Chronic Migraine, Episodic Migraine
Conditions
Keywords
Chronic Migraine, Episodic Migraine, Atogepant
Brief summary
This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic (CM) or episodic migraine (EM).
Detailed description
The study recruited the following 2 cohorts: 3101-303-002 CM Completers: Japanese participants who completed lead-in Study 3101 303-002 (PROGRESS; NCT03855137), a Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study of atogepant for the prevention of CM. All 3101 303-002 CM Completers rolled over at Visit 7 (the end of the double-blind treatment period) of the lead-in study, which functioned as Visit 1 for this study, Study 3101-306-002. De Novo EM Participants: Japanese participants with EM who were newly recruited for this study at selected sites. Participation began with a 4-week Screening/Baseline period starting at Visit -1, and those who completed the 4-week Screening/Baseline period and met all entry criteria were enrolled into the 52-week open-label treatment period at Visit 1.
Interventions
DRUGAtogepant 60 mg
Tablets containing 60 mg atogepant
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
3101-303-002 Completers: * Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk. De Novo EM Participants: * Age of the participant at the time of migraine onset \< 50 years. * At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018. * History of 4 to 14 migraine days per month on average in the 3 months prior to Visit -1 in the investigator's judgment. * 4 to 14 migraine days in the 28-day baseline period per eDiary. * Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment.
Exclusion criteria
* Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment. * Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo EM Participants) or Visit 1 (3103-303-002 Completers). * Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit -1 (De Novo EM Participants) or Visit 1 (for all participants) * Significant risk of self-harm based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. * Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease. De Novo EM Participants only: * Difficulty distinguishing migraine headaches from tension-type or other headaches. * Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018. * Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018. * Has \>= 15 headache days per month on average across the 3 months prior to Visit -1 in the investigator's judgment. * Has \>= 15 headache days in the 28-day baseline period per eDiary. * Usage of opioids or barbiturates \> 2 days/month, triptans or ergots \>= 10 days/month, or simple analgesics \>= 15 days/month in the 3 months prior to Visit -1 per investigator's judgment or during the baseline period.
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 first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) | 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 (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) | Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis. |
| Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52 | 12-lead ECGs were performed at select study visits. |
| Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) | Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], and weight. |
| Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | From first dose of study drug until the last dose of study drug (up to 52 weeks) | The 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. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). |
| Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Up to 4 weeks following the last dose of study drug | The 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. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). |
Countries
Japan
Participant flow
Pre-assignment details
The study consisted of a 52-week open-label treatment period and a 4-week safety follow-up period for all participants.
Participants by arm
| Arm | Count |
|---|---|
| Atogepant 60 mg Chronic Migraine Participants with chronic migraine (CM) who completed lead-in Study 3101-303-002 (NCT03855137) received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks. | 155 |
| Atogepant 60 mg Episodic Migraine Participants with episodic migraine (EM) who were newly recruited and met all study entry criteria received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks. | 31 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 0 |
| Overall Study | Lack of Efficacy | 4 | 0 |
| Overall Study | Met Withdrawal Criteria at Visit 1- ECG | 1 | 0 |
| Overall Study | Met Withdrawal Criteria at Visit 1- Laboratory Values | 7 | 0 |
| Overall Study | Other, not specified | 0 | 1 |
| Overall Study | Protocol Deviation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Atogepant 60 mg Chronic Migraine | Atogepant 60 mg Episodic Migraine | Total |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 9.47 | 42.4 years STANDARD_DEVIATION 11.95 | 43.2 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 31 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 155 Participants | 31 Participants | 186 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 141 Participants | 29 Participants | 170 Participants |
| Sex: Female, Male Male | 14 Participants | 2 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 155 | 0 / 31 | 0 / 186 |
| other Total, other adverse events | 108 / 155 | 24 / 31 | 132 / 186 |
| serious Total, serious adverse events | 7 / 155 | 0 / 31 | 7 / 186 |
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 first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)
Population: Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | Any TEAE | 88.4 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | TESAE | 4.5 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | Any TEAE | 90.3 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | TESAE | 0.0 percentage of participants |
Secondary
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period
The 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. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior).
Time frame: From first dose of study drug until the last dose of study drug (up to 52 weeks)
Population: Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.; participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Suicidal behavior | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Suicidal ideation | 1.3 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Actual attempt | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Non-specific active suicidal thoughts | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Interrupted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Aborted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Wish to be dead | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Preparatory acts or behavior | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Active suicidal ideation with specific plan and intent | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Completed Suicide | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | No suicidal behavior | 100 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Non-suicidal self-injurious behavior | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | No suicidal ideation | 98.1 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Non-suicidal self-injurious behavior | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | No suicidal ideation | 100 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Suicidal ideation | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Active suicidal ideation with specific plan and intent | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Non-specific active suicidal thoughts | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal ideation: Wish to be dead | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | No suicidal behavior | 100.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Suicidal behavior | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Actual attempt | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Interrupted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Aborted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Most severe suicidal behavior: Preparatory acts or behavior | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | Completed Suicide | 0.0 percentage of participants |
Secondary
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period
The 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. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior).
Time frame: Up to 4 weeks following the last dose of study drug
Population: Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.; participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Suicidal behavior | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Suicidal ideation | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Actual attempt | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Non-specific active suicidal thoughts | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Interrupted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Aborted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Wish to be dead | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Preparatory acts or behavior | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Active suicidal ideation with specific plan and intent | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Completed Suicide | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | No suicidal behavior | 100 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Non-suicidal self-injurious behavior | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | No suicidal ideation | 100 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Non-suicidal self-injurious behavior | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | No suicidal ideation | 93.5 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Suicidal ideation | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Active suicidal ideation with specific plan and intent | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Non-specific active suicidal thoughts | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal ideation: Wish to be dead | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | No suicidal behavior | 93.5 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Suicidal behavior | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Actual attempt | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Interrupted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Aborted attempt | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Most severe suicidal behavior: Preparatory acts or behavior | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | Completed Suicide | 0.0 percentage of 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.
Time frame: Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52
Population: Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | PR Interval (msec): ≥ 250 | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QRS Duration (msec): ≥ 150 | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF Interval (msec): > 500 | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF Interval (msec): Increase from Baseline of > 60 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF Interval (msec): Increase from Baseline of > 60 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | PR Interval (msec): ≥ 250 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QTcF Interval (msec): > 500 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | QRS Duration (msec): ≥ 150 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) 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. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis.
Time frame: From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)
Population: Safety population: all participants who received at least 1 dose of study intervention (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 Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Calcium (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hemoglobin (g/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Calcium (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Neutrophils (10^9/L): < 0.7 x Lower Limit of Normal (LLN) | 2.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Chloride (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hematocrit (RATIO): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Chloride (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Neutrophils (10^9/L): > 1.3 x Upper Limit of Normal (ULN) | 0.7 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Cholesterol (mmol/L): > 1.6 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Leukocytes, Hematology (10^9/L): < 0.9 x Lower Limit of Normal (LLN) | 12.8 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Creatine Kinase (U/L): > 2.0 x Upper Limit of Normal (ULN) | 2.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Platelets (10^9/L): < 0.5 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Creatinine (umol/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Eosinophils (10^9/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glomerular Filtration Rate, Estimated (mL/min/1.73): < 60 mL/min/1.73m^2 | 1.9 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Platelets (10^9/L): > 1.5 x Upper Limit of Normal (ULN) | 1.3 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glucose, Chemistry (mmol/L): < 0.8 x Lower Limit of Normal (LLN) | 1.9 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Leukocytes, Hematology (10^9/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glucose, Chemistry (mmol/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Alanine Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN) | 5.8 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Lactate Dehydrogenase (U/L): > 3.0 x Upper Limit of Normal (ULN) | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hematocrit (RATIO): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Phosphate (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Albumin (g/L): < 0.8 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Phosphate (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Lymphocytes (10^9/L): < 0.7 x Lower Limit of Normal (LLN) | 1.9 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Potassium (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Albumin (g/L): > 1.2 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Potassium (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Erythrocytes, Hematology (10^12/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Protein, Chemistry (g/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Alkaline Phosphatase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN) | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Protein, Chemistry (g/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Lymphocytes (10^9/L): > 1.3 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Sodium (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Aspartate Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN) | 3.2 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Sodium (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hemoglobin (g/L): < 0.9 x Lower Limit of Normal (LLN) | 3.3 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Urate (umol/L): > 1.2 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Bicarbonate (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Urea Nitrogen (mmol/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Monocytes (10^9/L): < 0.5 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glucose, Urinalysis: At least 1+ | 1.3 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Bicarbonate (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Protein, Urinalysis: At least 1+ | 28.7 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Erythrocytes, Hematology (10^12/L): < 0.9 x Lower Limit of Normal (LLN) | 3.2 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Specific Gravity: > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Bilirubin, Chemistry (umol/L): ≥ 1.5 x Upper Limit of Normal (ULN) | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | pH: < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Monocytes (10^9/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | pH: > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Basophils (10^9/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | pH: > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Basophils (10^9/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Eosinophils (10^9/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Erythrocytes, Hematology (10^12/L): < 0.9 x Lower Limit of Normal (LLN) | 3.2 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Erythrocytes, Hematology (10^12/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hematocrit (RATIO): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hematocrit (RATIO): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hemoglobin (g/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Hemoglobin (g/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Leukocytes, Hematology (10^9/L): < 0.9 x Lower Limit of Normal (LLN) | 17.2 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Leukocytes, Hematology (10^9/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Lymphocytes (10^9/L): < 0.7 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Lymphocytes (10^9/L): > 1.3 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Monocytes (10^9/L): < 0.5 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Monocytes (10^9/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Neutrophils (10^9/L): < 0.7 x Lower Limit of Normal (LLN) | 3.2 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Neutrophils (10^9/L): > 1.3 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Platelets (10^9/L): < 0.5 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Platelets (10^9/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Alanine Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Albumin (g/L): < 0.8 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Albumin (g/L): > 1.2 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Alkaline Phosphatase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Aspartate Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Bicarbonate (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 3.2 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Bicarbonate (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Bilirubin, Chemistry (umol/L): ≥ 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Calcium (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Calcium (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Chloride (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Chloride (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Cholesterol (mmol/L): > 1.6 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Creatine Kinase (U/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Creatinine (umol/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glomerular Filtration Rate, Estimated (mL/min/1.73): < 60 mL/min/1.73m^2 | 3.3 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glucose, Chemistry (mmol/L): < 0.8 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glucose, Chemistry (mmol/L): > 2.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Lactate Dehydrogenase (U/L): > 3.0 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Phosphate (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Phosphate (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Potassium (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Potassium (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Protein, Chemistry (g/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Protein, Chemistry (g/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Sodium (mmol/L): < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Sodium (mmol/L): > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Urate (umol/L): > 1.2 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Urea Nitrogen (mmol/L): > 1.5 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Glucose, Urinalysis: At least 1+ | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Protein, Urinalysis: At least 1+ | 26.7 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Specific Gravity: > 1.1 x Upper Limit of Normal (ULN) | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | pH: < 0.9 x Lower Limit of Normal (LLN) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], and weight.
Time frame: From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)
Population: Safety population: all participants who received at least 1 dose of study intervention (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 Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Diastolic Blood Pressure (mmHg): ≤ 50 and decrease from Baseline of ≥ 15 | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Increase from Baseline of ≥ 7% | 4.5 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Diastolic Blood Pressure (mmHg): ≥ 105 and increase from Baseline of ≥ 15 | 4.5 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Decrease from Baseline of ≥ 7% | 32.9 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Pulse Rate (bpm): ≥ 120 and increase from Baseline of ≥ 15 | 0.6 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Orthostatic Systolic Blood Pressure (mmHg): ≤ -20 | 12.4 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Systolic Blood Pressure (mmHg): ≤ 90 and decrease from Baseline of ≥ 20 | 5.8 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Orthostatic Diastolic Blood Pressure (mmHg): ≤ -15 | 3.9 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Pulse Rate (bpm): ≤ 50 and decrease from baseline of ≥ 15 | 1.3 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Orthostatic Pulse Rate (bpm): ≥ 25 | 4.5 percentage of participants |
| Atogepant 60 mg Chronic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Systolic Blood Pressure (mmHg): ≥ 180 and increase from Baseline of ≥ 20 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Orthostatic Pulse Rate (bpm): ≥ 25 | 6.5 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Systolic Blood Pressure (mmHg): ≥ 180 and increase from Baseline of ≥ 20 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Systolic Blood Pressure (mmHg): ≤ 90 and decrease from Baseline of ≥ 20 | 9.7 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Diastolic Blood Pressure (mmHg): ≥ 105 and increase from Baseline of ≥ 15 | 3.2 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Diastolic Blood Pressure (mmHg): ≤ 50 and decrease from Baseline of ≥ 15 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Pulse Rate (bpm): ≥ 120 and increase from Baseline of ≥ 15 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Sitting, Standing Pulse Rate (bpm): ≤ 50 and decrease from baseline of ≥ 15 | 0.0 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Increase from Baseline of ≥ 7% | 3.2 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Weight (kg): Decrease from Baseline of ≥ 7% | 25.8 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Orthostatic Systolic Blood Pressure (mmHg): ≤ -20 | 6.5 percentage of participants |
| Atogepant 60 mg Episodic Migraine | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Orthostatic Diastolic Blood Pressure (mmHg): ≤ -15 | 0.0 percentage of participants |