Migraine, With or Without Aura
Conditions
Brief summary
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Interventions
DRUGRimegepant
75 mg oral tablet
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects with 2-8 moderate to severe migraines/month * Age of onset of migraines prior to 50 years of age * Migraine attacks, on average, lasting 4-72 hours if untreated * Ability to distinguish migraine attacks from tension/cluster headaches * Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria Key
Exclusion criteria
* History of basilar migraine or hemiplegic migraine * History of HIV disease * History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. * Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening * History of gastric or small intestinal surgery or has a disease that causes malabsorption * BMI ≥ 30 * HbA1c ≥ 6.5%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | 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. |
| Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | 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. |
| Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 103 centers in the United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,033 |
| 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. | 481 |
| 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. | 286 |
| Total | 1,800 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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 | No Migraine Treated by Week 8 Visit | 1 | 2 | 0 |
| Long-term Treatment Period | Non-Compliance | 126 | 57 | 7 |
| Long-term Treatment Period | Other Reasons | 5 | 0 | 0 |
| Long-term Treatment Period | Positive Sheehan-STS Score > 0 | 0 | 1 | 0 |
| 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 |
| Observational Period | Eligibility Failure- Baseline Lab Values | 3 | 1 | 0 |
| Observational Period | Lost to Follow-up | 8 | 12 | 4 |
| Observational Period | Non-compliance | 18 | 12 | 10 |
| Observational Period | Other Reasons | 3 | 0 | 1 |
| Observational Period | Protocol Deviation | 1 | 0 | 0 |
| Observational Period | Screen Failure: Eligibility Criteria | 439 | 228 | 140 |
| Observational Period | Withdrawal by Subject | 44 | 22 | 13 |
Baseline characteristics
| Characteristic | PRN (2-8) Group | Total | Scheduled EOD + PRN Group | PRN (9-14) Group |
|---|---|---|---|---|
| Age, Continuous | 44.0 years STANDARD_DEVIATION 11.79 | 43.1 years STANDARD_DEVIATION 12.15 | 41.1 years STANDARD_DEVIATION 12.69 | 42.4 years STANDARD_DEVIATION 12.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 99 Participants | 177 Participants | 24 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 934 Participants | 1623 Participants | 262 Participants | 427 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 10 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 32 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 149 Participants | 250 Participants | 35 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 17 Participants | 28 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 847 Participants | 1475 Participants | 234 Participants | 394 Participants |
| Region of Enrollment United States | 1033 participants | 1800 participants | 286 participants | 481 participants |
| Sex: Female, Male Female | 917 Participants | 1609 Participants | 248 Participants | 444 Participants |
| Sex: Female, Male Male | 116 Participants | 191 Participants | 38 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,033 | 0 / 481 | 0 / 286 |
| other Total, other adverse events | 224 / 1,033 | 100 / 481 | 27 / 286 |
| serious Total, serious adverse events | 28 / 1,033 | 16 / 481 | 3 / 286 |
Outcome results
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks
Population: The analysis was performed on treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Alanine Aminotransferase (ALT) | 3 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Albumin | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Alkaline Phosphatase | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Bicarbonate | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Bilirubin | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Calcium, Low | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Calcium, High | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Cholesterol | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Creatine Kinase | 16 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Creatinine | 1 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glomerular Filtration Rate, Estimated | 1 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glucose, Low | 1 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glucose, High | 10 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | LDL-cholesterol | 31 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lactate Dehydrogenase | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Potassium, Low | 2 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Potassium, High | 3 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Sodium, High | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Triglycerides | 1 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Uric Acid | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Hemoglobin | 2 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lymphocytes, Low | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lymphocytes, High | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Neutrophils | 4 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Platelets | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | White Blood Cells | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Erythrocytes | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Glucose | 10 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Protein | 0 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Aspartate Aminotransferase (AST) | 4 Participants |
| PRN (2-8) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Sodium, Low | 1 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Glucose | 2 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Alanine Aminotransferase (ALT) | 2 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Albumin | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Sodium, High | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lymphocytes, High | 1 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Alkaline Phosphatase | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lactate Dehydrogenase | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glucose, High | 1 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Bicarbonate | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Triglycerides | 1 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | LDL-cholesterol | 15 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Bilirubin | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Potassium, Low | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Neutrophils | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Calcium, Low | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Uric Acid | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glucose, Low | 1 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Calcium, High | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Protein | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Sodium, Low | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Cholesterol | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Hemoglobin | 1 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Platelets | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Creatine Kinase | 10 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Potassium, High | 2 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Erythrocytes | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Creatinine | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lymphocytes, Low | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Aspartate Aminotransferase (AST) | 2 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glomerular Filtration Rate, Estimated | 0 Participants |
| PRN (9-14) Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | White Blood Cells | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glomerular Filtration Rate, Estimated | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glucose, Low | 1 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | White Blood Cells | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Glucose, High | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Aspartate Aminotransferase (AST) | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | LDL-cholesterol | 2 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lactate Dehydrogenase | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Erythrocytes | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Potassium, Low | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Sodium, Low | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Sodium, High | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Glucose | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Triglycerides | 3 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Potassium, High | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Uric Acid | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Hemoglobin | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Urine Protein | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lymphocytes, Low | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Albumin | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Alkaline Phosphatase | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Lymphocytes, High | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Bicarbonate | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Alanine Aminotransferase (ALT) | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Bilirubin | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Calcium, Low | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Neutrophils | 1 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Calcium, High | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Cholesterol | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Creatine Kinase | 3 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Platelets | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | Creatinine | 0 Participants |
Primary
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Population: The analysis was performed on treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AEs leading to discontinuation | 24 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Severe-Sinusitis | 1 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Nasopharyngitis | 19 Participants |
| PRN (2-8) Group | 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 |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Sinusitis | 30 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Upper respiratory tract infection | 56 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | SAEs | 28 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Sinusitis | 26 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Sinusitis | 57 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Severe-Upper respiratory tract infection | 1 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Upper respiratory tract infection | 108 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Nasopharyngitis | 72 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Upper respiratory tract infection | 51 Participants |
| PRN (2-8) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Nasopharyngitis | 53 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Sinusitis | 9 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Overall number of participants with at least 1 AE | 315 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Upper respiratory tract infection | 38 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Upper respiratory tract infection | 21 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Upper respiratory tract infection | 17 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Severe-Upper respiratory tract infection | 0 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Nasopharyngitis | 41 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Nasopharyngitis | 28 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Nasopharyngitis | 13 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Sinusitis | 28 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Sinusitis | 19 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Severe-Sinusitis | 0 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | SAEs | 16 Participants |
| PRN (9-14) Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AEs leading to discontinuation | 16 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Upper respiratory tract infection | 12 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Nasopharyngitis | 9 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Severe-Upper respiratory tract infection | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Upper respiratory tract infection | 8 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Sinusitis | 2 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Nasopharyngitis | 7 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Overall number of participants with at least 1 AE | 109 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Severe-Sinusitis | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Upper respiratory tract infection | 4 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AEs leading to discontinuation | 8 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | AE ≥5%-Sinusitis | 7 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Moderate-Nasopharyngitis | 2 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | SAEs | 3 Participants |
| Scheduled EOD + PRN Group | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Mild-Sinusitis | 5 Participants |
Secondary
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period
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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Population: The analysis was performed on treated participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRN (2-8) Group | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | Hepatic-related AE | 16 Participants |
| PRN (2-8) Group | 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 |
| PRN (9-14) Group | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | Hepatic-related AE | 10 Participants |
| PRN (9-14) Group | 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 |
| Scheduled EOD + PRN Group | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | Hepatic-related AE | 0 Participants |
| Scheduled EOD + PRN Group | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | Hepatic-related AE leading to discontinuation | 0 Participants |
Secondary
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
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.
Time frame: PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks
Population: The analysis was performed on treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRN (2-8) Group | 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 |
| PRN (9-14) Group | 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 Percentage of participants |
| Scheduled EOD + PRN Group | 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 Percentage of participants |