Episodic Migraine, Migraine, Phonophobia, Photophobia
Conditions
Brief summary
The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.
Detailed description
This is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.
Interventions
DRUGRimegepant
rimegepant ODT 75mg daily
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: * Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following: * Age of onset of migraines prior to 50 years of age * Migraine attacks, on average, lasting 4 -72 hours if untreated * Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol) * Subjects ≥ 18 years Key
Exclusion criteria
* Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit. * Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes. * The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study * History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit * WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug * Women who are pregnant or breastfeeding * Women with a positive pregnancy test at screening or prior to study drug administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM. |
| Number of Participants With On-Treatment Serious Adverse Events (SAEs) | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) | An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. |
| Number of Participants With AEs Leading to Study Drug Discontinuation | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure. |
| Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) | The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening). |
| Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks) | The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening). |
Countries
United States
Participant flow
Pre-assignment details
Out of the 441 enrolled participants, only 250 received study treatment; 184 participants failed screening, 6 participants were lost to follow-up and 1 participant withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Rimegepant Participants received a single dose of Rimegepant 75 mg ODT daily for 24 weeks during the open-label treatment phase. | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up Phase | Lost to Follow-up | 1 |
| Follow-up Phase | Non-compliance | 1 |
| Follow-up Phase | Not collected | 11 |
| Follow-up Phase | Not reported | 2 |
| Open-Label Treatment Phase | Adverse Event | 7 |
| Open-Label Treatment Phase | Lost to Follow-up | 8 |
| Open-Label Treatment Phase | Non-compliance | 3 |
| Open-Label Treatment Phase | Other | 17 |
| Open-Label Treatment Phase | Physician Decision | 2 |
| Open-Label Treatment Phase | Pregnancy | 1 |
| Open-Label Treatment Phase | Protocol-specified withdrawal criterion met | 14 |
| Open-Label Treatment Phase | Protocol Violation | 1 |
| Open-Label Treatment Phase | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Rimegepant |
|---|---|
| Age, Continuous | 42.6 Years STANDARD_DEVIATION 14.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 215 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 216 Participants |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 250 | 0 / 235 |
| other Total, other adverse events | 48 / 250 | 2 / 235 |
| serious Total, serious adverse events | 0 / 250 | 2 / 235 |
Outcome results
Primary
Number of Participants With AEs Leading to Study Drug Discontinuation
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. Number of participants with AEs leading to study drug discontinuations are reported in this outcome measure.
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rimegepant | Number of Participants With AEs Leading to Study Drug Discontinuation | 7 Participants |
Primary
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale
The following laboratory parameters were assessed: eosinophils, hemoglobin low and high, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium low and high, cholesterol, creatine kinase, creatinine, glomerular filtration rate estimated, glucose low and high, lactate dehydrogenase, low-density lipoprotein (LDL) cholesterol, LDL cholesterol fasting and not fasting, potassium low and high, sodium low and high, triglycerides, triglycerides fasting and not fasting, uric acid, urine glucose and urine protein. Laboratory abnormalities were graded according to NCI CTCAE v5.0; where grade 3=severe and grade 4=life-threatening except for glucose, LDL cholesterol, and urinalysis where DAIDS v2.1 was used. (grade 3= severe and grade 4= life-threatening).
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row and Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Eosinophils | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Hemoglobin, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Hemoglobin, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Leukocytes, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Lymphocytes, low | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Lymphocytes, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Neutrophils | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Platelets | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Alanine Aminotransferase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Albumin | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Alkaline Phosphatase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Aspartate Aminotransferase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Bicarbonate | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Bilirubin | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Calcium, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Calcium, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Cholesterol | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Creatine Kinase | 9 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Creatinine | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Glomerular Filtration Rate, Estimated | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Glucose, low | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Glucose, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Lactate Dehydrogenase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | LDL Cholesterol | 22 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | LDL Cholesterol, fasting | 14 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | LDL Cholesterol, not fasting | 9 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Potassium, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Potassium, high | 3 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Sodium, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Sodium, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Triglycerides | 2 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Triglycerides, fasting | 2 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Triglycerides, not fasting | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Uric Acid | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Urine Glucose | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Common Technical Criteria for Adverse Events- Division of Acquired Immune Deficiency Syndrome (CTCAE/DAIDS) Toxicity Grading Scale | Urine Protein | 0 Participants |
Primary
Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale
The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes low, lymphocytes low and high, neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urine nitrogen, calcium low and high, cholesterol, creatine, glucose low and high, potassium low and high, protein, sodium low and high, urine glucose and urine protein. Laboratory abnormality events were graded according to FDA toxicity grading scale (grade 3= severe and grade 4= life-threatening).
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row and Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Eosinophils | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Hemoglobin | 4 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Leukocytes, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Leukocytes, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Lymphocytes | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Neutrophils | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Platelets | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Alanine Aminotransferase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Albumin | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Alkaline Phosphatase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Aspartate Aminotransferase | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Bilirubin | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Blood Urine Nitrogen | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Calcium, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Calcium, high | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Cholesterol | 54 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Creatinine | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Glucose, low | 4 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Glucose, high | 19 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Potassium, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Potassium, high | 10 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Protein | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Sodium, low | 0 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Sodium, high | 6 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Urine Glucose | 1 Participants |
| Rimegepant | Number of Participants With Grade 3 to 4 Laboratory Abnormalities On-Treatment Using Food and Drug Administration (FDA) Toxicity Grading Scale | Urine Protein | 0 Participants |
Primary
Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and did not necessarily have causal relationship with treatment. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment. AEs were classified according to intensity as: mild: transient and required minimal treatment or therapeutic intervention, event did not interfere with usual activities of daily living; moderate: alleviated with additional specific therapeutic intervention, event interfered with activities of daily living, causing discomfort; severe: interrupted activities of daily living, affected clinical status, or required intensive treatment. AEs occurring in \>=5% participants are reported in this OM.
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Population: Safety analysis set included participants in the enrolled analysis set who took greater than or equal to (\>=) 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rimegepant | Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity | Mild | 33 Participants |
| Rimegepant | Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity | Moderate | 17 Participants |
| Rimegepant | Number of Participants With On-Treatment Adverse Events (AEs) (Frequency >=5%) According to Intensity | Moderate or severe | 17 Participants |
Primary
Number of Participants With On-Treatment Serious Adverse Events (SAEs)
An SAE was any event that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; was persistent or caused significant disability/incapacity or congenital anomaly/birth defect in the offspring of a participant who received Rimegepant, or other important medical events. On-treatment AEs were those AEs which occurred after the study treatment start date until 7 days after last dose of study treatment.
Time frame: From start of study treatment (Day 1) up to 7 days after the last dose of study treatment (Up to 25 weeks)
Population: Safety analysis set included participants in the enrolled analysis set who took \>= 1 dose of study drug (rimegepant), i.e., nonmissing study drug start date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rimegepant | Number of Participants With On-Treatment Serious Adverse Events (SAEs) | 0 Participants |