Trial Outcomes & Findings for Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults (NCT NCT03732638)
NCT ID: NCT03732638
Last Updated: 2024-06-07
Results Overview
A migraine day: any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache: a migraine with or without aura, lasting for ≥30 minutes, and meeting at least 1 of the following criteria (a and/or b): a) ≥2 of the following: unilateral location, pulsating quality, moderate to severe pain intensity, aggravation by or causing avoidance of routine physical activity; b) ≥1 of the following: nausea and/or vomiting, photophobia, and phonophobia. If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the last 4 weeks of the DBT phase (Weeks 9 to 12) minus number of monthly migraine days during the OP.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1590 participants
Primary outcome timeframe
OP and Weeks 9 to 12 of the DBT phase
Results posted on
2024-06-07
Participant Flow
The study was conducted at 92 sites in the United States.
A total of 1590 participants were enrolled in the study, of which 747 participants were randomized and 844 were not randomized. Of 747 randomized participants, 741 participants received treatment with blinded study medication. The study was divided into 4 phases: a 4-week observation period (OP), a 12-week double-blind treatment (DBT) phase, a 52-week open-label extension (OLE) phase, and an 8-week follow-up safety phase.
Participant milestones
| Measure |
DBT Rimegepant/OL Rimegepant
DBT phase (Weeks 1 through 12): Participants received a single oral dose of rimegepant 75 mg tablet every other day (EOD) for 12 weeks.
OLE phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed \[PRN\] dosing).
After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
DBT Placebo/OL Rimegepant
DBT phase (Weeks 1 through 12): Participants received a single oral dose of placebo matching to rimegepant tablet EOD for 12 weeks.
OLE phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing).
After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
|---|---|---|
|
DBT Phase (Weeks 1 to 12)
STARTED
|
370
|
371
|
|
DBT Phase (Weeks 1 to 12)
COMPLETED
|
316
|
310
|
|
DBT Phase (Weeks 1 to 12)
NOT COMPLETED
|
54
|
61
|
|
OLE Phase (Weeks 13 to 64)
STARTED
|
302
|
301
|
|
OLE Phase (Weeks 13 to 64)
COMPLETED
|
209
|
219
|
|
OLE Phase (Weeks 13 to 64)
NOT COMPLETED
|
93
|
82
|
|
Follow-up Phase (up to 72 Weeks)
STARTED
|
332
|
336
|
|
Follow-up Phase (up to 72 Weeks)
COMPLETED
|
267
|
274
|
|
Follow-up Phase (up to 72 Weeks)
NOT COMPLETED
|
65
|
62
|
Reasons for withdrawal
| Measure |
DBT Rimegepant/OL Rimegepant
DBT phase (Weeks 1 through 12): Participants received a single oral dose of rimegepant 75 mg tablet every other day (EOD) for 12 weeks.
OLE phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed \[PRN\] dosing).
After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
DBT Placebo/OL Rimegepant
DBT phase (Weeks 1 through 12): Participants received a single oral dose of placebo matching to rimegepant tablet EOD for 12 weeks.
OLE phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing).
After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
|---|---|---|
|
DBT Phase (Weeks 1 to 12)
Adverse Event
|
5
|
2
|
|
DBT Phase (Weeks 1 to 12)
Eligibility failure due to baseline laboratory values
|
8
|
13
|
|
DBT Phase (Weeks 1 to 12)
Lack of Efficacy
|
1
|
1
|
|
DBT Phase (Weeks 1 to 12)
Lost to Follow-up
|
19
|
12
|
|
DBT Phase (Weeks 1 to 12)
Non-compliance
|
6
|
5
|
|
DBT Phase (Weeks 1 to 12)
Physician Decision
|
0
|
1
|
|
DBT Phase (Weeks 1 to 12)
Protocol deviation
|
4
|
5
|
|
DBT Phase (Weeks 1 to 12)
Withdrawal by Subject
|
11
|
22
|
|
OLE Phase (Weeks 13 to 64)
Adverse Event
|
10
|
9
|
|
OLE Phase (Weeks 13 to 64)
Death
|
1
|
1
|
|
OLE Phase (Weeks 13 to 64)
Extension phase eligibility failure due to week 12 laboratory values
|
2
|
0
|
|
OLE Phase (Weeks 13 to 64)
Lack of Efficacy
|
2
|
2
|
|
OLE Phase (Weeks 13 to 64)
Lost to Follow-up
|
19
|
13
|
|
OLE Phase (Weeks 13 to 64)
Non-compliance
|
15
|
14
|
|
OLE Phase (Weeks 13 to 64)
Physician Decision
|
9
|
9
|
|
OLE Phase (Weeks 13 to 64)
Pregnancy
|
2
|
2
|
|
OLE Phase (Weeks 13 to 64)
Protocol deviation
|
2
|
3
|
|
OLE Phase (Weeks 13 to 64)
Sponsor Recommendation
|
1
|
0
|
|
OLE Phase (Weeks 13 to 64)
Withdrawal by Subject
|
29
|
28
|
|
OLE Phase (Weeks 13 to 64)
Other than specified
|
1
|
1
|
|
Follow-up Phase (up to 72 Weeks)
Not reported
|
49
|
48
|
|
Follow-up Phase (up to 72 Weeks)
Lost to Follow-up
|
10
|
6
|
|
Follow-up Phase (up to 72 Weeks)
Non-compliance
|
2
|
1
|
|
Follow-up Phase (up to 72 Weeks)
Withdrawal by Subject
|
4
|
7
|
Baseline Characteristics
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
Baseline characteristics by cohort
| Measure |
Rimegepant - Randomization Phase
n=370 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
Total
n=741 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 13.01 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 13.13 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
300 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
613 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
265 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
538 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
295 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
604 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: OP and Weeks 9 to 12 of the DBT phasePopulation: The analysis was performed on evaluable modified intent to treat (mITT) participants. Evaluable participants are those with ≥ 14 days of electronic diary efficacy data (not necessarily consecutive) in both the OP and ≥ 1 month (4-week interval) in the DBT phase.
A migraine day: any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache: a migraine with or without aura, lasting for ≥30 minutes, and meeting at least 1 of the following criteria (a and/or b): a) ≥2 of the following: unilateral location, pulsating quality, moderate to severe pain intensity, aggravation by or causing avoidance of routine physical activity; b) ≥1 of the following: nausea and/or vomiting, photophobia, and phonophobia. If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the last 4 weeks of the DBT phase (Weeks 9 to 12) minus number of monthly migraine days during the OP.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=348 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=347 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase
|
-4.3 Total Migraine Days per Month
Interval -4.83 to -3.87
|
-3.5 Total Migraine Days per Month
Interval -4.0 to -3.04
|
SECONDARY outcome
Timeframe: OP and Weeks 9 to 12 of the DBT phasePopulation: The analysis was performed on evaluable mITT participants.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. A moderate or severe migraine day was a migraine day of moderate or severe pain intensity. Months were defined as 28-day intervals. A reduction of at least 50% in the mean number of moderate or severe monthly migraine days was determined if the number of moderate or severe monthly migraine days in the last 4 weeks of the DBT (Weeks 9 to 12) was less than or equal to half (50%) of the number of moderate or severe monthly migraine days in the OP.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=348 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=347 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants Who Had ≥ 50% Reduction in Moderate or Severe Migraine Days Per Month in the Last 4 Weeks of the DBT Phase
|
49.1 percentage of participants
Interval 43.9 to 54.3
|
41.5 percentage of participants
Interval 36.3 to 46.7
|
SECONDARY outcome
Timeframe: OP and Weeks 1 to 12 of the DBT phasePopulation: The analysis was performed on evaluable mITT participants.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the DBT phase (Weeks 1 to 12) minus the number of monthly migraine days during the OP.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=348 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=347 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Mean Number of Migraine Days Per Month Over the Entire Course of the DBT Phase
|
-3.6 Total Migraine Days per Month
Interval -3.97 to -3.17
|
-2.7 Total Migraine Days per Month
Interval -3.14 to -2.34
|
SECONDARY outcome
Timeframe: Weeks 9 to 12 of the DBT phasePopulation: The analysis was performed on evaluable mITT participants
A rescue medication day was a day on which the participant took triptan, ergotamine, or other permitted medication to acutely treat headache or aura. Months were defined as 28-day intervals.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=348 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=347 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Frequency of Use of Rescue Medication Days Per Month in the Last Month of the DBT Phase
|
3.7 rescue medication Days per Month
Interval 3.29 to 4.15
|
4.0 rescue medication Days per Month
Interval 3.53 to 4.39
|
SECONDARY outcome
Timeframe: OP and Weeks 1 to 4 of the DBT phasePopulation: The analysis was performed on evaluable mITT participants.
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the first 4 weeks of the DBT phase (Weeks 1 to 4) minus the number of monthly migraine days during the OP.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=348 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=347 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Mean Number of Total Migraine Days Per Month in the First Month of the DBT Phase
|
-2.9 migraine days per month
Interval -3.32 to -2.46
|
-1.7 migraine days per month
Interval -2.15 to -1.29
|
SECONDARY outcome
Timeframe: Weeks 1 to 12 of the DBT phasePopulation: The analysis was performed on the participants treated in the DBT phase.
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=370 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase
AEs leading to study drug discontinuation
|
7 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase
AEs
|
133 Participants
|
133 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase
SAEs
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: OLE Phase (Weeks 13 through 64)Population: Open-Label (OL) rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date).
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=302 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=301 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase
AEs
|
150 Participants
|
162 Participants
|
|
Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase
SAEs
|
7 Participants
|
6 Participants
|
|
Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase
AEs leading to study drug discontinuation
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Weeks 1 to 12 of the DBT phasePopulation: The analysis was performed on the participants treated in the DBT phase.
Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, LDL-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the DBT phase to be included for a given parameter.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=370 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Hemoglobin
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Lymphocytes, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Lymphocytes, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Neutrophils
|
4 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Alanine Aminotransferase (ALT)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Aspartate Aminotransferase (AST)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Bilirubin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Calcium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Cholesterol
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Creatine Kinase
|
4 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Creatinine
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Glucose, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
LDL-cholesterol, fasting
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
LDL-cholesterol, not fasting
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Triglycerides, fasting
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Glomerular Filtration Rate, Estimated
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Urine Protein
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Eosinophils
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Platelets
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
White Blood Cells
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Albumin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Bicarbonate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Calcium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Glucose, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
LDL-cholesterol
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Lactate Dehydrogenase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Urine Glucose
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Potassium, high
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Potassium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Sodium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Sodium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Triglycerides
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Triglycerides, not fasting
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase
Uric acid
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OLE Phase (Weeks 13 through 64)Population: OL rimegepant treated participants with available data were included in the analysis.
Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in CTCAE Version 5.0 (2017) if available; otherwise, according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, LDL-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the OLE phase to be included for a given parameter.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=297 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=296 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Eosinophils
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Neutrophils
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Alanine Aminotransferase (ALT)
|
0 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Calcium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Creatinine
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Glucose, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
LDL-cholesterol
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Sodium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Triglycerides
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Urine Protein
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Hemoglobin
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Lymphocytes, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Lymphocytes, low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Platelets
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
White Blood Cells
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Aspartate Aminotransferase (AST)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Albumin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Bicarbonate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Bilirubin
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Calcium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Cholesterol
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Creatine Kinase
|
4 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Glucose, low
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
LDL-cholesterol, fasting
|
2 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
LDL-cholesterol, not fasting
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Lactate Dehydrogenase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Potassium, high
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Potassium, low
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Sodium, high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Triglycerides, fasting
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Triglycerides, not fasting
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Uric acid
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Glomerular Filtration Rate, Estimated
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase
Urine Glucose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 1 to 12 of the DBT phasePopulation: The analysis was performed on the participants treated in the DBT phase.
Elevations of AST or ALT \> 3 x ULN concurrent with TBL \> 2 x ULN were defined as elevations on the same collection date. Participants must have had a non-missing AST, ALT, or TBL measurement in the OLE phase to be included.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=370 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin (TBL) > 2 x ULN During the DBT Phase
|
0 Percentage of participants
Interval 0.0 to 1.24
|
0 Percentage of participants
Interval 0.0 to 1.24
|
SECONDARY outcome
Timeframe: OLE Phase (Weeks 13 through 64)Population: OL rimegepant treated participants with available data were included in the analysis.
Elevations of AST or ALT \> 3 x ULN concurrent with TBL \> 2 x ULN were defined as elevations on the same collection date. Participants must have had a non-missing AST, ALT, or TBL measurement in the DBT phase to be included.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=297 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=296 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Elevations of AST or ALT > 3 x ULN Concurrent With TBL > 2 x ULN During the OLE Phase
|
0 Percentage of participants
Interval 0.0 to 1.51
|
0 Percentage of participants
Interval 0.0 to 1.52
|
SECONDARY outcome
Timeframe: Weeks 1 to 12 of the DBT phasePopulation: The analysis was performed on the participants treated in the DBT phase.
Hepatic AEs were defined as all preferred terms in the DBT phase under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=370 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase
Severe hepatic-related AE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase
Hepatic-related AE leading to study drug discontinuation
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase
Hepatic-related AE
|
6 Participants
|
2 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase
Hepatic-related SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: OLE Phase (Weeks 13 through 64)Population: OL rimegepant treated participants were included in the analysis.
Hepatic AEs were defined as all preferred terms in the OLE phase under the "Hepatic Disorders" SMQ, except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.
Outcome measures
| Measure |
Rimegepant - Randomization Phase
n=302 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=301 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase
Hepatic-related AE
|
2 Participants
|
9 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase
Severe hepatic-related AE
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase
Hepatic-related SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase
Hepatic-related AE leading to study drug discontinuation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 of the DBT PhasePopulation: The analysis was performed on evaluable mITT participants.
The Migraine Specific Quality of Life (MSQoL) is a self-administered, 14-item instrument that has been 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
| Measure |
Rimegepant - Randomization Phase
n=269 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=266 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase
|
18.0 score on a scale
Interval 15.54 to 20.56
|
14.6 score on a scale
Interval 12.07 to 17.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12 of the DBT PhasePopulation: The analysis was performed on evaluable mITT participants
The Migraine Disability Assessment (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
| Measure |
Rimegepant - Randomization Phase
n=269 Participants
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=266 Participants
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
|---|---|---|
|
Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase
|
-11.8 Scores on a scale
Interval -15.41 to -8.21
|
-11.7 Scores on a scale
Interval -15.29 to -8.1
|
Adverse Events
Rimegepant - Randomization Phase
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo - Randomization Phase
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
DBT Rimegepant/OLE Rimegepant - OLE Phase
Serious events: 7 serious events
Other events: 41 other events
Deaths: 1 deaths
DBT Placebo/OLE Rimegepant - OLE Phase
Serious events: 6 serious events
Other events: 37 other events
Deaths: 1 deaths
DBT Rimegepant/OLE Rimegepant - Follow-up Phase
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
DBT Placebo/OLE Rimegepant - Follow-up Phase
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rimegepant - Randomization Phase
n=370 participants at risk
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 participants at risk
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
DBT Rimegepant/OLE Rimegepant - OLE Phase
n=302 participants at risk
OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants, who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed \[PRN\] dosing).
|
DBT Placebo/OLE Rimegepant - OLE Phase
n=301 participants at risk
OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants, who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing).
|
DBT Rimegepant/OLE Rimegepant - Follow-up Phase
n=332 participants at risk
Participants received rimegepant during the DBT phase (Week 1 to Week 12) and OLE phase (Week 13 to Week 64). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the EOT visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
DBT Placebo/OLE Rimegepant - Follow-up Phase
n=336 participants at risk
Participants received placebo during the DBT phase (Week 1 to Week 12) and rimegepant OLE phase (Week 13 to Week 64). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the EOT visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.27%
1/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.27%
1/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.27%
1/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.27%
1/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
1/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.27%
1/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.30%
1/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Psychiatric disorders
Depressive delusion
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.33%
1/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.30%
1/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.30%
1/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Nervous system disorders
Headache
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.30%
1/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
Other adverse events
| Measure |
Rimegepant - Randomization Phase
n=370 participants at risk
Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks.
|
Placebo - Randomization Phase
n=371 participants at risk
Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
|
DBT Rimegepant/OLE Rimegepant - OLE Phase
n=302 participants at risk
OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants, who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed \[PRN\] dosing).
|
DBT Placebo/OLE Rimegepant - OLE Phase
n=301 participants at risk
OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants, who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing).
|
DBT Rimegepant/OLE Rimegepant - Follow-up Phase
n=332 participants at risk
Participants received rimegepant during the DBT phase (Week 1 to Week 12) and OLE phase (Week 13 to Week 64). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the EOT visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
DBT Placebo/OLE Rimegepant - Follow-up Phase
n=336 participants at risk
Participants received placebo during the DBT phase (Week 1 to Week 12) and rimegepant OLE phase (Week 13 to Week 64). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the EOT visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
7.0%
21/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
7.3%
22/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
6.3%
21/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
5.7%
19/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/370 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
0.00%
0/371 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
7.6%
23/302 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
5.0%
15/301 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
6.9%
23/332 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
4.5%
15/336 • DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study. Randomized phase: Participants treated in the DBT phase were included. OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is less than or equal to 60 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER