Trial Outcomes & Findings for Open Label Safety Study in Acute Treatment of Migraine (NCT NCT03266588)
NCT ID: NCT03266588
Last Updated: 2023-02-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
3019 participants
Primary outcome timeframe
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Results posted on
2023-02-16
Participant Flow
The study was conducted at 103 centers in the United States.
A total of 3019 participants were screened for this open-label study. A total of 2867 participants entered the observational period, and 1908 participants subsequently enrolled in the long-term treatment period of whom 1800 received treatment. A total of 807 participants failed screening mainly due to failure to meet eligibility criteria.
Participant milestones
| Measure |
PRN (2-8) Group
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Observational Period
STARTED
|
1605
|
786
|
476
|
|
Observational Period
COMPLETED
|
1089
|
511
|
308
|
|
Observational Period
NOT COMPLETED
|
516
|
275
|
168
|
|
Long-term Treatment Period
STARTED
|
1089
|
511
|
308
|
|
Long-term Treatment Period
Treated
|
1033
|
481
|
286
|
|
Long-term Treatment Period
COMPLETED
|
683
|
271
|
243
|
|
Long-term Treatment Period
NOT COMPLETED
|
406
|
240
|
65
|
Reasons for withdrawal
| Measure |
PRN (2-8) Group
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Observational Period
Screen Failure: Eligibility Criteria
|
439
|
228
|
140
|
|
Observational Period
Withdrawal by Subject
|
44
|
22
|
13
|
|
Observational Period
Non-compliance
|
18
|
12
|
10
|
|
Observational Period
Lost to Follow-up
|
8
|
12
|
4
|
|
Observational Period
Eligibility Failure- Baseline Lab Values
|
3
|
1
|
0
|
|
Observational Period
Protocol Deviation
|
1
|
0
|
0
|
|
Observational Period
Other Reasons
|
3
|
0
|
1
|
|
Long-term Treatment Period
Adverse Event
|
33
|
17
|
8
|
|
Long-term Treatment Period
Lack of Efficacy
|
41
|
31
|
5
|
|
Long-term Treatment Period
Lost to Follow-up
|
39
|
37
|
8
|
|
Long-term Treatment Period
Non-Compliance
|
126
|
57
|
7
|
|
Long-term Treatment Period
Pregnancy
|
11
|
5
|
0
|
|
Long-term Treatment Period
Protocol Deviation
|
17
|
10
|
4
|
|
Long-term Treatment Period
Screen Failure: Eligibility Criteria
|
33
|
17
|
17
|
|
Long-term Treatment Period
Withdrawal by Subject
|
100
|
63
|
16
|
|
Long-term Treatment Period
No Migraine Treated by Week 8 Visit
|
1
|
2
|
0
|
|
Long-term Treatment Period
Other Reasons
|
5
|
0
|
0
|
|
Long-term Treatment Period
Positive Sheehan-STS Score > 0
|
0
|
1
|
0
|
Baseline Characteristics
Open Label Safety Study in Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
PRN (2-8) Group
n=1033 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
Total
n=1800 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 12.41 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 12.69 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 12.15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
917 Participants
n=5 Participants
|
444 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
1609 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
99 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
934 Participants
n=5 Participants
|
427 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
1623 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
149 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
847 Participants
n=5 Participants
|
394 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
1475 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1033 participants
n=5 Participants
|
481 participants
n=7 Participants
|
286 participants
n=5 Participants
|
1800 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeksPopulation: The analysis was performed on treated participants.
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 |
PRN (2-8) Group
n=1033 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Overall number of participants with at least 1 AE
|
664 Participants
|
315 Participants
|
109 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
AE ≥5%-Upper respiratory tract infection
|
108 Participants
|
38 Participants
|
12 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Mild-Upper respiratory tract infection
|
56 Participants
|
21 Participants
|
8 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Moderate-Upper respiratory tract infection
|
51 Participants
|
17 Participants
|
4 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Severe-Upper respiratory tract infection
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
AE ≥5%-Nasopharyngitis
|
72 Participants
|
41 Participants
|
9 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Mild-Nasopharyngitis
|
53 Participants
|
28 Participants
|
7 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Moderate-Nasopharyngitis
|
19 Participants
|
13 Participants
|
2 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
AE ≥5%-Sinusitis
|
57 Participants
|
28 Participants
|
7 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Mild-Sinusitis
|
26 Participants
|
19 Participants
|
5 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Moderate-Sinusitis
|
30 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
Severe-Sinusitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
SAEs
|
28 Participants
|
16 Participants
|
3 Participants
|
|
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
AEs leading to discontinuation
|
24 Participants
|
16 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeksPopulation: The analysis was performed on treated participants.
Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment 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 on-treatment period to be included for a given parameter.
Outcome measures
| Measure |
PRN (2-8) Group
n=1033 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Alanine Aminotransferase (ALT)
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Aspartate Aminotransferase (AST)
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Albumin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Bicarbonate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Lactate Dehydrogenase
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Potassium, Low
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Potassium, High
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Sodium, Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Sodium, High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Triglycerides
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Uric Acid
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Hemoglobin
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Lymphocytes, Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Lymphocytes, High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Neutrophils
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
White Blood Cells
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Urine Erythrocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Urine Glucose
|
10 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Urine Protein
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Calcium, Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Calcium, High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Cholesterol
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Creatine Kinase
|
16 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Creatinine
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Glomerular Filtration Rate, Estimated
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Glucose, Low
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
Glucose, High
|
10 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
LDL-cholesterol
|
31 Participants
|
15 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeksPopulation: The analysis was performed on treated participants.
Elevations of on-treatment AST or ALT \> 3 x ULN concurrent with total bilirubin \> 2 x ULN were defined as elevations on the same collection date.
Outcome measures
| Measure |
PRN (2-8) Group
n=1033 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0 Percentage of participants
Interval 0.0 to 0.96
|
0 Percentage of participants
Interval 0.0 to 1.6
|
SECONDARY outcome
Timeframe: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeksPopulation: The analysis was performed on treated participants.
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 patient administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Hepatic AEs were defined as all on-treatment PTs under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those PTs in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.
Outcome measures
| Measure |
PRN (2-8) Group
n=1033 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 Participants
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period
Hepatic-related AE
|
16 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period
Hepatic-related AE leading to discontinuation
|
3 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
PRN (2-8) Group
Serious events: 28 serious events
Other events: 224 other events
Deaths: 0 deaths
PRN (9-14) Group
Serious events: 16 serious events
Other events: 100 other events
Deaths: 0 deaths
Scheduled EOD + PRN Group
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRN (2-8) Group
n=1033 participants at risk
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 participants at risk
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 participants at risk
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While ontreatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
General disorders
Chest pain
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
General disorders
Pyrexia
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.62%
3/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Influenza
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Mastitis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Pneumonia
|
0.19%
2/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Sepsis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.35%
1/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Viral sepsis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.29%
3/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
2/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Nervous system disorders
Headache
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Nervous system disorders
Hemiplegia
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Nervous system disorders
Hemiplegic migraine
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Nervous system disorders
Migraine with aura
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Psychiatric disorders
Suicidal ideation
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.35%
1/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.35%
1/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Vascular disorders
Aortic dissection
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.21%
1/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.10%
1/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
0.00%
0/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
Other adverse events
| Measure |
PRN (2-8) Group
n=1033 participants at risk
To meet entry criteria, these participants had to have a self-reported historical rate of 2 to 8 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
PRN (9-14) Group
n=481 participants at risk
To meet entry criteria, these participants had to have a self-reported historical rate of 9 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose as needed (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While on-treatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 52 weeks.
|
Scheduled EOD + PRN Group
n=286 participants at risk
To meet entry criteria, these participants had to have a self-reported historical rate of 4 to 14 moderate to severe migraine attacks per month preceding enrollment in the group. Participants were allowed to dose every other day (EOD); on the days that participants were not scheduled for dosing, the participants were allowed to dose on an as-needed basis (PRN), up to 1 tablet per calendar day, with 75 mg of rimegepant tablet. While ontreatment, participants were allowed to treat migraine attacks of any severity (mild, moderate, or severe) for a planned duration up to 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.0%
72/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
8.5%
41/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
3.1%
9/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Sinusitis
|
5.5%
57/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
5.8%
28/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
2.4%
7/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
108/1033 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
7.9%
38/481 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
4.2%
12/286 • Adverse events were reported from start of study drug treatment up to 52 weeks
The analysis was performed on treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60