Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine (ATO ACUTE)

Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.

Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.

All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).

There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Atogepant; Drug: Placebo for Atogepant

• Study Type: Interventional
• Enrollment (Estimated): 1300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium, 8500
    • AZ Groeninge /ID# 257586
  • Lier, Belgium, 2500
    • H.-Hartziekenhuis Lier /ID# 257577
  • Liège, Belgium, 4000
    • CHR de la Citadelle /ID# 257587
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen /ID# 257582
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • Universitair Ziekenhuis Brussel /ID# 257584
  • Liege
    • Saint-Nicolas, Liege, Belgium, 4420
      • Cabinet Prive Dr Sava /ID# 257581
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis /ID# 257578
  • West-Vlaanderen
    • Bruges, West-Vlaanderen, Belgium, 8000
      • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 257585
• China
  • Baotou, China, 014040
    • Baotou Central Hospital /ID# 258786
  • Shanghai, China, 200080
    • The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554
  • Anhui
    • Bengbu, Anhui, China, 233004
      • The first affiliated hospital of bengbu medical college /ID# 258758
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100032
      • Beijing Friendship Hospital /ID# 258830
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital Capital Medical University /ID# 258510
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital /ID# 259573
    • Beijing, Beijing Municipality, China, 100853
      • Chinese PLA General Hospital /ID# 257540
    • Xicheng District, Beijing Municipality, China, 100034
      • Peking University First Hospital /ID# 258672
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital /ID# 259575
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University /ID# 259576
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital /ID# 259667
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People's Hospital /ID# 258656
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638
    • Shenzhen, Guangdong, China, 518053
      • The University Of Hong Kong - Shenzhen Hospital /ID# 258462
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • The Affiliated Hospital of Guizhou Medical University /ID# 259536
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital /ID# 259548
  • Hebei
    • Shijiazhuang, Hebei, China, 500051
      • Hebei General Hospital /ID# 258583
  • Henan
    • Zhengzhou, Henan, China, 450012
      • Zhengzhou People's Hospital /ID# 258670
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University /ID# 260623
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University /ID# 258787
    • Zhuzhou, Hunan, China, 412007
      • Zhuzhou Central Hospital /ID# 260076
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University /ID# 258648
    • Suzhou, Jiangsu, China, 215004
      • The Second Affiliated Hospital of Soochow University /ID# 259551
    • Suzhou, Jiangsu, China, 215031
      • The First Affiliated Hospital of Soochow University /ID# 258783
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Jiangxi Pingxiang Peoples Hospital /ID# 258652
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University /ID# 259585
    • Changchun, Jilin, China, 130022
      • The Second hospital of Jilin university /ID# 258556
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • General Hospital of Northern Theater Command /ID# 259556
  • Shaanxi
    • Xi'an, Shaanxi, China, 710054
      • Shaanxi Provincial PeopleS Hospital /ID# 259529
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Second Hospital of Shanxi Medical University /ID# 259669
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 258664
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital /ID# 259513
    • Tianjin, Tianjin Municipality, China, 300120
      • Tianjin People's Hospital /ID# 258625
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 258860
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University /ID# 258939
• Czechia
  • Hradec Králové, Czechia, 500 09
    • NeuroHK s.r.o. /ID# 257671
  • Prague, Czechia, 160 00
    • FORBELI s.r.o. /ID# 259019
  • Prague, Czechia, 100 00
    • Clintrial s.r.o. /ID# 257663
  • Prague, Czechia, 120 00
    • DADO MEDICAL s.r.o. /ID# 257672
  • Prague, Czechia, 140 00
    • Axon Clinical, s.r.o. /ID# 259024
  • Prague, Czechia, 140 59
    • Fakultni Thomayerova nemocnice /ID# 259021
  • Prague, Czechia, 186 00
    • INEP medical s.r.o. /ID# 257669
  • Rychnov nad Kněžnou, Czechia, 516 01
    • Vestra Clinics s.r.o. /ID# 259022
  • Ostrava-mesto
    • Ostrava, Ostrava-mesto, Czechia, 702 00
      • CCR Ostrava, s.r.o. /ID# 257743
    • Ostrava, Ostrava-mesto, Czechia, 708 52
      • Fakultni Nemocnice Ostrava /ID# 259023
  • Praha 5
    • Prague, Praha 5, Czechia, 150 00
      • Praglandia /ID# 257667
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 258076
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen /ID# 258023
  • Kassel, Germany, 34131
    • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 258008
  • Bavaria
    • Unterhaching, Bavaria, Germany, 82008
      • Neuropraxis Muenchen Sued /ID# 258077
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 65929
      • Kopfschmerzzentrum - Frankfurt /ID# 258019
    • Wiesbaden, Hesse, Germany, 65189
      • Velocity Clinical Research - Wiesbaden /ID# 258020
  • Lower Saxony
    • Westerstede, Lower Saxony, Germany, 26655
      • Studienzentrum Nord-West /ID# 258024
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitaetsklinikum Duesseldorf /ID# 258078
  • Saxony
    • Leipzig, Saxony, Germany, 04107
      • Ambenet Hausarztpraxis /ID# 258075
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24149
      • Schmerzklinik Kiel /ID# 258005
• Hungary
  • Budapest, Hungary, 1026
    • Cortex Study Center /ID# 259032
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 258546
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 258800
  • Budapest, Hungary, 1135
    • UNO Medical Trials /ID# 259186
  • Budapest, Hungary, 1138
    • S-Medicon Kft /ID# 258547
  • Pest County
    • Vác, Pest County, Hungary, 2600
      • Jávorszky Ödön Kórház /ID# 258969
• Italy
  • Bologna, Italy, 40126
    • Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 261089
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia /ID# 258594
  • Latina, Italy, 04100
    • ICOT Istituto Marco Pasquali /ID# 258621
  • Pavia, Italy, 27100
    • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 258589
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 258588
  • Savona, Italy, 17100
    • Ospedale San Paolo - ASL2 /ID# 258622
  • Isernia
    • Pozzilli, Isernia, Italy, 86077
      • Istituto Neurologico Mediterraneo Neuromed /ID# 258593
  • L Aquila
    • Avezzano, L Aquila, Italy, 67051
      • ASL 1 Abruzzo - Ospedale SS. Filippo and Nicola /ID# 258590
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 258592
    • Milan, Milano, Italy, 20145
      • Istituto Auxologico Italiano - Irccs /ID# 258623
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258591
• Japan
  • Hiroshima, Japan, 730-0031
    • DOI Internal Medicine-Neurology Clinic /ID# 259009
  • Kyoto, Japan, 600-8811
    • Tatsuoka Neurology Clinic /ID# 258771
  • Chiba
    • Ichikawa-shi, Chiba, Japan, 272-0824
      • Tokyo Dental College Ichikawa General Hospital /ID# 259570
  • Fukuoka
    • Kasuga-shi, Fukuoka, Japan, 816-0824
      • Ikeda Neurosurgical Clinic /ID# 259085
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0003
      • Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 262708
  • Kochi
    • Kochi, Kochi, Japan, 780-8011
      • Umenotsuji Clinic /ID# 258717
  • Miyagi
    • Sendai, Miyagi, Japan, 982-0014
      • Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862
  • Osaka
    • Osaka, Osaka, Japan, 556-0015
      • Tominaga Clinic - Osaka /ID# 258553
  • Tokyo
    • Setagaya-ku, Tokyo, Japan, 156-0043
      • Usuda Clinic Of Internal Medicine /ID# 260422
    • Shibuya-ku, Tokyo, Japan, 151-0051
      • Tokyo Headache Clinic /ID# 258534
  • Yamanashi
    • Kai, Yamanashi, Japan, 400-0124
      • Nagaseki Headache Clinic /ID# 259214
• Poland
  • Wroclaw, Poland, 52-210
    • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-529
      • Solumed Centrum Medyczne /ID# 258288
    • Poznan, Greater Poland Voivodeship, Poland, 60-848
      • Clinical Research Center Medic-R /ID# 258268
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
      • Vitamed Galaj i Cichomski Sp.j. /ID# 258278
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
      • Athleticomed Sp. z o.o /ID# 258253
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-105
      • Linden Medical Centre /ID# 258283
    • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
      • Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-582
      • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 258250
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-282
      • Silmedic Sp. z o.o. /ID# 258249
• Portugal
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz Lisboa /ID# 257983
  • Lisbon, Portugal, 1649-035
    • Unidade Local de Saude de Santa Maria /ID# 257989
  • Porto, Portugal, 4099-003
    • Unidade Local de Saude de Santo Antonio /ID# 258140
  • Setúbal, Portugal, 2910-446
    • Unidade Local de Saude da Arrabida, EPE /ID# 258139
  • Braga District
    • Guimarães, Braga District, Portugal, 4835-044
      • Unidade Local de Saude do Alto Ave, EPE /ID# 257986
  • Setúbal District
    • Almada, Setúbal District, Portugal, 2805-267
      • Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987
• Slovakia
  • Banská Bystrica, Slovakia, 974 04
    • MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901
  • Bratislava Region
    • Bratislava, Bratislava Region, Slovakia, 811 08
      • Univerzitna nemocnica - Nemocnica svateho Michala a.s. /ID# 257909
    • Bratislava, Bratislava Region, Slovakia, 811 09
      • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961
    • Bratislava, Bratislava Region, Slovakia, 831 01
      • University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947
  • Presov
    • Prešov, Presov, Slovakia, 080 01
      • Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176
  • Žilina Region
    • Liptovský Mikuláš, Žilina Region, Slovakia, 031 23
      • Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315
• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Health System Severance Hospital /ID# 257998
  • Gyeonggido
    • Hwaseong, Gyeonggido, South Korea, 18450
      • Hallym University Dongtan Sacred Heart Hospital /ID# 257999
  • Jeonranamdo
    • Gwangju, Jeonranamdo, South Korea, 61469
      • Chonnam National University Hospital /ID# 259154
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 01830
      • Nowon Eulji Medical Center, Eulji University /ID# 258000
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 258002
    • Seoul, Seoul Teugbyeolsi, South Korea, 03181
      • Kangbuk Samsung Hospital /ID# 258001
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall de Hebron /ID# 257652
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 257654
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 257657
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 257655
  • Valladolid, Spain, 47003
    • Hospital Clinico Universitario de Valladolid /ID# 257653
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa /ID# 257661
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla /ID# 257658
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona /ID# 257656
• Sweden
  • Linköping, Sweden, 582 13
    • CTC EbbePark Linkoping /ID# 261170
  • Skåne County
    • Lund, Skåne County, Sweden, 227 33
      • Skaneuro Privatmottagning /ID# 258833
  • Stockholm County
    • Huddinge, Stockholm County, Sweden, 141 57
      • Karolinska Universitetssjukhuset - Huddinge /ID# 258837
    • Stockholm, Stockholm County, Sweden, 114 33
      • Neurology Clinic /ID# 258835
    • Upplands Vasby, Stockholm County, Sweden, 194 61
      • Optimuskliniken /ID# 258834
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 258417
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital /ID# 258064
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 259171
  • Taichung
    • Taichung, Taichung, Taiwan, 433
      • Kuang-Tien General Hospital /ID# 258063
  • Taipei
    • Taipei City, Taipei, Taiwan, 11217
      • Taipei Veterans General Hospital /ID# 258062
• United Kingdom
  • Birmingham, United Kingdom, B16 8LT
    • Re:Cognition Health Birmingham /ID# 258186
  • Bristol, United Kingdom, BS32 4SY
    • Re:Cognition Health Bristol /ID# 258187
  • Guildford, United Kingdom, GU2 7YD
    • Re:Cognition Health - Guildford /ID# 258188
  • Nottingham, United Kingdom, NG7 2QW
    • The University of Nottingham Health Service /ID# 259380
  • Sheffield, United Kingdom, S9 4EU
    • Primary Care Sheffield /ID# 259448
  • Cheshire
    • Chester, Cheshire, United Kingdom, CH2 1HX
      • St Pancras Clinical Research - Chester /ID# 277704
  • Cornwall
    • Newquay, Cornwall, United Kingdom, TR7 1RU
      • North Coast Medical Ltd - Newquay Health Centre /ID# 260019
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S40 4AA
      • Ashgate Medical Practice /ID# 258923
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 4JQ
      • The Adam Practice /ID# 258190
  • Greater London
    • London, Greater London, United Kingdom, EC2Y 8EA
      • St Pancras Clinical Research - London /ID# 258183
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 259384

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of migraine (with or without aura) according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) for >= 12 months prior to Visit 1/Screening.
• History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
• Migraine onset before the age of 50.
• History of migraines lasting between 4 and 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.

Exclusion Criteria:

• History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
• Require hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sequence 1; Participants will receive both atogepant and placebo to treat qualifying migraines.	Drug: Atogepant; Oral Tablet; Other Names: Qulipta; Aquipta; Drug: Placebo for Atogepant; Oral Tablet
Experimental: Sequence 2; Participants will receive both atogepant and placebo to treat qualifying migraines.	Drug: Atogepant; Oral Tablet; Other Names: Qulipta; Aquipta; Drug: Placebo for Atogepant; Oral Tablet
Experimental: Sequence 3; Participants will receive both atogepant and placebo to treat qualifying migraines.	Drug: Atogepant; Oral Tablet; Other Names: Qulipta; Aquipta; Drug: Placebo for Atogepant; Oral Tablet
Experimental: Sequence 4; Participants will receive both atogepant and placebo to treat qualifying migraines.	Drug: Atogepant; Oral Tablet; Other Names: Qulipta; Aquipta; Drug: Placebo for Atogepant; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.	Approximately 16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) will be assessed.	Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack	Percentage of participants with use of rescue medication within 24 hours after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Percentage of Participants With Ability to Function Normally at 2 Hours After DB Dose for the First Attack	Percentage of participants with ability to function normally at 2 hours after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After DB Dose for the First Attack	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After DB Dose for the First Attack	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants With Absence of Photophobia at 2 Hours After the DB Dose for the First Attack	Photophobia is defined as sensitivity to light.	Approximately 16 Weeks
Percentage of Participants With Absence of Phonophobia at 2 Hours After the DB Dose for the First Attack	Phonophobia is defined as sensitivity to sound.	Approximately 16 Weeks
Percentage of Participants Achieving Pain Freedom at 8 Hours After the DB Dose for the First Attack	Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.	Approximately 16 Weeks
Percentage of Participants With Ability to Function Normally at 8 Hours After DB Dose for the First Attack	Percentage of participants with ability to function normally at 8 hours after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 1 Hour After the Double-Blind (DB) Dose for the First Attack	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Percentage of Participants With Absence of Nausea at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Percentage of participants with absence of nausea at 2 hours after the DB dose for the first attack.	Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 30 Minutes After the Double-Blind (DB) Dose for the First Attack	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Percentage of Participants With Ability to Function Normally at 1 Hour After DB Dose for the First Attack	Percentage of participants with ability to function normally at 1 hour after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Percentage of Participants Achieving Pain Freedom at 2 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.	Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 2 Hours After Receiving Double-Blind (DB) Atogepant for at least 2 out of 3 Attacks	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Gago-Veiga AB, Lopez-Rodriguez AB, Sanchez Jimenez M, Iglesias Rubio A, Montes N, Camina Muniz J, Dominguez Gallego M, Calle de Miguel C, Latorre G, Rodriguez-Vico J, Jaimes A, Gomez Garcia A, Urtiaga S, Gonzalez Salaices M, Dileone M, Gonzalez-Garcia N, Porta-Etessam J, Cuadrado ML, Herrero San-Martin A, Guerrero-Peral AL, Gonzalez-Osorio Y, Casas-Limon J, Sanchez-Soblechero A, Lozano-Ros A, Diaz-De-Teran J, Portocarrero-Sanchez L, Molina-Martinez FJ, Santos-Lasaosa S, Martin-Avila G, Riva E, Fernandez-Lazaro I. Atogepant for migraine in real-world clinical practice: Insights from a large multicentre study in a treatment-resistant population (GEMA project). Cephalalgia. 2026 Apr;46(4):3331024261431337. doi: 10.1177/03331024261431337. Epub 2026 Apr 1.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): July 7, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; ECLIPSE; Atogepant; Qulipta; Aquipta
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Substandard Drugs; Pharmaceutical Preparations; atogepant
• Other Study ID Numbers: M24-305; 2023-506029-12-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes