Trial Outcomes & Findings for A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine (NCT NCT04437433)

NCT ID: NCT04437433

Last Updated: 2025-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

186 participants

Primary outcome timeframe

From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)

Results posted on

2025-07-22

Participant Flow

The study consisted of a 52-week open-label treatment period and a 4-week safety follow-up period for all participants.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
155
31
Overall Study
COMPLETED
130
28
Overall Study
NOT COMPLETED
25
3

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Met Withdrawal Criteria at Visit 1- Laboratory Values
7
0
Overall Study
Met Withdrawal Criteria at Visit 1- ECG
1
0
Overall Study
Adverse Event
9
0
Overall Study
Lack of Efficacy
4
0
Overall Study
Withdrawal by Subject
4
1
Overall Study
Protocol Deviation
0
1
Overall Study
Other, not specified
0
1

Baseline Characteristics

A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
Total
n=186 Participants
Total of all reporting groups
Age, Continuous
43.4 years
STANDARD_DEVIATION 9.47 • n=5 Participants
42.4 years
STANDARD_DEVIATION 11.95 • n=7 Participants
43.2 years
STANDARD_DEVIATION 9.90 • n=5 Participants
Sex: Female, Male
Female
141 Participants
n=5 Participants
29 Participants
n=7 Participants
170 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
2 Participants
n=7 Participants
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
155 Participants
n=5 Participants
31 Participants
n=7 Participants
186 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
155 Participants
n=5 Participants
31 Participants
n=7 Participants
186 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
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
90.3 percentage of participants
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
0.0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
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
0.0 percentage of participants
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
0.0 percentage of participants
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
3.2 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
3.2 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
3.3 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
26.7 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
3.2 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
17.2 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants

SECONDARY outcome

Timeframe: 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.

12-lead ECGs were performed at select study visits.

Outcome measures

Outcome measures
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
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
0.0 percentage of participants
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
9.7 percentage of participants
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
3.2 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
3.2 percentage of participants
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
25.8 percentage of participants
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
6.5 percentage of participants
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
0.0 percentage of participants
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
6.5 percentage of participants

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
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
100 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
100.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure
Atogepant 60 mg Chronic Migraine
n=155 Participants
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.
Atogepant 60 mg Episodic Migraine
n=31 Participants
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.
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
93.5 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
93.5 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants
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
0.0 percentage of participants

Adverse Events

Atogepant 60 mg Chronic Migraine

Serious events: 7 serious events
Other events: 108 other events
Deaths: 0 deaths

Atogepant 60 mg Episodic Migraine

Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths

Total

Serious events: 7 serious events
Other events: 132 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Atogepant 60 mg Chronic Migraine
n=155 participants at risk
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.
Atogepant 60 mg Episodic Migraine
n=31 participants at risk
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.
Total
n=186 participants at risk
Participants received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.
Ear and labyrinth disorders
VERTIGO
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Hepatobiliary disorders
CHOLELITHIASIS
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Infections and infestations
APPENDICITIS
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Nervous system disorders
LOSS OF CONSCIOUSNESS
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Nervous system disorders
MIGRAINE
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Psychiatric disorders
DEPRESSION
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.54%
1/186 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.

Other adverse events

Other adverse events
Measure
Atogepant 60 mg Chronic Migraine
n=155 participants at risk
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.
Atogepant 60 mg Episodic Migraine
n=31 participants at risk
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.
Total
n=186 participants at risk
Participants received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.
Eye disorders
DRY EYE
2.6%
4/155 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
3.2%
6/186 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
3.9%
6/155 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
4.3%
8/186 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Gastrointestinal disorders
CONSTIPATION
11.0%
17/155 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
12.9%
4/31 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
11.3%
21/186 • Number of events 22 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Gastrointestinal disorders
DIARRHOEA
5.2%
8/155 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
5.4%
10/186 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Gastrointestinal disorders
STOMATITIS
1.9%
3/155 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
2.7%
5/186 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
General disorders
MALAISE
5.8%
9/155 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
3.2%
1/31 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
5.4%
10/186 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
General disorders
PYREXIA
33.5%
52/155 • Number of events 68 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
29.0%
54/186 • Number of events 70 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Infections and infestations
COVID-19
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
19.4%
6/31 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
3.8%
7/186 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Infections and infestations
CYSTITIS
7.1%
11/155 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
3.2%
1/31 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
12/186 • Number of events 13 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Infections and infestations
GINGIVITIS
0.65%
1/155 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
1.6%
3/186 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Infections and infestations
NASOPHARYNGITIS
11.6%
18/155 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
38.7%
12/31 • Number of events 19 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
16.1%
30/186 • Number of events 38 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
6.5%
10/155 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
9.7%
3/31 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
7.0%
13/186 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
4.5%
7/155 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
4.8%
9/186 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Metabolism and nutrition disorders
DECREASED APPETITE
3.2%
5/155 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
3.8%
7/186 • Number of events 7 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
5.2%
8/155 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
6.5%
2/31 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
5.4%
10/186 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Musculoskeletal and connective tissue disorders
MYALGIA
6.5%
10/155 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
0.00%
0/31 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
5.4%
10/186 • Number of events 14 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
Nervous system disorders
HEADACHE
5.2%
8/155 • Number of events 11 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
3.2%
1/31 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.
4.8%
9/186 • Number of events 12 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 392 days for the Atogepant 60 mg Chronic Migraine group, 421 days for the Atogepant 60 mg Episodic Migraine group, and 392 days for all participants.

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