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A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed.
Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan.
Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant Dose A | Experimental | Participants will receive atogepant dose A once daily (QD) for 24 weeks. |
|
| Atogepant Dose B | Experimental | Participants will receive atogepant dose B QD for 24 weeks. |
|
| Atogepant Dose C | Experimental | Participants will receive atogepant dose C QD for 24 weeks. |
|
| Placebo | Experimental | Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Migraine Days | Participants recorded daily duration of migraine in an eDiary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in eDiary divided by total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects Model for Repeated Measure (MMRM) was used for analysis. | Up to Week 12 |
| Number of Participants Experiencing With Adverse Events (AEs) | 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. | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Headache Days | Participants recorded daily total duration of a headache in an eDiary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the eDiary divided by the total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Dental College Ichikawa General Hospital /ID# 247436 | Ichikawa-shi | Chiba | 272-0824 | Japan | ||
| Takanoko Hospital /ID# 245658 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41002192 | Derived | Matsumori Y, Yamada H, Nagaseki Y, Shimizu K, Nagy K, Matsuzawa R, Otani T, He MY, Guo H, Ahmadyar G, Takeshima T. Atogepant for the preventive treatment of episodic migraine in Japanese participants: A phase 2/3, randomized, double-blind, placebo-controlled trial with an active treatment extension (RELEASE). Cephalalgia. 2025 Sep;45(9):3331024251374569. doi: 10.1177/03331024251374569. Epub 2025 Sep 26. |
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AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants who were randomized to placebo QD for Weeks 1-12. |
| FG001 | Placebo/Atogepant 10 mg | Participants who were randomized to placebo QD for 12 weeks, then re-randomized to receive atogepant 10 mg QD for Weeks 12-24. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Double-Blind Treatment (Wks 1-12) |
|
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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 18, 2024 | Feb 4, 2026 |
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| Placebo for Atogepant | Drug | Oral Tablet |
|
| Up to Week 12 |
| Change From Baseline in Mean Monthly Acute Medication Use Days | Participants recorded allowed medication(s) to treat an acute migraine in the daily eDiary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the eDiary divided by the total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis. | Up to Week 12 |
| Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days | Participants recorded daily duration of migraine in an eDiary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in eDiary divided by total number of days with eDiary records in each 4-week period multiplied by 28. Each 4-week period was averaged. | Up to Week 12 |
| Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score | MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis. | Up to Week 12 |
| Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) | The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine. | Up to Week 12 |
| Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D | The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine. | Up to Week 12 |
| Matsuyama |
| Ehime |
| 790-0925 |
| Japan |
| Fukuiken Saiseikai Hospital /ID# 245662 | Fukui-shi | Fukui | 918-8503 | Japan |
| Jinnouchi Neurosurgical Clinic /ID# 245510 | Kasuga-shi | Fukuoka | 816-0802 | Japan |
| Ikeda Neurosurgical Clinic /ID# 245881 | Kasuga-shi | Fukuoka | 816-0824 | Japan |
| SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948 | Ota-shi | Gunma | 373-8585 | Japan |
| Hiroshima City Hiroshima Citizens Hospital /ID# 246683 | Hiroshima | Hiroshima | 730-8518 | Japan |
| Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667 | Sapporo | Hokkaido | 003-0003 | Japan |
| Nakamura Memorial Hospital /ID# 247379 | Sapporo | Hokkaido | 060-8570 | Japan |
| Konan Medical Center /ID# 245557 | Kobe | Hyōgo | 658-0064 | Japan |
| Nishinomiya Municipal Central Hospital /ID# 246571 | Nishinomiya-shi | Hyōgo | 663-8014 | Japan |
| Yamaguchi Clinic /ID# 246370 | Nishinomiya-shi | Hyōgo | 663-8204 | Japan |
| Mito Kyodo General Hospital /ID# 245487 | Mito | Ibaraki | 310-0015 | Japan |
| Tsukuba Neurosurgery/Headache Clinic /ID# 254665 | Tsukuba | Ibaraki | 305-0822 | Japan |
| Kijima Neurosurgery Clinic /ID# 245758 | Kahoku-gun | Ishikawa-ken | 929-0342 | Japan |
| Kanazawa Neurosurgical Hospital /ID# 254210 | Nonoichi-shi | Ishikawa-ken | 921-8841 | Japan |
| Kokubu Clinic /ID# 245810 | Takamatsu | Kagawa-ken | 769-0103 | Japan |
| Tokai University Hospital /ID# 245971 | Isehara | Kanagawa | 259-1193 | Japan |
| Fujitsu Clinic /ID# 245811 | Kawasaki-shi | Kanagawa | 211-8588 | Japan |
| Atago Hospital /ID# 245818 | Kochi | Kochi | 780-0051 | Japan |
| Umenotsuji Clinic /ID# 246103 | Kochi | Kochi | 780-8011 | Japan |
| Saiseikai Kumamoto Hospital /Id# 253546 | Kumamoto | Kumamoto | 861-4101 | Japan |
| Narikawa Neurological Clinic /ID# 254023 | Sendai | Miyagi | 981-3126 | Japan |
| Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664 | Sendai | Miyagi | 982-0014 | Japan |
| Ooba Clinic for Neurosurgery & Headache /ID# 246201 | Ōita | Oita Prefecture | 8700831 | Japan |
| Makabe Clinic /ID# 246621 | Okayama | Okayama-ken | 700-0964 | Japan |
| Okayama City General Medical Center /ID# 246007 | Okayama | Okayama-ken | 700-8557 | Japan |
| Gokeikai Osaka Kaisei Hospital /ID# 246623 | Osaka | Osaka | 532-0003 | Japan |
| Chibune General Hospital /ID# 245973 | Osaka | Osaka | 555-0034 | Japan |
| Tominaga Clinic /ID# 245812 | Osaka | Osaka | 5560015 | Japan |
| Takase Internal Medicine Clinic /ID# 245532 | Toyonaka-shi | Osaka | 560-0012 | Japan |
| Saitama Medical University Hospital /ID# 245663 | Iruma-gun | Saitama | 350-0495 | Japan |
| Saino Clinic /ID# 245921 | Tokorozawa-shi | Saitama | 359-1141 | Japan |
| Japanese Red Cross Shizuoka Hospital /ID# 246204 | Shizuoka | Shizuoka | 420-0853 | Japan |
| Dokkyo Medical University Hospital /ID# 246472 | Mibu | Tochigi | 321-0293 | Japan |
| Tokai University Hachioji Hospital /ID# 248326 | Hachioji-shi | Tokyo | 192-0032 | Japan |
| Kitasato University Kitasato Institute Hospital /ID# 246470 | Minato-ku | Tokyo | 108-8642 | Japan |
| Usuda Clinic Of Internal Medicine /ID# 246166 | Setagaya-ku | Tokyo | 156-0043 | Japan |
| Tokyo Headache Clinic /ID# 245486 | Shibuya-ku | Tokyo | 151-0051 | Japan |
| Keio University Hospital /ID# 245660 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Suzuki Kei Yasuragi Clinic /ID# 253493 | Tachikawa-shi | Tokyo | 190-0001 | Japan |
| Sakura neuro Clinic /ID# 248320 | Toyama | Toyama | 930-0803 | Japan |
| Tendo Brain Clinic /ID# 246205 | Tendo-shi | Yamagata | 994-0083 | Japan |
| Nagaseki Headache Clinic /ID# 245485 | Kai | Yamanashi | 400-0124 | Japan |
| DOI Internal Medicine-Neurology Clinic /ID# 245661 | Hiroshima | 730-0031 | Japan |
| Tanaka Neurosurgery & Headache Clinic /ID# 245488 | Kagoshima | 890-0052 | Japan |
| Tatsuoka Neurology Clinic /ID# 245328 | Kyoto | 600-8811 | Japan |
| Shinagawa Strings Clinic /ID# 245665 | Tokyo | 108-0075 | Japan |
| FG002 | Placebo/Atogepant 30 mg | Participants who were randomized to placebo QD for 12 weeks, then re-randomized to receive atogepant 30 mg QD for Weeks 12-24. |
| FG003 | Placebo/Atogepant 60 mg | Participants who were randomized to placebo QD for 12 weeks, then re-randomized to receive atogepant 60 mg QD for Weeks 12-24. |
| FG004 | Atogepant 10 mg | Participants who were randomized to atogepant 10 mg once daily (QD) for Weeks 1-24. |
| FG005 | Atogepant 30 mg | Participants who were randomized to atogepant 30 mg once daily (QD) for Weeks 1-24. |
| FG006 | Atogepant 60 mg | Participants who were randomized to atogepant 60 mg once daily (QD) for Weeks 1-24. |
|
| Never Received Any Study Treatment |
|
| Received Randomized Study Treatment |
|
| Received Study Treatment Other Than Randomized |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Active Treatment Extension (Wks 12-24) |
|
|
Safety Population 1; One participant was randomized but never received any study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants who received placebo QD for 12 weeks. Participants were re-randomized at Week 12 to receive atogepant 10 mg, 30 mg or 60 mg QD for 12 weeks. |
| BG001 | Atogepant 10 mg | Participants who received atogepant 10 mg once daily (QD) for 24 weeks. |
| BG002 | Atogepant 30 mg | Participants who received atogepant 30 mg once daily (QD) for 24 weeks. |
| BG003 | Atogepant 60 mg | Participants who received atogepant 60 mg once daily (QD) for 24 weeks. |
| BG004 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Change From Baseline in Mean Monthly Migraine Days | Participants recorded daily duration of migraine in an eDiary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in eDiary divided by total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects Model for Repeated Measure (MMRM) was used for analysis. | Modified Intent-to-Treat Population (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | migraine days per month | Up to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing With Adverse Events (AEs) | 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. | Safety Population 1 (Double-Blind Treatment Period) | Posted | Count of Participants | Participants | Up to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Monthly Headache Days | Participants recorded daily total duration of a headache in an eDiary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the eDiary divided by the total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis. | mITT Population | Posted | Least Squares Mean | Standard Error | headache days per month | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days | Participants recorded allowed medication(s) to treat an acute migraine in the daily eDiary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the eDiary divided by the total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis. | mITT Population | Posted | Least Squares Mean | Standard Error | acute medication use days per month | Up to Week 12 |
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| Secondary | Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days | Participants recorded daily duration of migraine in an eDiary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in eDiary divided by total number of days with eDiary records in each 4-week period multiplied by 28. Each 4-week period was averaged. | mITT Population | Posted | Number | percentage of participants | Up to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score | MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) | The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D | The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine. | mITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Up to Week 12 |
|
All-cause mortality & AE tables include events reported from time of informed consent to end of study. Median time on follow-up was 200, 200.5, 200, 200, 200, 201 & 200 days for Pbo, Pbo/10mg, Pbo/30mg, Pbo/60mg, Atogepant 10mg, 30mg & 60mg, respectively. One subject randomized to 60mg never recd study treatment (included in ITT 60mg but not in SP1); one subject randomized to 10mg took 60mg; one subject randomized to placebo then re-randomized to 60mg at Wk 12 recd 30mg from Wk 12-24.
All-cause mortality table is based on the ITT population. The ITT subjects were included in the analysis according to the treatment group to which they were randomized. The SAEs and Other tables are based on Safety Population 1 (includes all subjects who received at least 1 dose of study drug during the double-blind treatment period), and subjects were included in the analysis according to the actual treatment received (rather than as randomized).
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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 | Placebo | Participants who were randomized to placebo QD for Weeks 1-12. | 0 | 134 | 1 | 134 | 38 | 134 |
| EG001 | Placebo/Atogepant 10 mg | Participants who were randomized to placebo QD for 12 weeks, then re-randomized to receive atogepant 10 mg QD for Weeks 12-24. | 0 | 46 | 1 | 46 | 18 | 46 |
| EG002 | Placebo/Atogepant 30 mg | Participants who were randomized to placebo QD for 12 weeks, then re-randomized to receive atogepant 30 mg QD for Weeks 12-24. | 0 | 43 | 0 | 44 | 15 | 44 |
| EG003 | Placebo/Atogepant 60 mg | Participants who were randomized to placebo QD for 12 weeks, then re-randomized to receive atogepant 60 mg QD for Weeks 12-24. | 0 | 42 | 0 | 41 | 12 | 41 |
| EG004 | Atogepant 10 mg | Participants who were randomized to atogepant 10 mg once daily (QD) for Weeks 1-24. | 0 | 127 | 2 | 126 | 39 | 126 |
| EG005 | Atogepant 30 mg | Participants who were randomized to atogepant 30 mg once daily (QD) for Weeks 1-24. | 0 | 131 | 1 | 131 | 40 | 131 |
| EG006 | Atogepant 60 mg | Participants who were randomized to atogepant 60 mg once daily (QD) for Weeks 1-24. | 0 | 132 | 0 | 132 | 40 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PRINZMETAL ANGINA | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| OROPHARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | AbbVie | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2024 | Feb 4, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718987 | atogepant |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Not Disclosed |
|
| Male |
|
| 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 |
|
| LS Mean |
| -1.90 |
| 2-Sided |
| 95 |
| -2.57 |
| -1.22 |
| Superiority |
| Mixed-effects Model for Repeated Measure | <0.0001 | LS Mean | -2.10 | 2-Sided | 95 | -2.78 | -1.43 | Superiority |
|
|
| OG003 | Atogepant 60 mg | Participants who were randomized to atogepant 60 mg once daily (QD) for 24 weeks. |
|
|
|
| OG003 | Atogepant 60 mg | Participants who were randomized to atogepant 60 mg once daily (QD) for 24 weeks. |
|
|
|
Participants who were randomized to atogepant 60 mg once daily (QD) for 24 weeks. |
|
|
|
| OG002 |
| Atogepant 30 mg |
Participants who were randomized to atogepant 30 mg once daily (QD) for 24 weeks. |
| OG003 | Atogepant 60 mg | Participants who were randomized to atogepant 60 mg once daily (QD) for 24 weeks. |
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|
|
| OG003 | Atogepant 60 mg | Participants who were randomized to atogepant 60 mg once daily (QD) for 24 weeks. |
|
|
|
| OG003 |
| Atogepant 60 mg |
Participants who were randomized to atogepant 60 mg once daily (QD) for 24 weeks. |
|
|
|