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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).
The study recruited the following 2 cohorts:
3101-303-002 CM Completers: Japanese participants who completed lead-in Study 3101 303-002 (PROGRESS; NCT03855137), a Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study of atogepant for the prevention of CM. All 3101 303-002 CM Completers rolled over at Visit 7 (the end of the double-blind treatment period) of the lead-in study, which functioned as Visit 1 for this study, Study 3101-306-002.
De Novo EM Participants: Japanese participants with EM who were newly recruited for this study at selected sites. Participation began with a 4-week Screening/Baseline period starting at Visit -1, and those who completed the 4-week Screening/Baseline period and met all entry criteria were enrolled into the 52-week open-label treatment period at Visit 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant 60 mg Chronic Migraine | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant 60 mg | Drug | Tablets containing 60 mg atogepant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis. |
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Inclusion Criteria:
3101-303-002 Completers:
De Novo EM Participants:
Exclusion Criteria:
De Novo EM Participants only:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takanoko Hospital /ID# 232723 | Matsuyama | Ehime | 790-0925 | Japan | ||
| Fukuiken Saiseikai Hospital /ID# 232988 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41814051 | Derived | Matsumori Y, Nagy K, Takahashi A, Tanaka S, Takeshima T, Forero G, Bao J, Guo H, Ahmadyar G, de Abreu Ferreira R, Yamamoto T. Atogepant for the Preventive Treatment of Migraine in Japanese Participants: A Phase 3, Open-Label, 52-Week Extension Study. Neurol Ther. 2026 Jun;15(3):1137-1154. doi: 10.1007/s40120-026-00905-3. Epub 2026 Mar 11. |
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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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
The study consisted of a 52-week open-label treatment period and a 4-week safety follow-up period for all participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Atogepant 60 mg Episodic Migraine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2022 | Jun 5, 2025 |
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| From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) |
| Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | 12-lead ECGs were performed at select study visits. | Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52 |
| Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], and weight. | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 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 | 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). | From first dose of study drug until the last dose of study drug (up to 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 | 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). | Up to 4 weeks following the last dose of study drug |
| Fukui-shi |
| Fukui |
| 918-8503 |
| Japan |
| Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710 | Sapporo | Hokkaido | 003-0003 | Japan |
| Konan Medical Center /ID# 232922 | Kobe | Hyōgo | 658-0064 | Japan |
| Mito Kyodo General Hospital /ID# 232990 | Mito | Ibaraki | 310-0015 | Japan |
| Atsuchi Neurosurgical Hospital /ID# 232907 | Kagoshima | Kagoshima-ken | 892-0842 | Japan |
| Duplicate_Tokai University Hospital /ID# 233071 | Isehara-shi | Kanagawa | 259-1193 | Japan |
| Fujitsu Clinic /ID# 232717 | Kawasaki-shi | Kanagawa | 211-8588 | Japan |
| Umenotsuji Clinic /ID# 232675 | Kochi | Kochi | 780-8011 | Japan |
| Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677 | Sendai | Miyagi | 982-0014 | Japan |
| Saitama Medical University Hospital /ID# 233017 | Iruma-gun | Saitama | 350-0495 | Japan |
| Saitama Neuropsychiatric Institute /Id# 232711 | Saitama-shi | Saitama | 338-8577 | Japan |
| Japanese Red Cross Shizuoka Hospital /ID# 232992 | Shizuoka | Shizuoka | 420-0853 | Japan |
| Duplicate_Dokkyo Medical University Hospital /ID# 232995 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| Niwa Family Clinic /ID# 232713 | Chofu-shi | Tokyo | 182-0006 | Japan |
| Duplicate_Tokyo Headache Clinic /ID# 232715 | Shibuya-ku | Tokyo | 151-0051 | Japan |
| Keio University Hospital /ID# 233030 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Duplicate_Nagaseki Headache Clinic /ID# 232719 | Kai-shi | Yamanashi | 400-0124 | Japan |
| DOI Internal Medicine-Neurology Clinic /ID# 232722 | Hiroshima | 730-0031 | Japan |
| Hiroshima Neurology Clinic /ID# 232720 | Hiroshima | 732-0822 | Japan |
| Tanaka Neurosurgical Clinic /ID# 232884 | Kagoshima | 892-0844 | Japan |
| Tatsuoka Neurology Clinic /ID# 232912 | Kyoto | 600-8811 | Japan |
| Tominaga Hospital /ID# 232909 | Osaka | 556-0017 | Japan |
| Shinagawa Strings Clinic /ID# 232908 | Tokyo | 108-0075 | Japan |
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. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study | Posted | Number | percentage of participants | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) |
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|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis. | 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. | Posted | Number | percentage of participants | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | 12-lead ECGs were performed at select study visits. | Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study. | Posted | Number | percentage of participants | Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], and weight. | 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. | Posted | Number | percentage of participants | From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). | Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.; participants with available data | Posted | Number | percentage of participants | From first dose of study drug until the last dose of study drug (up to 52 weeks) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). | Safety population: all participants who received at least 1 dose of study intervention (atogepant) in this extension study.; participants with available data | Posted | Number | percentage of participants | Up to 4 weeks following the last dose of study drug |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 155 | 7 | 155 | 108 | 155 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 24 | 31 |
| EG002 | Total | Participants received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks. | 0 | 186 | 7 | 186 | 132 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERTIGO | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY EYE | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| GINGIVITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2024 | Jun 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000718987 | atogepant |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
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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. |
|
|
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. |
|
|