Atogepant

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.

A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.

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. Treatment-emergent adverse events (TEAEs) are defined as any AE with an onset date on or after the date of first dose of study drug during the Double Blind (DB) treatment period; and on or before the date of last dose of study drug during the DB treatment period (including tapering off phase, if applicable) + 30 days; and before the date of first dose of study drug during the Open Label (OL) treatment period, if applicable.

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.

AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product.

Percentage of participants with abnormal change in clinical laboratory test results like hematology, chemistry and urinalysis will be assessed.

12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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).

Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.

Tanner's staging is used to assess growth and pubertal development.

The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties

An 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.

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.

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. Glomerular Filtration Rate (GFR) is a clinical measurement that calculates how many milliliters of blood the kidneys filter every second. Glucose, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of sugar. Protein, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of protein.

Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Number of participants with non-PCS baseline values who met the PCS criterion at least once post-baseline are reported.

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).

12-lead ECGs were performed at select study visits.

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. 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.

Number of participants with clinically significant change from baseline for any detectable clinical laboratory tests like hematology will be reported.

Number of participants with clinically significant change from baseline for any vital signs like standing BP, sitting and standing pulse rate will be reported.

12-lead ECG will be performed.

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 being wish to be dead and 5 being active suicidal ideation with specific plan and intent. Suicidal behavior is classified on a 5-item scale: 0 being no suicidal behavior and 4 being actual attempt.

Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.

Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.

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.

Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.

Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.

Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.

Cmax of Atogepant

Cmax of Ubrogepant

Tmax of Atogepant

Tmax of Ubrogepant

Apparent terminal phase elimination rate constant of Atogepant

Apparent terminal phase elimination rate constant of Ubrogepant

T1/2 of Atogepant

T1/2 of Ubrogepant

AUCt of Atogepant

AUCinf of Atogepant

CMAX of Atogepant

CMAX of Ubrogepant

TMAX of Atogepant

TMAX of Ubrogepant

AUCLST of Atogepant

AUCLST of Ubrogepant

AUCINF of Atogepant

AUCINF of Ubrogepant

Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when Ubrogepant is administered.

Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when ubrogepant and atogepant are coadministered.

Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when Ubrogepant is administered.

Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when ubrogepant and atogepant are coadministered.

Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when Atogepant is administered.

Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when ubrogepant and atogepant are coadministered.

Maximum plasma drug concentration (Cmax) when ubrogepant is administered.

Maximum plasma drug concentration (Cmax) when atogepant is administered.

Maximum plasma drug concentration (Cmax) of ubrogepant when ubrogepant and atogepant are coadministered.

Maximum plasma drug concentration (Cmax) of atogepant when ubrogepant and atogepant are coadministered.