A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Temporomandibular Disorders (TMD)
Phase: PHASE3
Conditions: Temporomandibular Disorders (TMD)
Sponsor: Pfizer

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DRUG: 
BHV-3000 (rimegepant) 
 
 
STUDY NUMBER(S): 
BHV3000-317 
 
 
PROTOCOL TITLE: 
A Phase 2/3, Double-Blind, Randomized, Placebo- 
Controlled, Safety and Efficacy Trial of BHV-3000 
(rimegepant) Orally Disintegrating Tablet (ODT) for 
the Acute Treatment of Temporomandibular 
Disorders (TMD) 
 
 
IND NUMBER: 
158955 
 
 
SPONSOR: 
Biohaven Pharmaceuticals Holding Company Limited 
 
 
ORIGINAL PROTOCOL DATE: 
09 December 2021 
 
 
VERSION NUMBER: 
Amended Protocol Version 3 
 
 
VERSION DATE: 
31 March 2022 

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SUMMARY OF CHANGES 
 
Version Number 
Brief Description Summary of Changes 
Date 
Version 1.0 – Original 
Not Applicable 
09 December 2021 
Version 2.0 – Amendment 1 To further clarify how a subject should choose which rescue 
medication to take, the following sentence has been added to 
the Study Design section in the synopsis and to Sections 
4.1.2.1 and 5.5: Subjects may administer whichever 
protocol permitted standard of care rescue medication they 
choose to reduce symptoms and that they have available. 
The following sentence was added to the same sections to 
clarify how a subject should choose which medication to 
take when they have non-qualifying TMD pain: Subjects 
may administer whichever protocol permitted standard of 
care medication they choose to reduce symptoms and that 
they have available. 
To provide guidance to women of childbearing potential 
who will administer a home pregnancy test, Table 1 
Schedule of Activities and Section 6.3.4.2 have been 
updated to include the following statement: Subjects will be 
provided with the accompanying package insert that contains 
instructions for use and interpretation of results. 
To ensure safety to subjects and ensure that subjects do not 
experience opioid withdrawal, Section 5.4, Number 10 was 
updated from “Use of narcotic medication, such as opioids 
(e.g., morphine, codeine, oxycodone and hydrocodone) is 
prohibited for at least 2 days prior to randomization” to “Use 
of narcotic medication, such as opioids (e.g., morphine, 
codeine, oxycodone and hydrocodone) is prohibited for at 
least 30 days prior to the Screening Visit and throughout the 
study”. 
To clarify that the eDiary will be recording the date and time 
subjects take study therapy and the eDiary is set up to follow 
study-specific specifications developed by the eDiary 
Vendor and the Sponsor, Section 4.1.2.1 was updated from 
“Subjects will record the date and time study therapy was 
taken in their eDiary” to “Subjects will record the date and 
time study therapy was taken in their eDiary according to the 
eDiary vendor’s specifications.” 
In Section 5.5, Cyclobenzaprine was removed from the list 
of allowable daily medication because cyclobenzaprine is 
allowed as a rescue medication and as a permitted 
medication to treat a non-qualifying TMD-associated pain 
(i.e., pain < 6 on a NRS[0-10] in the jaw and/or temple area 
on either side). 
09 February 2022 

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Version 3.0 – Amendment 2 Synopsis and Section 2.1 Primary Objective(s): The primary 
objective was changed from To evaluate the efficacy of 
rimegepant compared with placebo in the acute treatment of 
Temporomandibular Disorders on change from baseline of 
pain on NRS (0-10) score at 2 hours post-dose. To To 
evaluate the efficacy of rimegepant compared with placebo 
in the acute treatment of Temporomandibular Disorders on 
the time-weighted sum of pain intensity difference from 
baseline scores for the first 2 hours post-dose (SPID-2). 
Synopsis and Section 2.2 Secondary Objective(s): The 
secondary objectives were changed from: 
1. To evaluate rimegepant compared to placebo on ≥ 30% 
reduction from baseline of pain NRS (0-10) score at 2 
hours post-dose. (this objective was deleted) 
2. To evaluate rimegepant compared to placebo on ≥ 50% 
reduction from baseline of pain NRS (0-10) score at 2 
hours post-dose. (this objective was deleted) 
3. To evaluate rimegepant compared to placebo on the 
proportion of subjects that are pain free at 2 hours post- 
dose. 
4. To evaluate rimegepant compared to placebo on the 
probability of requiring rescue medication within 24 
hours of initial treatment. 
To 
1. To evaluate rimegepant compared with placebo on the 
time-weighted sum of pain intensity difference from 
baseline scores for the first 24 hours post-dose (SPID- 
24). (this objective was added 
2. To evaluate rimegepant compared to placebo on 
change from baseline of pain on NRS (0-10) score at 2 
hours post-dose.(this was the old primary objective. It 
was moved and is now a secondary objective) 
3. To evaluate rimegepant compared to placebo on the 
proportion of subjects that are pain free at 2 hours post- 
dose. 
4. To evaluate rimegepant compared to placebo on time 
to onset of meaningful pain relief post-dose. (this is a 
new secondary objective) 
5. To evaluate rimegepant compared to placebo on time 
to onset of initial pain relief post-dose. (this is a new 
secondary objective) 
31 March 2022 

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6. To evaluate rimegepant compared to placebo on the 
probability of requiring rescue medication within 24 
hours of initial treatment. 
Synopsis and Section 2.3 CCI 
: Two 
secondary objectives were moved to CCI 
 
 
The two are: 
CCI 
The remainder of theCCI 
 remained 
unchanged. 
Section 3.1 Primary Endpoint(s) was changed from: 
Change from baseline of pain will be assessed using the 
number of evaluable subjects that report TMD-associated 
pain level of ≥ 6 on NRS (0-10) at baseline and report pain 
level at 2 hours post-dose recorded in the eDiary. 
To: Difference in SPID-2 scores between treatment groups 
will be assessed across the first 2 hours post-dose using the 
number of randomized and treated subjects. 
Section 3.2 Secondary Endpoints was changed from: 
1. Greater than 30% reduction from baseline of pain will 
be assessed using the number of subjects that 
experience at least a 30% reduction from baseline of 
pain on NRS (0-10) at 2 hours post-dose recorded in 
the eDiary (this was removed). 
2. Greater than 50% reduction from baseline of pain will 
be assessed using the number of subjects that 
experience at least a 50% reduction from baseline of 
pain on NRS (0-10) at 2 hours post-dose recorded in 
the eDiary. (this was removed) 
3. Pain freedom will be assessed using the number of 
evaluable subjects that report no pain at 2 hours post- 
dose. Pain will be measured on NRS (0-10). 
4. The probability of requiring rescue medication will 
be assessed using the number of subjects that take 
rescue medication within 24 after administration of 
study medication (rimegepant or placebo). 

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To: 
1. Difference in SPID-24 scores between treatment 
groups will be assessed across the first 24 hours post- 
dose using the number of randomized and treated 
subjects on NRS (0-10). (this was added) 
2. Change from baseline will be assessed at 2 hours post- 
dose using the number of randomized and treated 
subjects. (this was added) 
3. Pain freedom will be assessed using the number of 
evaluable subjects that report no pain at 2 hours post- 
dose. Pain will be measured on NRS (0-10). 
4. Onset of meaningful pain relief will be assessed by the 
first nominal timepoint at which the pain on NRS (0- 
10) decreases by 30% from baseline. (this was added) 
5. Onset of initial pain relief will be assessed by the first 
nominal timepoint at which the pain on NRS (0-10) 
decreases by 1 point from baseline. (this was added) 
6. The probability of requiring rescue medication will 
be assessed using the number of subjects that take 
rescue medication within 24 hours after administration 
of study medication (rimegepant or placebo). 
5.2 Inclusion Criteria #2.e: The following text was removed 
The following is not exclusionary but does not qualify as 
primary diagnosis for inclusion: 
 
Disc disorders (I.2.A.1-4), when not associated with 
mechanically induced arthralgia 
 
Degenerative joint diseases (I.3.A.1-2) 
 
Tendonitis (II.1.B) 
 
Contracture (II.2) 
 
Hypertrophy (II.3) 
 
Headache attributed to TMD (III.1) 
Section 5.3 Exclusion Criteria Number 1.c.ii. Joint Disorders 
was clarified. Previous text: 
i. 
Joint Disorders: 
(1) Disc disorders (I.2.A.1-4), when 

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associated with mechanically induced 
arthralgia 
(2) Hypomobility disorders other than disc 
disorders (I.2.B) 
(3) Hypermobility disorders (I.2.C.) 
New text: 
i. 
Joint Disorders: 
(1) Disc disorders (I.2.A.1-4) only when 
associated with mechanically induced 
arthralgia 
(2) Other hypomobility disorders (I.2.B), such 
as adhesions/adherence, ankylosis 
(3) Hypermobility disorders (I.2.C.), such as 
subluxation, luxation 
In addition, Contracture (II.2) was added as vii, which also 
caused the remainder of the list under section 2.C to be 
renumbered viii through xi. 
Section 5.3, 1.d was clarified as follows: 
From: 
d. 
Subject has a history of neuropathic/idiopathic 
pain disorder. 
To: 
d. Subject has a history of neuropathic (e.g., 
trigeminal neuralgia, postherpetic neuralgia) 
or idiopathic pain disorder. 
Section 5.3 Exclusion Criteria, 5.g.: Severe hepatic 
impairment (Child-Pugh C) is exclusionary in all cases was 
added. 
Section 9.2 Sample Size was updated from If 80% of the 200 
randomized (100 per treatment arm) have a TMD associated 
pain reaching intensity of ≥ 6 on the NRS prior to 
treatment, and provide at least one post baseline efficacy 
data point, we expect roughly 160 total or 80 per treatment 
group in the Modified Intent to Treat (mITT) population for 
analysis. To If 80% of the 200 randomized (100 per 
treatment arm) treat with study drug, we expect roughly 160 
total or 80 per treatment group in the randomized and 
treated population for analysis. 

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The third paragraph in Section 9.3 Population for Analysis 
was updated from The set of treated subjects consists of all 
subjects who take study therapy (rimegepant or placebo) to 
The set of treated subjects consists of all randomized 
subjects who take study therapy (rimegepant or placebo). 
In addition the following paragraph was deleted from 
Section 9.3: The mITT set consists of randomized subjects 
that take study therapy, have a TMD associated pain in the 
jaw and/or temple area which reaches pain intensity of ≥ 6 
on the NRS (0-10) prior to treatment, and provide at least 
one post baseline efficacy data point, 
Section 9.4.2 Primary Endpoint(s) was updated from The 
change from baseline efficacy endpoint is analyzed on the 
mITT population using a generalized linear mixed effect 
model that includes subject as a random effect, the baseline 
NRS (0-10) value as a covariate, and fixed effects for 
treatment group, stratification factor (use of daily 
medications / oral devices to reduce the intensity of TMD 
symptoms), scheduled time point, and time point by 
treatment group interaction. Time points included in the 
model are nominally at 15, 30, 45, 60, 90 and 120 minutes 
post-dose. Repeated measurements within-subject will be 
modeled using an unstructured covariance structure for 
within-subject error. In the case that the model fails to 
converge, a Huynh-Feldt error structure will be attempted, 
followed by an AR(1) structure. Error degrees of freedom 
will be calculated using a Kenward-Roger approximation. 
The difference estimate (rimegepant - placebo), standard 
error, 95% confidence interval, and p-value will be reported 
for 2 hours post-dose. 
In the event a subject uses a non-study rescue medication on 
or before 2 hours post-dose, all data points after rescue 
medication was administered will be set to missing (RM = 
M: Rescue medication use = Missing). Likewise, if a subject 
fails to log their pain score after study drug is administered, 
through 2 hours post-dose, this data will be considered 
missing (NC = M: Non-completers = Missing). 
Sensitivity analyses will be described in the SAP. 
To The SPID-2 will be calculated by multiplying the PID 
score (difference between NRS at each time point and 
baseline NRS) at each post-dose timepoint by the duration 
(in hours) since the preceding timepoint, then summing the 
values over the 2 hours. This is analyzed on the treated 
population using an analysis of covariance (ANCOVA) 
model that includes the baseline NRS (0-10) value as a 
covariate, and main effects for treatment group and 
stratification factor (use of daily medications / oral devices 

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to reduce the intensity of TMD symptoms). 
The least squares mean (LS mean), standard error (SE), 
and 95% confidence interval (CI) for each treatment group 
will be reported, as well as the difference estimate 
(rimegepant - placebo), SE, 95% CI, and p-value. 
Intercurrent events will be treated as failures, with the 
assumption that the subject does not improve once the 
intercurrent event occurs. In the event a subject uses a non- 
study rescue medication on or before 2 hours post-dose, all 
data points after rescue medication was administered will be 
set to the last available observation prior to rescue 
medication usage (RM = Rescue medication use, F = 
Failure). Likewise, if a subject fails to log their pain score at 
any time after study drug is administered, through 2 hours 
post-dose, this data will be imputed to the last available 
observation (NC = Non-completers, F= Failure). 
Sensitivity analyses will be described in the SAP. 
The first paragraph in Section 9.4.3 Secondary Endpoint(s) 
was updated from If the primary endpoint test is significant, 
then the secondary endpoints are evaluated using a 
hierarchical gate-keeping procedure, with each test in the 
hierarchy conducted at p=0.05. These secondary endpoints 
will be tested in the order shown in the Study Objectives 
section of this protocol. Secondary endpoints will be 
analyzed on the mITT population. to If the primary 
endpoint test is significant at alpha  0.05, then the 
secondary endpoints will be analyzed at an alpha level of  
0.05 using Hochberg’s procedure. Secondary endpoints will 
be analyzed on the treated population. 
Section 9.4.3.1 SPID-24; Section 9.4.3.2 Change from 
Baseline of Pain on NRS; Section 9.4.3.4 Time to Onset of 
Meaningful Pain Relief; section 9.4.3.5 Time to Onset of 
Initial Pain Relief were all added. Sections 9.4.3.3 Pain 
Freedom at 2 Hours, and 9.4.3.6 Rescue Medication Use 
through 24 Hours are new sections that were edited from 
previous Section 9.4.3 text. 
Section 9.4.4 Adjustment for Multiplicity was updated from 
Type 1 error is controlled through the use of hierarchical 
testing. The significance of the primary endpoint is 
evaluated at the two-sided alpha level of 0.05. If the primary 
endpoint is significant, then the following secondary 
endpoints will be tested hierarchically in the following 
order, each at the 0.05 level: 
1. 
Proportion of subjects with a ≥ 30% reduction from 
baseline of pain NRS (0-10) score at 2 hours post-dose. 

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2. Proportion of subjects with a ≥ 50% reduction from 
baseline of pain NRS (0-10) score at 2 hours post-dose. 
3. Proportion of subjects that are pain free at 2 hours 
post-dose. 
4. Proportion of subjects requiring rescue medication 
within 24 hours of initial treatment. 
Thus, a secondary endpoint will be tested only if the 
preceding secondary endpoint in the hierarchy is 
determined to be significant. Descriptive p-values will be 
provided for any non-significant secondary endpoints and 
comparative CCI 
 
The
significance of the primary endpoint is evaluated at the two- 
sided alpha level of 0.05. If the primary endpoint is 
significant, then the secondary endpoints are tested using 
Hochberg’s procedure. 
No attempt will be made to adjust for multiplicity when 
testing the CCI 
Section 9.4.5 Missing Data was updated from For the 
primary endpoint of change in NRS from baseline, subjects 
who fail to record their pain at 2 hours post-dose will be 
considered missing (NC = M); the MMRM analysis model 
will be used, which assumes missing data are missing at 
random (MAR). 
For the secondary endpoints of proportion of subjects with 
30% reduction from baseline of pain at 2 hours post-dose, 
50% reduction from baseline of pain at 2 hours post-dose, 
and pain freedom at 2 hours post-dose, missing data at 2 
hours post-dose will be imputed as a failure (NC = F). 
For the secondary endpoint of proportion of subjects who 
use rescue medication through 24 hours-post dose, there will 
be no imputation for missing data, the analysis will be based 
on non-missing, observed data. 
Additional methods for handling of missing data, including 
sensitivity analyses, will be described in detail in the SAP. to 
For the primary and secondary endpoints of SPID-2, SPID- 
24, change in NRS from baseline, time to onset of 

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meaningful pain relief, and time to onset of initial pain 
relief, subjects who fail to record their pain during the 
timeframe of interest for each endpoint will be considered 
failures (NC = F) and this data will be imputed to the last 
available observation prior to the missing data occurrence. 
For the secondary endpoint of proportion of subjects that are 
pain free at 2 hours post-dose, missing data at 2 hours post- 
dose will be imputed as a failure (NC = F), and these 
subjects will not be considered as having achieved pain 
freedom. 
For the secondary endpoint of proportion of subjects who 
use rescue medication through 24 hours-post dose, there will 
be no imputation for missing data, the analysis will be based 
on non-missing, observed data. 
Additional methods for handling of missing data, including 
sensitivity analyses, will be described in detail in the SAP. 
Section 9.4.6 Rescue Medication was updated from For the 
primary endpoint of change from baseline in NRS, the 
intercurrent event of use of non-study rescue medications 
on or before the time point of interest (2 hours post-dose) 
will be handled with a hypothetical strategy. Specifically, 
the assumption will be that had the subject not used a 
rescue medication, their efficacy would have been similar 
to the efficacy of subjects from the same treatment group 
who did not use rescue medication. These data points after 
rescue medication was administered will be set to missing 
(RM = M). 
For the secondary endpoints of proportion of subjects with 
30% reduction from baseline of pain at 2 hours post-dose, 
50% reduction from baseline of pain at 2 hours post-dose, 
and pain freedom at 2 hours post-dose, subjects that take 
rescue medication on or before the time point of interest (2 
hours post-dose) will be considered as failures (RM = F). 
Rescue medications are described in more detail in Section 
5.5 to For the primary and secondary endpoints of SPID-2, 
SPID-24, change in NRS from baseline, time to onset of 
meaningful pain relief, and time to onset of initial pain 
relief, use of non-study rescue medications on or before the 
time point of interest (2 hours post-dose or 24 hours post- 
dose) will be handled as failures (RM = F). Specifically, the 
assumption will be that once the subject has used a rescue 
medication, their pain will not improve any further and 
these data points will be set to the last value recorded prior 
to the use of the rescue medication. 

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For the secondary endpoint of pain freedom at 2 hours 
post-dose, subjects that take rescue medication on or before 
the time point of interest (2 hours post-dose) will be 
considered as failures (RM = F). 
Rescue medications are described in more detail in Section 
5.5 

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BHV3000-317 
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety 
and Efficacy Trial of BHV-3000 (rimegepant) Orally Disintegrating 
Tablet (ODT) for the Acute Treatment of Temporomandibular 
Disorders (TMD) 
Protocol v3.0 Amendment 2: 31Mar2022 
 
 
CONFIDENTIALITY AND INVESTIGATOR STATEMENT 
The information contained in this protocol and all other information relevant to BHV-3000 
(rimegepant) are the confidential and proprietary information of Biohaven Pharmaceutical 
Holding Company Limited. 
I have read the protocol, including all appendices, and I agree that it contains all of the necessary 
information for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein, in accordance with the regulations stated in the Federal Code of Regulations for 
Good Clinical Practices and International Conference on Harmonization guidelines and will 
make a reasonable effort to complete the study within the time designated. 
I will provide all study personnel under my supervision copies of the protocol and any 
amendments, and access to all information provided by Biohaven Pharmaceutical Holding 
Company Limited or specified designees. I will discuss the material with them to ensure that 
they are fully informed about BHV-3000 (rimegepant) and the study. 
 
 
 
 
 
 
 
 
Principal Investigator Name (printed) 
Signature 
Date 

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STUDY SUMMARY (SYNOPSIS) 
 
 
Title: 
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and 
Efficacy Trial of BHV-3000 (rimegepant) Orally Disintegrating Tablet 
(ODT) for the Acute Treatment of Temporomandibular Disorders (TMD) 
Rationale: 
Temporomandibular Disorders (TMD) is a heterogenous group of 30+ 
conditions involving the temporomandibular joint and surrounding muscles 
and tissues. It is characterized by pain, functional limitations of the 
mandible, and/or clicking in the TMJ during motion. TMD is considered 
the most common cause of non-dental facial pain, with reported prevalence 
ranging from 4.6-25% of the US population.1 
Despite high prevalence and disability associated with TMD, there are no 
clear guidelines for treatment or evidence to support a single agent. 
Treatment can be invasive or non-invasive and first-line approach is 
usually a combination of self-care techniques and NSAIDs.2 
The proposed study is based on the evolving preclinical and clinical 
evidence suggesting a role for calcitonin gene related peptide (CGRP) in 
the development of TMD. BHV-3000 (rimegepant) is a small molecule 
CGRP receptor antagonist that is being developed for the potential 
treatment of TMD. The data from this study will allow characterization of 
the safety and efficacy of orally disintegrating tablet (ODT) of rimegepant 
versus placebo in the treatment of Temporomandibular Disorders. 
Target 
Population: 
The study will recruit male and female subjects 18 years of age and older 
with a history of TMD diagnosed by healthcare provider that meets the 
criteria consistent with a diagnosis according to the DC/TMD (Diagnostic 
Criteria for Temporomandibular Disorders) and includes at least one of the 
following: Myalgia (II.1.A.1-3) and/or Arthralgia (I.1.A.).3 Subjects will 
have had a minimum 3-month to a maximum 5-year history of TMD prior 
to the Screening Visit. 
Subjects must have had at least one instance of TMD-associated pain in the 
jaw and/or temple area on either side that reached intensity of  6 on a 11- 
point Numerical Rating Scale (NRS, 0-10) in the past 30 days prior to the 
Screening Visit. 
Number of 
Subjects: 
Approximately 200 subjects will be randomized to result in 160 (80 per 
arm) evaluable subjects. The subjects will be randomized in a 1:1 ratio to 
the rimegepant or placebo treatment groups. The randomization will be 
stratified by the use of daily medications and/or oral devices to reduce the 

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Objectives 
(Primary): 
 
 
Objectives 
(Secondary): 
intensity of TMD symptoms (yes or no). 
To evaluate the efficacy of rimegepant compared with placebo in the acute 
treatment of Temporomandibular Disorders on the time-weighted sum of 
pain intensity difference from baseline scores for the first 2 hours post- 
dose (SPID-2). 
1. To evaluate rimegepant compared with placebo on the time-weighted 
sum of pain intensity difference from baseline scores for the first 24 
hours post-dose (SPID-24). 
2. To evaluate rimegepant compared to placebo on change from baseline 
of pain on NRS (0-10) score at 2 hours post-dose. 
3. To evaluate rimegepant compared to placebo on the proportion of 
subjects that are pain free at 2 hours post-dose. 
4. To evaluate rimegepant compared to placebo on time to onset of 
meaningful pain relief post-dose. 
5. To evaluate rimegepant compared to placebo on time to onset of initial 
pain relief post-dose. 
6. To evaluate rimegepant compared to placebo on the probability of 
requiring rescue medication within 24 hours of initial treatment. 
CCI 
 

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CCI 
Study 
Design: 
This is a double-blind, randomized, multicenter, outpatient evaluation of 
the safety and efficacy of rimegepant as compared to placebo for the acute 
treatment of Temporomandibular Disorders (TMD). The study drug will be 
rimegepant presented in a 75 mg ODT or matching placebo. 
A subject whose TMD-associated pain of  6 on a NRS (0-10) and who is 
otherwise found acceptable for entry into this trial based on inclusion and 
exclusion criteria will first participate in the screening phase (3 to 14 day 
period). Subjects must remain on the same dose of daily medications used 
to reduce the intensity of TMD symptoms from screening through the 
duration of the study and may not start new daily medication. Subjects 
must remain on the consistent use of oral devices used to reduce the 
intensity of TMD symptoms from screening through the duration of the 
study and may not start use of new oral devices. 
After randomization, the subject will be dispensed a single dose of the 
double-blind study medication. The subject will be instructed to take their 
study medication, as an outpatient, when (if) they have an TMD-associated 
pain in the jaw and/or temple area on either side which reaches pain 
intensity of  6 on the NRS (0-10). The subject will record efficacy data in 
an eDiary for 24 hours after taking study medication. CCI 
Pain severity will be recorded 
using a NRS (0-10) at time of taking study medication and after dosing at 
time points of 15, 30, 45, 60, and 90 minutes and 2, 4, 8 and 24 hours. 
CCI 
The subject will be instructed to 

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telephone the study center immediately if a severe or serious adverse event 
occurs. 
At the end of 2 hours after dosing with study medication (and after the 2- 
hour assessments have been completed on the eDiary), subjects will be 
permitted to use the following rescue medication: acetaminophen (up to 
1000 mg/day); or aspirin, ibuprofen, naproxen (or any other type of non- 
steroidal anti-inflammatory [NSAID]), or cyclobenzaprine (all up to the 
daily recommended dose indicated on the drug packaging). Subjects may 
administer whichever protocol permitted standard of care rescue 
medication they choose to reduce symptoms and that they have available. 
These are the only medications allowed for rescue treatment after 2 hours 
post dose of study medication. If at the end of 24 hours after dosing with 
study medication (but before the End of Treatment Visit) subjects are in 
need of pain relief, they may take their prescribed standard of care 
medications, including muscle relaxants if not contraindicated, provided all 
of the assessments have been completed on the eDiary. Exclusionary 
rescue medication such as opioids and butalbital compounds are not 
allowed on this study. 
Similarly, if the TMD-associated pain is relieved by study medication at 2 
hours after dosing but then recurs to a pain intensity of  6 on the NRS (0- 
10) between 2 and 24 hours, the subject will be permitted to take the same 
rescue therapy as outlined above. In all circumstances, the subject will 
always continue to complete his or her eDiary for up to 24-four hours after 
consuming the study medication. During the [up to] 66 days the subject is 
participating in the study, if the subject has a non-qualifying TMD- 
associated pain (i.e., pain < 6 on a NRS[(0-10]) in the jaw and/or temple 
area on either side), the subject is permitted to use only the following 
medications: acetaminophen (up to 1000 mg/day); or aspirin, ibuprofen, 
naproxen (or any other type of non- steroidal anti-inflammatory [NSAID]), 
or cyclobenzaprine (all up to the daily recommended dose indicated on the 
drug packaging). Subjects may administer whichever protocol permitted 
standard of care medication they choose to reduce symptoms and that they 
have available. 
Subjects will return to the study site within 7 days (+2) of study treatment 
for review of the eDiary, assessment of medication compliance, and 
monitoring of tolerability and safety (including vital signs, laboratory tests, 
and electrocardiography). If a subject has NOT experienced a TMD- 
associated pain of sufficient severity within 45 days after randomization, 
they still are required to complete all EOT visit procedures. All subjects 
must return used/unused study medication and eDiary to the study center. 

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STUDY SCHEMATIC 
BHV3000-317 Acute Treatment of Temporomandibular Disorders Study 
 
 
 
 

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TABLE OF CONTENTS 
SUMMARY OF CHANGES ......................................................................................................... 2 
CONFIDENTIALITY AND INVESTIGATOR STATEMENT .............................................. 12 
STUDY SUMMARY (SYNOPSIS) ............................................................................................. 13 
CCI 
 
STUDY SCHEMATIC ................................................................................................................. 17 
TABLE OF CONTENTS ............................................................................................................. 18 
LIST OF TABLES ....................................................................................................................... 20 
LIST OF ABBREVIATIONS ...................................................................................................... 21 
1 
INTRODUCTION AND RATIONALE .............................................................................. 22 
1.1 
Background ....................................................................................................................... 22 
1.2 
Product Development Background ................................................................................. 23 
1.2.1 
Clinical Adverse Event Profile .................................................................................. 23 
1.3 
Study Rationale ................................................................................................................ 23 
1.3.1 
Study Design Rationale .............................................................................................. 24 
1.3.2 
Dose Selection Rationale ............................................................................................ 25 
1.3.3 
Research Hypothesis .................................................................................................. 25 
1.3.4 
Benefit/Risk ................................................................................................................. 25 
1.3.4.1 
Benefit/Risk Assessment ...................................................................................... 25 
2 
STUDY OBJECTIVES ......................................................................................................... 26 
2.1 
Primary Objective(s) ........................................................................................................ 26 
2.2 
Secondary Objective(s) .................................................................................................... 26 
3 
STUDY ENDPOINTS ........................................................................................................... 28 
3.1 
Primary Endpoint(s) ........................................................................................................ 28 
3.2 
Secondary Endpoint(s) ..................................................................................................... 28 
3.3 
Measures of interest ......................................................................................................... 28 
4 
STUDY PLAN ....................................................................................................................... 29 
4.1 
Study Design and Duration ............................................................................................. 29 
4.1.1 
Screening Phase (3-14 days) ...................................................................................... 35 
4.1.2 
Acute Treatment (Randomization) Phase ................................................................ 35 
4.1.2.1 
eDiary Data Collection ......................................................................................... 35 
4.1.3 
Extension Phase .......................................................................................................... 36 
4.1.4 
Washout Phase ........................................................................................................... 36 
4.1.5 
End of Treatment ....................................................................................................... 36 
4.2 
Post Study Access to Therapy ......................................................................................... 37 
5 
POPULATION ...................................................................................................................... 37 
5.1 
Number of Subjects .......................................................................................................... 37 
5.2 
Inclusion Criteria ............................................................................................................. 37 
5.3 
Exclusion Criteria............................................................................................................. 38 
5.4 
Prohibited and Restricted Concomitant Medications ................................................... 43 
5.5 
Daily and Rescue Medications and Oral Devices ........................................................... 44 
5.6 
Women of Childbearing Potential .................................................................................. 46 

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5.7 
Other Restrictions and Precautions ................................................................................ 47 
5.8 
Protocol Deviations ........................................................................................................... 47 
6 
STUDY CONDUCT AND DESCRIPTION OF STUDY PROCEDURES ...................... 48 
6.1 
Study Materials ................................................................................................................ 48 
6.2 
Eligibility Assessments ..................................................................................................... 49 
6.2.1 
Symptom Questionnaire – DC/TMD ........................................................................ 49 
6.2.2 
Clinical Exam Form (NA) – DC/TMD ..................................................................... 49 
6.3 
Safety Assessments ........................................................................................................... 49 
6.3.1 
Vital Signs and Physical Measurements (Height and Weight) ............................... 49 
6.3.2 
Electrocardiogram (ECG) ......................................................................................... 49 
6.3.3 
Physical Exam ............................................................................................................. 49 
6.3.4 
Laboratory Assessments ............................................................................................ 49 
6.3.4.1 
Safety Laboratory Testing ................................................................................... 49 
6.3.4.2 
Pregnancy Testing ................................................................................................ 50 
6.3.5 
Columbia Suicidality Severity Rating Scale (CSSRS)............................................. 50 
6.4 
Efficacy Assessments ........................................................................................................ 51 
6.4.1 
Pain .............................................................................................................................. 51 
6.4.2 
Rescue Medication ...................................................................................................... 51 
6.5 
Early Discontinuation from the Study ........................................................................... 51 
6.5.1 
Lost to Follow Up ....................................................................................................... 52 
7 
STUDY DRUG MANAGEMENT ....................................................................................... 53 
7.1 
Description of Study Drug ............................................................................................... 53 
7.1.1 
Investigational Product .............................................................................................. 53 
7.1.2 
Non-Investigational Product ..................................................................................... 53 
7.1.3 
Packaging, Shipment and Storage ............................................................................ 53 
7.2 
Dose and Administration ................................................................................................. 53 
7.2.1 
Method of Assigning Subject Identification ............................................................. 54 
7.2.2 
Selection and Timing of Dose and Administration .................................................. 54 
7.2.3 
Dose Modifications. .................................................................................................... 54 
7.3 
Blinding and Unblinding ................................................................................................. 54 
7.4 
Treatment Compliance .................................................................................................... 55 
7.5 
Destruction and Return of Study Drug .......................................................................... 55 
8 
ADVERSE EVENTS ............................................................................................................. 56 
8.1 
Serious Adverse Events .................................................................................................... 57 
8.1.1 
Definition of Serious Adverse Event (SAE) ............................................................. 57 
8.1.2 
Collection and Reporting Serious Adverse Events .................................................. 58 
8.2 
Non-serious Adverse Events ............................................................................................ 59 
8.2.1 
Collection and Reporting of Non-Serious Adverse Events ..................................... 60 
8.2.2 
Laboratory Test Abnormalities ................................................................................. 60 
8.3 
Overdose ............................................................................................................................ 60 
8.4 
Pregnancy .......................................................................................................................... 60 
8.5 
Potential Drug Induced Liver Injury (DILI) ................................................................. 61 
8.6 
Adverse Events of Special Interest .................................................................................. 61 

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9 
STATISTICS ........................................................................................................................ 62 
9.1 
General Procedures ..........................................................................................................62 
9.2 
Sample Size ...................................................................................................................... 62 
9.3 
Populations for Analysis ................................................................................................. 62 
9.4 
Statistical Methods .......................................................................................................... 62 
9.4.1 
Demographic and Baseline Characteristics ............................................................. 62 
9.4.2 
Primary Endpoint(s) ................................................................................................. 63 
9.4.3 
Secondary Endpoint(s) .............................................................................................. 63 
9.4.3.1 
SPID-24 ................................................................................................................ 63 
9.4.3.2 
Change from Baseline of Pain on NRS .............................................................. 63 
9.4.3.3 
Pain Freedom at 2 Hours .................................................................................... 64 
9.4.3.4 
Time to Onset of Meaningful Pain Relief .......................................................... 64 
9.4.3.5 
Time to Onset of Initial Pain Relief ................................................................... 64 
9.4.3.6 
Rescue Medication Use through 24 Hours ........................................................ 64 
9.4.4 
Adjustment for Multiplicity ..................................................................................... 64 
9.4.5 
Missing Data .............................................................................................................. 64 
9.4.6 
Rescue Medication ..................................................................................................... 65 
9.4.7 
Analysis of Safety ...................................................................................................... 65 
9.5 
Schedule of Analyses. ....................................................................................................... 66 
10 ETHICS AND RESPONSIBILITIES ................................................................................. 67 
10.1 
Good Clinical Practice .....................................................................................................67 
10.2 
Institutional Review Board/Independent Ethics Committee ....................................... 68 
10.3 
Informed Consent ............................................................................................................ 68 
10.4 
Case Report Forms .......................................................................................................... 69 
11 RECORDS MANAGEMENT ............................................................................................. 70 
11.1 
Source Documentation .....................................................................................................70 
11.2 
Study Files and Record Retention. ................................................................................ 71 
12 AMENDMENTS .................................................................................................................. 72 
13 STUDY REPORT AND PUBLICATIONS ........................................................................ 73 
14 STUDY DISCONTINUATION ........................................................................................... 74 
15 CONFIDENTIALITY .......................................................................................................... 75 
16 CLINICAL PROTOCOL APPROVAL FORM ................................................................ 76 
17 APPENDICES ...................................................................................................................... 77 
17.1 
APPENDIX I – Strong Inhibitors and inducers of CYP3A4 protein (Not all- 
inclusive) ........................................................................................................................... 77 
18 REFERENCES ..................................................................................................................... 78 
LIST OF TABLES 
Table 1 
BHV3000-317 Schedule of Assessments ............................................................. 30 

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AE 
Adverse Event 
LIST OF ABBREVIATIONS 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase 
BP 
Blood Pressure 
BUN 
Blood Urea Nitrogen 
CGRP 
 Calcitonin Gene Related Peptide 
CRF 
Case Report Form 
C-SSRS 
Columbia Suicidality Severity Rating Scale 
ECG 
 Electrocardiogram 
EOD 
Every other day 
ePRO 
Electronic Patient Reported Outcome 
GCP 
 Good Clinical Practice 
HRT 
Hormone Replacement Therapy 
ICF 
Informed Consent Form 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
CCI  
mg 
Milligram 
mm 
Millimeter 
min 
Minute 
NRS 
Numerical Rating Scale 
ODT 
Oral disintegrating tablet 
PK 
Pharmacokinetic 
PRN 
As needed pro re nata 
SAE 
TMD 
TMJ 
Serious Adverse Event 
Temporomandibular Disorder 
Temporomandibular Joint 
ULN 
Upper Limit of Normal 

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1 INTRODUCTION AND RATIONALE 
1.1 
Background 
Temporomandibular disorders are a large group of conditions associated with the 
temporomandibular joint, masticatory muscles, and surrounding musculoskeletal tissues. 
Most common symptoms are pain in the jaw and/or temple area, masticatory muscle soreness, 
functional limitations of the jaw and “clicking” sounds in the temporomandibular joint (TMJ).4,5 
Other associated symptoms may include ear pain, headache, neck pain, and teeth grinding 
(bruxism).2,6 Symptoms can range from mild and intermittent to severe and continuous causing 
significant disability, and a reduction in quality of life and work productivity.4,6 In the 
epidemiological studies, the prevalence ranged between 4.6 - 25% of the US population.1,6 
The etiology of TMD is multifactorial, encompassing biologic, environmental, social, 
behavioral, and multiple co-morbid factors in the development. In addition, multiple medical 
conditions co-occur with TMD, such as headaches, fibromyalgia, back pain, and irritable bowel 
syndrome.7 
Diagnosis is primarily based on patient history and physical exam, while imaging modalities are 
typically reserved for those with severe and persistent symptoms. 
Noninvasive therapies, such as self-care and pharmacological agents, should be attempted first 
and those typically include NSAIDs and acetaminophen as first line agents.5 In addition, muscle 
relaxants and benzodiazepines may be useful for muscle spasm and chronic bruxism while 
antidepressants are used for management of chronic pain. However, none of these agents have 
consistent efficacy demonstrated in clinical trials.1 
BHV-3000 (rimegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist in 
development for the acute treatment of TMD. The CGRP receptor is located within pain- 
signaling pathways, intracranial arteries, and the trigeminal ganglion. Its activation is thought to 
play a causal role in TMD pathophysiology. 
Treatment with a CGRP receptor antagonist is believed to exert multiple downstream effects that 
may provide benefits in treatment of TMD through the following possible mechanisms: 
 
Blocking Neurogenic Inflammation: Binding of CGRP receptor antagonists to CGRP 
receptors located on satellite glial cells would inhibit inflammation caused by trigeminal 
nerve release of CGRP onto satellite glial cells and cell bodies of a-delta fibers in the 
trigeminal ganglion. 
 
Decreasing Artery Dilation: By blocking the CGRP receptors located in smooth muscle 
cells within vessel walls, CGRP receptor antagonists would inhibit the pathologic dilation of 
arteries without the unwanted effect of active vasoconstriction. 

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 Inhibiting Pain Transmission: Binding of CGRP receptor antagonists to CGRP receptors 
would suppress the transmission of pain by inhibiting the central relay of pain signals from 
the trigeminal nerve to the caudal trigeminal nucleus. 
1.2 
Product Development Background 
Details of the clinical and preclinical studies are provided in the most current Investigator 
Brochure. A summary of data relevant to the study are presented below. 
1.2.1 
Clinical Adverse Event Profile 
Nurtec® ODT (rimegepant) is approved in the United States for the treatment of acute migraine 
and the preventive treatment of episodic migraine in adults. Nurtec® ODT (rimegepant) is 
generally safe and well tolerated in humans when given as single oral dose of 75 mg for the acute 
treatment of migraine as well as when given every other day for the preventive treatment of 
migraine. The BHV3000-201 study is a Phase 2/3, 52-week, open-label, safety study with 
rimegepant 75 mg, in which 1800 subjects received rimegepant up to once daily for up to one 
year. In the BHV3000-305 preventive treatment of migraine study, long-term safety was 
assessed in an open-label extension that included 603 patients who received rimegepant 75 mg at 
least every other day for up to one year. Please refer to the Investigators Brochure for a summary 
of the clinical safety profile. 
 
The primary identified AE of interest is potential change in liver function tests. Investigators 
must carefully monitor routine liver function tests (ALT, AST, total bilirubin, and ALP) and 
potentially liver related symptoms and signs. Clinicians should also monitor changes in 
hematology and other laboratory measures. Please refer to the current Investigators Brochure for 
further information regarding the clinical safety profile of rimegepant. 
1.3 
Study Rationale 
Temporomandibular Disorders (TMD) is a large group of 30+ conditions involving the 
temporomandibular joint and surrounding muscles and tissues. It typically manifests as 
intermittent or continuous pain in the jaw area, functional limitations of the jaw, and clicking 
sounds in the TMJ during motion.1 

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The joint and surrounding tissues receive sensory and nociceptive innervation from distal 
branches of mandibular nerve, the largest of the three divisions of the trigeminal nerve. Although 
the underlying mechanisms of TMD have not been fully elucidated, numerous studies have 
implicated trigeminal nerve and CGRP in the pathophysiology of the disease and suggested 
therapeutic benefits of CGRP antagonism. For example, a preclinical study showed that injection 
of CGRP into the TMJ capsule in rodents upregulated expression of proteins implicated in the 
development and maintenance of peripheral and central sensitization and nociception.8 
Furthermore, in the acute TMD model in mice, pretreatment with CGRP antagonist led to 
significant reduction in spontaneous orofacial pain behaviors.9 Moreover, induction of myogenic- 
TMD in mice triggered migraine-like hypersensitivity that could be attenuated by pretreatment 
with a CGRP antagonist and sumatriptan.10 Clinical studies have also shown that synovial CGRP 
levels are elevated in TMD patients and correlate with pain, impairment of mandibular mobility, 
and occlusal alterations.11,12 
BHV-3000 (rimegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist in 
development for the acute treatment of TMD. The CGRP receptor is located within pain- 
signaling pathways, intracranial arteries and the trigeminal ganglion, and its activation is thought 
to play a causal role in TMD pathophysiology. 
Currently, there are no TMD-specific therapies or clear guidelines on the treatment and most 
often TMD is treated with self-care techniques and NSAIDs. However, most patients have an 
inadequate relief of pain and recurrence of symptoms, prompting the need for novel 
pharmacologic interventions.1,2 
This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant for 
the acute treatment of TMD. It will also further define the safety profile of rimegepant 
administration in this patient population, separately from the approved indication of acute and 
preventive treatment of migraine. 
1.3.1 
Study Design Rationale 
This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy 
of rimegepant as compared to placebo in the acute treatment of TMD-associated pain. The study 
drug will be rimegepant formulated in a 75 mg ODT (administered sublingually) or a matching 
placebo. The subjects will be instructed to take their study medication, as an outpatient, when (if) 
they have a TMD-associated pain which reaches pain intensity of  6 on the NRS (0-10). 
The study will randomize approximately 200 subjects. The subjects will be randomized in a 1:1 
ratio to the rimegepant or placebo treatment groups. The randomization will be stratified by the 
use of daily medications / oral devices to reduce the intensity of TMD symptoms (yes or no). 
This study design is being utilized to assess the safety and efficacy in the acute treatment of 
Temporomandibular Disorders. 

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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. This observation and the flat dose-response with 
rimegepant and other CGRP receptor antagonists suggest that rimegepant 75 mg may be an 
effective dose for the acute treatment of Temporomandibular Disorders. The pharmacokinetic 
profile of rimegepant supports the dosing schedule of this protocol with up to daily dosing. 
Please refer to the current version of Investigators Brochure for a summary of the clinical safety 
profile. 
1.3.3 
Research Hypothesis 
Rimegepant will have efficacy superior to placebo in the acute treatment of Temporomandibular 
Disorders with a favorable safety profile. 
1.3.4 
Benefit/Risk 
1.3.4.1 
Benefit/Risk Assessment 
As of the approval in February 2020 of Nurtec® ODT, more than 6,000 subjects have 
participated in Phase 1 studies in healthy subjects or Phase 2 and 3 studies in subjects with 
migraine. Among these subjects, more than 3,569 unique subjects have received the rimegepant 
clinical dose of 75 mg in Phase 2b/3 studies. Additionally, at the time of the Nurtec® ODT sNDA 
submission for the treatment of prevention in migraine, the pivotal prevention study had a total 
of 526 subjects received rimegepant (EOD or EOD plus as needed [EOD + PRN] up to once 
daily) for at least 6 months, and 138 subjects received rimegepant for at least 1 year. 
Collectively, the current data demonstrate a favorable benefit-risk profile for rimegepant in 
adults for the acute and preventative treatment of migraine and suggests a favorable benefit/risk 
assessment for the acute treatment of Temporomandibular Disorders. 

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2 STUDY OBJECTIVES 
2.1 
Primary Objective(s) 
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of 
Temporomandibular Disorders on the time-weighted sum of pain intensity difference from 
baseline scores for the first 2 hours post-dose (SPID-2). 
2.2 
Secondary Objective(s) 
1. To evaluate rimegepant compared with placebo on the time-weighted sum of pain intensity 
difference (SPID) from baseline scores for the first 24 hours post-dose (SPID-24). 
2. To evaluate rimegepant compared to placebo on change from baseline of pain on NRS (0-10) 
score at 2 hours post-dose. 
3. To evaluate rimegepant compared to placebo on the proportion of subjects that are pain free 
at 2 hours post-dose. 
4. To evaluate rimegepant compared to placebo on time to onset of meaningful pain relief post- 
dose. 
5. To evaluate rimegepant compared to placebo on time to onset of initial pain relief post-dose. 
6. To evaluate rimegepant compared to placebo on the probability of requiring rescue 
medication within 24 hours of initial treatment. 
 
 
 
 
 
 
 

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3 STUDY ENDPOINTS 
3.1 
Primary Endpoint(s) 
 
Difference in SPID-2 scores between treatment groups will be assessed across the first 2 hours 
post-dose using the number of randomized and treated subjects. 
 
3.2 
Secondary Endpoint(s) 
1. Difference in SPID-24 scores between treatment groups will be assessed across the first 24 
hours post-dose using the number of randomized and treated subjects on NRS (0-10). 
2. Change from baseline will be assessed at 2 hours post-dose using the number of randomized 
and treated subjects. 
3. Pain freedom will be assessed using the number of evaluable subjects that report no pain at 
2 hours post-dose. Pain will be measured on NRS (0-10). 
4. Onset of meaningful pain relief will be assessed by the first nominal timepoint at which the 
pain on NRS (0-10) decreases by 30% from baseline. 
5. Onset of initial pain relief will be assessed by the first nominal timepoint at which the pain 
on NRS (0-10) decreases by 1 point from baseline. 
6. The probability of requiring rescue medication will be assessed using the number of 
subjects that take rescue medication within 24 hours after administration of study medication 
(rimegepant or placebo). 
3.3 
Measures of interest 
 
Safety and Other assessments: 
 
 
Adverse Events 
 
ECG assessments 
 
Vital Sign and Physical Measurements 
 
Routine Laboratory Tests 
 
Columbia Suicidality Rating Scale 
 
Assessment of TMD-associated Pain and Symptoms 
 
CCI 
 

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4 STUDY PLAN 
4.1 
Study Design and Duration 
This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy 
of rimegepant as compared to placebo in the acute treatment of Temporomandibular Disorders. 
Subjects will be dispensed one dose of study medication consisting of a rimegepant 75 mg ODT 
(administered sublingually) or a matching placebo. The total duration of the study will be up to 
approximately 66 days. This includes a 3 to 14 day (+2 days for scheduling purposes, if needed) 
Screening Period, an Acute Treatment Phase that can last up to 45 days or until the subject has a 
TMD-associated pain that reaches intensity of  6 on the NRS (0-10), followed by an End of 
Treatment Visit 7 days after the administration of the study medication. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 1 
BHV3000-317 Schedule of Assessments 
 
Procedure 
Screening 
Visit 
(3-14 days) 
Baseline 
Visit 
(Randomizat 
ion) 
TMD- 
associated 
pain  6 on 
NRS (0-10) 
During 
Treatment 
15, 30, 45, 60 
and 90 mins 
Post-Dose 
During 
Treatment 
2, 4, 8 
hours Post- 
Dose 
During 
Treatment 24 
hours Post- 
Dose 
End of 
Treatment 
Visit (within 7 
(+2) days of 
treating TMD- 
associated pain) 
Comments 
Eligibility Assessments 
Informed Consent 
X 
Inclusion/Exclusion 
Criteria 
X 
X 
Medical History 
X 
Collect Daily Use of 
Medications / Oral 
Devices to Reduce 
Intensity of TMD 
Symptoms / 
Concomitant 
Medications 
X 
X 
X 
Subjects will be given a paper 
diary to track of concomitant 
medications, including rescue 
medications, and use of oral 
devices. All medications taken 
for any reason should be 
documented. Site staff should 
instruct subjects on proper use 
of the paper diary(ies) and 
instruct subjects that the 
diary(ies) will be collected, 
reviewed, and discussed with 
the subject at each visit. 
Assessment of 
TMD History 
(Signs and 
Symptoms) 
X 
Paper source document will 
be used to capture TMD 
History and entered in eCRF 

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Procedure 
Screening 
Visit 
(3-14 days) 
Baseline 
Visit 
(Randomizat 
ion) 
TMD- 
associated 
pain  6 on 
NRS (0-10) 
During 
Treatment 
15, 30, 45, 60 
and 90 mins 
Post-Dose 
During 
Treatment 
2, 4, 8 
hours Post- 
Dose 
During 
Treatment 24 
hours Post- 
Dose 
End of 
Treatment 
Visit (within 7 
(+2) days of 
treating TMD- 
associated pain) 
Comments 
Safety Assessments 
Physical 
Examination 
X 
X 
Vital Signs/Physical 
Measurements 
X 
X 
X 
Vital Signs consist of sitting 
arterial systolic and diastolic 
blood pressure, heart rate, oral 
body temperature, body weight 
and height. Height and weight 
will only be measured at 
Screening. 
Clinical Safety 
Laboratory Testing 
X 
X 
All Screening visit laboratory 
test results must be received 
prior to Baseline Visit 
(randomization) 
Urine drug screen 
for drugs of abuse 
X 
X 
HbA1c, Lipid 
Panel, FSH 
X 
ECG 
X 
X 
Pregnancy Test 
X 
X 
X 
X 
A serum pregnancy test will be 
completed at Screening and 
End of Treatment Visits as part 
of the standard laboratory tests 
(if appropriate). Confirmatory 
urine pregnancy test for 
WOCBP should be completed 
on site at the Baseline Visit 
and any subsequent visits for 
confirmation at the 
Investigator’s discretion. 
Home pregnancy test will be 

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Procedure 
Screening 
Visit 
(3-14 days) 
Baseline 
Visit 
(Randomizat 
ion) 
TMD- 
associated 
pain  6 on 
NRS (0-10) 
During 
Treatment 
15, 30, 45, 60 
and 90 mins 
Post-Dose 
During 
Treatment 
2, 4, 8 
hours Post- 
Dose 
During 
Treatment 24 
hours Post- 
Dose 
End of 
Treatment 
Visit (within 7 
(+2) days of 
treating TMD- 
associated pain) 
Comments 
provided to WOCBP after 
completion of baseline visit. 
Subjects will be provided with 
the accompanying package 
insert that contains instructions 
for use and interpretation of 
results. WOCBP subjects must 
complete the urine pregnancy 
test at home. WOCBP must 
have a negative serum or urine 
pregnancy test at the Screening 
Visit, Baseline Visit, and prior 
to taking study medication. 
Adverse Event and 
Serious Adverse 
Event Assessment 
X 
X 
X 
X 
X 
X 
X 
SAEs are reported from the 
time of informed consent and 
non-serious AEs are reported 
from baseline. See Section 8 
of the protocol for further 
information. 
Columbia 
Suicidality Rating 
Scale 
X 
X 
X 
This scale will be clinician 
administered, completed on 
site, and will be in paper. The 
source document will be 
provided by Biohaven. 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. 

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Procedure 
Screening 
Visit 
(3-14 days) 
Baseline 
Visit 
(Randomizat 
ion) 
TMD- 
associated 
pain  6 on 
NRS (0-10) 
During 
Treatment 
15, 30, 45, 60 
and 90 mins 
Post-Dose 
During 
Treatment 
2, 4, 8 
hours Post- 
Dose 
During 
Treatment 24 
hours Post- 
Dose 
End of 
Treatment 
Visit (within 7 
(+2) days of 
treating TMD- 
associated pain) 
Comments 
Clinical Drug Supplies/Study Supplies 
Randomize 
X 
Subjects will be randomized in 
the IWRS system at the 
Baseline Visit 
(Randomization) 
Dispense Study 
Medication 
X 
Administer 1 dose 
of study medication 
X 
Instruct subjects: STUDY 
DRUG only to be taken to treat 
a TMD-associated pain  6 
on NRS (0-10) AND after the 
subject has completed all 
required assessments in the 
eDiary. The eDiary will 
prompt the subject to take 
study medication. 
Return used study 
medication 
packaging or 
unused study 
medication 
X 
eDiary returned/ 
reviewed for 
completeness 
X 
Staff to review eDiary entries 
with subjects, confirm all data 
points are transferred to the 
system, and reset eDiary for 
future subject use, PRIOR to 
the subject leaving the clinic 

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X 
X 
 
 
Procedure 
Screening 
Visit 
(3-14 days) 
Baseline 
Visit 
(Randomizat 
ion) 
TMD- 
associated 
pain  6 on 
NRS (0-10) 
During 
Treatment 
15, 30, 45, 60 
and 90 mins 
Post-Dose 
During 
Treatment 
2, 4, 8 
hours Post- 
Dose 
During 
Treatment 24 
hours Post- 
Dose 
End of 
Treatment 
Visit (within 7 
(+2) days of 
treating TMD- 
associated pain) 
Comments 
Efficacy Assessments 
(±windows for timeframe around efficacy assessments (15, 30, 45, 60, 90 min, 2, 4, 8, and 24 hours) will be automated and captured in the eDiary.) 
Assessment of 
TMD-associated 
pain 
X 
X 
X 
X 
This scale is captured in the 
eDiary, 
CCI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.1.1 
Screening Phase (3-14 days) 
All subjects who are screened will be entered into the IWRS system and assigned a patient 
identifier. After obtaining informed consent, subjects will undergo all screening procedures 
as detailed in Table 1. After all screening procedures are complete, subjects may return 3 to 
14 days (+2 days if needed for scheduling purposes) from signing informed consent to be 
randomized at the Baseline visit if they meet all eligibility criteria. 
Subjects in this study may be screened only once. Rescreening is not permitted. 
4.1.2 
Acute Treatment (Randomization) Phase 
If the subject meets all eligibility criteria, they will be randomized at the Baseline Visit via 
the IWRS. The subjects will be provided with an eDiary. Study personnel will educate the 
subject on the proper use of the eDiary, accurate reporting, and placebo response prior to the 
subject leaving the office. 
After randomization via the IWRS, the subject will be dispensed a single dose of the double- 
blind study medication to take home for up to 45 days. This study medication is to be taken 
when an TMD-associated pain in the jaw and/or temple area on either side which reaches 
pain intensity of  6 on the NRS (0-10) in the eDiary. The subject will be instructed to take 
their study medication, as an outpatient, when (if) they have an TMD-associated pain in the 
jaw and/or temple area on either side which reaches pain intensity of  6 on the NRS (0-10) 
after they answer eDiary questions about their current pain and symptoms. The subject will 
complete an eDiary for 24 hours after taking study medication to record efficacy and other 
quality of life measures. 
Subjects in this study may be randomized only once. Under no circumstances may a subject 
be re-randomized. 
4.1.2.1 
eDiary Data Collection 
Subjects will record efficacy and other quality of life measures in their eDiary. This includes 
the following: onset time of TMD-associated pain, intensity of the TMD-associated pain prior 
to and at time of taking study medication. The subjects should not dose with study medication 
until the TMD-associated pain in the jaw and/or temple area on either side which reaches 
pain intensity of  6 on the NRS (0-10). TMD-associated pain severity will be recorded using 
a NRS (0-10) at the onset of the pain and after dosing at time points of 15, 30, 45, 60, and 90 
minutes and 2, 4, 8, and 24 hours. Subjects will record the date and time study therapy was 
 
 
 
 
After dosing with study medication, all other medication to relieve TMD-associated 
symptoms is prohibited during the 2 hours post dose. At the end of 2 hours after dosing with 
study medication (and after the 2-hour assessments have been completed on the eDiary) 
subjects will be permitted to use the following rescue medication: acetaminophen (up to 1000 
mg/day); or aspirin, ibuprofen, naproxen (or any other type of non- steroidal anti- 
taken in their eDiary according to the eDiary vendor’s specifications. CCI 

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inflammatory [NSAID]), or cyclobenzaprine (all up to the daily recommended dose indicated 
on the drug packaging). Subjects may administer whichever protocol permitted standard of 
care rescue medication they choose to reduce symptoms and that they have available. These 
are the only medications allowed for rescue treatment after 2 hours post dose of study 
medication. However, if needed, after 24 hours of administering the one dose of study 
medication (and before returning for the End of Treatment Visit) subject may take their 
prescribed standard of care medications for treatment of TMD-associated pain provided all 
the assessments have been completed on the eDiary. Exclusionary rescue medication such as, 
opioids, butalbital compounds, and muscle relaxants (except cyclobenzaprine used as rescue 
medication, see above) are not allowed on this study. Similarly, if the TMD-associated pain is 
relieved by study medication at 2 hours after dosing but then recurs to intensity level of  6 
on the NRS (0-10) between 2 and 24 hours, the subject will be permitted to take the same 
rescue therapy as outlined above. 
Subjects should be encouraged to treat the first qualifying TMD-associated pain (intensity 
level of  6 on the NRS (0-10)) that occurs during the treatment phase. If subjects are unable 
to treat their first qualifying TMD-associated pain due to scheduling, etc. the same 
medication restrictions would still apply (i.e., acetaminophen [up to 1000 mg/day]; or aspirin, 
ibuprofen, naproxen (or any other type of non- steroidal anti-inflammatory [NSAID]), or 
cyclobenzaprine [all up to the daily recommended dose indicated on the drug packaging]). 
Subjects may administer whichever protocol permitted standard of care medication they 
choose to reduce symptoms and that they have available. 
Similarly, for treatment of non-qualifying TMD-associated pain (i.e., pain of < 6 on the NRS 
(0-10), or other non-TMD related pain in the jaw and/or temple area on either side) that occur 
during the randomization period before a qualifying TMD-associated pain is reported, subject 
will only be permitted to use the medications listed above. Acetaminophen (over 1000 
mg/day) is prohibited after randomization except as rescue medication as described in Section 
5.5. In all circumstances, the subject will continue to complete his or her eDiary for up to 24 
hours after consuming the study medication. 
4.1.3 
Extension Phase 
Not applicable. 
4.1.4 
Washout Phase 
Not applicable. 
4.1.5 
End of Treatment 
Subjects will return to the study site within 7 days of study treatment (+2 days) for review of 
the eDiary assessment, of medication compliance, and monitoring of tolerability and safety 
(including vital signs, laboratory tests, and electrocardiography). If a subject has NOT 
experienced a TMD-associated pain of sufficient severity within 45 days after randomization, 
they still are required to complete all EOT visit procedures. All subjects must return unused 
study medication and eDiary to the study center. 

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4.2 
Post Study Access to Therapy 
At the end of the study, the Sponsor will not continue to supply study drug to 
subjects/Investigators. The Investigator should ensure that the subject receives the 
appropriate standard of care to treat the condition under study. 
5 POPULATION 
Individuals entered in this trial will be subjects who suffer from temporomandibular disorders 
as specified under Section 5.2. The treatment setting for these subjects may include clinics, 
institutions, or private office practices. Subjects may be recruited through a variety of 
sources, including referral from physicians and other health care professionals. 
5.1 
Number of Subjects 
It is anticipated that approximately 200 subjects will be randomized to result in 
approximately 160 evaluable subjects. The subjects will be randomized in a 1:1 ratio to the 
rimegepant or placebo treatment groups. It is anticipated that enrollment will occur at 
approximately 25 sites in the United States over a period of approximately 10 months during 
this trial. 
5.2 
Inclusion Criteria 
1. Signed Written Informed Consent 
a. 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 prior to the initiation of any protocol-required procedures. 
b. Subject must agree to provide all requested demographic information (i.e. gender, 
race). 
c. Subject must be able to read and understand English or Spanish. 
2. Target population 
a. Subject has a minimum 3-month to a maximum 5-year history of temporomandibular 
disorder diagnosed by a healthcare provider, including the following: 
i. 
Meets criteria consistent with a diagnosis according to the DC / TMD (Diagnostic 
Criteria for Temporomandibular Disorders)3 that include at least one of the 
following: 
(1) Arthralgia (I.1.A.) 
(2) Myalgia (II.1.A.1-3) 
b. At least one instance of pain  6 on a Numeric Rating Scale (0-10) in the jaw and/or 
temple area on either side in the past 30 days prior to the Screening Visit. 

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c. Subject with daily use of medications to reduce intensity of TMD symptoms is 
permitted to remain on therapy if they have been on a stable dose for at least 3 months 
prior to the Screening Visit, and the dose is not expected to change during the course 
of the study. 
d. Subject with daily use of oral devices to reduce intensity of TMD symptoms is 
permitted to remain on therapy if they have been using them consistent for at least 3 
months prior to the Screening Visit, and the regimen is not expected to change during 
the course of the study. 
e. Subject agrees to not commence new pain medication, injection therapy, occlusal 
splint therapy or any other pain management techniques during the course of the 
study. 
3. Age and Reproductive Status 
a. Male and Female subjects ≥ 18 years and older. 
b. Women of childbearing potential (WOCBP) with male partners and men with women 
partners of childbearing potential must be using two acceptable methods of 
contraception to avoid pregnancy throughout the study in such a manner that the risk 
of pregnancy is minimized. See Section 5.5 for the definition of WOCBP. WOCBP 
must agree to use an acceptable contraceptive method or abstinence to avoid 
pregnancy from the Screening Visit through 60 days after dosing with study drug. 
Males with vasectomy are considered surgically sterile provided the procedure 
occurred greater than 6 months prior to the Screening Visit. 
c. No clinically significant abnormality identified on the medical or laboratory 
evaluation. A subject with a clinical abnormality or laboratory parameters outside the 
reference range may be included only if the Investigator considers that the finding is 
not clinically significant and will not introduce additional risk factors and will not 
interfere with the study procedures. 
d. WOCBP must have a negative serum or urine pregnancy test at the Screening Visit, 
Baseline Visit, and prior to taking study medication. 
e. Women must not be breastfeeding. 
5.3 
Exclusion Criteria 
1. Disease Target Exclusion 
a. Subject has a history of primary headache disorder consistent with diagnostic criteria 
according to the International Classification of Headache Disorders, 3rd Edition. If 
the majority of pain associated with tension-type headache diagnosis is attributable to 
TMD by the site PI, then it is not exclusionary. 
b. Subject has a history of headache disorder attributed to trauma or injury to the head 
and/or neck consistent with diagnostic criteria according to the International 
Classification of Headache Disorders, 3rd Edition. 

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c. Meets criteria consistent with a diagnosis according to the DC / TMD (Diagnostic 
Criteria for Temporomandibular Disorders)3 that include at least one of the following: 
i. Joint Pain: 
(1) Arthritis (I.1.B) 
ii. Joint Disorders: 
(1) Disc disorders (I.2.A.1-4) only when associated with mechanically induced 
arthralgia 
(2) Other hypomobility disorders (I.2.B), such as adhesions/adherence, ankylosis 
(3) Hypermobility disorders (I.2.C.), such as subluxation, luxation 
iii. Joint Diseases: 
(1) Systemic arthritides (I.3.B) 
(2) Condylysis/idiopathic condylar resorption (I.3.C) 
(3) Osteochondritis dissecans (I.3.D) 
(4) Ostonecrosis (I.3.E) 
(5) Neoplasm (I.3.F) 
(6) Synovial chondromatosis (I.3.G) 
iv. Fractures: 
(1) Fractures (I.4) 
v. Congenital/Developmental Disorders: 
(1) Aplasia (I.5.A) 
(2) Hypoplasia (I.5.B) 
(3) Hyperplasia (I.5.C) 
vi. Muscle Pain: 
(1) Myositis (II.1.C) 
(2) Spasm (II.1.D) 
vii. Contracture (II.2) 
viii. 
Neoplasm: 

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(1) Neoplasm (II.4) 
ix. Movement Disorders: 
(1) Orofacial dyskinesia (II.5.A) 
(2) Oromandibular dystonia (II.5.B) 
x. Masticatory Muscle Pain Attributed to Systemic/Central Pain Disorders: 
(1) Fibromyalgia/widespread pain (II.6.A) 
xi. Associated Structures: 
(1) Coronoid hyperplasia (IV.1) 
d. Subject has a history of neuropathic (e.g., trigeminal neuralgia, postherpetic 
neuralgia) or idiopathic pain disorder. 
e. Subject has a history of pain of dental origin within the 3 months prior to the 
Screening Visit. 
f. Subject has a history of trauma in the craniocervical area, including joint sprain/strain, 
within the 3 months prior to the Screening Visit. 
g. Subject has a history of or is planning TMJ surgery (e.g., arthrocentesis, arthroscopy, 
TMJ implants) or ear surgery. 
h. Subject has a history of radiation treatment to head and neck. 
i. Subject has a history of connective tissue disorders. 
2. Medical History and Concurrent Diseases 
a. Body Mass Index  33kg/m2 
b. Subject history of HIV disease. 
c. Subject history with current evidence of uncontrolled, unstable, or recently diagnosed 
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, 
and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary 
Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke 
or transient ischemic attack (TIA) during the 6 months prior to the Screening Visit. 
d. Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes (however 
subjects can be included who have stable hypertension and/or diabetes for at least 3 
months prior to the Screening Visit). 
e. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric 
conditions (e.g., schizophrenia), dementia, or significant neurological disorders that, 
in the Investigator’s opinion, might interfere with study assessments. 

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f. Subject has a history of gastric or small intestinal surgery (including Gastric Bypass, 
Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes 
malabsorption. 
g. The subject has a history or current evidence of any significant and/or unstable 
medical conditions (e.g., history of congenital heart disease or arrhythmia, known 
suspected infection, hepatitis B or C, or cancer) that, in the Investigator’s opinion, 
would expose them to undue risk of a significant adverse event (AE) or interfere with 
assessments of safety or efficacy during the course of the trial. Severe hepatic 
impairment (Child-Pugh C) is exclusionary in all cases. 
h. Subjects with a history of, treatment for, or evidence of, alcohol or drug abuse or who 
have met DSM-V criteria13 for any significant substance use disorder within the past 
12 months from the date of the Screening Visit. 
i. Subjects should be excluded if they have a 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: 
Detectable levels of cocaine, amphetamine, and phencyclidine (PCP) in the drug 
screen are exclusionary. Subjects who are positive for amphetamines, and who are 
on a prescribed amphetamine medication for an approved indication (e.g., ADHD) 
will be allowed into the study at the Investigator’s discretion. This determination 
by the Investigator must be well documented in the subject’s source medical 
records. The stimulant dose must be stable from 3 months prior to the Screening 
Visit until the end of treatment visit occurs. 
Detectable levels of cannabinoids (e.g., marijuana, CBD) in the drug screen at the 
Screening Visit are not exclusionary, if in the Investigator’s documented opinion 
the subject does not meet DSM-V criteria13 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. 
j. Hematologic or solid malignancy diagnosis within 5 years prior to the Screening 
Visit. 
3. Allergies and Adverse Drug Reactions 
a. History of drug or other allergy which, in the opinion of the Principal Investigator, 
makes the subject unsuitable for participation in the study. 
4. ECG and Laboratory Test Findings 
a. Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated 
(four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 40 
ml/min/1.73m2. 
b. Corrected QT interval > 470 msec (QTc by method of Frederica), at Screening. 
c. Left Bundle Branch block. 

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d. Right Bundle Branch Block with a QRS duration ≥ 150 msec. 
e. Intraventricular Conduction Defect with a QRS duration ≥ 150 msec. 
f. Serum bilirubin (Total, Direct or Indirect) > 1 x ULN (Only abnormal values of 
between 1-1.5x ULN may be repeated once for confirmation during the screening 
period). 
g. Neutrophil count ≤ 1000/μL (or equivalent). 
h. HbA1c ≥ 6.5%. 
i. AST (SGOT) or ALT (SGPT) > 1 x ULN (Only abnormal values of between 1-1.5x 
ULN may be repeated once for confirmation during the screening period). 
5. Excluded Current or Recent Treatments 
a. Subject has a history of new or recently modified use of night guards, splints, dental 
orthotics, or dental appliances within the 3 months prior to the Screening Visit. 
b. Subject has a history of dental orthodontic use within the 3 months prior to the 
Screening Visit. 
c. Subject has a history of dental restorative care (e.g., crowns, bridges) within the 3 
months prior to the Screening Visit. 
d. Subject has a history of new or recently modified physical therapy treatment in the 
head and/or neck area within the 3 months prior to the Screening Visit. 
e. Subject has a history of new or recently modified botulinum therapy (e.g., 
onabotulinum toxin A, abobotulinum toxin A, and incobotulinum toxin A) within the 
3 months prior to the Screening Visit. 
f. Subject has a history of injection therapy other than botulinum therapy (e.g., 
lidocaine, corticosteroids, hyaluronic acid) within the 30 days prior to the Screening 
Visit. 
g. Subject has a history of Transcutaneous Electrical Nerve Stimulation (TENS) use 
within the 3 months prior to the Screening Visit. 
6. Other Exclusion Criteria 
a. Prisoners or subjects who are involuntary incarcerated. 
b. Subjects who are compulsorily detained for treatment of either a psychiatric or 
physical (e.g., infectious disease) illness. 
c. Participation in clinical trial with non-biological investigational agents or 
investigational interventional treatments within the 30 days prior to Screening Visit. 

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d. Subjects who have previously participated in any BHV-3000/ BMS-927711/ 
rimegepant study. 
e. Participation in clinical trial with biological investigational agents within the 3 
months prior to Screening Visit. 
f. Subjects who meet criteria for C-SSRS Suicidal Ideation Items 4 or 5 within the last 
12 months prior to the Screening Visit, OR subjects who endorse any of the five C- 
SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, 
preparatory acts, or behavior) within the last 10 years prior to the Screening Visit, OR 
subjects who, in the opinion of the Investigator, present a serious risk of suicide (See 
Section 6.3.5). 
g. Planned participation in any other investigational clinical trial while participating in 
this clinical trial. 
h. Subjects engaged in, or with plans to engage in, litigation or Worker’s Compensation 
in which monetary gain or loss (or other compensation) may affect their objective 
participation in the trial. 
See Section 5.4 for prohibited medications and Section 5.5 for allowable medications to 
consider when evaluating subject eligibility. 
Subjects must be willing to comply with all concomitant medication requirements and study 
procedures. 
5.4 
Prohibited and Restricted Concomitant Medications 
The below medications are prohibited prior to randomization and during the course of this 
study or as specified. 
1. History of non-narcotic analgesic intake on greater than/equal to 15 days per month for 
greater than/equal to 3 months (e.g., acetaminophen, NSAIDs, gabapentin etc.) for other 
pain indications. (Please refer to Section 5.5 for rescue medication). 
2. Use of all acetaminophen or acetaminophen containing products must be discontinued at 
least 2 days prior to randomization (acetaminophen < 1000 mg/day is allowed as rescue 
medication, see Section 5.5). During the screening phase (3-14 days) use of 
acetaminophen or acetaminophen containing products at daily dosing levels of greater 
than 1000 mg/day is prohibited. 
3. Muscle relaxants should not be taken 14 days prior to randomization and throughout the 
study (cyclobenzaprine is allowed as rescue medication, see Section 5.5). 
4. Systemic corticosteroids should not be taken 30 days prior to randomization and 
throughout the study. 
5. Benzodiazepines should not be taken 14 days prior to randomization and throughout the 
study. 

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6. St. John’s Wort should not be taken 14 days prior to randomization and throughout the 
study. 
7. Barbiturate-containing products (e.g., Fioricet, Fiorinal, butalbital, phenobarbital) should 
not be taken 14 days prior to randomization and throughout the study. 
8. Modafinil (PROVIGIL®) should not be taken 14 days prior to randomization and 
throughout the study. 
9. The use of CGRP antagonists (biologic or small molecule) is prohibited during the study. 
CGRP antagonist biologics must be discontinued 3 months prior to screening. CGRP 
small molecule antagonists must be discontinued 2 weeks prior to screening and 
throughout the course of the study. 
10. Use of narcotic medication, such as opioids (e.g., morphine, codeine, oxycodone and 
hydrocodone) is prohibited for at least 30 days prior to the Screening Visit and throughout 
the study. 
11. Use of cannabinoids (e.g., marijuana, CBD) is prohibited during the study. 
12. Concomitant use of strong CYP3A4 inhibitors, such as HIV Protease Inhibitors, Hepatitis 
C protease inhibitors, certain azole antifungals, or clarithromycin, is prohibited during the 
study. Strong CYP3A4 inhibitors must be discontinued 14 days prior to screening and 
throughout the course of the study. Please see Section 17.1, Appendix I, for additional 
resources. 
13. Concomitant use of moderate to strong CYP3A4 inducers, such as carbamazepine, 
phenytoin, or rifampin, is prohibited during the study. Moderate or strong CYP3A4 
inducers must be discontinued 14 days prior to screening and throughout the course of the 
study. Please see Section 17.1, Appendix I, for additional resources. 
14. Atypical antipsychotics such as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel 
(quetiapine), Geodon (ziprasidone), or Risperdal (risperidone) or Depakote/Depakene 
(valproic acid/valproate) should not be taken 3 months prior to randomization and 
throughout the study. 
15. LAMICTAL (lamotrigine) should not be taken 3 months prior to randomization and 
throughout the study. 
16. Subjects with daily use of medications to reduce intensity of TMD symptoms are 
permitted to remain on therapy provided they have been on a stable dose for at least 3 
months prior to study entry (see Section 5.5. Daily and Rescue Medications and Oral 
Devices) 
Low dose aspirin (e.g., 81 mg or less) for documented cardiovascular prophylaxis is allowed. 
5.5 
Daily and Rescue Medications and Oral Devices 
Subjects may not use more than 1 of the following medications and not more than 1 of the 
oral devices if not otherwise prohibited by the protocol. Medication doses must be stable 

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within 3 months prior to the Screening Visit and throughout the study. Use of oral devices 
must be consistent (i.e., non-active) within 3 months prior to the Screening Visit and 
throughout the study. 
Daily medications and therapy that are permitted during the study include: 
 
Tricyclic antidepressants (such as: amitriptyline, nortriptyline) 
 
Venlafaxine, desvenlafaxine, duloxetine, milnacipran 
 
Gabapentin, pregabalin 
 
Feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day) 
 
Botulinum therapy (e.g., onabotulinum toxin A, abobotulinum toxin A, and 
incobotulinum toxin A) 
Oral devices that are permitted during the study include: 
 
Night guards, splints, dental orthotics, dental appliances 
 
Dental orthodontics 
The use of CGRP antagonists (biologic [e.g., Aimovig®, Ajovi®, Emgality®, Vyepti®] or 
small molecule) other than rimegepant is prohibited during the study. 
After dosing with study medication, all other pain medication is prohibited during the 2 hours 
post dose. However, a subject who does not experience relief of their pain at the end of 2 
hours after dosing with study medication (and after the 2-hour assessments have been 
completed on the eDiary), will be permitted to use the following rescue medication: 
acetaminophen (up to 1000 mg/day); or aspirin, ibuprofen, naproxen (or any other type of 
non- steroidal anti-inflammatory [NSAID]), or cyclobenzaprine (all up to the daily 
recommended dose indicated on the drug packaging). Subjects may administer whichever 
protocol permitted standard of care rescue medication they choose to reduce symptoms and 
that they have available. These are the only medications allowed for rescue treatment after 2 
hours post dose of study medication. 
However, if needed, after 24 hours of administering the one dose of study medication (and 
before coming in for the End of Treatment Visit) subject may take their prescribed standard 
of care medications for treatment of TMD provided all the assessments have been completed 
on the eDiary. Exclusionary rescue medication such as opioids, butalbital compounds, and 
muscle relaxants (except cyclobenzaprine as a rescue medication, see above) are not allowed 
on this study. Similarly, if the pain is relieved by study medication at 2 hours after dosing but 
then recurs to intensity level of  6 on NRS (0-10) between 2 and 24 hours, the subject will 
be permitted to take the same rescue therapy as outlined above. In all circumstances, the 
subject will always continue to complete his or her eDiary entries through the 24-hour 
assessment after consuming the study medication. Use of concomitant medication after 
randomization, including rescue medication, will be recorded by the subject on a paper diary 
and reported to the site. The site will record medications that were taken within 14 days of 
dosing with study medication (or until the End of Treatment Visit). 

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During the [up to] 66 days the subject is participating in the study, if the subject has a non- 
qualifying TMD-associated pain (i.e., pain < 6 on a NRS (0-10) in the jaw and/or temple area 
on either side), the subject is permitted to use only the following medications: acetaminophen 
(up to 1000 mg/day); or aspirin, ibuprofen, naproxen (or any other type of non- steroidal anti- 
inflammatory [NSAID]), or cyclobenzaprine (all up to the daily recommended dose indicated 
on the drug packaging). Subjects may administer whichever protocol permitted standard of 
care medication they choose to reduce symptoms and that they have available. 
After completing all assessments (through 24 hours and before End of Treatment Visit) in 
their eDiary, if subjects experience pain they are allowed to take their prescribed standard of 
care medication. 
5.6 
Women of Childbearing Potential 
Women of childbearing potential (WOCBP) includes any female who has experienced 
menarche and who has not undergone successful surgical sterilization (hysterectomy, 
bilateral salpingectomy, or bilateral oophorectomy) or is not postmenopausal. Tubal ligation 
is considered one form of contraception; therefore, one additional form of contraception must 
be used to fulfill contraception requirements for the study. Essure, tubal occlusion and 
endometrial ablation are not acceptable methods of contraception. Menopause is defined as: 
Amenorrhea greater than or equal to 12 consecutive months without another cause 
and a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL. 
NOTE: FSH level testing is not required for women greater than or equal to 62 years 
old with amenorrhea of greater than or equal to 1 year. 
OR 
Woman on hormone replacement therapy (HRT) who no longer menstruate. 
Women of childbearing potential (WOCBP) and all men must understand the following 
requirements and use an acceptable method of contraception to avoid pregnancy throughout 
the study and for up to 60 days for WOCBP and 90 days for male subjects after the last dose 
of investigational product in such a manner that risk of pregnancy is minimized. 
It is required that all WOCBP use 2 methods of contraception to prevent pregnancy, for the 
duration of the study (i.e., this study begins with signed consent form through 60 days after 
dosing with study drug). The 2 methods should include 1 barrier method (ex. condom with 
spermicidal gel, non-hormonal intrauterine devices, cervical cap etc.) and 1 other method. 
The other method could include another barrier method or hormonal contraceptives (e.g., oral 
contraceptives, injectable contraceptives, patch, or contraceptive implant [e.g., hormonal 
intrauterine device]) used since at least 4 weeks prior to sexual intercourse. 
WOCBP and all male subjects must be counseled on the requirements to avoid pregnancy 
throughout the study and for 60 days for WOCBP and 90 days for male subjects after the last 
dose of study drug, as well as acceptable methods of contraception to use during the study. 
Subjects who report abstinence, or who report exclusively being in same-sex relationships are 
still required to understand the contraception requirements in this study to prevent pregnancy. 

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If subjects who report abstinence or who report exclusively being in a same-sex relationship 
engage in heterosexual activity, then the contraception requirements must be followed. 
Males with vasectomy are considered surgically sterile provided the procedure occurred 
greater than 6 months (24) weeks prior to the screening visit. Vasectomy is considered one 
form of contraception; therefore, one additional form of contraception must be used to fulfill 
the contraception requirements for the study. Male subjects must not donate sperm until 90 
days following the last study drug administration. 
 
All WOCBP must complete the pregnancy test schedule in Table 1. 
 
5.7 
Other Restrictions and Precautions 
Not applicable. 
5.8 
Protocol Deviations 
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 throughout the clinical monitoring of the trial. Deviations will be 
reported to the IRB/EC at the frequency required by the IRB/EC. Prospective approval of 
protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or 
exemptions, is not permitted. See Section 10.1 for further information on serious breaches of 
the protocol. 

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6 STUDY CONDUCT AND DESCRIPTION OF STUDY 
PROCEDURES 
6.1 
Study Materials 
The following study materials may be provided at the study start: 
 
Investigator File/Regulatory Binder 
 
Pharmacy Binder 
 
Drug Accountability Logs 
 
Sample source documents, where applicable 
 
Concomitant and Rescue Medication Logs (take home for subject) 
 
Investigator Brochure 
 
Interactive Web-based Response System (IWRS) 
 
Electronic Case Report Form (eCRF) instructions 
 
Electronic Diary (eDiary): 1 will be given to each randomized subject 
 
Instructions for the ePRO device and access to the portal 
 
Laboratory Kits and Laboratory Manual 
 
Pregnancy Test 
 
ECG Machine and Instructions 
 
Serious Adverse Event (SAE) forms 
 
Pregnancy Surveillance Forms 
 
Symptom Questionnaire – DC/TMD 
 
Clinical Exam Form (NA) – DC/TMD 
 
 
CCI 
 
All sites will use an Electronic Data Capture (EDC) tool to submit study data to the Sponsor’s 
CRO. Electronic Case Report Forms (eCRFs) will be prepared for all data collection fields. 
SAE data (including responses to queries) will be submitted to the CRO using a paper SAE 
report form. Electronic Patient Reported Outcomes (ePRO) will be used for all patient-rated 
scales and will be captured on an eDiary. Any assessment completed by the subject in the 
eDiary will be transferred from the site/subject to the vendor and from the vendor to the CRO 

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and/or Sponsor. No additional source documents are required for scales and assessments 
completed by the subject in eDiary. 
Safety laboratory, plasma, serum, instructions for all specimens collected will be provided by 
a designated central laboratory. ECG equipment, supplies, instructions, and training materials 
will be supplied by a centralized ECG vendor. 
6.2 
Eligibility Assessments 
6.2.1 
Symptom Questionnaire – DC/TMD 
Subjects will undergo an assessment using the DC/TMD Symptom Questionnaire during the 
Screening Phase as outlined in Table 1. 
6.2.2 
Clinical Exam Form (NA) – DC/TMD 
Subjects will undergo an assessment during the Screening Phase using the DC/TMD 
Symptom Questionnaire at the scheduled visits as outlined in Table 1. 
6.3 
Safety Assessments 
6.3.1 
Vital Signs and Physical Measurements (Height and Weight) 
Sitting arterial systolic and diastolic blood pressure and pulse rate, height, weight and body 
temperature will be measured at Screening and End of Treatment. Height and weight will be 
done at Screening only see Table 1. 
6.3.2 
Electrocardiogram (ECG) 
A standard 12-lead ECG will be recorded during the Screening Phase and at the scheduled 
visits as outlined in Table 1. A central ECG service will be utilized for all ECGs and the 
Investigator will determine if any abnormalities are clinically significant or not. 
6.3.3 
Physical Exam 
Subjects will undergo a routine physical examination during the Screening Phase and at the 
scheduled visits as outlined in Table 1. Physical examinations include examination of the 
heart, abdomen, lungs, and any other body system to be guided by symptoms. 
6.3.4 
Laboratory Assessments 
6.3.4.1 
Safety Laboratory Testing 
Blood and urine samples will be obtained as outlined in Table 1 for clinical laboratory 
evaluations. A central laboratory vendor will be utilized for this study and a laboratory 
manual will be provided to each site. If possible, subjects should be fasting for a minimum of 
8 hours prior to all blood draws. However, if a subject is not fasting at a given visit, the blood 
draw should still be performed, and the non-fasting status should be documented. 
Hematology: Hemoglobin, hematocrit, red blood cell count, white blood cell count (WBC) 
with differential, and platelets. 

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Blood chemistry/electrolyte: Sodium, potassium, chloride, bicarbonate, calcium; glucose, 
BUN (urea), serum creatinine, uric acid, ALT, AST, alkaline phosphatase, LDH, total 
protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin, CK. End of Treatment 
Visit – elevations in CK (>5x ULN) may have further CK fractionation tests performed 
through the central lab. 
Lipid Panel: Total cholesterol, LDL, HDL and triglycerides will be performed through the 
central lab at screening. 
HbA1c: measured at screening only. 
Estimated glomerular filtration rate: eGFR using the estimated MDRD formula will be 
calculated and reported by the central lab at each visit that clinical laboratory tests are 
collected as outlined in Table 1. 
Urinalysis: pH, specific gravity, ketones, nitrites, urobilinogen, leukocyte esterase, protein, 
glucose, and blood. If blood, protein, or leukocytes are positive, reflex to microscopic 
examination. 
Urine Drug Screen: For drugs of abuse. 
 
Reflex tests: If ALT or AST ≥ 3 x ULN OR total bilirubin ≥ 2 x ULN at any visit after the 
baseline visit, the central laboratory will perform reflex tests that may include: CK, GGT, and 
anti-viral serologies. Subjects may have to return to the study site to provide additional blood 
samples for these laboratory tests. 
 
FSH: A confirmatory FSH level will be measured at screening on post-menopausal women 
(as defined in Section 5.6) to confirm post-menopausal status. FSH level testing is not 
required for women greater than or equal to 62 years old with amenorrhea of greater than or 
equal to 1 year. 
Additional laboratory tests may be required. 
6.3.4.2 
Pregnancy Testing 
Pregnancy tests will be conducted on women of childbearing potential as outlined in Table 1. 
Women of childbearing potential must have a negative serum or urine pregnancy test at the 
Screening Visit, Baseline Visit, and prior to taking study medication. Subjects will be 
provided with the accompanying package insert that contains instructions for use and 
interpretation of results. 
6.3.5 
Columbia Suicidality Severity Rating Scale (CSSRS) 
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide 
assessment.14 The C-SSRS “Screening version” will be used at the Screening Visit and the 
“Since Last Visit version”15 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. 

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This scale will be collected on site with a paper form. The C-SSRS should be reviewed by the 
Investigator or designee before the subject is allowed to leave clinic. 
At the Screening Visit, the recall period for completing is 12 months for suicidal ideation and 
10 years for suicidal behavior; at all other visits, the recall period for completing the C-SSRS 
is since the last visit (Table 1). 
Any “Yes” responses must be immediately evaluated by the investigator. If the Investigator 
determines that a participant is at risk of suicide, self-harm, appropriate measures to ensure 
the participant’s safety and obtain mental health evaluation must be implemented. In such 
circumstances, the participant must immediately be discontinued from the study. The event 
should be recorded as either an AE or SAE as determined by the Investigator and reported 
within 24 hours to the Sponsor. 
6.4 
Efficacy Assessments 
6.4.1 
Pain 
Subjects are given an eDiary to record their current TMD-associated pain score, on a NRS (0- 
10) at the time points indicated in Table 1. 
6.4.2 
Rescue Medication 
The subject’s use of rescue medication is recorded by the subject in a paper diary. 
CCI 
 
 
 
6.5 
Early Discontinuation from the Study 
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). 

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 
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 Biohaven Pharmaceuticals. 
 
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. 
All subjects who discontinue should comply with protocol specified End of Treatment 
procedures as outlined in Table 1. The only exception to this requirement is when a subject 
withdraws consent for all study procedures or loses the ability to consent freely (i.e., is 
incapacitated, imprisoned, or involuntarily incarcerated for the treatment of either a 
psychiatric or physical illness). 
6.5.1 
Lost to Follow Up 
A participant 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 participant fails to return to the clinic for a required 
study visit: 
 
The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in 
the study. 
 
Before a participant is deemed lost to follow up, the Investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record. 
 
Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 

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7 
STUDY DRUG MANAGEMENT 
7.1 
Description of Study Drug 
7.1.1 
Investigational Product 
An investigational product, also known as investigational medicinal product in some regions, 
is defined as follows: 
 
A pharmaceutical form of an active substance or placebo being tested or used as a 
reference in a clinical study, including products already with a marketing authorization 
but used or assembled (formulated or packaged) in a way different from the authorized 
form, or used for an unauthorized indication, or when used to gain further information 
about the authorized form. 
The investigational product should be stored in a secure area according to local regulations. It 
is the responsibility of the Investigator to ensure that investigational product is only 
dispensed to study subjects. The investigational product must be dispensed only from official 
study sites by authorized personnel according to local regulations. 
In this protocol, investigational product is/are: 
 
Rimegepant ODT and matching placebo. The rimegepant ODT and the matching placebo 
appear identical visually, via touch, smell, and taste. 
7.1.2 
Non-Investigational Product 
Other medications used as support or rescue medication for preventative, diagnostic, or 
therapeutic reasons, as components of the standard of care for a given diagnosis, may be 
considered non-investigational products. 
In this protocol, non-investigational product(s) is/are: 
 
Standard of care / rescue medications and/or oral devices for the treatment of TMD- 
associated symptoms. 
7.1.3 
Packaging, Shipment and Storage 
The investigational product storage manager should ensure that the study drug is stored in 
accordance with the environmental conditions (temperature, light, and humidity) as 
determined by the Sponsor. Please see the Pharmacy Manual/Investigator Brochure for 
specific conditions. If concerns regarding the quality or appearance of the study drug arise, do 
not dispense the study drug and contact the Sponsor/CRO immediately. 
7.2 
Dose and Administration 
One dose of rimegepant ODT (75 mg) or matching placebo will be dispensed to the subject 
and will be taken at the time the subject has a TMD-associated pain that reaches intensity of  
6 on a NRS (0-10) and after completing the eDiary questions. 

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7.2.1 
Method of Assigning Subject Identification 
Immediately after written informed consent is obtained and before performing any study- 
related procedures, each subject will be assigned a unique sequential subject number for 
identification throughout the study through an IWRS. This subject number must not be reused 
for any other subject in the study. The physician/coordinator must contact the IWRS to enroll 
each subject into a centralized database after signing consent. 
After completion of all screening evaluations, all eligible subjects will be randomized in a 1:1 
ratio to the rimegepant or matching placebo treatment groups. The randomization will be 
stratified by the daily use of medications / oral devices to reduce intensity of TMD symptoms 
(yes or no). It is important to correctly enter subjects who are using daily medications / oral 
devices in the IWRS system. Once a subject is stratified in the IWRS, this cannot be changed. 
Randomization schedules will be generated and kept by the IWRS vendor in a secure network 
folder with access limited to only unblinded team members. Each subject who is qualified for 
treatment will be randomized via the IWRS randomization option. Subjects will maintain 
their subject number assigned at screening throughout the trial. The IWRS will provide the 
double-blind treatment assignments. 
The randomization will trigger dispensation for the subject and assign a bottle number for the 
appropriate randomized treatment type. The drug is dispensed at the time of randomization. 
7.2.2 
Selection and Timing of Dose and Administration 
Study medication (one 75 mg orally disintegrating tablet or matching placebo) will be 
packaged in a single blister in a subject-specific bottle. There are no dose adjustments in this 
study and subjects will receive one dose to treat TMD-associated pain of  6 on a NRS (0-10) 
within 45 days of randomization (Baseline Visit). Subjects will be dispensed the study 
medication at randomization (Baseline Visit) and will take the ODT from the blister/bottle at 
the time of TMD-associated pain of  6 on a NRS (0-10) onset ONLY after answering 
questions regarding their TMD-associated symptoms in the eDiary device. The ODT should 
be placed on or under the tongue until fully dissolved then swallowed. Subjects should be 
instructed to use dry hands when handling the study medication. 
7.2.3 
Dose Modifications 
There will be no dose adjustments in this study. 
7.3 
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. 
Before breaking the blind of an individual subject’s treatment, the Investigator should have 
determined that the information is necessary, (i.e., that it will alter the subject’s immediate 
management). In many cases, particularly when the emergency is clearly not investigational 

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product related, the problem may be properly managed by assuming that the subject is 
receiving active product without the need for unblinding. 
In cases of accidental unblinding, contact the Medical Monitor and ensure every attempt to 
preserve the blind is made. 
7.4 
Treatment Compliance 
Responsible study personnel will dispense the study drug. Accountability and compliance 
verification should be documented in the subject’s study records. 
Subjects have to be counseled on the importance of taking the study drug as directed when a 
TMD-associated pain occurs and reaches intensity of  6 on a NRS (0-10). If the subject does 
not have a TMD-associated pain of  6 on a NRS (0-10) or take their study medication within 
45 days of the Baseline Visit, they should return to the clinic for their End of Study Visit and 
return their unused study medication. 
7.5 
Destruction and Return of Study Drug 
Subjects will be instructed to return all unused study drug or packaging from used study drug 
to the study site for drug accountability. All unused study drug can be sent back to the drug 
depot for destruction 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 used study drug packaging can only be destroyed after being inspected and 
reconciled by the responsible Study Monitor or the Sponsor’s designee. 

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8 ADVERSE EVENTS 
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of 
a pre-existing medical condition in a subject or clinical investigation subject administered an 
investigational (medicinal) product and that does not necessarily have a causal relationship 
with this treatment. An AE can therefore be any unfavorable and unintended sign (including 
an abnormal laboratory finding for example) symptom, or disease temporally associated with 
the use of the investigational product, whether or not considered 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. 
If a specific diagnosis or syndrome is identified by the Investigator, this should be recorded 
as the AE, rather than recording (as separate AEs) the individual signs/symptoms or clinically 
significant laboratory abnormalities known to be associated with, and considered by the 
Investigator to be a component of, the disease/syndrome. 
Definition of terms related to all 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 AEs that are considered life threatening should be considered SAEs. An AE 
is life threatening if the subject was at immediate risk of death from the event as it occurred, 
i.e., it does not include a reaction that if it had occurred in a more serious form might have 
caused death. For example, drug induced hepatitis that resolved without evidence of hepatic 
failure would not be considered life threatening even though drug induced hepatitis can be 
fatal. 
Hospitalization: AEs requiring hospitalization should be considered SAEs. Hospitalization 
for elective surgery or routine clinical procedures that are not the result of AE (e.g., elective 
surgery for a pre-existing condition that has not worsened) need not be considered AEs or 
SAEs. If anything untoward is reported during the procedure, that occurrence must be 
reported as an AE, either 'serious' or 'non-serious' according to the usual criteria. 

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Assessment for Determining Relationship of AE to Study Drug: 
The relatedness of each AE to study drug must be classified based on medical judgement and 
according to the following categories. The definitions are as follows: 
Related: This category applies to AEs that are considered, with a high degree of certainty, to 
be related to the study drug. An AE may be considered related when it follows a temporal 
sequence from the administration of study drug, it cannot reasonably be explained by the 
known characteristics of the subject’s clinical state, environment, or toxic factors, or other 
modes of therapy administered to the subject. An AE may be considered related when it 
follows a known pattern of response to the study drug, or if the AE reappears upon re- 
challenge. This category also applies to AEs that are considered to have an unlikely 
connection to study drug, but a relationship cannot be ruled out with certainty. 
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): 
○ Intensive treatment in an emergency room or at home for allergic bronchospasm 
○ Blood dyscrasias or convulsions that do not result in inpatient hospitalization 
○ Development of drug dependency or drug abuse 

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○ Potential drug induced liver injury (see Section 8.5) 
○ Abuse or Overdose of medication 
▪ 
Potential study medication abuse (including cases of excessive non-compliance 
with study medication dosing instructions or subjects who discontinue treatment 
without returning study medication) should be documented in the source record 
and reported as an AE or SAE as appropriate. Investigators must monitor subjects 
for possible cases of abuse of study medication (subjects taking study drug for 
non-therapeutic purposes, e.g., for psychoactive effects such as high or euphoria). 
Investigators should obtain more information and explanation from subjects when 
there are study drug accountability discrepancies. 
▪ 
Potential study medication overdose is defined in Section 8.3. 
In general, hospitalization signifies that the subject has been detained (usually involving at 
least an overnight stay) at the hospital or emergency ward for observation and/or treatment 
that would not have been appropriate in the physician's office or outpatient setting. When in 
doubt as to whether 'hospitalization' occurred or was necessary, the AE should be considered 
serious. 
The following hospitalizations are not considered SAEs in Biohaven clinical studies (but may 
be considered non-serious AEs): 
 A visit to the emergency room or other hospital department for <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 that occur during the screening 
period and throughout the course of the study up to and including the End of Treatment Visit 
/ 30 days after last dose. The Investigator should report any SAE occurring after this time 
period that is believed to be related to study drug or protocol-specific procedures. 

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All SAEs should be followed to resolution or stabilization. 
An SAE report should be completed for any event where doubt exists regarding its status of 
seriousness. 
If the Investigator believes that an SAE is not related to the study drug, but is potentially 
related to the conditions of the study (such as a withdrawal of previous therapy or a 
complication related to study procedure), the relationship should be specified in the narrative 
section of the SAE Report Form. 
SAEs, whether related or not related to study drug, overdose (see Section 8.3), potential drug 
induced liver injury (see Section 8.5) and pregnancies (see Section 8.4) 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). 
Any serious adverse event must be reported immediately or no later than 24 hours after 
awareness of the event to PPD Pharmacovigilance (PVG). A written description of any 
serious adverse event, using the PPD SAE report form, must be sent to PPD PVG by 
facsimile (fax), which is the preferred method of submission, within 24 hours after awareness 
of the event: 
 
North America - 1-888-488-9697 
If a form is unable to be submitted within 24 hours, the SAE may be reported by telephone 
via the Safety Hotline Number: 
 
North America – 1-800-201-8725 
If only limited information is initially available, follow-up reports are required. If an ongoing 
SAE changes in its intensity or relationship to study drug or if new information becomes 
available, a follow-up SAE report should be sent within 24 hours of the Investigator 
becoming aware of the updated information using the same procedure used for the 
transmission of the initial SAE and the same event term should be used. 
The minimum information required for an initial SAE report is: 
 
Sender of report (Site number, Investigator name) 
 
Subject identification (subject number) 
 
Protocol number 
 
SAE term (if an SAE is being reported) 
8.2 
Non-serious Adverse Events 
A non-serious adverse event is an AE not classified as serious. 

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8.2.1 
Collection and Reporting of Non-Serious Adverse Events 
The collection of non-serious AE information should begin at the initiation of study drug 
through the Follow up Safety Visit (End of Treatment Visit). 
Non-serious adverse events should be followed until conclusion or stabilization, or reported 
as SAEs if they become serious. Follow-up is also required for non-serious AEs that cause 
interruption or discontinuation of study drug or those that are present at the end of study 
treatment. 
8.2.2 
Laboratory Test Abnormalities 
The following laboratory test abnormalities should be captured on the non-serious AE CRF 
page or SAE Report Form (paper or electronic) as appropriate: 
 
Any laboratory test result that is clinically significant or meets the definition of an SAE. 
 
Any laboratory abnormality that required the subject to have the study drug discontinued 
or interrupted. 
 
Any laboratory abnormality that required the subject to receive specific corrective 
therapy. 
8.3 
Overdose 
An overdose is defined as the accidental or intentional administration of any dose of a 
product that is considered both excessive and medically important. 
All occurrences of medically significant overdose (suspected or confirmed and irrespective of 
whether it involved BHV-3000) must be communicated to Biohaven or a specified designee 
within 24 hours and be fully documented as an SAE. Details of any signs or symptoms and 
their management should be recorded including details of any treatments administered. 
Asymptomatic dosing errors (e.g., accidentally taking two tablets instead of prescribed dose 
of one tablet in one calendar day) should be reported as deviations. 
8.4 
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 product 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 study discontinuation and 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. 
Sites should instruct subjects to contact the Investigator if they become pregnant during the 
course of the study. The Investigator must immediately notify the Biohaven (or designee) 
Medical Monitor and PPD of the event and complete the Pregnancy Form in accordance with 
SAE reporting procedures as described in Section 8.1.2. The pregnancy should be reported 

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using paper forms, which should be faxed to PPD PVG by facsimile (fax), which is the 
preferred method of submission, within 24 hours after Investigator/site awareness of the 
event: 
 
North America - 1-888-488-9697 
Or if the form cannot be faxed or emailed (wilsafety@ppdi.com; subject line must include 
“Biohaven Protocol BHV3000-314”), reported via phone to the PPD Safety Hotline at North 
America: 1-800-201-8725. 
Once the paper form is available, the data must be reported per standard procedures. 
Follow-up information regarding the course of the pregnancy, including perinatal and 
neonatal outcome, and where applicable offspring information must also be reported on a 
Pregnancy Report Form. 
Any pregnancy that occurs in a female partner of a male study participant should be reported 
to the Sponsor/PPD. Information on this pregnancy will be collected on the Pregnancy 
Report Form, as appropriate. 
8.5 
Potential Drug Induced Liver Injury (DILI) 
Wherever possible, timely confirmation of the initial liver-related laboratory abnormalities 
should occur prior to the reporting of a potential DILI event. All occurrences of potential 
DILIs, meeting the defined criteria, must be reported as SAEs as per Section 8.1.2. 
Potential drug induced liver injury is defined as: 
1. ALT or AST elevation > 3 times the upper limit of normal (ULN). 
AND 
2. Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum 
alkaline phosphatase). 
AND 
3. No other immediately apparent possible causes of ALT or AST elevation and 
hyperbilirubinemia, including but not limited to, viral hepatitis, pre-existing chronic 
or acute liver disease, or the administration of other drug(s) known to be hepatotoxic. 
If any potential DILI is identified and meets the criteria above, the Biohaven Medical 
Monitor (or designee) should immediately be contacted for further instruction and whether 
the subject must discontinue from the trial and appropriate follow up requirements. 
8.6 
Adverse Events of Special Interest 
None 

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9 STATISTICS 
Complete details on the statistical methods for this study may be found in the Statistical 
Analysis Plan (SAP). 
9.1 
General Procedures 
Categorical variables are tabulated with counts and percentages. Continuous variables are 
summarized with univariate statistics (e.g., n, mean, standard error, median, minimum and 
maximum). 
For the calculation of descriptive statistics of observed data, subjects must have a baseline 
value to be evaluable for endpoints based on values and changes from baseline over time. 
Tabulations of the following endpoints present the number of unique subjects with an event: 
protocol deviations; interruptions of study therapy; non-study medications; adverse events; 
and laboratory abnormalities. Thus, for these endpoints, multiple occurrences of the same 
event are counted only once per subject. 
9.2 
Sample Size 
If 80% of the 200 randomized (100 per treatment arm) treat with study drug, we expect 
roughly 160 total or 80 per treatment group in the randomized and treated population for 
analysis. 
Assuming rimegepant provides a 2-point reduction in NRS pain, and a 1.5-point advantage 
over placebo on the primary endpoint, and a common standard deviation of 3.0, then the 
study will have roughly 88% power on the primary endpoint. 
9.3 
Populations for Analysis 
The set of enrolled subjects consists of all subjects who signed the informed consent form 
and were assigned a subject identification number. 
The set of randomized subjects consists of enrolled subjects who were assigned a randomized 
treatment group. 
The set of treated subjects consists of all randomized subjects who take study therapy 
(rimegepant or placebo). 
9.4 
Statistical Methods 
9.4.1 
Demographic and Baseline Characteristics 
Tabulations of demographic and baseline characteristics are made for: subjects randomized 
but not treated; subjects randomized and treated; and overall. A separate set of tabulations are 
made for subjects enrolled but not randomized. 

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9.4.2 
Primary Endpoint(s) 
The SPID-2 will be calculated by multiplying the PID score (difference between NRS at each 
time point and baseline NRS) at each post-dose timepoint by the duration (in hours) since the 
preceding timepoint, then summing the values over the 2 hours. This is analyzed on the 
treated population using an analysis of covariance (ANCOVA) model that includes the 
baseline NRS (0-10) value as a covariate, and main effects for treatment group and 
stratification factor (use of daily medications / oral devices to reduce the intensity of TMD 
symptoms). 
The least squares mean (LS mean), standard error (SE), and 95% confidence interval (CI) for 
each treatment group will be reported, as well as the difference estimate (rimegepant - 
placebo), SE, 95% CI, and p-value. 
Intercurrent events will be treated as failures, with the assumption that the subject does not 
improve once the intercurrent event occurs. In the event a subject uses a non-study rescue 
medication on or before 2 hours post-dose, all data points after rescue medication was 
administered will be set to the last available observation prior to rescue medication usage 
(RM = Rescue medication use: F = Failure). Likewise, if a subject fails to log their pain score 
at any time after study drug is administered, through 2 hours post-dose, this data will be 
imputed to the last available observation (NC = Non-completers; F = Failure). 
Sensitivity analyses will be described in the SAP. 
9.4.3 
Secondary Endpoint(s) 
If the primary endpoint test is significant at alpha  0.05, then the secondary endpoints will 
be analyzed at an alpha level of  0.05 using Hochberg’s procedure. Secondary endpoints 
will be analyzed on the treated population. 
9.4.3.1 
SPID-24 
The SPID-24 will be analyzed in the same manner as the primary endpoint, with the SPID 
calculated by multiplying the PID score at each post-dose timepoint by the duration (in hours) 
since the preceding timepoint, then summing the values over the 24 hour period. 
9.4.3.2 
Change from Baseline of Pain on NRS 
The change from baseline of pain on NRS score at 2 hours post-dose will be analyzed with a 
generalized linear mixed effect model that includes subject as a random effect, the baseline 
NRS (0-10) value as a covariate, and fixed effects for treatment group, stratification factor 
(use of daily medications / oral devices to reduce the intensity of TMD symptoms), scheduled 
time point, and time point by treatment group interaction. Time points included in the model 
are nominally at 15, 30, 45, 60, 90 and 120 minutes post-dose. Repeated measurements 
within-subject will be modeled using an unstructured covariance structure for within-subject 
error. In the case that the model fails to converge, a Huynh-Feldt error structure will be 
attempted, followed by an AR(1) structure. Error degrees of freedom will be calculated using 
a Kenward-Roger approximation. The difference estimate (rimegepant - placebo), SE, 95% 
CI, and p-value will be reported for 2 hours post-dose. 

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CCI 
Interurrent events of use of a non-study rescue medication at or before 2 hours post-dose, or 
if a subject fails to log their pain score at any time after study drug is administered through 2 
hours post-dose, will be handled in the same manner as they are for the primary endpoint. 
9.4.3.3 
Pain Freedom at 2 Hours 
The number of subjects that are pain free at 2 hours post-dose will be analyzed after first 
imputing missing data at 2 hours to be failure (NC = F). Additionally, subjects who use 
rescue medication on or before assessment of pain at 2 hours will also be assigned as failures 
(RM = F). The analysis will be done using a stratified Cochran-Mantel-Haenszel (CMH) test 
after imputation is done, with the stratification factor as use of daily medications / oral 
devices to reduce the intensity of TMD symptoms. 
9.4.3.4 
Time to Onset of Meaningful Pain Relief 
Time to onset of meaningful pain relief post-dose will be defined as the first nominal 
timepoint at which a 30% reduction of pain from baseline on NRS is achieved. This will be 
analyzed using Kaplan-Meier methods for a “time to event” analysis. Rimegepant will be 
compared to placebo using a log-rank test which will compare the survival distributions. 
Intercurrent events will be handled in the same manner as they are for the primary endpoint. 
9.4.3.5 
Time to Onset of Initial Pain Relief 
Time to onset of initial pain relief post-dose will be defined as the first nominal timepoint at 
which a 1-point reduction of pain from baseline on NRS is achieved. This will be analyzed 
using Kaplan-Meier methods for a “time to event” analysis. Rimegepant will be compared to 
placebo using a log-rank test which will compare the survival distributions. Intercurrent 
events will be handled in the same manner as they are for the primary endpoint. 
9.4.3.6 
Rescue Medication Use through 24 Hours 
The number of subjects that use rescue medication through 24 hours post-dose will be 
analyzed using a stratified CMH test, with the stratification factor as use of daily 
medications/oral devices to reduce the intensity of TMD symptoms. 
9.4.4 
Adjustment for Multiplicity 
Type 1 error is addressed in this study using a gatekeeping procedure. The significance of 
the primary endpoint is evaluated at the two-sided alpha level of 0.05. If the primary 
endpoint is significant, then the secondary endpoints are tested using Hochberg’s procedure. 
 
9.4.5 
Missing Data 
For the primary and secondary endpoints of SPID-2, SPID-24, change in NRS from baseline, 
time to onset of meaningful pain relief, and time to onset of initial pain relief, subjects who 
fail to record their pain during the timeframe of interest for each endpoint will be considered 

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failures (NC = F) and this data will be imputed to the last available observation prior to the 
missing data occurrence. 
For the secondary endpoint of proportion of subjects that are pain free at 2 hours post-dose, 
missing data at 2 hours post-dose will be imputed as a failure (NC = F), and these subjects 
will not be considered as having achieved pain freedom. 
For the secondary endpoint of proportion of subjects who use rescue medication through 24 
hours-post dose, there will be no imputation for missing data, the analysis will be based on 
non-missing, observed data. 
Additional methods for handling of missing data, including sensitivity analyses, will be 
described in detail in the SAP. 
9.4.6 
Rescue Medication 
For the primary and secondary endpoints of SPID-2, SPID-24, change in NRS from baseline, 
time to onset of meaningful pain relief, and time to onset of initial pain relief, use of non- 
study rescue medications on or before the time point of interest (2 hours post-dose or 24 
hours post-dose) will be handled as failures (RM = F). Specifically, the assumption will be 
that once the subject has used a rescue medication, their pain will not improve any further 
and these data points will be set to the last value recorded prior to the use of the rescue 
medication. 
For the secondary endpoint of pain freedom at 2 hours post-dose, subjects that take rescue 
medication on or before the time point of interest (2 hours post-dose) will be considered as 
failures (RM = F). 
Rescue medications are described in more detail in Section 5.5. 
9.4.7 
Analysis of Safety 
The Investigators determine the intensity of AEs and the relationship of AEs to study therapy. 
The Investigators’ terms are coded and grouped by system organ class using the latest version 
of the Medical Dictionary for Regulatory Activities (MedDRA) available. AEs are presented 
by system organ class and preferred term, ordered by the overall frequency of events. If a 
subject had an adverse event with different intensities over time, then only the greatest 
intensity is reported. 
AEs are tabulated in all treated subjects. SAEs occurring in subjects enrolled but not treated 
are listed. Deaths are listed for enrolled subjects without regard to onset. 
The frequencies of the following safety events are summarized by treatment regimen, and 
overall, for treated subjects: SAEs; all AEs, AEs by intensity; and AEs by relatedness. 
Clinically significant laboratory test abnormalities will be identified as Grade 3 to 4 
laboratory test results graded according to numeric laboratory test criteria in Common 
Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (2017), if available. 
Otherwise, if CTCAE grades are not available, then results will be graded according to 
numeric laboratory test criteria in Division of AIDS (DAIDS) Table for Grading the Severity 

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of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017). If a subject has a 
laboratory test abnormality with different toxicity grades over time, then only the highest 
toxicity grade will be reported. 
Further safety analyses will be described in the statistical analysis plan. 
9.5 
Schedule of Analyses 
The data from this study may be locked and analyzed at any point after the last subject 
completes their end of treatment visit and adequate time has been allowed for follow-up. 

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10 ETHICS AND RESPONSIBILITIES 
10.1 
Good Clinical Practice 
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP), 
Good Laboratory Practice (GLP), International Conference on Harmonization guidelines, and 
all applicable regulations, including the Federal Food, Drug and Cosmetic Act, U.S. 
applicable Code of Federal Regulations (title 21), any Independent Ethics Committee (IEC) 
requirements relative to clinical studies. The study will also be conducted in compliance with 
the recommendations laid down in the most recent version of the Declaration of Helsinki, 
with the exception that registration of such Phase 1 trials in a publicly accessible database is 
not mandatory. 
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. 
As per Section 5.8, any significant event that does not comply with the inclusion / exclusion 
criteria, study conduct, or study procedures will be documented as a deviation. 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. All serious breaches 
must be reported to Biohaven (or designee) immediately. Examples include (but are not 
limited to): 
 
Missing, inadequate, or delinquent informed consent. 
 
Randomization of a subject that does not meet key eligibility criteria. 
 
Failure to withdraw a subject meeting discontinuation criteria. 
 
Unreported serious adverse events. 
 
Improper breaking of the blind. 
 
Conducting the study without IRB approval. 
 
Working under an expired medical license, or a debarred or disqualified status. 
 
Falsifying research or medical records. 
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). 

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The Principal Investigator and the Sponsor’s representative must sign the protocol and its 
amendments (if any) before initiating the study. 
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 
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. 
10.3 
Informed Consent 
Investigators must ensure that subjects, or, in those situations where consent cannot be given 
by subjects, their legally acceptable representatives, are clearly and fully informed about the 
purpose, potential risks, and other critical issues regarding clinical studies in which they 
volunteer to participate. 
Biohaven (or designee) will provide the Investigator with an appropriate (i.e., Global or 
Local) sample informed consent form which will include all elements required by ICH, GCP 
and applicable regulatory requirements. The sample informed consent form will adhere to 
the ethical principles that have their origin in the Declaration of Helsinki. 
Before the potential subject has undergone any study-related screening procedures, the nature 
of the study and the potential risks associated with it will be explained to the subject, and the 
subject will be given an opportunity to ask questions to his or her satisfaction. After the 
questions are answered, but before proceeding further, the subject must read, 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. 
The informed consent form must also include a statement that Biohaven and its 
representatives and regulatory authorities may have direct access to subject records. 

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10.4 
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. 

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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. 
Biohaven 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 Biohaven. 
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 should include: 
 
amount of study drug received and placed in storage area 
 
label ID number or batch number or Kit number as specified for the protocol 
 
amount dispensed to and returned from each subject 
 
amount transferred to another area or site for dispensing or storage if applicable 
 
amount of drug lost or wasted 
 
amount destroyed at the site if applicable 
 
amount returned to sponsor, if applicable 
 
retain samples for bioavailability/bioequivalence, if applicable 
 
record of dates and initials of personnel responsible for IM 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 

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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 participants 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) should be maintained by the CRO. The Sponsor will be 
contacted to determine whether the study documents/materials that are retained outside of the 
TMF will be forwarded to the Sponsor, destroyed or kept at the CRO or at another facility for 
a longer period of time at the Sponsor's expense. 
The CRO will maintain adequate study records after completion or termination of study. 
After that period, the Sponsor will be contacted to determine whether the study records will 
be forwarded to the Sponsor, destroyed or kept at CRO or at another facility for a longer 
period of time at the Sponsor's expense. 

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12 AMENDMENTS 
Protocol modifications, except those intended to reduce immediate risk to study subjects, may 
be made only by Biohaven (or specified designee). A protocol change intended to eliminate 
an apparent immediate hazard to subjects may be implemented immediately, provided the 
IRB/IEC is notified within 5 days. 
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. Biohaven 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 Biohaven, 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 participant, 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. 

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13 STUDY REPORT AND PUBLICATIONS 
Biohaven (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 of Biohaven is discussed in the Investigator's Clinical Research 
Agreement. 

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14 STUDY DISCONTINUATION 
Both Biohaven and the Principal Investigator reserve the right to terminate the study at the 
Investigator’s site at any time. Should this be necessary, Biohaven or a specified designee 
will inform the appropriate regulatory authorities of the termination of the study and the 
reasons for its termination, and the Principal Investigator will inform the IRB/IEC of the 
same. In terminating the study, Biohaven and the Principal Investigator will assure that 
adequate consideration is given to the protection of the subjects’ interests. 

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15 CONFIDENTIALITY 
All information generated in this study is considered highly confidential and must not be 
disclosed to any person or entity not directly involved with the study unless prior written 
consent is gained from Biohaven. However, authorized regulatory officials, IRB/IEC 
personnel, Biohaven and its authorized representatives are allowed full access to the records. 
Identification of subjects and CRFs shall be by initials (when allowed), screening and 
treatment numbers only. If required, the subject's full name may be made known to an 
authorized regulatory agency or other authorized official. 
The Sponsor may approve the sharing of de-identified data from this study to be made 
available to researchers for the purpose of advancing the understanding of neurologic or 
psychiatric illness, rating scales, or trial methodology for the affected population. In any 
publication of this data, confidentiality of individual subjects will be protected. 

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Protocol Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial 
of BHV-3000 (rimegepant) Orally Disintegrating Tablet (ODT) for the Treatment of 
Temporomandibular Disorders (TMD) 
Study No: BHV3000-317 
Original Protocol Date: 09 Dec 2021 
Protocol Version No: V3.0 
Protocol Version Date: 31 Mar 2022 
Name and Title 
Author: 
Signature Approval 
Date 
PPD 
PPD 
MBA 
PPD 
Clinical Operations 
Clinical Operations: 
PPD 
Clinical Operations 
Biometrics: 
PPD 
PPD 
Ph.D 
Biostatistics 
PPD 
Ph.D. PPD 
 
Medical Lead: 
PPD 
PPD 
MD 
PPD 
Regulatory Affairs: 
PPD 
MA 
Regulatory Affairs 
PPD 
PPD 
PPD 
PPD 
 
16 CLINICAL PROTOCOL APPROVAL FORM 
 
 
 
 
The current risk-benefit evaluation of the investigational product. 
 The moral, ethical and scientific principles governing clinical research as set out in the 
Declaration of Helsinki, and principles of GCP as described in 21 CFR parts 50, 54, 56 
and 312 and according to applicable local requirements. 
The Investigator will be supplied with details of any significant or new findings, including 
adverse events, relating to treatment with the investigational product. 
 

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boceprevir, cobicistat, conivaptan, danoprevir and ritonavir, elvitegravir and ritonavir, 
indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and 
ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, 
telaprevir, tipranavir and ritonavir, troleandomycin, voriconazole, clarithromycin, 
nefazodone, nelfinavir, tacrolimus, mifepristone, mibefradil. 
Strong CYP3A4 inhibitors 
apalutamide, carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, St. John’s Wort 
Strong CYP3A4 inducers 
 
17 APPENDICES 
17.1 
APPENDIX I – Strong Inhibitors and inducers of CYP3A4 protein (Not all- 
inclusive) 
The following medications and medication combinations are some of the strong inhibitors of 
CYP3A4). This list should not be considered all-inclusive. As described in the study protocol, 
concomitant use of strong CYP3A4 inhibitors is prohibited. Individual drug labels should be 
reviewed for specific information on propensity to inhibit CYP3A4 enzymes for a specific 
compound. 
 
 
 
 
Resources: 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInter  
actionsLabeling/ucm093664.htm#table3-2 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInter  
actionsLabeling/ucm093664.htm#table3-3 
Hachad H, Ragueneau-Majlessi I, Levy RH. A useful tool for drug interaction evaluation: the 
University of Washington Metabolism and Transport Drug Interaction Database. Hum 
Genomics. 2010 Oct;5(1):61-72. 
University of Washington Metabolism and Transport Drug Interaction Database accessible at 
https://www.druginteractioninfo.org/ 

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