Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 7:00 PM
Study NCT ID:
NCT04437433
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine
Sponsor:
Organization:
Raw JSON
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A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 108, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 24, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 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[{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes, Hematology (10^9/L): > 1.5 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (10^9/L): < 0.7 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (10^9/L): > 1.3 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, 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'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin (g/L): < 0.8 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin (g/L): > 1.2 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Chemistry (umol/L): ≥ 1.5 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (mmol/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (mmol/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Chloride (mmol/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Chloride (mmol/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol (mmol/L): > 1.6 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (U/L): > 2.0 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine (umol/L): > 1.5 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Glomerular Filtration Rate, Estimated (mL/min/1.73): < 60 mL/min/1.73m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Chemistry (mmol/L): < 0.8 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Chemistry (mmol/L): > 2.0 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase (U/L): > 3.0 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate (mmol/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate (mmol/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium (mmol/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium (mmol/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Protein, Chemistry (g/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Protein, Chemistry (g/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L): < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L): > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Urate (umol/L): > 1.2 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen (mmol/L): > 1.5 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Urinalysis: At least 1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Protein, Urinalysis: At least 1+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'Specific Gravity: > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'pH: < 0.9 x Lower Limit of Normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'pH: > 1.1 x Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.'}], 'classes': [{'title': 'PR Interval (msec): ≥ 250', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'QRS Duration (msec): ≥ 150', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (msec): > 500', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (msec): Increase from Baseline of > 60', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52', 'description': '12-lead ECGs were performed at select study visits.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.'}], 'classes': [{'title': 'Sitting, Standing Systolic Blood Pressure (mmHg): ≥ 180 and increase from Baseline of ≥ 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting, Standing Systolic Blood Pressure (mmHg): ≤ 90 and decrease from Baseline of ≥ 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Sitting, Standing Diastolic Blood Pressure (mmHg): ≥ 105 and increase from Baseline of ≥ 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Sitting, Standing Diastolic Blood Pressure (mmHg): ≤ 50 and decrease from Baseline of ≥ 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting, Standing Pulse Rate (bpm): ≥ 120 and increase from Baseline of ≥ 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Sitting, Standing Pulse Rate (bpm): ≤ 50 and decrease from baseline of ≥ 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Weight (kg): Increase from Baseline of ≥ 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Weight (kg): Decrease from Baseline of ≥ 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '25.8', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Systolic Blood Pressure (mmHg): ≤ -20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Diastolic Blood Pressure (mmHg): ≤ -15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Pulse Rate (bpm): ≥ 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.'}], 'classes': [{'title': 'No suicidal ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Active suicidal ideation with specific plan and intent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Non-specific active suicidal thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Wish to be dead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'No suicidal behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Actual attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Interrupted attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Aborted attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Preparatory acts or behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Completed Suicide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Non-suicidal self-injurious behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until the last dose of study drug (up to 52 weeks)', 'description': '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).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.; participants with available data'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.'}], 'classes': [{'title': 'No suicidal ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '93.5', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Active suicidal ideation with specific plan and intent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Non-specific active suicidal thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal ideation: Wish to be dead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'No suicidal behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '93.5', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Actual attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Interrupted attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Aborted attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Most severe suicidal behavior: Preparatory acts or behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Completed Suicide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Non-suicidal self-injurious behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks following the last dose of study drug', 'description': '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).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.; participants with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.'}, {'id': 'FG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Met Withdrawal Criteria at Visit 1- Laboratory Values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Met Withdrawal Criteria at Visit 1- ECG', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study consisted of a 52-week open-label treatment period and a 4-week safety follow-up period for all participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atogepant 60 mg Chronic Migraine', 'description': '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.'}, {'id': 'BG001', 'title': 'Atogepant 60 mg Episodic Migraine', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'spread': '9.47', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '11.95', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '9.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-07', 'size': 1093898, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-05T16:02', 'hasProtocol': True}, {'date': '2024-06-26', 'size': 1053973, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-05T16:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2020-06-16', 'resultsFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-02', 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)', 'timeFrame': 'From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator', 'timeFrame': 'From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)', 'description': '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.'}, {'measure': 'Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator', 'timeFrame': 'Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52', 'description': '12-lead ECGs were performed at select study visits.'}, {'measure': 'Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator', 'timeFrame': 'From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)', 'description': '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.'}, {'measure': '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', 'timeFrame': 'From first dose of study drug until the last dose of study drug (up to 52 weeks)', 'description': '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).'}, {'measure': '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', 'timeFrame': 'Up to 4 weeks following the last dose of study drug', 'description': '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).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Migraine', 'Episodic Migraine', 'Atogepant'], 'conditions': ['Chronic Migraine', 'Episodic Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=3101-306-002', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The study recruited the following 2 cohorts:\n\n3101-303-002 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.\n\nDe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n3101-303-002 Completers:\n\n* 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.\n\nDe Novo EM Participants:\n\n* Age of the participant at the time of migraine onset \\< 50 years.\n* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.\n* History of 4 to 14 migraine days per month on average in the 3 months prior to Visit -1 in the investigator's judgment.\n* 4 to 14 migraine days in the 28-day baseline period per eDiary.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo EM Participants) or Visit 1 (3103-303-002 Completers).\n* 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)\n* 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.\n* Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.\n\nDe Novo EM Participants only:\n\n* Difficulty distinguishing migraine headaches from tension-type or other headaches.\n* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018.\n* 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.\n* Has \\>= 15 headache days per month on average across the 3 months prior to Visit -1 in the investigator's judgment.\n* Has \\>= 15 headache days in the 28-day baseline period per eDiary.\n* 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."}, 'identificationModule': {'nctId': 'NCT04437433', 'acronym': 'JPN ATO OLE', 'briefTitle': 'A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine', 'orgStudyIdInfo': {'id': '3101-306-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atogepant 60 mg Chronic Migraine', 'description': '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.', 'interventionNames': ['Drug: Atogepant 60 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Atogepant 60 mg Episodic Migraine', 'description': '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.', 'interventionNames': ['Drug: Atogepant 60 mg']}], 'interventions': [{'name': 'Atogepant 60 mg', 'type': 'DRUG', 'description': 'Tablets containing 60 mg atogepant', 'armGroupLabels': ['Atogepant 60 mg Chronic Migraine', 'Atogepant 60 mg Episodic Migraine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '790-0925', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Takanoko Hospital /ID# 232723', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '918-8503', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Fukuiken Saiseikai Hospital /ID# 232988', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '003-0003', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '658-0064', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Konan Medical Center /ID# 232922', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '310-0015', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Mito Kyodo General Hospital /ID# 232990', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '892-0842', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Atsuchi Neurosurgical Hospital /ID# 232907', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '259-1193', 'city': 'Isehara-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Duplicate_Tokai University Hospital /ID# 233071'}, {'zip': '211-8588', 'city': 'Kawasaki-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Fujitsu Clinic /ID# 232717'}, {'zip': '780-8011', 'city': 'Kochi', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Umenotsuji Clinic /ID# 232675', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '982-0014', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '350-0495', 'city': 'Iruma-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital /ID# 233017'}, {'zip': '338-8577', 'city': 'Saitama-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Neuropsychiatric Institute /Id# 232711'}, {'zip': '420-0853', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Japanese Red Cross Shizuoka Hospital /ID# 232992', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '321-0293', 'city': 'Shimotsuga-gun', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Duplicate_Dokkyo Medical University Hospital /ID# 232995'}, {'zip': '182-0006', 'city': 'Chofu-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Niwa Family Clinic /ID# 232713'}, {'zip': '151-0051', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Duplicate_Tokyo Headache Clinic /ID# 232715'}, {'zip': '160-8582', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital /ID# 233030'}, {'zip': '400-0124', 'city': 'Kai-shi', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Duplicate_Nagaseki Headache Clinic /ID# 232719'}, {'zip': '730-0031', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'DOI Internal Medicine-Neurology Clinic /ID# 232722', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '732-0822', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima Neurology Clinic /ID# 232720', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '892-0844', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Tanaka Neurosurgical Clinic /ID# 232884', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '600-8811', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Tatsuoka Neurology Clinic /ID# 232912', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '556-0017', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Tominaga Hospital /ID# 232909', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '108-0075', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Shinagawa Strings Clinic /ID# 232908', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}