Trial Outcomes & Findings for Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only) (NCT NCT05399485)

Last Updated: 2025-11-18

Results Overview

Migraine day: 1) day of electronic diary (eDiary) efficacy data with a qualified migraine headache, defined as: Headache lasted for \>= 30 minutes and had 2 or more of following pain features: Unilateral and pulsating, moderate or severe pain intensity, worsen or avoid physical activity with one or more of the following associated symptoms: nausea, vomiting, both photophobia and phonophobia or 2) Acute migraine-specific medication day as eDiary efficacy data with a "yes" response to either of the 2 questions about taking triptan or ergotamine to treat headache or non-scheduled OL Rimegepant dosing day. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days in month \[Week 9 to 12\])/ (total number of efficacy data days in month \[Week 9 to 12\]).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

496 participants

Primary outcome timeframe

Baseline, Week 9 to Week 12 of the DBT phase

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Rimegepant Participants received Rimegepant (RMG) at a dose of 75 mg, orally as an orally disintegrating tablets (ODT), once every other day (EOD) for 12 weeks in the double-blind treatment (DBT) period. Eligible participants continued to receive RMG in a similar way from Week 12 to Week 52 (40 weeks) in the OLE period.	Placebo Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period. Eligible participants continued to received Rimegepant at a dose of 75 mg, orally as an ODT from Week 12 to Week 52 (40 weeks) in the OLE period.
DBT Phase STARTED	247	249
DBT Phase COMPLETED	233	238
DBT Phase NOT COMPLETED	14	11
OLE Phase STARTED	227	231
OLE Phase COMPLETED	204	215
OLE Phase NOT COMPLETED	23	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Rimegepant Participants received Rimegepant (RMG) at a dose of 75 mg, orally as an orally disintegrating tablets (ODT), once every other day (EOD) for 12 weeks in the double-blind treatment (DBT) period. Eligible participants continued to receive RMG in a similar way from Week 12 to Week 52 (40 weeks) in the OLE period.	Placebo Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period. Eligible participants continued to received Rimegepant at a dose of 75 mg, orally as an ODT from Week 12 to Week 52 (40 weeks) in the OLE period.
DBT Phase Other	6	5
DBT Phase Protocol-specified withdrawal criterion met	1	1
DBT Phase Withdrawal by Subject	3	2
DBT Phase Protocol Violation	2	1
DBT Phase Physician Decision	0	1
DBT Phase Adverse Event	2	1
OLE Phase Protocol deviation	1	0
OLE Phase Other	5	5
OLE Phase Withdrawal by Subject	12	7
OLE Phase Pregnancy	0	2
OLE Phase Physician Decision	3	0
OLE Phase Adverse Event	2	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg, orally as an ODT, once EOD for 12 weeks in the DBT period. Eligible participants continued to receive RMG in a similar way from Week 12 to Week 52 (40 weeks) in the OLE period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period. Eligible participants continued to receive Rimegepant at a dose of 75 mg, orally as an ODT from Week 12 to Week 52 (40 weeks) in the OLE period.	Total n=496 Participants Total of all reporting groups
Age, Continuous	44.9 Years STANDARD_DEVIATION 9.52 • n=247 Participants	43.1 Years STANDARD_DEVIATION 10.68 • n=249 Participants	44.0 Years STANDARD_DEVIATION 10.15 • n=496 Participants
Sex: Female, Male Female	225 Participants n=247 Participants	221 Participants n=249 Participants	446 Participants n=496 Participants
Sex: Female, Male Male	22 Participants n=247 Participants	28 Participants n=249 Participants	50 Participants n=496 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline, Week 9 to Week 12 of the DBT phase

Population: DBT migraine analysis set included participants in the DBT efficacy analysis set with \>= 14 days of eDiary data (not necessarily consecutive) in both the observation period (OP) and \>= 1 month (4-week interval) during the DBT Phase.

Outcome measures

Outcome measures
Measure	Rimegepant n=240 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=244 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase	-2.4 Days/month Interval -2.93 to -1.96	-1.4 Days/month Interval -1.87 to -0.91

SECONDARY outcome

Timeframe: Baseline, Week 9 to Week 12 of the DBT phase

Population: DBT migraine analysis set included participants in the DBT efficacy analysis set with \>= 14 days of eDiary data (not necessarily consecutive) in both the OP and \>= 1 month (4-week interval) during the DBT Phase.

Percentage of participants with \>= 50% reduction, from baseline in mean number of pain intensity (moderate or severe) in each month of DBT phase are included in this outcome measure. Migraine days per month are assessed as "migraine days per 4 weeks" to correspond with the 4-week visit schedule. Migraine days per month are based on 4-week intervals and are prorated to account for missing migraine reports. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days in month \[Week 9 to 12\])/ (total number of efficacy data days in month \[Week 9 to 12\])

Outcome measures

Outcome measures
Measure	Rimegepant n=240 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=244 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Percentage of Participants With at Least 50% Reduction From Baseline in the Mean Number of Moderate to Severe Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase	41.7 Percentage of participants Interval 35.5 to 47.9	34.4 Percentage of participants Interval 28.5 to 40.4

SECONDARY outcome

Timeframe: Baseline, Week 1 to Week 12 of the DBT phase

Migraine day:1) day of eDiary efficacy data with a qualified migraine headache, defined as: Headache lasted for \>= 30 minutes and had 2 or more of following pain features: Unilateral and pulsating, moderate or severe pain intensity, worsen or avoid physical activity with one or more following associated symptoms: nausea, vomiting, both photophobia and phonophobia or 2) Acute migraine-specific medication day as eDiary efficacy data with a "yes" response to either of the 2 questions about taking triptan or ergotamine to treat headache or non-scheduled OL Rimegepant dosing day. In the model analysis, this outcome was also evaluated based on the monthly number of migraine days (and estimated the migraine days per month over the entire DBT phase). The number of migraine days per month were prorated to 28 days and derived for month (i.e.,4-week interval) in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days in month/ (total number of efficacy data days in month).

Outcome measures

Outcome measures
Measure	Rimegepant n=240 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=244 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Change From Baseline in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)	-2.5 Days/month Interval -2.91 to -2.15	-1.1 Days/month Interval -1.47 to -0.64

SECONDARY outcome

Timeframe: Baseline, Week 1 to Week 4 of the DBT phase

Migraine day: 1) day of eDiary efficacy data with a qualified migraine headache, defined as: Headache lasted for \>= 30 minutes and had 2 or more of following pain features: Unilateral and pulsating, moderate or severe pain intensity, worsen or avoid physical activity with one or more of the following associated symptoms: nausea, vomiting, both photophobia and phonophobia or 2) Acute migraine-specific medication day as eDiary efficacy data with a "yes" response to either of the 2 questions about taking triptan or ergotamine to treat headache or non-scheduled OL Rimegepant dosing day. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days in month \[Week 1 to 4\])/ (total number of efficacy data days in month \[Week 1 to 4\]).

Outcome measures

Outcome measures
Measure	Rimegepant n=240 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=244 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Change From Baseline in Number of Migraine Days Per Month From Week 1 to 4 of the DBT Phase	-2.7 Days/month Interval -3.11 to -2.2	-0.8 Days/month Interval -1.26 to -0.32

SECONDARY outcome

Timeframe: Week 9 to Week 12 of the DBT phase

An acute migraine-specific medication day was defined as day of eDiary efficacy data with a "yes" response to either of the 2 questions about taking triptan or ergotamine to treat headache or aura. Migraine days per month are assessed as "migraine days per 4 weeks" to correspond with the 4-week visit schedule. Migraine days per month are based on 4-week intervals and are prorated to account for missing migraine reports. The number of acute migraine-specific medication days per month was prorated to 28 days and derived for month (i.e., 4-week interval) in the on-DBT efficacy analysis period: 28\*(total number of acute migraine-specific medication days in the month \[Week 9 to 12\])/ (total number of efficacy data days in the month \[Week 9 to 12\]).

Outcome measures

Outcome measures
Measure	Rimegepant n=240 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=244 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Number of Acute Migraine-specific Medication Days Per Month From Week 9 to 12 of the DBT Phase	5.0 Days/month Interval 4.4 to 5.55	5.8 Days/month Interval 5.24 to 6.4

SECONDARY outcome

Timeframe: Baseline, Week 12 of the DBT phase

Population: DBT efficacy analysis set included participants in the full analysis set who (1) were randomized only once, and (2) took \>= 1 dose of DB study intervention. Analysis was based on DBT efficacy analysis set with paired data (i.e., Non missing scores at both baseline and Week 12). Here, " Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome.

MSQoL is a self-administered, 14-item instrument validated in 3 domains: role restriction, role prevention, and the emotional function. The role function-restrictive domain consists of 7 items that describe how migraine limits one's daily social and work-related activities. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Item scores are recoded using (7 - original score). Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life. The change from baseline was calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.

Outcome measures

Outcome measures
Measure	Rimegepant n=228 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=237 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) v 2.1 Role Function - Restrictive Domain Score at Week 12 of the DBT Phase	7.8 Score on a scale Interval 6.2 to 9.44	3.7 Score on a scale Interval 2.05 to 5.36

SECONDARY outcome

Timeframe: Baseline, Week 12 of the DBT phase

Population: DBT efficacy analysis set included participants in the full analysis set (FAS) who (1) were randomized only once, and (2) took \>= 1 dose of DB study intervention. Analysis was based on DBT efficacy analysis set with paired data (i.e., Non missing scores at both baseline and Week 12). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome.

MIDAS is a retrospective, self-administered, 5-item questionnaire that measures headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provide the number of missed work or school days; missed household chores days; missed social or leisure activity days; and days at work or school, and separately at home, where productivity was reduced by half or more in the last 3 months (scale: 0 - 90 for each of 5 subscales). The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability. The change from baseline was calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline.

Outcome measures

Outcome measures
Measure	Rimegepant n=228 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=237 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Change From Baseline in the Migraine Disability Assessment Total Score (MIDAS) at Week 12 of the DBT Phase	-4.0 Score on a scale Interval -5.57 to -2.42	-1.6 Score on a scale Interval -3.88 to 0.7

SECONDARY outcome

Timeframe: Baseline, Week 12 of the DBT phase

Population: DBT efficacy analysis set included participants in the full analysis set who (1) were randomized only once, and (2) took \>= 1 dose of DB study intervention. Analysis was based on DBT efficacy analysis set with paired data (i.e., nonmissing scores at both baseline and Week 12). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome.

EQ-5D-5L is a standardized measure of health status. The EQ-5D-5L consisted of EQ-5D-5L descriptive system and the EQ VAS. For EQ VAS participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

Outcome measures

Outcome measures
Measure	Rimegepant n=228 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=237 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Mean Change From Baseline in the EuroQol 5 Dimensions 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Week 12 of the DBT Phase	3.5 Score on a scale Interval 1.6 to 5.37	0.8 Score on a scale Interval -1.4 to 3.02

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: Double-blind safety analysis set (DBSAS) included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

An Adverse Event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Definition of AE in terms of intensity: 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 participant. Severe: Interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Adverse Events (AEs) By Intensity in DBT Phase Any AE	135 Participants	102 Participants
Number of Participants With Adverse Events (AEs) By Intensity in DBT Phase Mild AE	110 Participants	96 Participants
Number of Participants With Adverse Events (AEs) By Intensity in DBT Phase Moderate AE	24 Participants	6 Participants
Number of Participants With Adverse Events (AEs) By Intensity in DBT Phase Severe AE	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: Open label (OL) SAS included participants in the SAS who took \>= 1 dose of OL Rimegepant.

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Definition of AE in terms of intensity: 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 participant. Severe: Interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.

Outcome measures

Outcome measures
Measure	Rimegepant n=227 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With AEs By Intensity in Open-Label Extension (OLE) Phase Any AE	162 Participants	175 Participants
Number of Participants With AEs By Intensity in Open-Label Extension (OLE) Phase Mild AE	127 Participants	141 Participants
Number of Participants With AEs By Intensity in Open-Label Extension (OLE) Phase Moderate AE	33 Participants	33 Participants
Number of Participants With AEs By Intensity in Open-Label Extension (OLE) Phase Severe AE	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the off spring who received rimegepant were considered an important medical event.

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Serious Adverse Events (SAEs) in DBT Phase	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant.

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the offspring who received rimegepant were considered an important medical event.

Outcome measures

Outcome measures
Measure	Rimegepant n=227 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With SAEs in OLE Phase	4 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With AEs Leading to Discontinuation of Study Drug in DBT Phase	4 Participants	2 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up at Week 12 to Week 52 (40 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant.

Outcome measures

Outcome measures
Measure	Rimegepant n=227 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With AEs Leading to Discontinuation of Study Drug in OLE Phase	2 Participants	4 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). Here, '' Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

The laboratory parameters were graded according to the National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version (v)5.0 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE and Grade 4=life-threatening consequences; urgent intervention indicated. Hematology parameters included: eosinophils, hemoglobin (high, low), lymphocytes (high, low), white blood cell count (WBC) (low, high), platelets, and neutrophils. hematocrit, red blood cell count, Number of participants with non-zero laboratory abnormalities of hematology parameters were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=241 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=243 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Hematology Parameters Hemoglobin, low	2 Participants	0 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Hematology Parameters Neutrophils	4 Participants	0 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Hematology Parameters Platelets	1 Participants	0 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Hematology Parameters White blood cell count, low	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. Here, '' Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

The laboratory parameters were graded according to the NCI CTCAE v5.0 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE and Grade 4=life-threatening consequences; urgent intervention indicated. Hematology parameters included: eosinophils, hemoglobin (high, low), lymphocytes (high, low), WBC (low, high), platelets, and neutrophils. Number of participants with non-zero laboratory abnormalities of hematology parameters were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=226 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Hematology Parameters Hemoglobin, low	2 Participants	1 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Hematology Parameters Lymphocytes, low	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row.

The laboratory parameters were graded according to the NCI CTCAE v5.0 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Serum chemistry parameters included: creatine kinase, low density lipoprotein (LDL) cholesterol, LDL cholesterol, fasting, triglycerides, triglycerides, fasting and not fasting, alanine aminotransferase increased, albumin, alkaline phosphatase, aspartate aminotransferase increased, bicarbonate, bilirubin, calcium (high, low), cholesterol, creatinine, estimated glomerular filtration rate (eGFR), glucose (high, low), lactate dehydrogenase, LDL cholesterol, potassium (high, low), sodium (high, low), and uric acid. Number of participants with non-zero laboratory abnormalities of serum chemistry parameters were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Serum Chemistry Parameters Creatine kinase	4 Participants	0 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Serum Chemistry Parameters LDL cholesterol	0 Participants	4 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Serum Chemistry Parameters Triglycerides	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. Here, '' Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

The laboratory parameters were graded according to the NCI CTCAE v5.0 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Serum chemistry parameters included: creatine kinase, LDL cholesterol, LDL cholesterol, triglycerides, triglycerides, alanine aminotransferase increased, albumin, alkaline phosphatase, aspartate aminotransferase increased, bicarbonate, bilirubin, calcium (high, low), cholesterol, creatinine, eGFR, glucose (high, low), lactate dehydrogenase, potassium (high, low), sodium (high, low), uric acid. Number of participants with non-zero laboratory abnormalities of serum chemistry parameters were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=225 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Serum Chemistry Parameters LDL cholesterol	7 Participants	7 Participants
Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Serum Chemistry Parameters Triglycerides	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Grade 3 to 4 Changes in DBT Phase: Urinalysis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

The laboratory parameters were graded according to the NCI CTCAE v5.0 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE and Grade 4=life-threatening consequences; urgent intervention indicated. Urinalysis parameters included: urine glucose and urine protein. Number of participants with non-zero laboratory abnormalities of urinalysis parameters were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=217 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=224 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Grade 3 to 4 Changes in OLE Phase: Urinalysis	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

Number of participants with ALT or AST \>3\*ULN concurrent with TBIL \>2\*ULN in DBT phase were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3* Upper Lower Limit of Normal (ULN) Concurrent With Total Bilirubin (TBIL) >2*ULN in DBT Phase	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant.

Number of participants with ALT or AST \>3\*ULN concurrent with TBIL \>2\*ULN in OLE phase were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Rimegepant n=227 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With ALT or AST> 3* ULN Concurrent With TBIL >2* ULN in OLE Phase	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Hepatic-related AEs in the DBT Phase	3 Participants	4 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant.

Outcome measures

Outcome measures
Measure	Rimegepant n=227 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Hepatic-related AEs in the OLE Phase	8 Participants	7 Participants

SECONDARY outcome

Timeframe: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks)

Population: DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo).

Outcome measures

Outcome measures
Measure	Rimegepant n=247 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=249 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation in the DBT Phase	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks)

Population: OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant.

Outcome measures

Outcome measures
Measure	Rimegepant n=227 Participants Participants received Rimegepant at a dose of 75 mg orally as an ODT, once EOD for 12 weeks in the DBT period.	Placebo n=231 Participants Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period.
Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation in the OLE Phase	2 Participants	1 Participants

Adverse Events

DBT: Rimegepant

Serious events: 2 serious events

Other events: 85 other events

Deaths: 0 deaths

DBT: Placebo

Serious events: 1 serious events

Other events: 73 other events

Deaths: 0 deaths

DBT Rimegepant/OLE Rimegepant

Serious events: 4 serious events

Other events: 148 other events

Deaths: 0 deaths

DBT Placebo/OLE Rimegepant

Serious events: 0 serious events

Other events: 150 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DBT: Rimegepant n=247 participants at risk Participants received Rimegepant at a dose of 75 mg, orally as an ODT, once EOD for 12 weeks in the DBT period. Eligible participants continued to receive Rimegepant in a similar way from Week 12 to Week 52 (40 weeks) in the OLE period.	DBT: Placebo n=249 participants at risk Participants received placebo, orally as an ODT, once EOD for 12 weeks in the DBT period. Eligible participants continued to receive Rimegepant at a dose of 75 mg, orally as an ODT from Week 12 to Week 52 (40 weeks) in the OLE period.	DBT Rimegepant/OLE Rimegepant n=227 participants at risk Eligible participants continued to receive Rimegepant in a similar way from Week 12 to Week 52 (40 weeks) in the OLE period.	DBT Placebo/OLE Rimegepant n=231 participants at risk Eligible participants continued to receive Rimegepant at a dose of 75 mg, orally as an ODT from Week 12 to Week 52 (40 weeks) in the OLE period.
Gastrointestinal disorders Pancreatitis acute	0.40% 1/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.
Infections and infestations Appendicitis	0.00% 0/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.40% 1/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.
Infections and infestations COVID-19	0.40% 1/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.
Gastrointestinal disorders Constipation	0.00% 0/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.44% 1/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.44% 1/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.
Musculoskeletal and connective tissue disorders Nodal osteoarthritis	0.00% 0/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.44% 1/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.
Infections and infestations Coronavirus infection	0.00% 0/247 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/249 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.44% 1/227 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.	0.00% 0/231 • DBT phase: From Day 1 of dosing up to 7 days post last dose of study drug in DBT phase or prior to start of OL rimegepant dose, whichever was earlier (maximum up to 13 weeks); OLE phase: From Day 1 of OL Rimegepant dosing up to 7 days post last dose (maximum up to 41 weeks) Same event may appear as AE \& serious adverse events (SAE), what is presented are distinct events. Event may be categorized as serious in 1 and as non-SAE in another participant, or 1 participant may have experienced both serious \& non-SAE. DBSAS included participants in the SAS who took \>= 1 dose of DB study drug (Rimegepant or placebo). OLSAS included participants in the SAS who took \>= 1 dose of OL Rimegepant. For DBT phase MedDRA version v26.1 and for OLE phase version 27.1 was used.

Other adverse events

Additional Information

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Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER