Episodic Migraine
Conditions
Keywords
Migraine, Aura
Brief summary
The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.
Interventions
DRUGAtogepant
Atogepant Tablets
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. * Participants must be using a medically acceptable and effective method of birth control during the course of the entire study. * Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).
Exclusion criteria
* Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. * Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit 1. * Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Up to Week 44 | Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported. |
| Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | Up to Week 40 | 12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. |
| Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Up to Week 44 | PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. |
| Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44 | C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior. |
Countries
United States
Participant flow
Pre-assignment details
Participants rolled over from the lead-in study 3101-301-002 (NCT03777059) into this extension study. This study consisted of two periods: Open-label (OL) Treatment Period and Safety Follow-up Period.
Participants by arm
| Arm | Count |
|---|---|
| Atogepant 60 mg Participants received atogepant 60 mg, orally, QD for up to 40 weeks. | 685 |
| Total | 685 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| OL Treatment Period (40 Weeks) | Adverse Event | 25 |
| OL Treatment Period (40 Weeks) | Lack of Efficacy | 4 |
| OL Treatment Period (40 Weeks) | Lost to Follow-up | 19 |
| OL Treatment Period (40 Weeks) | Non-compliance With Study Drug | 4 |
| OL Treatment Period (40 Weeks) | Pregnancy | 3 |
| OL Treatment Period (40 Weeks) | Protocol Deviation | 16 |
| OL Treatment Period (40 Weeks) | Reason Not Specified | 22 |
| OL Treatment Period (40 Weeks) | Site Terminated by Sponsor | 3 |
| OL Treatment Period (40 Weeks) | Withdrawal by Subject | 35 |
| OL Treatment Period (40 Weeks) | Withdrawal Criteria at Visit 1 | 43 |
| Safety Follow-up 4 Weeks (Up to Week 44) | Lost to Follow-up | 4 |
| Safety Follow-up 4 Weeks (Up to Week 44) | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Atogepant 60 mg |
|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 631 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 86 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 578 Participants |
| Sex: Female, Male Female | 604 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 685 |
| other Total, other adverse events | 71 / 685 |
| serious Total, serious adverse events | 23 / 685 |
Outcome results
Primary
Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | TEAEs | 62.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | TESAEs | 3.4 percentage of participants |
Secondary
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.
Time frame: OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44
Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study. One Safety population was used for the entire study. If participants were eligible for the Safety Follow-up they were included in the analyses even if they did not participate in the Safety Follow-up Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atogepant 60 mg | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 4 Participants |
| Atogepant 60 mg | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 0 Participants |
| Safety Follow-up Period | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 1 Participants |
| Safety Follow-up Period | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 0 Participants |
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator
12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time frame: Up to Week 40
Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QRS Duration, Single Beat (msec): ≥ 150 milliseconds (msecs) | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | PR interval, Single Beat (msec): ≥ 250 msecs | 0.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcB interval, Single Beat (msec): > 500 msecs | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcB interval, Single Beat (msec): Increase > 60 msecs | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF interval, Single Beat (msec): Increase > 60 msecs | 0.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF interval, Single Beat (msec): >450 msecs | 3.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF interval, Single Beat (msec): >480 msecs | 0.1 percentage of participants |
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator
Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.
Time frame: Up to Week 44
Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study. Number analyzed are participants with data available for analyses of the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Hematocrit (Ratio): > 1.1 × ULN | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Eosinophils Absolute Cell Count (10^9/L): > 2.0 × Upper Limit of Normal (ULN) | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Hematocrit (Ratio): < 0.9 × Lower Limit of Normal (LLN) | 1.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Hemoglobin (g/L): < 0.9 × LLN | 2.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Lymphocytes Absolute Cell Count (10^9/L): < 0.7 × LLN | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Lymphocytes Absolute Cell Count (10^9/L): > 1.3 × ULN | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Monocytes Absolute Cell Count (10^9/L): < 0.5 × LLN | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Neutrophils Absolute Cell Count (10^9/L): < 0.7 × LLN | 1.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Neutrophils Absolute Cell Count (10^9/L): > 1.3 × ULN | 4.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Platelet Count (Thrombocytes) (10^9/L): < 0.5 × LLN | 0.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Platelet Count (Thrombocytes) (10^9/L): > 1.5 × ULN | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Red Blood Cell Count (10^12/L): < 0.9 × LLN | 2.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Red Blood Cell Count (10^12/L): > 1.1 × ULN | 0.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | White Blood Cell Count (10^9/L): < 0.9 × LLN | 3.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | White Blood Cell Count (10^9/L): > 1.5 × ULN | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Alanine Aminotransferase (SGPT) (U/L): ≥ 3.0 × ULN | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Aspartate Aminotransferase (SGOT) (U/L): ≥ 3.0 × ULN | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Bicarbonate (HCO3) (mmol/L): < 0.9 × LLN | 0.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Bilirubin, Total (umol/L): ≥ 1.5 × ULN | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Blood Urea Nitrogen (mmol/L): > 1.5 × ULN | 0.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Creatine Kinase (U/L): > 2.0 × ULN | 5.0 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Creatinine (umol/L): > 1.5 × ULN | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Glomerular Filtration Rate (GFR) Estimated Calculation (mL/min/1.73m^2): < 60 mL/min/1.73m^2 | 15.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Glucose, Non-fasting (mmol/L): < 0.8 × LLN | 2.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Glucose, Non-fasting (mmol/L): > 2.0 × ULN | 0.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Phosphorus (mmol/L): < 0.9 × LLN | 1.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Phosphorus (mmol/L): > 1.1 × ULN | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Potassium (mmol/L): > 1.1 × ULN | 2.2 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Protein, Total (g/L): < 0.9 × LLN | 0.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Uric Acid (Urate) (umol/L): > 1.2 × ULN | 0.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Urine Glucose: At Least 1+ | 0.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator | Urine Protein: At Least 1+ | 27.6 percentage of participants |
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time frame: Up to Week 44
Population: Safety population included all participants who received at least 1 dose of atogepant in this extension study. Number analyzed are participants with data available for analyses of the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Systolic Blood Pressure Sitting (mmHg): ≤ 90 and Decrease of ≥ 20 | 1.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Systolic Blood Pressure Standing (mmHg): ≤ 90 and Decrease of ≥ 20 | 0.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Systolic Blood Pressure Standing (mmHg): ≥ 180 and Increase of ≥ 20 | 0.1 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting Systolic Blood Pressure (mmHg): ≤ -20 | 9.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Diastolic Blood Pressure Sitting (mmHg): ≤ 50 and Decrease of ≥ 15 | 0.6 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Diastolic Blood Pressure Sitting (mmHg): ≥ 105 and Increase of ≥ 15 | 1.0 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Diastolic Blood Pressure Standing (mmHg): ≤ 50 and Decrease of ≥ 15 | 0.7 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Diastolic Blood Pressure Standing (mmHg): ≥ 105 and Increase of ≥ 15 | 1.5 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting Diastolic Blood Pressure (mmHg): ≤ -15 | 7.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Pulse Rate Sitting (beats/min): ≤ 50 and Decrease of ≥ 15 | 0.3 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Pulse Rate Standing (beats/min): ≤ 50 and Decrease of ≥ 15 | 0.4 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Pulse Rate Standing (beats/min): ≥ 120 and Increase of ≥ 15 | 1.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Standing - Sitting Pulse Rate (beats/min): ≥ 25 | 6.8 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Decrease of ≥ 7 percent (%) | 23.9 percentage of participants |
| Atogepant 60 mg | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Increase of ≥ 7% | 9.2 percentage of participants |