| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004337-32 | EudraCT Number |
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This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period. |
|
| Atogepant 30 mg BID | Active Comparator | Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. |
|
| Atogepant 60 mg QD | Active Comparator | Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant 30 mg | Drug | Tablets containing 30 mg atogepant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. |
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Inclusion Criteria:
At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018
Age of the participant at the time of migraine onset < 50 years
Confirmation of headache/migraine headache day frequency as follows:
Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neuro Institute /ID# 236776 | Phoenix | Arizona | 85013 | United States | ||
| Baptist Health Center for Clinical Research /ID# 237361 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41222899 | Derived | Schlachter L, Stodtmann S, Voelkner A, Jonsson F, Lagraauw HM, Boinpally RR. Population Pharmacokinetics of Atogepant for the Prevention of Migraine. Clin Pharmacokinet. 2026 Jan;65(1):149-164. doi: 10.1007/s40262-025-01566-5. Epub 2025 Nov 12. | |
| 40471213 | Derived | UpToDate(R). Nurse Pract. 2023 Jul 1;48(7):16. doi: 10.1097/01.NPR.0000000000000072. No abstract available. |
| Label | URL |
|---|---|
| Related Information | View source |
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Total of 778 participants were randomized in a 1:1:1 ratio to receive atogepant matching placebo, atogepant 30 mg twice daily (BID), or atogepant 60 mg once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period followed by 4 week follow up (FU) period till end of study up to approximately 16 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received atogepant-matching placebo tablets, orally, BID for 12 weeks in a DB treatment period. |
| FG001 | Atogepant 30 mg BID | Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DB Treatment Period (Day 1 to Week 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 | May 29, 2020 | Jan 18, 2023 |
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| Atogepant 60 mg |
| Drug |
Tablets containing 60 mg atogepant |
|
| Placebo | Drug | 30 mg/60 mg tablets containing atogepant-matching placebo |
|
| Baseline to Week 12 |
| Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value. | Baseline to Week 12 |
| Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value. | Baseline to Week 12 |
| Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand Population | The 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 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to 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 indicate better quality of life. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | At Week 12 |
| Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Baseline to Week 12 |
| Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population | HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses. | At Week 12 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| California Headache and Balance Center /ID# 236246 | Fresno | California | 93720 | United States |
| Wr-Pri Llc /Id# 236008 | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692 | Newport Beach | California | 92660 | United States |
| Schuster Medical Research Institute /ID# 236447 | Sherman Oaks | California | 91403 | United States |
| Alpine Clinical Research Center /ID# 234346 | Boulder | Colorado | 80301-1880 | United States |
| George Washington University Medical Faculty Associates /ID# 238011 | Washington D.C. | District of Columbia | 20037-3201 | United States |
| Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161 | St. Petersburg | Florida | 33709-3113 | United States |
| Accel Research Sites - Tampa Clinical Research Unit /ID# 237485 | Tampa | Florida | 33634 | United States |
| Premiere Research Institute - Palm Beach /ID# 238192 | West Palm Beach | Florida | 33407-3209 | United States |
| NeuroTrials Research Inc. /ID# 237364 | Atlanta | Georgia | 30328 | United States |
| Josephson-Wallack-Munshower Neurology - NE /ID# 238234 | Indianapolis | Indiana | 46256-4692 | United States |
| Collective Medical Research /ID# 236400 | Prairie Village | Kansas | 66208 | United States |
| Ochsner Clinic Foundation /ID# 236543 | Covington | Louisiana | 70433-8107 | United States |
| Beth Israel Deaconess Medical Center /ID# 237540 | Boston | Massachusetts | 02215-5400 | United States |
| BTC of New Bedford /ID# 236384 | New Bedford | Massachusetts | 02740 | United States |
| Clinical Research Institute, Inc /ID# 238299 | Minneapolis | Minnesota | 55402-2606 | United States |
| Headache Neurology Research Institute /ID# 236464 | Ridgeland | Mississippi | 39157 | United States |
| Nevada Headache Institute /ID# 236420 | Las Vegas | Nevada | 89113 | United States |
| Dartmouth-Hitchcock Medical Center /ID# 237444 | Lebanon | New Hampshire | 03756 | United States |
| Albuquerque Clinical Trials, Inc /ID# 236853 | Albuquerque | New Mexico | 87102 | United States |
| Albany Medical Center Rheumatology /ID# 236540 | Albany | New York | 12208-3412 | United States |
| Dent Neurosciences Research Center, Inc. /ID# 237040 | Amherst | New York | 14226 | United States |
| Headache Wellness Center /ID# 236431 | Greensboro | North Carolina | 27405 | United States |
| Raleigh Neurology Associates /ID# 237141 | Raleigh | North Carolina | 27607 | United States |
| Stetson-University of Cincinnati /ID# 236453 | Cincinnati | Ohio | 45219 | United States |
| Abington Neurological Associates - Abington /ID# 236258 | Abington | Pennsylvania | 19001 | United States |
| Preferred Primary Care Physicians, Inc. /ID# 236439 | Pittsburgh | Pennsylvania | 15236 | United States |
| WR-ClinSearch /ID# 238288 | Chattanooga | Tennessee | 37421-1605 | United States |
| Clinical Neuroscience Solutions - Memphis /ID# 237478 | Memphis | Tennessee | 38119 | United States |
| DiscoveResearch, Inc /ID# 236274 | Bryan | Texas | 77802 | United States |
| Texas Neurology /ID# 236359 | Dallas | Texas | 75214 | United States |
| University of Texas Southwestern Medical Center /ID# 236941 | Dallas | Texas | 75390-7208 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395 | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297 | Salt Lake City | Utah | 84121 | United States |
| Highland Clinical Research /ID# 237816 | Salt Lake City | Utah | 84124 | United States |
| MedStar Georgetown Neurology /ID# 236324 | McLean | Virginia | 22101 | United States |
| Sentara Neurology Specialists - Virginia Beach /ID# 234349 | Virginia Beach | Virginia | 23456-0019 | United States |
| Northwest Clinical Research Center /ID# 237581 | Bellevue | Washington | 98007 | United States |
| Puget Sound Neurology /ID# 236321 | Tacoma | Washington | 25328 | United States |
| Royal North Shore Hospital /ID# 237008 | St Leonards | New South Wales | 2065 | Australia |
| The Royal Melbourne Hospital /ID# 236859 | Parkville | Victoria | 3050 | Australia |
| CHAMP Clinic /ID# 236252 | Calgary | Alberta | T3M 1M4 | Canada |
| Vancouver Island Health Authority /ID# 238053 | Victoria | British Columbia | V8R 1J8 | Canada |
| Ottawa Headache Centre Research Inc /ID# 236432 | Ottawa | Ontario | K2G 6E2 | Canada |
| Clinique des cephalees de Montreal /ID# 236266 | Montreal | Quebec | H2W 1V1 | Canada |
| Montreal Neurological Institut /ID# 236329 | Montreal | Quebec | H3A 2B4 | Canada |
| Peking University Third Hospital /ID# 238150 | Beijing | Beijing Municipality | 100191 | China |
| Chinese PLA General Hospital /ID# 238237 | Beijing | Beijing Municipality | 100853 | China |
| Guangzhou First People's Hospital /ID# 236510 | Guangzhou | Guangdong | 510180 | China |
| The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133 | Guangzhou | Guangdong | 510260 | China |
| Hubei General Hospital /ID# 236486 | Wuhan | Hebei | 430060 | China |
| The First Affiliated Hospital of Zhengzhou University /ID# 237025 | Zhengzhou | Henan | 450052 | China |
| Jiangsu Province Hospital /ID# 237846 | Nanjing | Jiangsu | 210029 | China |
| The Second Hospital of Jilin University /ID# 236520 | Changchun | Jilin | 130022 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847 | Shanghai | Shanghai Municipality | 200065 | China |
| The Second Hospital of Shanxi Medical University /ID# 236529 | Taiyuan | Shanxi | 030000 | China |
| The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260 | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500 | Hangzhou | Zhejiang | 310020 | China |
| Beijing Friendship Hospital /ID# 237264 | Beijing | 100032 | China |
| The Second Hospital of Soochow University /ID# 234296 | Suzhou | 215004 | China |
| Tianjin Huanhu Hospital (THH) /ID# 236524 | Tianjin | 300350 | China |
| Tongji Hospital Tongji Medical College of HUST /ID# 237835 | Wuhan | 430030 | China |
| NEUROHK s.r.o. /ID# 236290 | Hradec Králové | 500 09 | Czechia |
| BRAIN-SOULTHERAPY s.r.o. /ID# 236380 | Kladno | 272 01 | Czechia |
| CCR Ostrava, s.r.o. /ID# 234291 | Ostrava | 702 00 | Czechia |
| CLINTRIAL s.r.o. /ID# 237793 | Prague | 100 00 | Czechia |
| CCR Prague s.r.o. /ID# 236250 | Prague | 130 00 | Czechia |
| CCR Czech a.s /ID# 236249 | Prague | 140 00 | Czechia |
| Thomayerova nemocnice /ID# 237175 | Prague | 140 59 | Czechia |
| FORBELI s.r.o. /ID# 236427 | Prague | 160 00 | Czechia |
| NeuroMed Zlin s.r.o. /ID# 236416 | Zlín | 760 01 | Czechia |
| Rigshospitalet Glostrup /ID# 236411 | Glostrup Municipality | Capital Region | 2600 | Denmark |
| AP-HM - Hopital de la Timone /ID# 236285 | Marseille | Bouches-du-Rhone | 13385 | France |
| CH Annecy Genevois Site Annecy /ID# 236385 | Pringy | Haute-Savoie | 74374 | France |
| Hôpital Pierre Wertheimer /ID# 236969 | Bron | 69677 | France |
| CHU Gabriel Montpied /ID# 237323 | Clermont-Ferrand | 63000 | France |
| Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256 | Berlin | 13353 | Germany |
| Praxis Dr. Gendolla /ID# 236311 | Essen | 45133 | Germany |
| Universitaetsklinikum Essen /ID# 237209 | Essen | 45147 | Germany |
| CTC North GmbH & Co. KG /ID# 236328 | Hamburg | 20251 | Germany |
| Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723 | Kassel | 34131 | Germany |
| Schmerzklinik Kiel /ID# 236444 | Kiel | 24149 | Germany |
| LMU Klinikum Campus Grosshadern /ID# 236293 | München | 81377 | Germany |
| Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492 | Bari | 70124 | Italy |
| Azienda Ospedaliero Universitaria Careggi /ID# 237598 | Florence | 50134 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291 | Milan | 20133 | Italy |
| AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361 | Naples | 80138 | Italy |
| Universita di Pavia /ID# 236363 | Pavia | 27100 | Italy |
| IRCCS San Raffaele Pisana /ID# 236552 | Rome | 00163 | Italy |
| Takanoko Hospital /ID# 234564 | Matsuyama | Ehime | 790-0925 | Japan |
| Fukuiken Saiseikai Hospital /ID# 236794 | Fukui-shi | Fukui | 918-8235 | Japan |
| Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549 | Sapporo | Hokkaido | 003-0003 | Japan |
| Konan Medical Center /ID# 236230 | Kobe | Hyōgo | 658-0064 | Japan |
| Atsuchi Neurosurgical Hospital /ID# 234779 | Kagoshima | Kagoshima-ken | 892-0842 | Japan |
| Tokai University Hospital /ID# 237595 | Isehara-shi | Kanagawa | 259-1193 | Japan |
| Fujitsu Clinic /ID# 237443 | Kawasaki-shi | Kanagawa | 211-8588 | Japan |
| Umenotsuji Clinic /ID# 234495 | Kochi | Kochi | 780-8011 | Japan |
| Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496 | Sendai | Miyagi | 982-0014 | Japan |
| Saitama Medical University Hospital /ID# 237019 | Iruma-gun | Saitama | 350-0495 | Japan |
| Saitama Neuropsychiatric Institute /Id# 234550 | Saitama-shi | Saitama | 338-8577 | Japan |
| Japanese Red Cross Shizuoka Hospital /ID# 234372 | Shizuoka | Shizuoka | 420-0853 | Japan |
| Dokkyo Medical University Hospital /ID# 236810 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| Niwa Family Clinic /ID# 234552 | Chofu-shi | Tokyo | 182-0006 | Japan |
| Tokyo Headache Clinic /ID# 234555 | Shibuya-ku | Tokyo | 151-0051 | Japan |
| Keio University Hospital /ID# 237210 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Nagaseki Headache Clinic /ID# 234561 | Kai-shi | Yamanashi | 400-0124 | Japan |
| DOI Internal Medicine-Neurology Clinic /ID# 234562 | Hiroshima | 730-0031 | Japan |
| Hiroshima Neurology Clinic /ID# 234563 | Hiroshima | 732-0822 | Japan |
| Tanaka Neurosurgical clinic /ID# 234760 | Kagoshima | 892-0844 | Japan |
| Tatsuoka Neurology Clinic /ID# 234782 | Kyoto | 600-8811 | Japan |
| Tominaga Hospital /ID# 234781 | Osaka | 556-0017 | Japan |
| Shinagawa Strings Clinic /ID# 234780 | Tokyo | 108-0075 | Japan |
| Solumed Centrum Medyczne /ID# 236452 | Poznan | Greater Poland Voivodeship | 60-529 | Poland |
| NZOZ Vitamed /ID# 237041 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Specjalistyczne Gabinety Sp. z o.o. /ID# 236348 | Krakow | Lesser Poland Voivodeship | 30-539 | Poland |
| Centrum Leczenia Padaczki i Migreny /ID# 236386 | Krakow | Lesser Poland Voivodeship | 31-209 | Poland |
| Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289 | Lublin | Lublin Voivodeship | 20-582 | Poland |
| Centrum Medyczne Pratia Gdynia /ID# 237077 | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| Silmedic Sp. z o.o. /ID# 237343 | Katowice | Silesian Voivodeship | 40-282 | Poland |
| EuroMedis sp. z o.o. /ID# 236417 | Szczecin | West Pomeranian Voivodeship | 70-111 | Poland |
| Kazan State Medical University /ID# 236298 | Kazan' | Tatarstan, Respublika | 420012 | Russia |
| State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354 | Kazan' | Tatarstan, Respublika | 420021 | Russia |
| University Headache Clinic /ID# 236371 | Moscow | 119221 | Russia |
| Clinics Chaika /ID# 236394 | Moscow | 125047 | Russia |
| Central Clinical Hospital RZHD Medicine /ID# 237024 | Moscow | 129128 | Russia |
| Dongtan Sacred Heart Hospital /ID# 238097 | Hwaseong | Gyeonggido | 18450 | South Korea |
| Kangbuk Samsung Hospital /ID# 237754 | Seoul | Seoul Teugbyeolsi | 03181 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 237839 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Pusan National University Hospital /ID# 237120 | Busan | 49241 | South Korea |
| Nowon Eulji Medical Center, Eulji University /ID# 236306 | Seoul | 01830 | South Korea |
| Seoul National University Hospital /ID# 237786 | Seoul | 03080 | South Korea |
| Samsung Medical Center /ID# 237785 | Seoul | 06351 | South Korea |
| Hospital Clínico Universitario de Santiago-CHUS /ID# 237623 | Santiago de Compostela | A Coruna | 15706 | Spain |
| CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645 | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 236467 | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen del Rocio /ID# 237106 | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia /ID# 237400 | Valencia | 46010 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 237087 | Valencia | 46026 | Spain |
| Hospital Clinico Universitario de Valladolid /ID# 234406 | Valladolid | 47003 | Spain |
| Hospital Clinico Universitario Lozano Blesa /ID# 237373 | Zaragoza | 50009 | Spain |
| Stortorgets Neurologmottagning /ID# 236454 | Helsingborg | 252 20 | Sweden |
| Kuang-Tien General Hospital /ID# 236309 | Taichung | 433 | Taiwan |
| Tainan Sin Lau Hospital /ID# 236358 | Tainan | 70142 | Taiwan |
| Chi-Mei Medical Center /ID# 236724 | Tainan | 71004 | Taiwan |
| Taipei Veterans General Hosp /ID# 237236 | Taipei | 11217 | Taiwan |
| Tri-Service General Hospital /ID# 237657 | Taipei | 11490 | Taiwan |
| Walton Centre /ID# 236468 | Liverpool | L9 7LJ | United Kingdom |
| King's College Hospital NHS Foundation Trust /ID# 236301 | London | SE5 9RS | United Kingdom |
| 39982105 | Derived | Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610. |
| 39715475 | Derived | Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23. |
| 39648629 | Derived | Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753. |
| 39648617 | Derived | Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305. |
| 38924724 | Derived | Goadsby PJ, Friedman DI, Holle-Lee D, Demarquay G, Ashina S, Sakai F, Neel B, Gandhi P, Dabruzzo B, Smith JH, Liu Y, Trugman JM. Efficacy of Atogepant in Chronic Migraine With and Without Acute Medication Overuse in the Randomized, Double-Blind, Phase 3 PROGRESS Trial. Neurology. 2024 Jul 23;103(2):e209584. doi: 10.1212/WNL.0000000000209584. Epub 2024 Jun 26. |
| 37516125 | Derived | Pozo-Rosich P, Ailani J, Ashina M, Goadsby PJ, Lipton RB, Reuter U, Guo H, Schwefel B, Lu K, Boinpally R, Miceli R, De Abreu Ferreira R, McCusker E, Yu SY, Severt L, Finnegan M, Trugman JM. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785. doi: 10.1016/S0140-6736(23)01049-8. Epub 2023 Jul 26. |
| 33942560 | Derived | Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4. |
| 33142014 | Derived | Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24. |
| FG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
| Safety Population | Safety population included all participants who received at least 1 dose of study intervention. |
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| Modified Intent-to-Treat (mITT) Population | mITT population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the double-blind treatment period. |
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| Off-treatment Hypothetical Estimand Population | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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| FU Period (Week 12 to Week 16) |
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Intent-to-treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received atogepant-matching placebo tablets, orally, BID for 12 weeks in a DB treatment period. |
| BG001 | Atogepant 30 mg BID | Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. |
| BG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Monthly Migraine Days in mITT Population | A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the double-blind treatment period. | Median | Full Range | migraine days per month |
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| Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population | A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. | Median | Full Range | migraine days per month |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the DB treatment period. | Posted | Median | Full Range | migraine days per month | Baseline to Week 12 |
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| Primary | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. | Posted | Median | Full Range | migraine days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the DB treatment period. | Posted | Median | Full Range | headache days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. | Posted | Median | Full Range | headache days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the DB treatment period. | Posted | Median | Full Range | acute medication use days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. | Posted | Median | Full Range | acute medication use days per month | Baseline to Week 12 |
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| Secondary | Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the DB treatment period. | Posted | Number | percentage of participants | Baseline to Week 12 |
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| Secondary | Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. The values are rounded off to the first decimal value. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. | Posted | Number | percentage of participants | Baseline to Week 12 |
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| Secondary | Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand Population | The 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 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to 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 indicate better quality of life. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. Overall number analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | At Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the DB treatment period. Overall number analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period. | mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the DB treatment period. Overall number analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
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| Secondary | Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population | HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses. | Off-treatment hypothetical estimand population included all randomized participants who received ≥ 1 dose of study intervention, had an evaluable baseline period of eDiary data and had ≥ 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data during the study, regardless of whether on study treatment or off study treatment. Overall number analyzed are the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | At Week 12 |
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From first dose of study drug up to end of study (Up to approximately 16 weeks)
All-Cause Mortality is reported for all randomized participants. Safety population included all participants who received at least 1 dose of study intervention and was used for serious adverse events and other adverse events.
Not provided
| 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 received atogepant-matching placebo tablets, orally, BID for 12 weeks in a DB treatment period. | 0 | 259 | 3 | 255 | 16 | 255 |
| EG001 | Atogepant 30 mg BID | Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. | 0 | 257 | 4 | 257 | 44 | 257 |
| EG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. | 0 | 262 | 7 | 261 | 46 | 261 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| ANAL ABSCESS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| EPICONDYLITIS | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| VACCINATION COMPLICATION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| BENIGN OVARIAN TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| PLASMA CELL MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| SPINAL CORD NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | 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 | Jan 24, 2022 | Jan 18, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000718987 | atogepant |
Not provided
Not provided
Not provided
| Protocol Deviation |
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| Reason not Specified |
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| MMRM | 0.0009 | Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons. | Least Squares Mean Difference | -1.82 | Standard Error of the Mean | 0.545 | 2-Sided | 95 | -2.89 | -0.75 | MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates. | Superiority |
| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG001 | Atogepant 30 mg BID | Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. |
| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG001 |
| Atogepant 30 mg BID |
Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. |
| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| Atogepant 30 mg BID |
Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period. |
| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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| OG002 | Atogepant 60 mg QD | Participants received atogepant 60 mg, orally, QD along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period. |
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