)
Procedure 
Screening Visit 
Baseline/ 
Randomization 
(Day 1)1
Moderate or Severe 
Migraine Before Study 
Drug 
Post Study Drug: 
Administration 15, 
30, 45, 60, 90 
minutes 
2, 3, 4, 6, 8, 24 and 
48 hours 
End of Treatment –
(DBT Phase) 
(7 days +2 days after 
dosing)2
Notes
Randomize 
subject in RTSM
X
Obtain subject ID
Safety Assessments
Physical 
Examination 
X
X*
*If subject is eligible to enroll 
into the OLE Phase, a physical 
exam at DBT EOT is not 
required.
Subjects will undergo a 
complete physical examination 
during the Screening Phase and 
targeted symptom-directed 
physical exam (physical 
examinations to include 
examination of heart, abdomen, 
and lungs, with review of any 
other system to be guided by 
symptoms) at DBT EOT.
see Section 6.3.3.
Vital Signs/ 
Physical 
Measurements
X
X
X
Height will only be captured at 
the Screening Visit. Weight, 
body temperature, respiratory 
rate, blood pressure and heart 
rate will be collected at all time 
points where indicated. Sitting 
arterial systolic and diastolic 
blood pressure and pulse rate 
will be measured.
ECG
X
X*
*If subject is eligible to enroll 
into the OLE Phase, an ECG at 
DBT EOT is not required
Urine drug screen 
for drugs of abuse 
X
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Screening Phase
(3-28 days)
DBT Phase (up to 45 days in duration)
Procedure 
Screening Visit 
Baseline/ 
Randomization 
(Day 1)1
Moderate or Severe 
Migraine Before 
Study Drug 
Post Study Drug: 
Administration 15, 30, 
45, 60, 90 minutes 
2, 3, 4, 6, 8, 24 and 48 
hours 
End of Treatment –
(DBT Phase) 
(7 days +2 days after 
dosing)2
Notes
AE, SAE, and 
Concomitant 
Procedure
assessment
X
X
X
X
SAEs and AEs are reported 
from the time of signed 
informed consent (See 
Section 8.2.1 and 8.1.2). All 
ongoing non-serious AEs 
and SAEs will be followed 
to resolution or until the 
Investigator deems there will 
be no further status change. 
AEs that occur during the 
treatment period must be 
reported to the site in real 
time. Non-serious AEs that 
occur during the treatment 
period must be reported to 
the site at each study visit.
Clinical Safety 
Laboratory 
Testing 
(hematology, 
chemistry)3
X
X
Liver Function 
Tests (LFTs)3
X
X
Pregnancy Test4
X (serum)
X (urine)
X (urine)4
X (serum or urine)
3 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 must be documented. See section 6.3.4.1 Safety Laboratory Testing
4 During the DBT Phase, WOCBP must complete a pregnancy test at Screening, Baseline, prior to taking blinded study medication, and at the DBT EOT Visit. If a WOCBP 
suspects that she might be pregnant she must not take any further doses of study drug and immediately contact the study doctor.
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Screening Phase
(3-28 days)
DBT Phase (up to 45 days in duration)
Procedure 
Screening Visit 
Baseline/ 
Randomization 
(Day 1)1
Moderate or 
Severe Migraine 
Before Study 
Drug 
Post Study Drug: 
Administration 15, 30, 
45, 60, 90 minutes 
2, 3, 4, 6, 8, 24 and 48 
hours 
End of Treatment –
(DBT Phase) 
(7 days +2 days after 
dosing)2
Notes
Clinical Drug Supplies/ Study Supplies
eDiary assigned to 
subject 
X
Subject education: 
eDiary subject 
training/ device 
training
X
Dispense study drug 
X
Subjects are to use blinded 
study drug to first treat a 
migraine attack of moderate 
or severe headache pain 
intensity. Subjects are to use 
the eDiary to indicate when 
it is time to take study drug.
Collect study drug 
X
Collect used and unused 
study drug.
Subject administers 
study drug 
X
Subject administers study 
drug ONLY after completion 
of the eDiary pre-dose 
migraine assessments.
eDiary completion
X
eDiary reviewed for 
completeness
X
Subject will return with 
eDiary. Site staff to review 
and confirm all data points 
are transferred from the 
eDiary. After study 
personnel review, the eDiary 
should be re-dispensed to the 
subject.
eDiary re-training for 
OLE subjects
X
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Screening Phase
(3-28 days)
DBT Phase (up to 45 days in duration)
Procedure 
Screening Visit 
Baseline/ 
Randomization 
(Day 1)1
Moderate or 
Severe Migraine 
Before Study Drug 
Post Study Drug: 
Administration 15, 
30, 45, 60, 90 
minutes 
2, 3, 4, 6, 8, 24 and 
48 hours 
End of Treatment 
– (DBT Phase) 
(7 days +2 days 
after dosing)2
Notes
Efficacy and Outcomes Research Assessments
Assessments of 
migraine pain, 
migraine symptoms 
Most Bothersome 
Symptoms (MBS) *
(phonophobia, 
photophobia, and 
nausea) and functional 
disability
X*
X
*MBS is captured 
before study drug 
administration
Other Assessments
Migraine-Specific 
Quality-of-Life 
Questionnaire (MSQ) 
v 2.1 
X 
Paper assessment –
recall 4 weeks 
Migraine Quality of 
Life Questionnaire 
(MQoL)
X (24 hours only)
eDiary 
Columbia-Suicide 
Severity Rating Scale 
(C-SSRS) 
X
X
X
Paper assessment 
Screening assessment 
for the Screening 
Visit and Since the 
last assessment for all 
other timepoints.
Migraine Interictal 
Burden Scale (MIBS)
X
Paper assessment. 
Recall for this scale is 
every 4 weeks.
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Table 2.
OLE Phase and Follow-up Phase Schedule of Assessments
Open-label Extension Phase
Follow-up Phase
Procedure
Eligibility 
Confirmation 
Phone Visit1
Week 2 Visit 
(OLE Day 15 +/- 2 
days)
Week 4 Visit
(OLE Day 29 
+/- 2 days)
Week 8 Visit 
(OLE Day 57 +/- 2 
days)
Week 12 Visit (OLE 
Day 85 +2 days) or
EOT for early 
discontinuation
Follow-up Week 2 
Visit (+/- 2days) 
NOTES
Confirm DBT EOT 
laboratory test results
X
Rescue Medication 
paper diary
X
X
X
Concomitant medication 
paperdiary
X
X
X
X
X
Concomitant medications,
including prophylactic 
migraine medications
(both prescribed and 
OTC), taken during the 
OLE Phase and Follow-up 
Phase are to 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 
must be collected at the 
Follow-up Week 2 Visit.
1 The DBT-EOT Visit represents OLE Day 1. 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 DBT EOT Visit.
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Open-label Extension Phase
Follow-up Phase
Procedure
Eligibility 
Confirmation 
Phone Visit1
Week 2 Visit 
(OLE Day 15 
+/- 2 days)
Week 4 Visit
(OLE Day 29 
+/- 2 days)
Week 8 Visit 
(OLE Day 57 +/-
2 days)
Week 12 Visit (OLE 
Day 85 +2 days) or
EOT for early 
discontinuation
Follow-up Week 2 
Visit (+/- 2days) 
NOTES
Safety Assessments
Physical Examination
X
Targeted symptom directed 
physical examination to 
include examination of 
heart, abdomen, and lungs, 
with review of any other 
system to be guided by 
symptoms. See Section
6.3.3
Vital Signs / 
Physical
Measurements
X
X
X
X
X
Height will only be 
captured at the Screening 
Visit. Weight, body 
temperature, respiratory 
rate, blood pressure and 
heart rate will be collected 
at all time points where 
indicated. Sitting arterial 
systolic and diastolic blood 
pressure and pulse rate will 
be measured.
Clinical Safety 
Laboratory Testing 
(hematology, 
chemistry)2
X
Liver Function Test (LFTs)2
X
X
ECG
X
Pregnancy Test3
X (urine)
X (urine)
X (urine)
X (serum)
X (urine)
2. 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 must be documented. See Section 6.3.4.1 Safety Laboratory Testing.
3 During the OLE Phase, WOCBP must complete a pregnancy test at the Week 2, Week 4, Week 8, Week 12/EOT, and Follow-up Week 2 Visits. If a WOCBP suspects that she 
might be pregnant she must not take any further doses of study drug and immediately contact the study doctor
.
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Open-label Extension Phase
Follow-up Phase
Procedure
Eligibility 
Confirmation 
Phone Visit1
Week 2 Visit 
(OLE Day 15 +/-
2 days)
Week 4 Visit
(OLE Day 29 +/-
2 days)
Week 8 Visit 
(OLE Day 57 +/- 2 
days)
Week 12 Visit (OLE 
Day 85 +2 days) or
EOT for early 
discontinuation
Follow-up Week 2 
Visit (+/- 2days) 
NOTES
AE, SAE, and 
ConcomitantProcedure
assessment
X
X
X
X
X
AEs and SAEs are 
collected through the 
Follow-up Week 2 
Visit 
Clinical Drug Supplies /Study Supplies
Dispense study drug4
X
X
X
Administer study drug
X
X
X
Subjects cannot take 
more than 1 ODT of 
study drug 
(rimegepant) per day, 
and no more than 18 
tablets of rimegepant 
per 28 days. Study 
drug is NOT to be used 
for rescue.
Return used and unused
study drug to site for 
compliance check
X
X
X
X
eDiary returned / reviewed 
for completeness5
X
X
X
X
Subject will return 
eDiary. Site staff to 
review and confirm all 
data points are 
transferred, PRIOR to 
the subject leaving the 
study center.
4 At the DBT Phase EOT Visit, subjects will be administered 2 wallet cards containing 8 ODTs. Subjects are to be instructed to complete a full wallet, as directed, before taking 
study drug from a new one. Day 1 of the OLE Phase = DBT EOT Visit.
5 eDiary will be used to record the occurrence of migraine attacks and headaches during the OLE Phase
. 
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Open-label Extension Phase
Follow-up Phase
Procedure
Eligibility 
Confirmation 
Phone Visit1
Week 2 Visit 
(OLE Day 15 +/-
2 days)
Week 4 Visit
(OLE Day 29 +/-
2 days)
Week 8 Visit 
(OLE Day 57 +/- 2 
days)
Week 12 Visit (OLE 
Day 85 +2 days) or
EOT for early 
discontinuation
Follow-up Week 2 
Visit (+/- 2days) 
NOTES
Other Assessments
Migraine-Specific Quality-
of-Life Questionnaire
(MSQ)
v 2.1
X
Paper assessment. 
Migraine Interictal Burden 
Scale (MIBS)
X
X
X
Paper assessment. 
Recall for this scale is 
every 4 weeks.
Migraine Quality of Life 
Questionnaire (MQoL)
X
X
Scale will populate on 
the eDiary 24 hours 
after each qualifying 
migraine attack until 5 
are completed.
Columbia-Suicide Severity
Rating Scale (C-SSRS)
X
X
Paper assessment. 
Since the last 
assessment will be 
used for all OL 
timepoints.
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4.3.1. Screening Phase
Approximately 900 subjects will be screened to randomize approximately 600 subjects to 
blinded study drug (rimegepant ODT or matching placebo). 
Before any study procedures are performed, subjects must sign informed consent. After 
informed consent is signed, subjects will be enrolled in the RTSM system. The subject’s 
migraine history and medical history will be collected at the Screening Visit. Subjects will 
also undergo all screening procedures as detailed in Table 1. Within 3-28 days from the 
Screening Visits, subjects will return to the site for the Baseline/Randomization Visit; if the 
subject does not meet all eligibility criteria, the subject will be considered a Screen Failure.
For LFT testing requirements:
For total bilirubin, > 1.5 × ULN may be repeated once for confirmation during the Screening 
Phase. 
For ALT/AST >2 × ULN, may be repeated once for confirmation during the Screening 
Phase. Screening Phase will have one screening visit that must be completed in person. 
Subjects on prophylactic migraine medication are permitted to remain on therapy (excluding 
CGRP antagonists) provided they have been on a stable dose for 3 months prior to the 
Screening Visit and the dose is not expected to change throughout the course of the study 
(DBT through OLE). The list of acceptable prophylactic migraine medications can be found 
in Section 16.2, Appendix 2.
A Concomitant Medication paper diary will be provided to subjects at the Screening Visit. 
Subjects are to keep track of all concomitant medications including acute migraine 
medications (used for non-rescue purposes only, see Section 6.4.4) and standard prophylactic 
migraine medications (see Section 16.2, Appendix 2), through the DBT EOT and OLE Week 
12/ EOT Visits on an IRB-approved Concomitant Medication paper diary. All paper diaries 
(the Concomitant Medication and the Rescue Medication paper diaries) are to be returned to 
the investigational site at each visit for review and electronic data capture (EDC) entry. The 
paper diaries must be kept as source documentation. See the Acute Migraine Medication 
section of the protocol (Section 5.5) for additional information. 
Subjects who were considered screen failures 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.
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4.3.2. Double-blind Treatment Phase
The DBT Phase will have 2 scheduled clinic visits, Baseline (Randomization) and DBT 
EOT. Both visits must be completed in person. Eligible subjects will be randomized at the 
Baseline (Randomization) Visit of the 45-day DBT Phase. Subjects will be dispensed a single 
dose of double-blind study drug for the DBT Phase. 
During the DBT Phase, subjects will record efficacy data in their assigned eDiary. Subjects 
will be instructed to take study drug as an outpatient. Subjects are not permitted to dose with 
study drug until the migraine headache pain reaches moderate or severe headache pain 
intensity. The eDiary will instruct the subject to take study drug after the initial assessments 
are completed in the device. The following will be recorded in the eDiary:
∀
Migraine headache pain intensity using a 4-point numeric rating scale (none, mild, 
moderate, severe) before taking study drug and after taking study drug at time points 
of 15, 30, 45, 60, and 90 minutes and 2, 3, 4, 6, 8, 24 and 48 hours postdose
∀
The presence or absence of associated symptoms (nausea, photophobia, phonophobia) 
and functional disability level (4-point numeric rating scale: normal, mildly impaired, 
severely impaired, requires bedrest) recorded at the same time points as migraine 
headache pain intensity
∀
MBS before taking study drug (with or without aura)
∀
Migraine Quality of Life Questionnaire (MQoL) at 24 hours postdose
Subjects who experience reduction of migraine headache pain intensity to a level of none or 
mild will be considered to have achieved migraine headache pain relief. Subjects will be 
allowed to take permitted acute migraine medication (specified in Section 16.3, Appendix 3), 
for the purposes of rescue, as needed and in accordance with the standard of care, only after 
the 2-hour postdose and after the 2-hour assessments have been completed within the 
eDiary. 
Subjects will be instructed to contact the study center immediately if a severe or serious 
adverse event occurs. At select study visits (see Table 1), subjects will be requested to 
complete the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ), MIBS (The 
Migraine Interictal Burden Scale) and the Columbia-Suicide Severity Rating Scale (C-SSRS) 
on paper forms.
Subjects will continue to record all concomitant medications, including acute migraine 
medications (used for non-rescue purposes only, see Section 5.5.2) and standard prophylactic 
migraine medications (see Section 16.2, Appendix 2), taken during the DBT Phase in the 
Concomitant Medication paper diary. All rescue medications, as defined in Section 6.4.4, are 
to be documented on the Rescue Medication paper diary. 
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4.3.2.1. Baseline (Randomization) Visit
Subjects are to return to the study site for the Baseline (Randomization) Visit, which must be 
completed in person. Subjects who continue to meet all study entry criteria may be 
randomized in the RTSM system and entered into the DBT Phase.
At the Baseline Visit, subjects will be randomized 1:1 across 2 treatment groups: blinded 
rimegepant 75 mg (n = 300) or matching placebo for rimegepant 75 mg (n = 300). 
Randomization will be stratified by history of clinically relevant CV disease (yes or no; see 
Section 7.1.6). In addition, randomization of subjects in the CV subgroup (“yes” category) 
will be capped at 15%.
4.3.2.2. DBT EOT Visit
Subjects will return to the study site within 7 (+2) days after administration of double-blind 
study drug, for review of the eDiary data, assessment of medication compliance, and 
monitoring of tolerability and safety (including vital signs, laboratory tests, and ECG). If a 
subject does NOT have a qualifying migraine attack (see Section 4.1) within 45 days after 
randomization, they still are required to complete all DBT EOT Visit procedures including 
assessment of medication compliance and monitoring of tolerability and safety (including 
vital signs, laboratory tests, and ECG). Subjects who do not have a qualifying migraine 
attack (see Section 4.1) during the 45-day DBT Phase will not be eligible for the OLE Phase.
At the DBT EOT Visit, the subject will return the eDiary for review and all study drug, 
including wallets with used or unused study drug. Subjects will also be evaluated at this visit 
for entry into the 12-week OLE Phase following laboratory results within acceptable ranges 
per protocol (see Table 2). Subjects in the DBT Phase who demonstrate poor compliance will 
be discussed with the Sponsor, corrective training will be completed by the site with the 
subject prior to the OLE Phase (see Sections 6.6 and 7.3).
4.3.3. Open-label Extension Phase
4.3.3.1. OLE Eligibility Confirmation Phone Visit
Study eligibility must be confirmed by DBT EOT Visit laboratory results prior to the first 
dose of open-label rimegepant. The site must contact the subject by phone to confirm OLE 
Phase eligibility prior to subject taking the first dose of open-label rimegepant.
4.3.3.2. OLE Day 1
Day 1 of the OLE Phase is the same day as the DBT EOT Visit. Sites are to instruct subjects 
to refrain from dosing with open-label study drug until they have received a phone call from 
the site confirming their eligibility to enter the OLE Phase. 
4.3.3.3. OLE Week 12 / OLE EOT Visit
The OLE Phase will last 12 weeks from the DBT EOT Visit through the OLE Week 12 / 
OLE EOT Visit.
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In the OLE Phase, subjects will be able to take up to 1 tablet of open-label study drug (75 mg 
ODT rimegepant) per calendar day as needed for acute treatment of migraine of moderate or 
severe headache pain intensity for a maximum of 18 doses per month (month is 28 days).
∀
During the OLE Phase 
o
Subjects are to use open-label study drug as the first treatment for migraine 
attacks of moderate or severe headache pain intensity, and should not take acute 
migraine medication before taking open-label study drug (see Section 16.3, 
Appendix 3). 
o
In association with each of the First 5 Qualifying Migraine Attacks (see 
Section 4.1), subjects are required to complete the MQoL Questionnaire within 
the eDiary at 24 hours after dosing with open-label study drug. In the event an 
MQoL Questionnaire is not completed for any of the first 5 qualifying migraine 
attacks (eg, inadvertently missed), MQoL Questionnaires will be collected for 
subsequent qualifying migraine attacks until a total of 5 MQoL Questionnaires are 
completed.
o
If migraine-associated symptoms persist beyond 2 hours after dosing with open-
label study drug, subjects may use permitted acute migraine medication (see 
Section 16.3, Appendix 3) for the purposes of rescue, as needed and in accordance 
with the standard of care. All dosing of rescue medication (permitted or 
exclusionary), as defined in Section 6.4.4, is to be recorded on the Rescue 
Medication paper diary.
Subjects will record the following about their migraine attacks in the eDiary:
∀
migraine occurrence (yes, no); 
∀
migraine headache pain intensity (mild, moderate, severe);
∀
study drug dosing (yes, no); 
∀
Migraine Quality of Life Questionnaire (MQoL) at 24 hours postdose (until 5 are 
completed)
Subjects will continue to record all concomitant medications, including acute migraine 
medications (used for non-rescue purposes only, see Section 5.5.2) and standard prophylactic 
migraine medications (see Section 16.2, Appendix 2) taken during the OLE Phase in the 
Concomitant Medication paper diary.
Subjects will return to the study site at the OLE Week 12 / OLE EOT Visit (OLE Day 85 +2 
days) for assessment of medication compliance and assessment of tolerability and safety 
(including vital signs, laboratory tests, and electrocardiography) (Table 2). Subjects must 
return the eDiary, unused study drug to the study site at each visit. 
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All subjects who discontinue early from the OLE Phase are to complete the OLE Week 12 / 
EOT Visit (see Table 2). 
In the event that the feasibility of study visits is impacted due to COVID-19, some selected 
study visits may be conducted remotely (Ex: Telephone, telemedicine) 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 
participation. During the OLE Phase, the following visits may be completed remotely due to 
COVID-19: Week 2, Week 4, Week 8 and the Follow-up Week 2 Visit. The following visits 
must be completed in-person: Week 12/ EOT Visit.
4.3.4. Follow-up Phase
The Follow-up Phase will have 1 scheduled visit at Follow-up Week 2, which will occur 
approximately 2 weeks (14 days +/- 2 days) after the OLE Week 12 / EOT Visit. Subjects 
will return to the study site to collect vital signs, assessment of AEs/SAEs, and to have a 
urine pregnancy test performed (WOCBP). Investigators are to assess subjects for AEs 
consistent with drug dependency or withdrawal effects and report as appropriate (see 
Section 7.4).
All subjects who enter the OLE Phase are to complete the Follow-up Week 2 Visit 
(regardless of completing the OLE Phase), except those who discontinue early from the OLE 
Phase due to withdrawal by subject or lost to follow-up.
Subjects will continue to record all concomitant medications, including acute migraine 
medications (used for non-rescue purposes only, see Section 5.5.2) and standard prophylactic 
migraine medications (see Section 16.2, Appendix 2), taken during the Follow-up Phase in 
the Concomitant Medication paper diary. 
4.4. Post Study Access to Therapy
At the end of the study, the Sponsor will not continue to supply study drug to subjects or 
investigators. The Investigator is to ensure that the subject receives permitted acute migraine 
standard of care medication used to treat the condition under study. 
5. POPULATION
Individuals entered in this trial will be subjects who suffer from migraine attacks. The 
treatment setting for these subjects may include clinics, institutions, or private office 
practices. Subjects may be recruited through a variety of sources, including referrals from 
physicians and other health care professionals.
5.1. Number of Subjects
It is anticipated that approximately 900 subjects will be screened in order to randomize 
approximately 600 subjects. The subjects will be randomized in a 1:1 ratio to blinded 
rimegepant or matching placebo during the Double-blind Treatment (DBT) Phase. It is 
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estimated that approximately 510 subjects will be entered into the Open-label Extension 
(OLE) Phase. 
5.2. Inclusion Criteria
1. Target Population 
Minimum 1 year documented history of migraine attacks (with or without aura) 
consistent with a diagnosis according to the International Classification of Headache 
Disorders, 3rd Edition.8
Per self-report, with confirmation from Investigator / supporting medication record, 
subjects must have:
a.
Migraine attacks present for more than 1 year with the age of onset prior to 50 years 
of age.
b. Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
c.
4 to 14 migraine days (see Section 6.4.5) per month on average across the 3 months 
prior to the Screening Visit (month is defined as 28 days for the purpose of this 
protocol).
d. Subjects must be able to distinguish migraine attacks from tension headaches.
e.
Subjects on prophylactic migraine medication (excluding CGRP antagonists) are 
permitted to remain on therapy if they have been on a stable dose for at least 3 
months (12 weeks) prior to the Screening Visit, and if the dose is not expected to 
change during the course of the study.
2. Triptan unsuitable (see Appendix 4). 
3. Age and Reproductive Status
a.
Subjects ≥18 years of age.
b. Subject meets reproductive criteria. Refer to Appendix 5 for reproductive criteria for 
female (Section 16.5.1) subjects. 
c.
At the Baseline Visit prior to dispensing investigational study drug, WOCBP must 
have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent 
units of HCG).
4. Subjects must be able to fully comply with the prohibitions and restrictions on the 
concomitant use of medications and therapies (including moderate to strong inhibitors 
and inducers of the CYP3A4 enzyme and strong inhibitors of the P-gp transporter) 
detailed in Section 16.1, Appendix 1.
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5.
For Germany only: Written informed consent must be obtained from the subject in 
accordance with requirements of the study center’s institutional review board (IRB) or 
ethics committee and in accordance with local regulations, prior to the initiation of any 
protocol-required procedures (as described in Section 10.5); refer to Section 16.7.2.
5.3. Exclusion Criteria
1. Target Disease Exclusion: 
a.
History of cluster headache, basilar migraine (migraine with brainstem aura), or 
hemiplegic migraine 
b. Current Medication-overuse headaches
c.
Headaches occurring 15 or more days per month (migraine or non-migraine) in any of 
the 3 months prior to the Screening Visit
d. 7 or more non-migraine headache days per month, on-average, across the 3-months 
prior to the Screening Visit 
2. History and Concurrent Diseases 
a.
History of gastric, or small intestinal surgery (including Gastric Bypass, Gastric 
Banding, Gastric Sleeve, Gastric Balloon, etc.), or other disease or condition (e.g. 
chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption
b. Body mass index ≥35 kg/m2
c.
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 
months or subjects who have met DSM-V criteria9 for any significant substance use 
disorder within the past 12 months prior to the Screening Visit
d. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
e.
History or current evidence of other major psychiatric disorder that might interfere 
with the ability to properly report clinical outcomes
f.
Major depressive (MDD) or any anxiety disorder (AD) which requires more than 1 
daily medication for each disorder, or major depressive episode (MDE) within last 12 
months. Medications to treat major depressive disorder or an anxiety disorder must 
have been at a stable dose for ≥3 months (12 weeks) prior to the Screening Visit 
g. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex 
regional pain syndrome [CRPS])
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h. Other pain syndromes (including trigeminal neuralgia), dementia, or significant 
neurological disorders (other than migraine) that, in the Investigator’s opinion, 
interfere with study assessments of safety or efficacy
i.
Current diagnosis of major depressive disorder requiring treatment with atypical 
antipsychotics, schizophrenia, bipolar disorder, or borderline personality
j.
History with current evidence of uncontrolled, unstable or recently diagnosed 
cardiovascular disease (including, but not limited to: ischemic heart disease, coronary 
artery vasospasm, myocardial infarction [MI], acute coronary syndrome [ACS], 
percutaneous coronary intervention [PCI], cardiac surgery), cerebral ischemia 
(including, but not limited to: stroke or transient ischemic attack [TIA]) during the 6 
months (24 weeks) prior to the Screening Visit
k. Systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg after 10 
minutes of rest. This may be repeated once at the Screening Visit to confirm 
reproducibility.
l.
History or current evidence of any unstable medical conditions (e.g. history of 
congenital heart disease, arrhythmia or cancer)
m. Positive drug screen for drugs of abuse that in the investigator’s judgment is 
medically significant, in that it would impact the safety of the subject or the 
interpretation of the study results
In addition:
i.
Detectable levels of cocaine, amphetamine, and phencyclidine (PCP) in the drug 
screen are exclusionary. Retesting is not allowed.
ii. Subjects who test 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 Baseline 
Visit until the OLE Week 12 or OLE EOT Visit occurs. 
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 criteria9 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. 
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3. Allergies and Adverse Drug Reactions 
a.
History of drug or other allergy which, in the opinion of the investigator, makes the 
subject unsuitable for participation in the study. “Rimegepant is contraindicated in 
subjects with a hypersensitivity to any component of its formulation.”
4. Sex and Reproductive Status 
a.
WOCBP who are unwilling or unable to use required contraception (Refer to 
Section 16.5 Appendix 5 for Contraceptive and Barrier Guidance).
b. Women who are pregnant, lactating or breastfeeding
c.
Women with a positive pregnancy test at the Screening Visit or prior to study drug 
administration
5. ECG and Laboratory Test Findings 
a.
Any clinically significant abnormality identified on the medical, ECG 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, nor interfere with the 
study procedures (not including exclusion criteria listed in Section 5.3). 
b. 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.
c.
Total bilirubin >1.5 x ULN (For Gilbert’s syndrome, direct bilirubin >ULN is 
exclusionary).
d. AST or ALT >2 x ULN. 
e.
Serum albumin <2.8g/dL
f.
Neutrophil count ≤ 1000/μL (or equivalent)
g. HbA1c >7.5%
h. Evidence of organ dysfunction or any clinically significant deviation from normal on 
physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical 
laboratory determinations beyond what is consistent with the target population.
6. Prohibited Medications and Devices 
a.
Non-Narcotic Analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], 
paracetamol [acetaminophen], gabapentin, etc.) taken >= 15 days per month for a 
non-headache indication during the 3 months (12 weeks) prior to the Screening Visit
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b. Other CGRP antagonists (beyond rimegepant), including: 
i.
CGRP antagonist monoclonal antibodies taken within 6 months (24 weeks) prior 
to the Screening Visit 
ii. CGRP antagonist small molecules taken within 10 days prior to the Screening 
Visit 
c.
Botulinum toxin injections (e.g., Botox®) used for the prevention of migraine taken 
within 3 months (12 weeks) prior to the Screening Visit
d. CefalyTM or any other device for migraine treatment or prevention used within 3 
months (12 weeks) prior to the Screening Visit 
e.
Ergotamine taken ≥10 days per month on a regular basis for ≥3 months (≥12 weeks) 
in the year prior to the Screening Visit
f.
Narcotics, such as opioids (e.g., morphine, codeine, oxycodone, hydrocodone) or 
barbiturates (e.g., butalbital) taken ≥4 days per month during the 3 months (12 weeks) 
prior to the Screening Visit
g. Permitted acute migraine medication taken ≥15 days per month for a non-headache 
indication during the 3 months (12 weeks) prior to the Screening Visit (see 
Section 5.5.2)
7. Other Exclusion Criteria: 
a.
For France and Germany only: Persons deprived of their liberty by a judicial or 
administrative decision. (Refer to Section 16.7 for France and Germany) 
b. For France and Germany only: Adults subject to a legal protection measure 
(guardianship, curatorship, and safeguard of justice). (Refer to Section 16.7 for 
France and Germany)
c.
For France only: Persons not affiliated to a social security scheme or equivalent. 
(Refer to Section 16.7 For France)
d. Exposure to non-biological investigational agents within 30 days prior to the 
Screening Visit
e.
Exposure to biological investigational agents (including monoclonal antibodies) 
within 6 months (24 weeks) prior to the Screening Visit
f.
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 screening, OR subjects who, in the 
opinion of the Investigator, present a serious risk of suicide (See Section 6.3.5). 
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g. Previous enrollment in any multiple dose BHV3000 (rimegepant) (PF-07899801) 
study, such as BHV3000-201, BHV3000-305, BHV3000-404, BHV3000-405, or 
BHV3000-407, regardless of the number of doses taken. Subjects may be considered 
for BHV3000-406 (C4951004) if the subject participated in any of the following 
single dose studies: BHV3000-301, BHV3000-302, BHV3000-303, but did not 
participate in any multiple dose rimegepant study. Note that subjects who were 
considered screen failures in a past BHV-3000 (PF-07899801) study may be 
considered after discussion with the Sponsor and written approval is received. 
h. Participation in any other investigational clinical trial while participating in this 
clinical trial. 
i.
Past participation in a clinical study within 30 days prior to the Screening Visit.
j.
Failure to complete the Baseline Visit within the timeframe specified in the schedule 
of assessments.
k. The subject is, in the investigator's opinion, considered to be otherwise clinically 
unsuitable for participation in the study including inability to complete the eDiary 
independently, (the reason for exclusion should be documented in the subject's source 
file).
l.
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.
m. For Germany only: Subjects who are compulsorily detained for treatment of either a 
psychiatric or physical (e.g., infectious disease) illness (refer to Section 16.7.2).
5.4. Prohibited and Restricted Concomitant Medications and Devices
All non-study medications, including vaccinations taken by subjects throughout the study 
(i.e., starting from the Screening Visit though the Follow-up Week 2 Visit) will be 
documented as concomitant medications in the Concomitant Medication paper diary. The 
only exception is the use of acute migraine medication (permitted or exclusionary) for the 
purposes of rescue (i.e., for the management of unresolved migraine-related symptoms 
following primary treatment with study medication [blinded or open-label]). All dosing with 
rescue medications should be recorded in the Rescue Medication paper diary. 
See Section 16.1, Appendix 1 for a full list of concomitant medications and devices 
prohibited during the study. 
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5.5. Permitted Non-study Standard of Care Migraine Medications
Non-study standard of care migraine medications (both acute and prophylactic) will be 
documented in paper diaries throughout the study. Subjects are to record all concomitant 
medications, including acute migraine medications (used for non-rescue purposes only, see 
Section 5.5.2) and standard prophylactic migraine medications (see Section 16.2, 
Appendix 2), taken throughout the study (DBT and OLE Phases), in the Concomitant 
Medication paper diary. All rescue medications, as defined in Section 6.4.4, are to be 
documented on the Rescue Medication paper diary. 
5.5.1. Prophylactic Migraine Medications 
Subjects may take standard prophylactic migraine medication throughout the study (see 
Section 16.2, Appendix 2). Doses must be stable for 3 months (12 weeks) prior to the 
Screening Visit and throughout the study.
5.5.2. Acute Migraine Medications 
Acute migraine medications are those agents recognized as having efficacy in the treatment 
of acute migraine. Permitted acute migraine medications are presented in Section 16.3, 
Appendix 3. 
Subjects are to keep track of all concomitant medications including acute migraine 
medications (used for non-rescue purposes only, see Section 6.4.4), throughout the course of 
the study, on an IRB-approved Concomitant Medication paper diary. 
Subjects are allowed to use permitted acute migraine medications (see Section 16.3, 
Appendix 3), as needed, for the treatment of migraine attacks of mild or no headache pain 
intensity. 
5.5.2.1. Acute Migraine Medications in the DBT Phase
In the DBT Phase, subjects should use blinded study drug to first treat a migraine attack of 
moderate or severe headache pain intensity. After dosing with blinded study drug for the 
treatment of a moderate or severe migraine attack, no acute migraine medications are 
permitted through 2 hours postdose AND completion of the 2-hour assessments within the 
eDiary. 
Subjects who do not experience relief of their migraine-related symptoms at 2 hours postdose 
but have completed the requisite 2-hour assessments within the eDiary, may take permitted 
acute migraine medication (see Section 16.3, Appendix 3) for the purposes of rescue, as 
needed and in accordance with the standard of care. In addition, if a moderate or severe 
migraine attack is relieved with study drug at 2 hours postdose but then returns to a moderate 
or severe headache pain intensity level between 2 and 48 hours (and prior to completion of 
48-hour postdose assessments within the eDiary), subjects may use permitted acute migraine 
medication as rescue. All dosing of rescue medication (permitted or exclusionary), as defined 
in Section 6.4.4, is to be recorded on the Rescue Medication paper diary. 
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After completing all assessments associated with a qualifying migraine attack (see 
Section 4.1) in the eDiary (through 48 hours postdose and before returning to the clinical site 
for DBT EOT Visit), if subjects have a migraine, then they may take permitted acute 
migraine medication (see Section 16.3, Appendix 3), as needed. If a subject takes a permitted 
acute migraine medication after the 48-hour postdose assessment and before returning to the 
study site for the DBT EOT Visit, this must be documented on the Concomitant Medication 
paper diary.
During the 45-day DBT Phase, subjects are not permitted to use blinded study drug for the 
treatment of a migraine attack of mild or no headache pain intensity. Subjects are only 
permitted to use non-study acute migraine medication to treat a migraine attack of mild or no 
headache pain intensity (see Section 16.3, Appendix 3). This dosing must be recorded on the 
Concomitant Medication paper diary.
5.5.2.2. Acute Migraine Medications in the OLE Phase
In the OLE Phase, subjects are to use open-label study drug as the first treatment of migraine 
attacks of moderate or severe headache pain intensity. After dosing with open-label study 
drug for the treatment of a moderate or severe migraine attack, no acute migraine 
medications are permitted through 2 hours postdose.
Subjects who do not experience relief of their migraine-related symptoms at 2 hours post-
dosing with open-label study drug may take permitted acute migraine medication (see 
Section 16.3, Appendix 3) for the purposes of rescue, as needed and in accordance with the 
standard of care. In addition, if a moderate or severe migraine attack is relieved with study 
drug at 2 hours postdose but then returns to a moderate or severe headache pain intensity 
level between 2 and 24 hours (and prior to the completion of the 24-hour MQoL assessment 
within the eDiary), subjects may use permitted acute migraine medication as rescue. All 
dosing of rescue medication (permitted or exclusionary), as defined in Section 6.4.4, is to be 
recorded on the Rescue Medication paper diary. 
During the 12-week OLE Phase, subjects are only permitted to use open-label study drug for 
the treatment of a migraine attack of moderate or severe headache pain intensity. Subjects are 
permitted to use non-study acute migraine medication (see Section 16.3, Appendix 3) for the 
primary management of migraines of mild or no headache pain intensity and/or as rescue 
medication. All dosing with concomitant (non-study) medication, including permitted and 
non-permitted acute migraine medications used for the primary treatment (non-rescue) of a 
migraine, must be recorded on the Concomitant Medication paper diary. All dosing with 
study medication throughout the course of the study (DBT and OLE Phases) must be 
recorded in the eDiary.
5.5.2.3. Migraine Medications in the Follow-up Phase
During the Follow-up Phase, subjects may take permitted acute migraine medication (see 
Section 16.3, Appendix 3) as needed. If a subject takes a permitted acute migraine 
medication at any time during the Follow-up Phase, this must be documented on the 
Concomitant Medication paper diary.
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5.6. Contraception
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. 
In addition, the investigator or designee will instruct the subject to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the subject will no longer use abstinence as 
the selected contraception method, or if pregnancy is known or suspected in the subject or 
partner.
All WOCBP (see Section 16.5) must complete the pregnancy test schedule outlined in 
Table 1 and Table 2. 
5.7. Deviation from Inclusion/ Exclusion Criteria
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 trial. Deviations will be 
reported to the IRB/EC at the frequency required by your IRB/EC. Prospective approval of 
protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or 
exemptions, is not permitted.
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 
∀
Investigational Product Manual
∀
Drug Accountability Logs
∀
Sample source documents, where applicable
∀
Concomitant Medication paper diary (take home for subject) 
∀
Rescue Medication paper diary (take home for subject)
∀
Investigator Brochure
∀
Interactive Web-based Response System (RTSM)
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∀
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. 
∀
Electronic Diary (eDiary): hand-held electronic device (1 will be assigned to each 
subject) 
o
Instructions for the eDiary device and access to the portal
∀
Laboratory kits and laboratory manual 
o
Safety laboratory, plasma, urine, and serum instructions for specimens collected 
will be provided by a designated central laboratory.
∀
ECG Machine and Instructions 
o
ECG equipment, supplies, instructions, and training materials will be supplied by 
a centralized ECG vendor.
∀
SAE forms (to be used only if PSSA is not available) and SAE reporting instructions. 
Exposure during Pregnancy Forms and Pregnant Partner Release of Information
∀
Columbia-Suicide Severity Rating Scale (C-SSRS) forms 
∀
Migraine-Specific Quality-of-Life Questionnaire (MSQ) v 2.1 form
∀
The Migraine Interictal Burden Scale (MIBS) form 
∀
Study system access: 
o
Electronic Data Capture (EDC) tool to submit study data to Sponsor / CRO
o
RTSM
o
Central Laboratory vendor portal
o
Central ECG vendor portal
o
eDiary vendor portal
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6.2. Eligibility Assessments
As outlined in Table 1: Informed consent, inclusion/ exclusion criteria, medical history study 
procedures, migraine history assessment, Concomitant Medication paper diary, ECG and 
randomize subject in RTSM.
6.3. Safety Assessments 
SAEs should be reported from signing of the ICF through the Follow up Week 2 Visit. 
Unresolved SAEs at the time of the Follow-up Week 2 Visit should be monitored until 
resolution of the acute aspects of the safety event, per the opinion of the Investigator. The 
Investigator should report any SAE occurring beyond the Follow-up Week 2 Visit when the 
event is believed to be related to study drug or other protocol-specific procedures.
Non-serious Adverse events must be reported from signing the ICF through the Follow-up 
Week 2 Visit.
6.3.1. 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 and Table 2.
6.3.2. Electrocardiogram (ECG)
A standard 12-lead ECG will be recorded during the Screening Phase and at scheduled visits 
as outlined in Table 1 and Table 2. A central ECG service will be utilized for all ECGs. The 
overread from the central ECG vendor is to be used to determine eligibility for the study. The
investigator will determine whether any ECG abnormalities are clinically significant based 
on the overread from the central ECG vendor (see Appendix 6). 
6.3.3. Physical Exam 
Subjects will undergo a complete physical examination during the Screening Phase and 
targeted symptom-directed physical exam at all scheduled visits as outlined Table 1 and 
Table 2. 
Physical examinations to include at minimum examination of heart, abdomen and lungs, with 
review of any other system to be guided by symptoms. The Physical exam will be performed 
by the Investigator or medically qualified delegate.
6.3.4. 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 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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All protocol-required laboratory assessments must be conducted in accordance with the 
laboratory manual and the Schedule of Assessments.
6.3.4.1. Safety Laboratory Testing
Blood and urine samples will be obtained as outlined in Table 1 and Table 2 for clinical 
laboratory evaluations. Unless otherwise noted approximately 15mL of venous blood will be 
obtained at each laboratory testing timepoint. This will include a pregnancy test if the subject 
is a woman that may be able to become pregnant. The result of the pregnancy test must be 
negative to qualify for the study. Additional diagnostic testing will be completed including 
blood tests to assess the general health, and wellness of the subject’s kidneys and liver. At the 
screening visit, end of treatment visit (in the double blind phase), and at the 12 week visit in 
the open-label phase, the subject will have a venous blood sample (approximately 15mL 
collected at each of these visits). A chemistry panel and hematology panel to assess general 
health, a blood test to check for liver function and a pregnancy test (if applicable) will be 
done. During the Open Label extension -week 4 visit the subject will have blood work to 
check their liver function. This venous blood draw will be approximately 5mL. 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 appropriately documented. 
1.
Clinical safety labs:
a.
Hematology: Hemoglobin, hematocrit, red blood cell count, white blood cell 
count with differential, and platelets. 
b. Chemistry: Sodium, potassium, chloride, bicarbonate, glucose, BUN (urea), 
serum creatinine 
c.
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 Study laboratory manual.
2.
Urine Drug Screen: For drugs of abuse (Screening Visits only)
3.
eGFR estimated using the MDRD formula (calculated at central lab) (Screening Visit 
only)
4.
FSH: in female subjects to confirm postmenopausal status, if applicable (Screening 
Visit only)
5.
Reflex/ add-on tests: 
a.
If ALT or AST > 3x ULN or total bilirubin > 2x ULN at any visit after the 
Baseline Visit, additional reflex or add-on tests may be performed that may 
include: CK, GGT, anti-viral serologies, and more. 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 required to evaluate eligibility, or in-study laboratory 
abnormalities and/or adverse events; please refer to the Laboratory Manual.
6.3.4.2. Pregnancy Testing
WOCBP must complete pregnancy testing at specified study visits and prior to initial dosing 
of blinded study medication (in the DBT Phase), as outlined in Table 1 and Table 2. If a 
WOCBP suspects that she might be pregnant, she must not take any further doses of study 
drug and immediately contact the study doctor.
6.3.5. Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide 
Assessment.10 The C-SSRS “Screening version” will be used at the Screening Visit and the 
“Since Last Visit version”11 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 is to 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 (reference Table 1 and Table 2). 
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 must 
be recorded as either an AE or SAE, as determined by the Investigator, and reported within 
24 hours to the Sponsor.
6.4. Efficacy Assessments
The eDiary and paper questionnaires will be used in the DBT and OLE Phases of the study. 
6.4.1. Pain 
Subjects record their migraine headache pain intensity using a 4-point numeric rating scale 
(none, mild, moderate, severe) in the eDiary at the time points indicated in Table 1 and 
Table 2.
6.4.2. Nausea, Phonophobia and Photophobia
During the DBT Phase, subjects will record the status (present or absent) of their migraine-
associated symptoms of photophobia, phonophobia and nausea in the eDiary at the time 
points indicated in Table 1. In addition, subjects will record the intensity of the symptoms on 
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a 4-point numeric rating scale (none, mild, moderate, or severe) in the eDiary at the same 
time points. Subjects will also record their current MBS (nausea, phonophobia or 
photophobia) and aura status (present or absent) in the eDiary before taking study drug. 
6.4.3. Functional Disability
During the DBT Phase, subjects will record their functional disability level using the 
functional disability scale, a 4-point numeric rating scale (normal, mild impairment, severe 
impairment, required bedrest), in the eDiary at the time points indicated in Table 1.
6.4.4. Rescue Medication 
Rescue medication is recognized acute migraine concomitant medication (see Section 16.3, 
Appendix 3) used for the management of persistent migraine-related symptoms as per 
standard of care following dosing with study drug. 
The use of rescue medication is NOT permitted within 2 hours of dosing study drug.
In the DBT Phase, rescue medication includes acute migraine medication (permitted or 
exclusionary) (see Section 16.3, Appendix 3) dosed after blinded study drug (rimegepant 75 
mg ODT or matching placebo) AND prior to 48 hours postdose and completion of the 48-
hour assessments within the eDiary. 
In the OLE Phase, rescue medication includes acute migraine medication (permitted or 
exclusionary) (see Section 16.3, Appendix 3) dosed after open-label study drug (rimegepant 
75 mg ODT) AND prior to 24 hours postdose and completion of the 24-hour assessments 
within the eDiary.
All non-study medications used as rescue (i.e., for the management of unresolved migraine-
related symptoms following primary treatment with study medication [blinded or open-
label]) (permitted or exclusionary) must be recorded on the Rescue Medication paper diary. 
All other non-study drugs should be recorded on the Concomitant Medication paper diary. 
Study medication (blinded or open-label) is not permitted to be used as rescue medication. 
All dosing of rescue medication (permitted or exclusionary), as defined above, is to be 
recorded on the Rescue Medication paper diary. 
Permitted acute migraine medications are presented in Section 16.3, Appendix 3. 
Non-permitted acute migraine medication include: opioids, ergotamines, lasmiditan, 
triptans, ubrogepant, barbiturates/barbiturate-containing products, and muscle relaxants 
(except baclofen) and other CGRP antagonists. A full list of restricted and exclusionary 
medications is located in Section 16.1 , Appendix 1).
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6.4.5. Migraine Days
For the purposes of this study, a migraine day is defined as any calendar day during which 
the subject experiences a migraine (regardless of headache pain intensity). Additionally, if a 
subject uses a migraine-specific standard of care medication (i.e., triptans, ergotamine, 
ubrogepant, lasmiditan, etc.), the corresponding dosing day will be counted as a migraine 
day. 
“Historical baseline” number of migraine days, for the purposes of inclusion and to 
determine the change in monthly migraine days, is the average number of days per month 
that subjects experience a migraine (of any headache pain intensity) over the 3 months prior 
to the Screening Visit, as reported by the subject and confirmed by the Investigator / 
supporting medical record. As above, if a subject uses a migraine-specific standard of care 
medication (i.e., triptans, ergotamine, ubrogepant, lasmiditan, etc.), the dosing day will 
automatically get counted as a migraine day
Of note, the use of triptans, ergotamine, ubrogepant, and lasmiditan is prohibited throughout 
the duration of the study. However, all dosing with acute migraine-specific medication 
(including non-permitted medications such as triptans, ergotamine, ubrogepant, and 
lasmiditan) must be reported within the appropriate (Concomitant or Rescue) medication 
paper diary (see Section 6.4.4), to help ensure accurate accounting of “migraine days”.
6.4.6. Headache Days
A Headache Day is any calendar day in which the subject experiences a qualified headache 
(initial onset, continuation, or recurrence of the headache). A qualified headache is defined 
as:
∀
A qualified migraine headache (including an aura-only event that is treated with acute 
migraine-specific medication [i.e., triptan, ergotamine, lasmiditan, or ubrogepant]), or
∀
A qualified non-migraine headache, which is a headache that lasts ≥ 30 minutes and is 
not a qualified migraine headache, or
∀
A headache of any duration for which medication(s) is taken (and recorded on the 
Concomitant Medication Paper Diary) for the purposes of treating headache-related 
symptoms.
6.5. Other Assessments
6.5.1. Migraine-Specific Quality-of-Life Questionnaire (MSQ) v 2.1
Impact of treatment on subject-reported quality of life will be assessed using the Migraine-
Specific Qualify-of-Life Questionnaire version 2.1 (MSQ v 2.1). The MSQ v 2.1 is a 14-item 
instrument that has been validated in 3 domains: role function - restrictive, role function -
preventive, and emotional function.12 The MSQ will be completed on a paper form at the site 
at the Baseline and OLE Week 12/ EOT Visits.
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6.5.2. Migraine Quality of Life Questionnaire (MQoL)
The Migraine Quality of Life Questionnaire (MQoL) version 3.0 is a 16-item instrument that 
has been validated in migraine sufferers to assess the effect of migraine and its treatment on 
health-related quality of life in the following 5 migraine-specific domains: work functioning, 
social functioning, energy/vitality, feelings and concerns, and migraine headache 
symptoms.13 During the DBT Phase, subjects will complete the MQoL using the eDiary at 24 
hours post-dose for a qualifying migraine attack (see Section 4.1) (see Table 1). 
During the OLE Phase, subjects will complete the MQoL 24 hours postdose in the eDiary for 
each qualifying migraine attack until 5 MQoL Questionnaires are completed (see Section
4.1) (see Table 2). 
6.5.3. Migraine Interictal Burden Scale (MIBS)
The Migraine Interictal Burden Scale (MIBS) is a 4-item self-administered questionnaire that 
measures: impairment in work or school, impairment in family and social life, difficulty 
making plans or commitments, and emotional/affective and cognitive distress.14
During the DBT and OLE Phase, subjects will complete the MIBS using a paper form at site. 
6.6. Subject Early Discontinuation Criteria
Subjects MUST discontinue investigational product (and non-investigational product at the 
discretion of the Investigator) 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 or sponsor, indicates that continued participation in 
the study is not in the best interest of the subject
∀
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
o
Subjects in the DBT Phase will be monitored closely for compliance with the 
eDiary and may not be considered for the OLE Phase, based on PI and/or Sponsor 
discretion if compliance is low. Subjects who demonstrate poor compliance will 
be discussed with the Sponsor and corrective training will be completed by the 
site with the subject.
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o
Subjects in the OLE Phase will be monitored closely for compliance with the 
eDiary. 
∀
Please see Section 6.3.5 for guidance on subject discontinuation based on results from 
the C-SSRS.
∀
All subjects who discontinue the DBT Phase must comply with protocol specified 
DBT EOT 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 (e.g., is imprisoned or involuntarily incarcerated for the treatment of 
either a psychiatric or physical illness).
∀
All subjects who discontinue the OLE Phase are to comply with protocol-specified 
OLE Week 12/EOT Visit procedures as outlined in Table 2. The only exception to 
this requirement is when a subject withdraws consent for all study procedures or loses 
the ability to consent freely (e.g., is imprisoned or involuntarily incarcerated for the 
treatment of either a psychiatric or physical illness).
∀
If a participant withdraws from the study, they may request destruction of any 
remaining samples taken and not tested, and the investigator must document any such 
requests in the site study records and notify the sponsor accordingly.
∀
If the participant withdraws from the study and also withdraws consent for collection 
of future information, no further evaluations will be performed and no additional data 
will be collected, except for publicly available information. The sponsor may retain 
and continue to use any data collected before such withdrawal of consent. 
6.6.1. 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 must be documented in the subject’s medical record.
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∀
Should the subject continue to be unreachable, he/she will be considered to have 
withdrawn from the study.
6.7. Study Early Discontinuation Criteria
The current clinical trial will be completed when the last subject finishes their final pre-
specified study assessment or is otherwise permanently discontinued from the trial. 
Early discontinuation of the study (in its entirety) may occur at the discretion of the Sponsor 
in the event there is an unacceptable shift in the benefit-risk assessment of the investigational 
therapy (rimegepant) for the target population under investigation (adults living with 
migraine who are unsuitable for triptan use). The change in benefit-risk profile of the study 
drug may be derived from events (adverse events, serious adverse events, etc.) occurring 
within the BHV3000-406 (C4951004) study and/or any other rimegepant safety data source, 
including other clinical trials, toxicological studies, or spontaneous reporting of real-world 
evidence.
Both Pfizer and the Principal Investigator at a specific study site reserve the right to 
terminate the study at a given study site at any time (see Section 14).
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 must 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.
∀
During the DBT Phase, investigational product (study drug/ study medication) is blinded 
rimegepant (BHV-3000) (PF-07899801) 75 mg ODT or matching placebo as directed. 
∀
During the OLE Phase, investigational product (study drug/ study medication) is open-
label rimegepant (BHV-3000) (PF-07899801) 75 mg ODT as directed. 
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Intervention Name
Rimegepant
Placebo
Type
drug
drug
Use
Experimental
Placebo
IMP or NIMP/AxMP
IMP
IMP
Dose Formulation
Oral disintegrating tablet
Oral disintegrating tablet
Unit Dose Strength(s)
75 mg
placebo for 75-mg tablet
Dosage Level(s)
DBT phase: 75 mg (single dose)
OLE phase: 75 mg per day, maximum 
18 tablets per month
DBT phase : 0 mg (single dose)
OLE phase: not applicable
Route of Administration
Oral
Oral
Sourcing
Provided by the sponsor
Provided by the sponsor
Packaging and Labeling
Study intervention will be provided in 
multi-laminated blisters, sealed with a 
foil backing into wallet cards. Each 
blister wallet will be labeled as 
required per country requirement.
Study intervention will be provided in 
multi-laminated blisters, sealed with a 
foil backing into wallet cards. Each 
blister wallet will be labeled as 
required per country requirement.
SRSD
IB
Not applicable
7.1.2. Concomitant Therapy
In this protocol, concomitant therapy(ies) is/are standard of care for acute treatment and acute 
migraine medication for migraine treatment. The standard of care and acute migraine 
medications are not being provided by the Sponsor. 
7.1.3. Formulation
Rimegepant (BHV-3000) (PF-07899801) is formulated as 75mg oral disintegrating tablets 
for which there is a matching placebo. 
7.1.4. Packaging, Shipment and Storage
The product storage manager must ensure that the study drug is stored in accordance with the 
environmental conditions (temperature and light) as determined by the sponsor. Please see 
the Investigational Product Manual/Investigator Brochure for specific conditions and 
packaging designs. If concerns regarding the quality or appearance of the study drug arise, do 
not dispense the study drug and contact the sponsor/CRO immediately.
For the DBT Phase, subjects will receive 1 tablet (ODT) of blinded rimegepant 75mg or 
matching placebo within a blister card, heat-sealed into a wallet.
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For the OLE Phase, subjects will receive blister cards containing 8 tablets (75mg ODT) of 
open-label Rimegepant, heat-sealed into a wallet. Subjects will receive enough IP at each 
dispensation visit to ensure appropriate supply between visits.
7.1.5. Dose and Administration
7.1.5.1. Double-blind Treatment Phase
In the DBT Phase, subjects will be instructed to take 1 tablet (75 mg ODT) of blinded 
rimegepant or matching placebo when they have a migraine attack of moderate or severe 
headache pain intensity that they have not already treated with acute migraine medication 
(see Section 16.3 Appendix 3). 
7.1.5.2. Open-label Extension Phase
In the OLE Phase, subjects will receive study drug in a blister card that is heat-sealed into a 
wallet. Subjects will be permitted to take up to 1 tablet of open-label study drug (75 mg ODT 
rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 
doses per month (month is 28 days). 
∀
During the OLE Phase 
o
Subjects should use open-label study drug as the first treatment of moderate or 
severe headache pain intensity that they have not already treated with acute 
migraine medication (see Section 16.3 Appendix 3). 
o
Throughout the 12-week OLE Phase, subjects are not permitted to use open-label 
study drug for the treatment of a migraine of mild or no headache pain intensity or 
as a rescue medication. If subjects treat a migraine of mild intensity during the 
OLE Phase, they are to only use permitted non-study acute migraine medication. 
This dosing must be recorded on the Concomitant Medication paper diary. 
7.1.6. Method of Assigning Subject Identification
The Investigator or designee will need to access the Randomization and Trial Supply 
Management (RTSM system) in order to register each subject. Initially, after informed 
consent is obtained at the Screening Visit, the Investigator or designee will enter the subject 
into the study and obtain a subject number assignment. 
At the Baseline Visit, eligible subjects will be randomized in a 1:1 ratio to rimegepant or 
placebo. Randomization will be stratified by history of clinically relevant CV disease (yes or 
no). In addition, randomization of subjects in the CV subgroup (“yes” category) will be 
capped at 15%. Subjects are to be categorized as “yes” if they meet the criteria for being in 
the CV subgroup (see Section 16.4, Appendix 4, Contraindication: Cardiovascular Events, 
Conditions, and Procedures). Otherwise, subjects are to be categorized as “no”.
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Once a subject completes the study, or if a subject is discontinued early from the study, the 
Investigator or designee must access the RTSM to document discontinuation of the subject 
from participation in the study.
7.1.7. Selection and Timing of Dose and Administration
Study drug will be assigned via the RTSM system; the system will assign specific kit 
numbers for all blinded study drug to be dispensed to the subject. Once a kit has been 
assigned it cannot be dispensed to another study subject. Sites will be responsible for 
recording the kit numbers dispensed to the subject on the Drug Accountability Form 
provided in the Regulatory Binder, as well as ensure appropriate documentation of 
dispensation in the subject’s medical record. 
For the DBT Phase, rimegepant 75 mg ODT or placebo will be assigned to subjects at the 
Baseline (Randomization) Visit via the RTSM system. Subjects will be instructed to 
administer 1 ODT when they have a migraine that is moderate or severe in headache pain 
intensity.
For the OLE Phase, rimegepant 75 mg ODT will be dispensed at study dispensation visits. 
Subjects must completely finish study drug wallets before starting new wallets. 
There are no dose adjustments in this study.
Subjects must be instructed that they CANNOT take more than 1 tablet of study drug daily 
during the study and no more than 18 tablets of rimegepant per month (28 days).
7.1.8. Dose Modifications
There will be no dose adjustments in this study.
7.2. Blinding and Unblinding
Blinding is critical to the integrity of this clinical study. However, in the event of a medical 
emergency or pregnancy in an individual subject, in which knowledge of the investigational 
product is critical to the subject’s management, the blind for that subject may be broken by 
the treating physician. 
The BHV3000-406 (C4951004) study is a double-blind placebo-controlled trial being 
conducted in accordance with Good Clinical Practice (GCP), International Conference on 
Harmonisation guidelines, Ethics Committee (EC) requirements, and all applicable 
regulations. Within the BHV3000-406 (C4951004) study, randomization and blinding are 
utilized to minimize the influence of bias on the conduct of the trial and its associated 
outcomes. 
At the Baseline Visit, eligible subjects will be randomized 1:1 across two blinded treatment 
arms (blinded rimegepant 75 mg or matching placebo) for the duration of the Double-Blind 
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Treatment (DBT) Phase. Blinded study drug assignment will be issued by centralized 
Interactive Response Technology (IRT) to follow block randomization of an undisclosed 
length. Randomization will be stratified by history of clinically relevant cardiovascular (CV) 
disease (yes or no; see Section 7.1.6 and 16.4, Appendix 4).
BHV3000-406 (C4951004) is a double-blind study in which neither the subject nor the Site 
staff involved in the conduct of the study or clinical evaluation of subjects are aware of study 
drug assignment. Sponsor staff too will be blinded to subjects’ treatment assignment, except 
for those sponsor staff involved in the assignment or distribution of blinded study drug. 
Blinded treatments (double-blind rimegepant or matching placebo) are packaged and labeled 
in accordance with the kit list, and supplies are dispensed through the IRT per the 
randomization schedule. Blinded rimegepant and blinded placebo are both oral disintegrating 
tablets matched in appearance, texture, and taste, and are supplied to the trial center in a 
manner that ensures no one involved in the conduct of the trial is aware of the specific 
treatment allocated to any particular subject. 
Unblinding (breaking the blind for a single subject) should be considered only when 
knowledge of the treatment assignment is deemed by the Investigator, as essential for the 
proper care of the subject. The IRT will be programmed with blind-breaking instructions. In 
case of an emergency, the Investigator has the sole responsibility for determining if 
unblinding of a subject’s treatment assignment is warranted. Subject safety must always be 
the first consideration in making such a determination. If the Investigator decides that 
unblinding is warranted, the Investigator should make every effort to contact the study 
Medical Monitor prior to unblinding a subject’s treatment assignment unless this could delay 
further management of the subject. If a subject’s treatment assignment is unblinded, the 
Sponsor must be notified within 24 hours after breaking the blind. The date and reason that 
the blind was broken must be recorded in the source documentation and CRF. 
In cases of accidental unblinding, the Site should contact the Medical Monitor and ensure 
every attempt is made to preserve the blind for remaining site personnel. 
Sponsor staff will be unblinded after the last subject completes the Double-blind Treatment 
End of Treatment Visit, as described in Section 9.4 Once the study is complete (i.e., after the 
last subject completes the Follow-up Week 2 Visit) or has otherwise permanently 
discontinued from the trial, individual subject assignments will be made available to 
associated Investigators, upon request. 
In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded 
study intervention records at the site(s) to verify that randomization/dispensing has been done 
accurately.
7.3. Treatment Compliance
Responsible study personnel will dispense the study drug. Accountability and compliance 
verification must be documented in the subject’s study records. 
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DBT Phase:
Subjects have to be counseled on the importance of taking the study drug as directed for a 
migraine attack of moderate or severe headache pain intensity, and not taking acute migraine 
medication before taking study drug (see Section 16.3, Appendix 3). A qualifying migraine 
attack is defined in Section 4.1. If the subject does not have a qualifying migraine attack 
within 45-days of the Baseline Visit, they are to return to the clinic for their DBT EOT Visit 
and return their study drug. If a subject does not have a qualifying migraine attack in the 
DBT Phase, they are not eligible for the OLE Phase. All cases of treatment non-compliance, 
during the DBT Phase, are to be discussed with the Sponsor, and corrective training is to be 
completed and documented, prior to the subjects’ enrollments into the OLE Phase.
OLE Phase: 
∀
Treatment compliance and review of study drug doses through review of returned study 
drug must 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 are to inform subjects that involuntary termination from the study will occur 
in cases where non-compliance is identified. 
∀
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). Also, Investigators are to assess study drug accountability discrepancies 
(e.g., missing study drug, loss of medication, or non-compliance cases in which more 
study drug was used, as compared to expected). Investigators are to obtain more 
information and explanation from subjects when there are study drug accountability 
discrepancies.
7.4. Destruction and Return of Study Drug
All unused and/or partially used study drug can be sent back to the determined 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. The 
unused study drugs can only be destroyed after being inspected and reconciled by the 
responsible Study Monitor or the Sponsor’s designee.
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 the study treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding for example) symptom, or disease temporally 
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associated with the use of the investigational product, whether or not considered related 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. Non-serious Adverse 
events and Serious Adverse events whether related or not related to study drug, must be 
collected after written informed consent to participate in the study.  
If a specific diagnosis or syndrome is identified by the Investigator, this must 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 Adverse Events (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, in accordance 
with the protocol. 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.
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 
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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 a possible connection to study drug and 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 Events
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, 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):
o
Intensive treatment in an emergency room or at home for allergic bronchospasm
o
Blood dyscrasias or convulsions that do not result in inpatient hospitalization
o
Development of drug dependency or drug abuse
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o
Potential drug induced liver injury (see Section 8.4)
o
Abuse or Overdose of medication
i.
Potential study drug abuse (including cases of excessive non-compliance with 
study drug dosing instructions or subjects who discontinue treatment without 
returning study drug) is to 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 are to obtain more information and explanation from subjects 
when there are study drug accountability discrepancies
ii.
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 is to be considered 
serious.
The following hospitalizations are not considered SAEs in Pfizer clinical studies (but may be 
considered non-serious AEs):
∀
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);
∀
Elective surgery planned prior to signing consent;
∀
Admissions as per protocol for a planned medical/surgical procedure;
∀
Routine health assessment requiring admission (i.e., routine colonoscopy);
∀
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.
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 from signing of consent through 
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the Follow-up Week 2 Visit. Unresolved SAEs at the time of the Follow-up Week 2 Visit 
should be monitored until resolution of the acute aspects of the safety event, per the opinion 
of the Investigator. The Investigator should report any SAE occurring beyond the Follow-up 
Week 2 Visit when the event is believed to be related to study drug or other protocol-specific 
procedures.
All SAEs must be followed to resolution or stabilization.
An SAE report must 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 must be specified in the narrative 
section of the SAE Report Form. 
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. 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/or 
system (i.e., event term, start/stop dates, causality, and severity).
The Investigator is responsible for reporting all SAEs and all Other Important Medical 
Events to Pfizer Drug Safety Unit (DSU) within 24 hours of learning of the event. Pfizer 
DSU will then immediately notify the Medical Monitor of the event. The Investigator is 
responsible for submitting all applicable events to the Independent Review Board (IRB)/ EC 
as per the IRB’s reporting requirements. Additionally, the Investigator, or designated staff, is 
responsible for entering the SAE information in the Electronic Data Capture (EDC) system 
(i.e., event term, start/stop dates, causality, severity).
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 by 
facsimile (fax) to your country’s Pfizer DSU. The CT SAE Report Form should only be used 
as a backup in the event PSSA is not operational.
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 must 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 is to be used.
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The minimum information required for an initial SAE report is:
∀
Sender of report (Site number, Investigator name)
∀
Subject identification (subject number)
∀
Protocol number
∀
SAE term (if an SAE is being reported)
The Sponsor or specified designee/authorized representative will report suspected 
unexpected serious adverse reactions (SUSARs) in an expedited manner (without delay) to 
the Regulatory Authorities and Ethics Committees concerned, in accordance with Food and 
Drug Administration Code of Federal Regulations (CFR) 21 CFR Parts 312 and 320, Clinical 
Trials Regulation EU No 536/2014 and the Detailed Guidance on collection, verification and 
presentation of adverse reaction reports arising from clinical trials on IPs for human use 
(ENTR/CT3) and also in accordance with country-specific requirements.
The Sponsor or specified designee/authorized representative shall notify the Investigator of 
the following information:
∀
Any AE that is both serious and unexpected and is suspected of being related to the use 
of the IP in this study or in other studies (i.e., SUSAR).
∀
Where required by local legislation, the Investigator shall notify his/her IRB/EC promptly 
of these new serious and unexpected AE(s) or significant risks to subjects.
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
The collection of non-serious AE information is to begin from signing the ICF through the 
Follow-up Week 2 Visit.
Non-serious adverse events are to 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 are to be captured on the non-serious AE CRF 
page or SAE Report Form (paper or electronic) as appropriate:
a.
Any laboratory test result that is clinically significant or meets the definition of an SAE;
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b. Any laboratory abnormality that required the subject to have the study drug discontinued 
or interrupted;
c.
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. 
There is limited clinical experience with overdose of rimegepant. Treatment of overdose with 
rimegepant should consist of general supportive measures. There is no known specific 
antidote for overdose with rimegepant. 
Overdose is reportable to Pfizer Safety only when associated with an SAE. 
∀
Cases of study drug non-adherence, including subjects who discontinue treatment without 
returning study drug, are to be reported as protocol deviations.
∀
Cases of excess dosing (e.g., taking >1 tablet of study medication in a single day) are to 
be reported as protocol deviations. In the event that an occurrence(s) of excess dosing is 
believed, in the opinion of the Principal Investigator, to have possibly caused or 
exacerbated a clinically-significant adverse outcome or serious adverse outcome, such 
event(s) are to be reported as an AE or SAE, respectively, of “Overdose”.
∀
Asymptomatic dosing errors (e.g., accidentally taking >1 tablet of study drug in one 
calendar day) need only be reported as deviations.
8.4. Potential Drug Induced Liver Injury (DILI)
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some subjects, transaminase elevations are a harbinger of a more 
serious potential outcome. These subjects fail to adapt and therefore are “susceptible” to 
progressive and serious liver injury, commonly referred to as DILI. Subjects who experience 
a transaminase elevation above 3 × ULN should be monitored more frequently to determine 
if they are “adaptors” or are “susceptible.” 
In the majority of DILI cases, elevations in AST and/or ALT precede T bili elevations (>2 × 
ULN) by several days or weeks. The increase in T bili typically occurs while AST/ALT 
is/are still elevated above 3 × ULN (ie, AST/ALT and T bili values will be elevated within 
the same laboratory sample). In rare instances, by the time T bili elevations are detected, 
AST/ALT values might have decreased. This occurrence is still regarded as a potential DILI. 
Therefore, abnormal elevations in either AST OR ALT in addition to T bili that meet the 
criteria outlined below are considered potential DILI (assessed per Hy’s law criteria) cases 
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and should always be considered important medical events, even before all other possible 
causes of liver injury have been excluded.
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:
∀
Subjects with AST/ALT and T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili value 
≥2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.
∀
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).
Rises in AST/ALT and T bili separated by more than a few weeks should be assessed
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
The subject should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment.
If any potential DILI is identified and meets the criteria above, the Sponsor Medical Monitor 
(or designee) must be immediately contacted for further instruction on whether the subject 
must discontinue from the trial and appropriate follow-up requirements.
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
T bili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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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 
unplanned direct contact with or exposure to the study intervention. 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 intervention 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 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 subject is found to be pregnant while receiving or after discontinuing study 
intervention. 
∀
A male subject who is receiving or has discontinued study intervention inseminates a 
female partner. 
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∀
A female subject is found to be pregnant while being exposed or having been exposed 
to study intervention 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 intervention by ingestion or skin 
contact.
o
A male family member or healthcare provider who has been exposed to the 
study intervention 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 
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 Report 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 intervention 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 Report 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).
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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 intervention. 
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, follow-up 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.
8.5.2. Exposure During Breastfeeding
An EDB occurs if:.
∀
A female subject is found to be breastfeeding while receiving or after discontinuing 
study intervention. 
∀
A female non subject is found to be breastfeeding while being exposed or having 
been exposed to study intervention (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 intervention by 
ingestion. 
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 or PSSA. 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.
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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 
intervention by the wrong subject, or at the wrong time, or at the wrong dosage strength. 
Medication errors are recorded and reported as follows:
Recorded on the Adverse Event Page of the CRF
Reported on the PSSA* to Pfizer Safety Within 24 
Hours of Awareness
All medication errors (regardless of whether 
associated with an AE).
Any AE or SAE associated with the medication 
error
Only if associated with an SAE
*The CT SAE Report Form should only be used as a backup in the event PSSA is not operational
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.
∀
The administration of expired study drug;
∀
The administration of an incorrect study drug;
∀
The administration of an incorrect dosage:
∀
Subjects taking > 2 tablets in one calendar day
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∀
The administration of study drug that has undergone temperature excursion from the 
specified storage range, unless it is determined by the sponsor that the study drug 
under question is acceptable for use.
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 only when 
associated with an SAE.
8.6. Adverse Events of Special Interest
Not applicable for this study. 
9. STATISTICS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in the Statistical Analysis Plan (SAP), which will be 
maintained by the sponsor. The SAP may modify what is outlined in the protocol where 
appropriate; however, any major modifications of the primary endpoint definitions or their 
analyses will also be reflected in a protocol amendment.
9.1. Sample Size
It is anticipated that about 90% of the 300 subjects randomized to each treatment group will 
have a migraine in the allotted time period of the DBT Phase, resulting in approximately 270 
subjects evaluable for efficacy in each treatment group. The sample size calculation is based 
on pooled results from Phase 3 single-dose migraine studies BHV3000-301, BHV3000-302, 
and BHV3000-303. Pooled response rates for migraine headache pain relief at 2 hours 
postdose were 57.9% for rimegepant 75 mg and 43.9% for placebo in these studies.
A total sample size of 540 evaluable subjects (270 per treatment group) will provide 
approximately 90% power for the primary endpoint of migraine headache pain relief at 2 
hours postdose in the DBT Phase. This is based on a chi-square test with a 2-sided alpha 
level of 0.05 and assumes that the true response rates in the subjects unsuitable for triptan use 
will be equivalent to the overall pooled response rates above.
9.2. Analysis Sets
∀
Enrolled: Subjects who sign informed consent and are assigned a subject 
identification number. 
∀
Full: Subjects in the enrolled analysis set who receive a randomized treatment group 
assignment (rimegepant or placebo) from RTSM. 
∀
DBT safety: Subjects in the enrolled analysis set who take double-blind study drug 
(rimegepant or placebo). 
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∀
OL rimegepant safety: Subjects in the enrolled analysis set who take ≥1 dose of OL 
rimegepant (75 mg ODT).
∀
DBT efficacy: Subjects in the full analysis set who: (1) are randomized only once; (2) 
take double-blind study drug; (3) have a qualifying migraine attack at the time of 
double-blind study drug dosing (see Section 4.1); and (4) have double-blind postdose 
efficacy data (i.e., nonmissing headache pain intensity, phonophobia status, 
photophobia status, nausea status, or functional disability level after taking double-
blind study drug). 
∀
OL rimegepant efficacy: Subjects in the DBT efficacy analysis set who take ≥1 dose 
of OL rimegepant (75 mg ODT).
9.3. Statistical Methods
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. Efficacy Analyses 
In the DBT Phase, the intercurrent event of rescue medication use will be handled using 
Rescue Medication = Failure (RM=F), i.e., subjects who take rescue medication (see 
Section 6.4.4) will be classified as failures for all efficacy assessments that are reported at or 
after taking acute migraine medication as rescue.
The RM=F method will apply to all binary efficacy endpoints (including reliability of 
rimegepant effect) except the secondary endpoint of rescue medication use within 24 hours 
postdose. 
In the OLE Phase, the intercurrent event of intervening OL rimegepant use will be handled 
using Intervening OL Rimegepant = Failure (IOL=F), i.e., for a given migraine attack, 
subjects who take intervening OL rimegepant will be classified as failures for an MQoL 
assessment that is reported at or after taking intervening OL rimegepant. The IOL=F method 
will apply only to the secondary endpoint of reliability of rimegepant effect during the OLE 
Phase.
9.3.1.1. Primary Endpoint
Rimegepant will be tested for superiority against placebo at a 2-sided alpha level of 0.05 for 
the primary endpoint of migraine headache pain relief at 2 hours postdose during the DBT 
Phase using the DBT efficacy analysis set. Treatment groups will be compared using Mantel-
Haenszel risk estimation with stratification by history of clinically relevant CV disease (yes, 
no), to estimate the difference in percentages of subjects achieving the endpoint response 
criteria (rimegepant – placebo). The percentage of subjects achieving the endpoint response 
criteria will be presented with a 95% confidence interval (CI) by treatment group. The 
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stratified difference in percentages between treatment groups will be presented with a 95% 
CI and p-value.
Subjects with missing data at 2 hours postdose will be classified as failures (i.e., Non-
completer = Failure; NC=F).
Sensitivity analyses will be described in the SAP.
9.3.1.2. Secondary Endpoints
The same statistics for key secondary endpoints during the DBT Phase (i.e., those listed in 
Section 3.2.1) will be presented as those for the primary endpoint. 
For endpoints based on a single time point during the DBT Phase, such as migraine headache 
pain freedom at 2 hours postdose, subjects with missing data at a single time point will be 
classified as failures.
For endpoints based on multiple time points during the DBT Phase, such as sustained 
migraine headache pain relief from 2 to 48 hours postdose, subjects with missing data at (1) 
2, 24, or 48 hours postdose, or (2) more than 1 time point from 3 to 8 hours postdose will 
also be classified as failures.
Reliability of rimegepant effect during the OLE Phase will be assessed using the percentages 
of subjects achieving response after (1) the single evaluable qualifying migraine attack in the 
DBT Phase (i.e., πDBT) for the DBT efficacy analysis set randomized to rimegepant, and (2) 
each of the first 5 evaluable qualifying migraine attacks ≥23 hours apart in the OLE Phase 
(i.e., πOLEi, i = 1,…,5) for the OL rimegepant efficacy analysis set. 
∀
Reliability of rimegepant effect during the OLE Phase is defined as percentages for ≥4 of 
the first 5 evaluable qualifying migraine attacks ≥23 hours apart in the OLE Phase being 
no more than 7% less than the percentage in the DBT Phase, i.e., πDBT - πOLEi ≤7% for ≥4 
of the 5 πOLEi. The cutoff of 23 hours aligns with the lower bound of the 24-hour postdose 
analysis window for eDiary MQoL data collection.
∀
Response is defined as a category of “moderately better” or “very much better” for 
MQoL Question 16 (overall change in migraine symptoms since taking study medication) 
at 24 hours postdose. 
∀
An evaluable qualifying migraine attack is defined as a qualifying migraine attack (see 
Section 4.1) with a nonmissing MQoL Question 16 category at 24 hours postdose.
The percentages of subjects achieving response will be presented descriptively using “n/N” 
and 95% CI by evaluable qualifying migraine attack.
A frequency table will display the number and percentage of subjects in each MQoL 
Question 16 category (plus additional categories for RM=F and IOL=F) by evaluable 
qualifying migraine attack. 
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9.3.1.3. Statistical Hypotheses
The null hypothesis of no difference between rimegepant and placebo will be tested for each 
primary and key secondary endpoint during the DBT Phase. The alternative hypothesis is that 
there is a difference between rimegepant and placebo.
Type 1 error is controlled through the use of hierarchical testing. First, the significance of the 
primary endpoint is evaluated at the 2-sided alpha level of 0.05. If the primary endpoint is not 
significant, then any further tests on key secondary endpoints will have p-values presented 
only for descriptive purposes. If the primary endpoint is significant, then key secondary 
endpoints will be tested, each at the 2-sided alpha level of 0.05, hierarchically in the order 
specified in Section 3.2.1.
9.3.2. Safety Analyses
Deaths will be listed regardless of onset for the enrolled analysis set.
The frequencies of safety endpoints will be assessed descriptively as the number and 
percentage of subjects with events/findings separately for the 2 safety analysis sets (DBT and 
OL rimegepant).
The frequencies of the following safety endpoints will be tabulated on treatment: AEs by 
intensity (mild, moderate, severe, total); AEs related to study drug ; SAEs; AEs leading to 
study drug discontinuation; CV AEs by intensity; grade 3 to 4 laboratory test abnormalities; 
and LFT elevations based on fold changes above ULN, including ALT or AST >3x ULN 
concurrent (i.e., on the same laboratory test collection date) with total bilirubin >2x ULN.
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) available at the start of the study. AEs will 
be tabulated 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. 
Laboratory test results will be graded according to numeric laboratory test criteria from the 
following toxicity grading scales:
∀
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (2017). If 
CTCAE numeric test criteria are not available for a laboratory test, then numeric test 
criteria from Division of AIDS (DAIDS) Table for Grading the Severity of Adult and 
Pediatric Adverse Events Corrected Version 2.1 (2017) will be used. 
∀
Food and Drug Administration (FDA) Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007).
If a subject has a laboratory test abnormality with different toxicity grades over time, then 
only the highest toxicity grade will be reported.
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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.
9.4. Schedule of Analyses
There are 2 planned database locks: (1) primary completion date (PCD) database lock, which 
will occur after the last subject completes the DBT EOT Visit; and (2) last subject last visit 
(LSLV) database lock, which will occur after the last subject completes the Follow-up Week 
2 Visit.
The PCD final clinical study report (CSR) will be produced after the PCD database lock. 
Analyses will focus on efficacy and safety endpoints during the DBT Phase.
The LSLV final CSR will be produced after the LSLV database lock. All endpoints will be 
assessed.
No interim analysis is planned.
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.
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
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of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of.
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
Not applicable. 
This study will not make use of a Data Safety Monitoring Committee (DMC). The study 
medication 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. 
10.3. Steering Committee
Not applicable. 
10.4. 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.
10.5. 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 related to the clinical trial in which they are 
considering voluntary participation. 
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 
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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, the subject must , sign and date an 
IRB/IEC approved written informed consent form for study. 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. 
10.6. 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 collection fields when 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. 
10.7. 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 
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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 following the end 
of the study globally.
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 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.
10.7.1. 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 
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be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.8. Sponsor’s Medically Qualified Individual 
The sponsor will designate a medically qualified individual (MQI, also known as the medical 
monitor) to advise the investigator on study-related medical questions. The contact 
information for the study medical monitor is documented in the Study Team Contact List 
located in the Investigator Site File or equivalent. 
Participants are provided with a Pfizer study information card at the time of informed consent 
which includes contact information for their investigator in case of study-related medical 
questions. The study information card contains, at a minimum, (a) study number, (b) 
participant’s study identification number, and (c) principal investigator contact information.
11. RECORDS MANAGEMENT
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 time 
period 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 (may be 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 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
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6. amount destroyed at the site if applicable
7. amount returned to sponsor, if applicable
8. retain samples for bioavailability/bioequivalence, if applicable
9. record of dates and initials of personnel responsible for IMP dispensing and 
accountability
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 trial outside of 
the eTMF (i.e., rater training tapes) must 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 (or specified designee). 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 (or specified designee) will submit 
protocol amendments to the appropriate regulatory authorities for approval.
If in the judgment of the IRB/IEC, the Investigator, and/or Pfizer (or specified designee), 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. STUDY REPORT AND PUBLICATIONS
Pfizer (or specified designee) is responsible for preparing and providing the appropriate 
regulatory authorities with clinical study reports according to the applicable regulatory 
requirements.
The publication policy is discussed in the Investigator's Clinical Research Agreement.
14. STUDY DISCONTINUATION 
Both Pfizer and the Principal Investigator at a specific study site reserve the right to 
terminate the study at a given study 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 at the specified site and the reasons for its termination. The affected Principal 
Investigator will inform the IRB/IEC of the same. In terminating the study at a specific trial 
site, Pfizer and the Principal Investigator will assure that adequate consideration is given to 
the protection of the subjects’ interests.
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 
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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 – Prohibited and Restricted Concomitant Medications and Devices
Use of the following medications and devices is prohibited or restricted during the study (i.e., 
starting from the screening visit and through the Follow-up Week 2 Visit), unless otherwise 
specified.
・Paracetamol (acetaminophen) and paracetamol-containing products (e.g., 
paracetamol/aspirin/caffeine, etc.) for non-headache indications (See Section 5.5.2)
o
Paracetamol (acetaminophen) and paracetamol-containing products are permitted 
for the treatment of headache indications only
o
Paracetamol (acetaminophen) and paracetamol-containing products, for the 
treatment of headache indications, are permitted up to a maximum dose of 2,000 
mg of paracetamol per calendar day, up to a maximum of 2 consecutive days at a 
time (i.e., if administer paracetamol 2,000 mg/day, only allowed to do this on 2 
consecutive days at a time)
・Non-narcotic analgesics (e.g., NSAIDs, gabapentin, etc.) taken ≥ 15 days per month for 
non-headache indications
・Triptans (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, 
zolmitriptan, etc.)
・CGRP antagonists (e.g., oral or injectable: atogepant, non-study rimegepant, ubrogepant, 
eptinezumab, erenumab, fremanezumab, galcanezumab, etc.) 
・Botulinum toxin injection (Botox®)
・Ergotamine
・Lamotrigine
・Muscle relaxants (except baclofen)
・Marijuana and all forms of ingested or inhaled cannabidiol (CBD) and THC-containing 
products 
・Narcotics 
o
Opioid (e.g., morphine, codeine, oxycodone and hydrocodone) 
o
Barbiturate/barbiturate-containing product (e.g., Fioricet, Fiorinal, butalbital, 
phenobarbital, etc.) 
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o
Atypical antipsychotics
o
Aripriprazole
o
Olanzapine
o
Quetiapine
o
Ziprasidone
o
Risperidone
・Any investigational agents other than rimegepant (provided for the purpose of this 
clinical study).
・Prohibited Concomitant Medications That May Result in DDI:
Drugs that are known strong or moderate inhibitors or inducers of CYP3A4, as well as drugs 
that inhibit P-gp transporters may impact the exposure of rimegepant.
The prohibited concomitant medications listed below should not be taken with study 
intervention for the period of time at least equal to the required washout period listed in the 
table, and during the study.
The Pfizer study team is to be notified of any prohibited medications taken during the study. 
After consulting with the sponsor, the investigator will make a judgment on the ongoing 
participation of any participant with prohibited medication use during the study.
This list of drugs prohibited for potential DDI concerns with the IMP may be revised during 
the course of the study with written notification from the sponsor to include or exclude 
specific drugs or drug categories for various reasons (eg, emerging DDI results for the IMP, 
availability of new information in literature on the DDI potential of other drugs) if the overall 
benefit/risk assessment is not impacted or if the changes do not significantly impact the 
safety of participants or the scientific value of the trial. This is not an all-inclusive list. Site 
staff should consult with the sponsor or designee with any questions regarding potential DDI.
Drug 
Category 
Drugs
Washout Period 
Requirement
Strong 
CYP3A4 
Inhibitors
Boceprevir, cobicistat, 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
2 weeks or 5 half-lives 
whichever is longer
Moderate 
CYP3A4 
Inhibitors
Amprenavir, aprepitant, casopitant, ciprofloxacin, conivaptan, 
diltiazem, dronedarone, erythromycin, fluconazole, 
2 weeks or 5 half-lives 
whichever is longer
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Drug 
Category 
Drugs
Washout Period 
Requirement
isavuconazole, lefamulin, letermovir, netupitant, 
ravuconazole, verapamil
Strong 
CYP3A4 
Inducers
Apalutamide, avasimibe, carbamazepine, phenytoin, rifampin, 
rifapentine, St. John’s Wort
5 half-lives plus 14 days
Moderate 
CYP3A4 
Inducers
Bosentan, efavirenz, etravirine, lopinavir, modafinil, nafcillin, 
rifabutin, phenobarbital
5 half-lives plus 14 days
Strong P-gp 
Inhibitors
Amiodarone, clarithromycin, cyclosporine, dronedarone, 
itraconazole, lapatinib, propafenone, quinidine, ritonavir, 
verapamil
2 weeks or 5 half-lives 
whichever is longer
Investigators should consult the product label of any other medication used during the study 
for information regarding medication that is prohibited for concomitant use.
All medications listed above are permitted to be used during the course of the trial, if 
administered as a topical agent or eye drops, and if applied in a routinely accepted manner.
All devices and/or invasive interventions used for the acute and preventive treatment of 
migraine (e.g., nerve blocks, occipital nerve stimulators [e.g., Cefaly], transcranial magnetic 
stimulation, etc.) administered within 3-months of the Screening Visit and throughout the 
study.
Approved vaccinations including COVID-19 vaccines and treatments with local emergency 
use authorization are permitted throughout the study, unless otherwise specified. 
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16.2. APPENDIX 2 – Permitted Prophylactic Migraine Medication
∀
ACE inhibitors/Angiotensin receptor blockers: lisinopril, candesartan
∀
Alpha-adrenergic agonists: clonidine, guanfacine
∀
Antidepressants: amitriptyline, desvenlafaxine, duloxetine, milnacipran, nortriptyline, 
protriptyline; venlafaxine
∀
Antiepileptics: gabapentin, topiramate, valproic acid (sodium valproate, divalproex 
sodium)
∀
Beta blockers: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, 
timolol
∀
Calcium-channel blocker: flunarizine, lomerizine, nifedipine, nimodipine
∀
Vitamins: butterbur, feverfew, magnesium citrate, riboflavin (Vitamin B2)
∀
Other locally-approved, or otherwise recognized standard of care, medications used for 
the preventative treatment of migraine (e.g. methysergide, oxetrone, pizotifen, etc), 
unless otherwise specified.
Standard prophylactic migraine medication(s) listed above are only permitted under 
the following conditions: 
∀
Drug dosing (frequency and strength) has been stable for at least 3 months prior to the 
screening visit
∀
Drug is being taken consistently (at regular dosing intervals; e.g., daily, etc.)
∀
Drug dosing (frequency and strength) remains unchanged throughout the course of the 
study (e.g., Screening, DBT, or OLE Phases)
o
Discontinuation or dose-reduction of standard prophylactic migraine medication 
is permitted for valid and documented safety reasons only
∀
Drug is NOT newly initiated at any time during the course of the study (e.g., Screening, 
DBT, or OLE Phases)
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16.3. APPENDIX 3 – Permitted Acute Migraine (Rescue) Medications
∀
Simple analgesics:
∀
Non-steroidal anti-inflammatory drug, including, but not limited to:
o
Aspirin, Ibuprofen, Naproxen
o
Low dose aspirin use for cardiovascular prophylaxis is permitted during the 
course of this study.
o
Paracetamol (acetaminophen) and paracetamol-containing products (e.g., 
paracetamol/aspirin/caffeine, etc.) 
∀
Paracetamol (acetaminophen) and paracetamol-containing products, for 
the treatment of headache indications, are permitted up to a maximum 
dose of 2,000 mg of paracetamol per calendar day, up to a maximum of 2 
consecutive days at a time (i.e., if administer paracetamol 2,000 mg/day, 
only allowed to do this on 2 consecutive days at a time)
∀
Antiemetics, including but not limited to:
o
Metoclopramide
o
Promethazine
∀
Other:
o
Baclofen
o
Other approved pharmacological treatment with established efficacy in the 
acute treatment of migraine, including locally-recognized standard of care, 
unless otherwise specified (See Section 16.2, Appendix 2)
These are the only acute migraine medications allowed for rescue treatment at ≥2 hours 
postdose study drug and after completing the 2-hour eDiary entry. 
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16.4. APPENDIX 4 – Triptan-unsuitable Criteria
Triptan-unsuitable - Documented failure (due to lack of efficacy or prior intolerance) on at 
least 2 triptan medications, or documented contraindication to the use of triptans
∀
Lack of Efficacya:
∀
Prior Intoleranceb, including, but not limited to:
o
Prior triptan-associated overuse headache
o
Arrhythmia associated to prior triptan use
o
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness associated with 
prior triptan use
o
Gastrointestinal ischemia or peripheral vasospastic reaction associated with 
prior triptan use 
o
Serotonin syndrome associated with prior triptan use
∀
Contraindicationc, including but not limited to:
o
Documented hypersensitivity to triptans
o
History of cardiovascular event, condition, or procedured
o
Uncontrolled hypertension for the purposes of the -406 study, “uncontrolled 
hypertension” is being defined as: "an active diagnosis of uncontrolled 
hypertension that is documented within the medical record and, in the 
opinion of the Principal Investigator, an indication for not using triptan 
medications.
NOTES
a Lack of Efficacy: 
∀
When previous treatment with a triptan medication(s) has yielded no, unsatisfactory, 
or inconsistent therapeutic effect (e.g., recurrent, incomplete relief of migraine-related 
symptoms [including pain, nausea, photophobia, phonophobia, etc.] at 2 hours 
postdose, non-sustained relief of migraine-related symptoms through 24 hours 
postdose, etc.), after repeated dosing (≥2 attempts) at recommended dose levels, as 
determined by the managing investigator and documented within the 
medical/pharmacy record. If the Principal Investigator is not the treating physician 
and the medical/pharmacy record is not available for documentation purposes, the 
Principal Investigator can interview the treating physician to confirm the above 
information and document the interview with date and his/her signature. When the 
medical/pharmacy records are available indicating the subject’s use of triptan but 
there is no documentation on the lack of efficacy, an interview with the subject and 
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documentation with date and time will suffice. This interview must probe on the same 
indicators of efficacy (e.g., 2-hour pain freedom, sustained pain freedom, freedom 
from disability, freedom from associated symptoms) described above and such 
evidence of unsatisfactory efficacy based on interview responses must be documented 
in sufficient detail to support the conclusion of lack of efficacy.
b Prior Intolerance:
∀
When treatment with a triptan medication(s) has been previously interrupted because 
of an adverse event(s) that made continuation of the drug intolerable for the 
individual, as determined by the managing investigator and documented within the 
medical/pharmacy record. If the Principal Investigator is not the treating physician 
and the medical/pharmacy record is not available for documentation purposes, the 
Principal Investigator can interview the treating physician to confirm the above 
information and document the interview with date and his/her signature. When the 
medical/pharmacy records are available indicating the subject’s use of triptan but 
there is no documentation on the lack of intolerance, an interview with the subject 
and documentation with date and time will suffice. This interview must capture a 
detailed description of the adverse effects from the prior triptan use and the reasons 
the subject found it to be intolerable (e.g., severity, duration, impact on function, etc). 
Such evidence based on interview responses must be documented in sufficient detail 
to support the conclusion of intolerance to previous treatment.
c Contraindication:
∀
When triptan medications are contraindicated, in accordance with locally recognized 
labelling, practice guidelines, and/or the current standard of care, as determined by 
the managing investigator with rationale documented within the medical record. If the 
Principal Investigator is not the treating physician and the medical record is not 
available for documentation purposes, the Principal Investigator can interview the 
treating physician to confirm the above information and document the interview with 
date and his/her signature. When the medical records or other objective evidence on 
screening are available indicating presence of a triptan contraindication, but there is 
insufficient documentation on the details of this contraindication, a supplemental 
interview with the subject and documentation with date and time will suffice.
∀
d Cardiovascular Events, Conditions, and Procedures - Cardiovascular events, 
conditions, and procedures considered contraindications to the use of triptan 
medications. Within the current protocol, eligible subjects with any of the following 
events, conditions, or procedures (as confirmed by information within the medical 
record) will be included within the study’s “CV Subgroup” for the purposes of 
stratification and subgroup analysis
∀
Events:
o
Myocardial infarction (MI)
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o
Cerebrovascular accident (CVA; e.g., Intracerebral hemorrhage, Intracranial 
hemorrhage, Subarachnoid hemorrhage, Ischemic stroke, etc.)
o
Prior cardiac arrest
o
Transient ischemic attack(s) (TIA)
∀
Conditions:
o
Angina pectoris (myocardial ischemia)
o
Cardiac conduction disorder (e.g., Wolff-Parkinson-White [WPW], other life-
threatening arrhythmia/heart block)
o
Coronary artery vasospasm (Prinzmetal’s angina)
o
Ischemic coronary artery disease (CAD)
o
Ischemic bowel disease
o
Peripheral artery disease (including claudication)
∀
Procedures:
o
Angioplasty (with or without stent placement)
o
Coronary artery bypass grafting (CABG)
o
Carotid endarterectomy
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16.5. Appendix 5: Contraceptive and Barrier Guidance 
16.5.1. Female Participant Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criterion 3 (Age and Sex; Section 5.2) and specify 
the reproductive requirements for including female participants. Refer to Section 16.5.3 for a 
complete list of contraceptive methods permitted in the study. 
A female participant 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 16.5.2).
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 
intervention). The investigator should evaluate the effectiveness of the contraceptive 
method in relationship to the first dose of study intervention.
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.
16.5.2. 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 intervention, 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;
∀
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.
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Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
3. 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 (>35 mIU/mL) 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.
16.5.3. Contraception 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 intervention. 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 participant.
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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16.6. APPENDIX 6 - 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, symptomfree 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, symptomfree 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.
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∀
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.
∀
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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16.7. Appendix 7: Country-Specific Requirements
16.7.1. France 
Contrat Unique
1. Study Intervention 
No participants or third-party payers will be charged for study intervention.
2. Urgent Safety Measures 
In addition, the investigator will inform Pfizer immediately of any urgent safety 
measures taken by the investigator to protect the study participants against any 
immediate hazard, and of any serious breaches of this protocol or of ICH GCP that 
the investigator becomes aware of.
3. Termination Rights 
Pfizer retains the right to discontinue development of BHV-3000 (PF-07899801) at 
any time.
4. Exclusion Criteria 
・Persons deprived of their liberty by a judicial or administrative decision, 
・Adults subject to a legal protection measure (guardianship, curatorship, and safeguard 
of justice), 
・Persons not affiliated to a social security scheme or equivalent 
   Covered by Articles 1121-6, 1121-8 and L1122-2 of the Public Health Code.
The investigator agrees to abide by the ethical principles set forth in the World Health 
Organization’s Guiding Principles for Human Cell, Tissue and Organ Transplantation 
(WHA63.22) with regard to the study. 
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16.7.2. Germany
1. Inclusion criteria
Written informed consent must be obtained from the subject in accordance with requirements 
of the study center’s institutional review board (IRB) or ethics committee and in accordance 
with local regulations, prior to the initiation of any protocol-required procedures (as 
described in Section 10.5).
2. Exclusion criteria
Persons deprived of their liberty by a judicial or administrative decision. 
Adults subject to a legal protection measure (guardianship, curatorship, and safeguard of 
justice).
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., 
infectious disease) illness.
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16.7.3. European Union
This study will be conducted in compliance with Regulation (EU) No 536/2014. The 
recruitment plans for each EU Member State concerned are included in the respective 
Recruitment and Informed Consent Procedure documents.
The sponsor will notify EU Member States concerned of the following: 
∀
Any SUSAR via reporting to the EudraVigilance database
∀
Any unexpected event that affects the benefit risk-profile of the study, but are not 
SUSARs, no later than 15 days of becoming aware of that event 
∀
Any serious breach, as described in Section 10.1 no later than 7 days of becoming aware 
of that breach
∀
Any urgent safety measure, as described in Section 10.1, no later than 7 days of the 
measure being taken
∀
Any inspection report of a third-country authority concerning the study
Records and documents, including signed ICFs, pertaining to the conduct of this study must 
be retained by the investigator for 25 years or longer if required by other European Union 
law
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16.8. APPENDIX 8– Protocol Amendment History
Version Number
Brief Description Summary of Changes
Date
Version 1.0 – Original 
Not Applicable
14-July-2022
Version 2.0
Updated the wording and provided further 
details in some objectives in Sections 2.2.1, 
2.2.2 and 2.3 to improve readability and 
understanding of the objectives
Clarified that the RM=F method will apply to all 
binary efficacy endpoints in Sections 3 and 9.3.1
Updated the wording and provided further 
details in some endpoints in Sections 3.2.1 and 
3.2.2 to improve readability and understanding 
of the secondary endpoints
Updated Section 4.1, Study Design and Duration 
to define the end of study.
Further clarified the pregnancy testing 
requirements for WOCBP in the DBT 
(Section 4.2, Table 1) and OLE (Section 4.2, 
Table 2) Phases and throughout the study, 
Section 6.3.4.2
Removed footnote 2 from Section 4.3, Table 2
(OLE Phase and Follow-up Phase Schedule of 
Assessments). All dosing of study medication 
(both blinded and open-label) is to be recorded 
in the eDiary 
Clarified that chronic Hepatitis C viral infection 
will be determined at Screening by the 
combination of a positive HCV antibody plus 
positive HCV RNA, Section 5.3 (2q)
Clarified low dose aspirin use for cardiovascular 
prophylaxis is permitted during the course of 
this study, Sections 5.3 (6c) and 17.4 
Appendix 4
Clarified that exposure to investigational 
biological agents (including monoclonal 
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Version Number
Brief Description Summary of Changes
Date
antibodies) is prohibited within 6 months (24 
weeks) of the Screening Visit, Section 5.3 (7d)
Added failure to complete Baseline Visit as an 
exclusion criterion, Section 5.3 (7i)
Clarified the exclusionary provision which 
permits Investigators to exclude individuals 
from participation in the study based on 
documented clinical concern, beyond the strict 
confines of the protocol defined I/E criteria, 
Section 5.3 (7j) 
Further emphasized: subjects are permitted to 
use non-study acute migraine medication for the 
primary treatment of migraine headaches of 
mild pain intensity (Sections 5.5.2 and 7.1.7); 
that study medication is not to be used as rescue 
medication (Section 7.1.7); and the proper 
recording of all dosing with concomitant (non-
study) medication, both rescue and non-rescue 
(on Rescue and Concomitant Medication paper 
diaries, respectively, Sections 5.4 and 6.4.4)
Updated the definition of WOCBP (women of 
childbearing potential) (Section 5.6) and 
contraception requirements (Section 5.2 [4b] 
and Section 5.3 [4a]) to more closely align with 
CTFG (Clinical Trials Facilitation and 
Coordination Group) Guidance
Removed routine collection of creatine kinase 
blood samples due to lack of safety signal across 
the rimegepant clinical development program, 
Section 6.3.4.1
Clarified, during the OLE Phase, rescue 
medication is non-study acute migraine 
medication dosed after open-label study 
medication and prior to 24 hours postdose and 
completion of the 24-hour assessments within 
the eDiary, and clarified proper recording of 
rescue and non-rescue concomitant (non-study) 
medications (in the Rescue and Concomitant 
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Version Number
Brief Description Summary of Changes
Date
Medication paper diaries, respectively), 
Section 6.4.4
Added Section 6.4.6 to clearly define what 
constitutes a Headache Day in the current study
Clarified, in the case of Potential Drug Induced 
Liver Injury (pDILI), the disposition of the 
subject is left to the discretion of the managing 
Investigator, and provided further detail on the 
management of abnormal liver tests in treated 
subjects during the conduct of the study, 
Section 8.5 
Provided further details about the definition and 
assessment of reliability of rimegepant effect 
during the OLE Phase in Section 9.3.1.2
Updated Sections 16 and 17.1 with updated 
medical monitor contact information, and 
signatory section. 
Reordered text and provided further detail to 
improve readability and understanding on proper 
study conduct. Made updates to list of 
prohibited medications to comply with current 
understanding of the rimgepant DDI profile; 
provided further detail on the restrictions of 
acetaminophen use during the study, 
Section 17.2 Appendix 2 
Reordered text and provided further detail to 
improve readability and understanding on proper 
study conduct. Added recognized herbals and 
vitamins to the list of permitted prophylactic 
migraine medication; Provided further detail on 
the restrictions of permitted prophylactic 
medication use during the study, Section 17.3 
Appendix 3 
Provided further detail on the restrictions of 
paracetamol (acetaminophen) use during the 
study, Section 17.4 Appendix 4
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Version Number
Brief Description Summary of Changes
Date
Re-arranged text, corrected typographical errors, 
added detail, and addressed potential 
inconsistencies in messaging throughout the 
document to improve readability and intended 
study conduct
Added section ANNEX 1., Benefit Risk 
Assessment
Version 3.0       
The following modifications have been made to 
study exclusion criteria: 
・Added a provision which excludes 
individuals who experience 7 or more 
non-migraine headache days per month, 
on-average, across the 3-months prior to 
the Screening Visit, in accordance with 
current CHMP Guidelines on Clinical 
Investigation of Medicinal Products for 
the Treatment of Migraine, Section 5.3
(Exclusion Criteria 1, Target Disease 
Exclusion; criterion 1d) 
・Removed exclusion criteria related to the 
following: History of gallstones or 
cholecystectomy; History or diagnosis of 
Gilbert’s Syndrome or any other active 
hepatic or biliary disorder); History of 
HIV disease; and History of acute 
hepatitis within 6 months of Screening or 
chronic hepatitis [including nonalcoholic 
steatohepatitis]. Restrictions were 
considered unwarranted per rimegepant 
labelling, Section 5.3 (Exclusion Criteria 
2, History and Concurrent Diseases)
・Modified exclusion criteria related to: 
Body Mass Index (BMI) (increased 
exclusionary cutoff from ≥ 33 kg/m2 to ≥ 
35 kg/m2). Degree of restriction was 
considered unwarranted per rimegepant 
labelling, Section 5.3 (Exclusion Criteria 
2, History and Concurrent Diseases; 
criterion 2b)
・Modified exclusion 3a: Added 
Rimegepant is contraindicated in 
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Brief Description Summary of Changes
Date
subjects with a hypersensitivity to any 
component of its formulation.
・Modified exclusion criteria related to: 
Serum bilirubin (increased exclusionary 
cutoff from >1x ULN to >1.5x ULN); 
Serum transaminases (increased 
exclusionary cutoff from >1x ULN to 
>1.5x ULN); and HbA1c (increased 
exclusionary cutoff from ≥ 6.5% to 
≥7.5%). Degrees of restrictions were 
considered unwarranted per rimegepant 
labelling, Section 5.3 (Exclusion Criteria 
5, ECG and Laboratory Test Findings; 
criteria 5c, 5d, and 5g, respectively) 
・Inclusion Criterion 5 in Section 5.2
(Inclusion Criteria) was added. It states, 
Subjects must be able to fully comply 
with the prohibitions and restrictions on 
the concomitant use of medications and 
therapies (including moderate to strong 
inhibitors and inducers of the CYP3A4 
enzyme and strong inhibitors of the P-gp 
transporter) detailed in Section 17.2, 
Appendix 2.
Updated Section 4.3.3.2 to clarify that Day 1 of 
the OLE Phase is the same day as the DBT EOT 
Visit. Sites are to instruct subjects to refrain 
from dosing with open-label study drug until 
they have received a phone call from the site 
confirming their eligibility to enter the OLE 
Phase.
Clarified that hysterectomy and bilateral 
salpingectomy plus bilateral oophorectomy are 
considered sterilizing procedures with regards to 
the definition of Women of Childbearing 
Potential and contraceptive requirements during 
participation in the trial, Section 5.6 (Women of 
Childbearing Potential) 
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Version Number
Brief Description Summary of Changes
Date
Clarifying text was added with regards to 
complete abstinence and associated 
contraception requirements of subjects in the 
clinical trial, Section 5.6 (Women of 
Childbearing Potential)
Clarified that bilateral tubal ligation is an 
acceptable highly effective contraception for 
Women of Childbearing Potential, Section 5.6
(Women of Childbearing Potential)
Provided clarifying text regarding reporting of 
Serious Adverse Events, Section 6.3 (Safety 
Assessments) and Section 8.1.2 (Collection and 
Reporting Serious Adverse Events) 
Modified the title of Section 6.6 from “Early 
Discontinuation from the Study” to “Subject 
Early Discontinuation Criteria”, to more 
accurately reflect key messaging in that 
respective section, Section 6.6 (Subject Early 
Discontinuation Criteria) 
Provided further detail regarding conditions 
determining the termination of the overall trial, 
including unacceptable shift in benefit-risk, in 
accordance with ICH Guideline E6 (R2), 
Section 6.7 (Study Early Discontinuation 
Criteria) 
Provided clarifying text regarding strategies 
used to minimize bias in the conduct of the trial, 
in accordance with ICH E6 (R2), Section 7.2
(Blinding and Unblinding) 
Provided clarifying text regarding the definition 
of treatment non-compliance by subjects and 
corrective actions to be implemented in response 
subject non-compliance, Section 6.6 (Subject 
Early Discontinuation Criteria) and 7.3
(Treatment Compliance) 
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Version Number
Brief Description Summary of Changes
Date
Corrected typographical errors and provided 
detail to proactively address potential 
inconsistencies in messaging throughout the 
document in an effort to improve readability and 
intended study conduct
Updated wording for blood sampling in 
section 6.3.4.1
Version 4.0
Substantial Modification(s)
Referenced study number BHV3000-406 to 
C4951004 and compound name BHV3000 to 
PF-07899801 to reflect identification changes by 
sponsor.
Inclusion criterion #1 “Signed written Informed 
Consent” deleted
Inclusion criterion #3.b and Exclusion criterion 
#4.a for reproductive status updated
Inclusion criterion #3.a -removed upper age 
limit
Addition of an exclusion criterion #7.j “Subject 
unable to complete eDiary independently in the 
opinion of the Investigator.”
Exclusion criterion #2.c for “History of 
hematologic or solid malignancy diagnosis 
within 5 years prior to screening” deleted
Exclusion criterion #2.b for body mass index 
changed to ≥ 35.0 kg/m2 (instead of > 35.0 
kg/m2).
Exclusion criterion #5.g for HbA1c changed to ≥ 
7.5 % (instead of > 7.5%)
Exclusion criterion #5.c for liver enzymes (ALT 
and AST) changed to >2 x ULN (instead 
>1.5xULN) 
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Version Number
Brief Description Summary of Changes
Date
Exclusion criteria #5.i for “QTcF, Left Bundle 
Branch Block, Right Bundle Branch Block and 
Intra Conduction defect” deleted and replaced 
with “Abnormal ECG that in the investigator’s 
opinion makes the subject unsuitable for a 
clinical trial” added
Exclusion criterion #5.b for eGFR criteria 
changed to < 30 ml/min/1.73m2
Exclusion criterion #6c Changed the term 
onabotulinumtoxinA to botulinum toxin 
injection
Guidance relative to Women of Childbearing 
Potential replaced with Contraception section 
and Appendix 5
Added exclusion criterion for involvement in the 
conduct of the clinical trial by staff or family 
members.
Added exclusion criterion #7a, b, and c for 
France only
Changed term non-migraine to non-headache 
and migraine to headache.
Potential DILI cases identification and 
management update
Added Appendix for ECG findings of Potential 
Clinical Concern
Clarified definition of Sponsor's Medically 
Qualified Individual.
Included detailed information about the known 
and expected benefits and risks and reasonably 
expected AEs of rimegepant and referenced to 
the Investigator Brochure.
Non-substantial Modification(s)
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Brief Description Summary of Changes
Date
Updated Serious Adverse Event (SAE) reporting 
destination and electronic reporting system 
administrative changes and clarifications
Updated Overdose section
Section 15 “Confidentiality” renamed to “Data 
Protection” and updated and updated text for 
Data Protection.
Addition of exploratory objective for pain 
relapse in the DBT phase 
Addition of 2 exploratory objectives for 
subgroups
Updated to include US, UK, EU reference and 
Investigator’s Brochure reference.
Clarified study drug destruction
Updated Non-Investigational Product section to 
Concomitant Therapy
Removal of “humidity” from environmental 
condition requirements
Increased the daily dosage of Paracetamol 
(acetaminophen) and paracetamol-containing 
products from 1000mg/day to 2000mg/day
Clarified definition of Qualifying Migraine and 
simplified subsequent references in protocol
Removed Clinical Protocol Approval Form
Removed PI declaration page 
Clarified definition of analysis sets
Added reference to quality tolerance limits
Removed Phase I study exception. Removed 
statement regarding Principal Investigator and 
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Version Number
Brief Description Summary of Changes
Date
the Sponsor’s representative signatory. Added 
Sponsor’s regulatory and ethics responsibilities. 
Added AE information on lack of efficacy and 
medication errors
Added Pfizer standard safety language for 
environmental exposure, exposure during 
pregnancy, exposure during breastfeeding, 
occupational exposure
Moved Pregnancy AE safety section to 8.5.1
Added Pfizer standard text for Dissemination of 
Clinical Study Data.
Moved prior Protocol Amendment Summary of 
Changes to Appendix 
Updated List of abbreviations
Schedule of Activities DBT Phase Table 1 
updated to add line item for eDiary completion 
and re-training at the EOT visit for subjects 
eligible for the OLE phase for clarity
Clarified the blood volumes in mL from 
tablespoons and teaspoons
Addressed typographical errors
Clarified the protocol restriction around the use 
of acetaminophen and paracetamol-containing 
products for non-migraine indications during the 
study
Clarified how medical documentation for 
previous failed treatment is to be recorded.
Corrections to the statistical methodology
Stated that there are 2 planned database locks 
and final CSRs, and no interim analysis is 
planned
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Version Number
Brief Description Summary of Changes
Date
Re-screening policy updated
Clarified that subject must sign and date an 
IRB/IEC approved written informed consent 
form for study
Removed statement that IRB/IEC has to be 
notified at least 5 days prior to implementing 
protocol change
Minor grammatical and spelling corrections; 
Section renumbering 
Schedule of Activities DBT Phase Table 1 –
added option for urine pregnancy test in addition 
to serum at EOT visit
Clarification note added to Schedule of 
Activities DBT Phase Table -Under Physical 
Exam; If subject is eligible to enroll into the 
OLE Phase, a physical exam at DBT EOT is not 
required
Clarification note added to Schedule of 
Activities DBT Phase Table under ECG; If 
subject is eligible to enroll into the OLE Phase, 
an ECG at DBT EOT is not required
Version 5.0
Inclusion criterion #5 “Written informed 
consent” added
Exclusion criteria #7.a and 7.b modified to 
include Germany
Exclusion #7.m “Subjects detained for treatment 
of either a psychiatric or physical illness” added
Appendix 7 modified to include Germany-
specific country requirement
06 Feb 2024
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17. REFERENCES
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Biohaven-Vydura. Vydura SmPC. EPAR product information: EMA. Available from: 
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PF-07899801 (Rimegepant/BHV-3000) Investigator Brochure. 2024;V3.0.
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Banholzer ML, Wandel C, Barrow P, et al. Clinical trial considerations on male 
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Diener H-C, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache 
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Headache-Classification-Committee-of-the-International-Headache-Society-(IHS). The 
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Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Chapter 
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Posner K, Brent D, Lucas C, et al. Columbia-Suicide Severity Rating Scale. The 
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Martin BC, Pathak DS, Sharfman MI, et al. Validity and reliability of the migraine-
specific quality of life questionnaire (MSQ Version 2.1). Headache 2001;40:204-15.
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Hartmaier SL, Santanello NC, Epstein RS, Silberstein SD. Development of a brief 24-
hour migraine-specific quality of life questionnaire. Headache 1995;35:320-9.
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Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: 
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