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)
2 other identifiers
interventional
1,300
15 countries
149
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2024
Typical duration for phase_3
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedJune 24, 2026
May 1, 2026
1.3 years
January 28, 2024
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
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
Approximately 16 Weeks
Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack
Approximately 16 Weeks
Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack
Approximately 16 Weeks
Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack
Approximately 16 Weeks
- +17 more secondary outcomes
Study Arms (4)
Sequence 1
PLACEBO COMPARATORParticipants will receive both atogepant and placebo to treat qualifying migraines.
Sequence 2
EXPERIMENTALParticipants will receive both atogepant and placebo to treat qualifying migraines.
Sequence 3
EXPERIMENTALParticipants will receive both atogepant and placebo to treat qualifying migraines.
Sequence 4
EXPERIMENTALParticipants will receive both atogepant and placebo to treat qualifying migraines.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (149)
Universitair Ziekenhuis Antwerpen /ID# 257582
Edegem, Antwerpen, 2650, Belgium
Universitair Ziekenhuis Brussel /ID# 257584
Jette, Brussels Capital, 1090, Belgium
Cabinet Prive Dr Sava /ID# 257581
Saint-Nicolas, Liege, 4420, Belgium
Jessa Ziekenhuis /ID# 257578
Hasselt, Limburg, 3500, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge /ID# 257585
Bruges, West-Vlaanderen, 8000, Belgium
AZ Groeninge /ID# 257586
Kortrijk, 8500, Belgium
H.-Hartziekenhuis Lier /ID# 257577
Lier, 2500, Belgium
CHR de la Citadelle /ID# 257587
Liège, 4000, Belgium
The first affiliated hospital of bengbu medical college /ID# 258758
Bengbu, Anhui, 233004, China
Beijing Friendship Hospital /ID# 258830
Beijing, Beijing Municipality, 100032, China
Xuanwu Hospital Capital Medical University /ID# 258510
Beijing, Beijing Municipality, 100053, China
Peking University Third Hospital /ID# 259573
Beijing, Beijing Municipality, 100191, China
Chinese PLA General Hospital /ID# 257540
Beijing, Beijing Municipality, 100853, China
Peking University First Hospital /ID# 258672
Xicheng District, Beijing Municipality, 100034, China
Fujian Medical University Union Hospital /ID# 259575
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University /ID# 259576
Xiamen, Fujian, 361003, China
Lanzhou University Second Hospital /ID# 259667
Lanzhou, Gansu, 730030, China
Guangzhou First People's Hospital /ID# 258656
Guangzhou, Guangdong, 510180, China
The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638
Guangzhou, Guangdong, 510260, China
The University Of Hong Kong - Shenzhen Hospital /ID# 258462
Shenzhen, Guangdong, 518053, China
The Affiliated Hospital of Guizhou Medical University /ID# 259536
Guiyang, Guizhou, 550004, China
Hainan General Hospital /ID# 259548
Haikou, Hainan, 570311, China
Hebei General Hospital /ID# 258583
Shijiazhuang, Hebei, 500051, China
Zhengzhou People's Hospital /ID# 258670
Zhengzhou, Henan, 450012, China
The Second Xiangya Hospital Of Central South University /ID# 260623
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University /ID# 258787
Changsha, Hunan, 410013, China
Zhuzhou Central Hospital /ID# 260076
Zhuzhou, Hunan, 412007, China
The Second Affiliated Hospital of Nanjing Medical University /ID# 258648
Nanjing, Jiangsu, 210011, China
The Second Affiliated Hospital of Soochow University /ID# 259551
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University /ID# 258783
Suzhou, Jiangsu, 215031, China
Jiangxi Pingxiang Peoples Hospital /ID# 258652
Pingxiang, Jiangxi, 337055, China
The First Hospital of Jilin University /ID# 259585
Changchun, Jilin, 130021, China
The Second hospital of Jilin university /ID# 258556
Changchun, Jilin, 130022, China
General Hospital of Northern Theater Command /ID# 259556
Shenyang, Liaoning, 110016, China
Shaanxi Provincial PeopleS Hospital /ID# 259529
Xi'an, Shaanxi, 710054, China
Second Hospital of Shanxi Medical University /ID# 259669
Taiyuan, Shanxi, 030001, China
West China Hospital, Sichuan University /ID# 258664
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital /ID# 259513
Tianjin, Tianjin Municipality, 300052, China
Tianjin People's Hospital /ID# 258625
Tianjin, Tianjin Municipality, 300120, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 258860
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 258939
Wenzhou, Zhejiang, 325000, China
Baotou Central Hospital /ID# 258786
Baotou, 014040, China
The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554
Shanghai, 200080, China
CCR Ostrava, s.r.o. /ID# 257743
Ostrava, Ostrava-mesto, 702 00, Czechia
Fakultni Nemocnice Ostrava /ID# 259023
Ostrava, Ostrava-mesto, 708 52, Czechia
Praglandia /ID# 257667
Prague, Praha 5, 150 00, Czechia
NeuroHK s.r.o. /ID# 257671
Hradec Králové, 500 09, Czechia
Clintrial s.r.o. /ID# 257663
Prague, 100 00, Czechia
DADO MEDICAL s.r.o. /ID# 257672
Prague, 120 00, Czechia
Axon Clinical, s.r.o. /ID# 259024
Prague, 140 00, Czechia
Fakultni Thomayerova nemocnice /ID# 259021
Prague, 140 59, Czechia
FORBELI s.r.o. /ID# 259019
Prague, 160 00, Czechia
INEP medical s.r.o. /ID# 257669
Prague, 186 00, Czechia
Vestra Clinics s.r.o. /ID# 259022
Rychnov nad Kněžnou, 516 01, Czechia
Neuropraxis Muenchen Sued /ID# 258077
Unterhaching, Bavaria, 82008, Germany
Kopfschmerzzentrum - Frankfurt /ID# 258019
Frankfurt am Main, Hesse, 65929, Germany
Velocity Clinical Research - Wiesbaden /ID# 258020
Wiesbaden, Hesse, 65189, Germany
Studienzentrum Nord-West /ID# 258024
Westerstede, Lower Saxony, 26655, Germany
Universitaetsklinikum Duesseldorf /ID# 258078
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Ambenet Hausarztpraxis /ID# 258075
Leipzig, Saxony, 04107, Germany
Schmerzklinik Kiel /ID# 258005
Kiel, Schleswig-Holstein, 24149, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 258076
Berlin, 10117, Germany
Universitaetsklinikum Essen /ID# 258023
Essen, 45147, Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 258008
Kassel, 34131, Germany
Jávorszky Ödön Kórház /ID# 258969
Vác, Pest County, 2600, Hungary
Cortex Study Center /ID# 259032
Budapest, 1026, Hungary
Semmelweis Egyetem /ID# 258546
Budapest, 1085, Hungary
Semmelweis Egyetem /ID# 258800
Budapest, 1085, Hungary
UNO Medical Trials /ID# 259186
Budapest, 1135, Hungary
S-Medicon Kft /ID# 258547
Budapest, 1138, Hungary
Istituto Neurologico Mediterraneo Neuromed /ID# 258593
Pozzilli, Isernia, 86077, Italy
ASL 1 Abruzzo - Ospedale SS. Filippo and Nicola /ID# 258590
Avezzano, L Aquila, 67051, Italy
IRCCS Ospedale San Raffaele /ID# 258592
Milan, Milano, 20132, Italy
Istituto Auxologico Italiano - Irccs /ID# 258623
Milan, Milano, 20145, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258591
Turin, Piedmont, 10126, Italy
Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 261089
Bologna, 40126, Italy
ASST degli Spedali Civili di Brescia /ID# 258594
Brescia, 25123, Italy
ICOT Istituto Marco Pasquali /ID# 258621
Latina, 04100, Italy
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 258589
Pavia, 27100, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 258588
Roma, 00128, Italy
Ospedale San Paolo - ASL2 /ID# 258622
Savona, 17100, Italy
Tokyo Dental College Ichikawa General Hospital /ID# 259570
Ichikawa-shi, Chiba, 272-0824, Japan
Ikeda Neurosurgical Clinic /ID# 259085
Kasuga-shi, Fukuoka, 816-0824, Japan
Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 262708
Sapporo, Hokkaido, 003-0003, Japan
Umenotsuji Clinic /ID# 258717
Kochi, Kochi, 780-8011, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862
Sendai, Miyagi, 982-0014, Japan
Tominaga Clinic - Osaka /ID# 258553
Osaka, Osaka, 556-0015, Japan
Usuda Clinic Of Internal Medicine /ID# 260422
Setagaya-ku, Tokyo, 156-0043, Japan
Tokyo Headache Clinic /ID# 258534
Shibuya-ku, Tokyo, 151-0051, Japan
Nagaseki Headache Clinic /ID# 259214
Kai, Yamanashi, 400-0124, Japan
DOI Internal Medicine-Neurology Clinic /ID# 259009
Hiroshima, 730-0031, Japan
Tatsuoka Neurology Clinic /ID# 258771
Kyoto, 600-8811, Japan
Solumed Centrum Medyczne /ID# 258288
Poznan, Greater Poland Voivodeship, 60-529, Poland
Clinical Research Center Medic-R /ID# 258268
Poznan, Greater Poland Voivodeship, 60-848, Poland
Vitamed Galaj i Cichomski Sp.j. /ID# 258278
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Athleticomed Sp. z o.o /ID# 258253
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland
Linden Medical Centre /ID# 258283
Krakow, Lesser Poland Voivodeship, 30-105, Poland
Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281
Lublin, Lublin Voivodeship, 20-582, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 258250
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Silmedic Sp. z o.o. /ID# 258249
Katowice, Silesian Voivodeship, 40-282, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287
Wroclaw, 52-210, Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 257986
Guimarães, Braga District, 4835-044, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987
Almada, Setúbal District, 2805-267, Portugal
Hospital da Luz Lisboa /ID# 257983
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria /ID# 257989
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Santo Antonio /ID# 258140
Porto, 4099-003, Portugal
Unidade Local de Saude da Arrabida, EPE /ID# 258139
Setúbal, 2910-446, Portugal
Univerzitna nemocnica - Nemocnica svateho Michala a.s. /ID# 257909
Bratislava, Bratislava Region, 811 08, Slovakia
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961
Bratislava, Bratislava Region, 811 09, Slovakia
University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947
Bratislava, Bratislava Region, 831 01, Slovakia
Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176
Prešov, Presov, 080 01, Slovakia
MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901
Banská Bystrica, 974 04, Slovakia
Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315
Liptovský Mikuláš, Žilina Region, 031 23, Slovakia
Hallym University Dongtan Sacred Heart Hospital /ID# 257999
Hwaseong, Gyeonggido, 18450, South Korea
Chonnam National University Hospital /ID# 259154
Gwangju, Jeonranamdo, 61469, South Korea
Nowon Eulji Medical Center, Eulji University /ID# 258000
Seoul, Seoul Teugbyeolsi, 01830, South Korea
Seoul National University Hospital /ID# 258002
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Kangbuk Samsung Hospital /ID# 258001
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Yonsei University Health System Severance Hospital /ID# 257998
Seoul, 03722, South Korea
Hospital Universitario Marques de Valdecilla /ID# 257658
Santander, Cantabria, 39008, Spain
Clinica Universidad de Navarra - Pamplona /ID# 257656
Pamplona, Navarre, 31008, Spain
Hospital Universitario Vall de Hebron /ID# 257652
Barcelona, 08035, Spain
Hospital Universitario La Paz /ID# 257654
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio /ID# 257657
Seville, 41013, Spain
Hospital Universitario y Politecnico La Fe /ID# 257655
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid /ID# 257653
Valladolid, 47003, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 257661
Zaragoza, 50009, Spain
Skaneuro Privatmottagning /ID# 258833
Lund, Skåne County, 227 33, Sweden
Karolinska Universitetssjukhuset - Huddinge /ID# 258837
Huddinge, Stockholm County, 141 57, Sweden
Neurology Clinic /ID# 258835
Stockholm, Stockholm County, 114 33, Sweden
Optimuskliniken /ID# 258834
Upplands Vasby, Stockholm County, 194 61, Sweden
CTC EbbePark Linkoping /ID# 261170
Linköping, 582 13, Sweden
Kuang-Tien General Hospital /ID# 258063
Taichung, Taichung, 433, Taiwan
Taipei Veterans General Hospital /ID# 258062
Taipei City, Taipei, 11217, Taiwan
China Medical University Hospital /ID# 258417
Taichung, 40447, Taiwan
Tri-Service General Hospital /ID# 258064
Taipei, 11490, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 259171
Taoyuan City, 333, Taiwan
St Pancras Clinical Research - Chester /ID# 277704
Chester, Cheshire, CH2 1HX, United Kingdom
North Coast Medical Ltd - Newquay Health Centre /ID# 260019
Newquay, Cornwall, TR7 1RU, United Kingdom
Ashgate Medical Practice /ID# 258923
Chesterfield, Derbyshire, S40 4AA, United Kingdom
The Adam Practice /ID# 258190
Poole, Dorset, BH15 4JQ, United Kingdom
St Pancras Clinical Research - London /ID# 258183
London, Greater London, EC2Y 8EA, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 259384
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Re:Cognition Health Birmingham /ID# 258186
Birmingham, B16 8LT, United Kingdom
Re:Cognition Health Bristol /ID# 258187
Bristol, BS32 4SY, United Kingdom
Re:Cognition Health - Guildford /ID# 258188
Guildford, GU2 7YD, United Kingdom
The University of Nottingham Health Service /ID# 259380
Nottingham, NG7 2QW, United Kingdom
Primary Care Sheffield /ID# 259448
Sheffield, S9 4EU, United Kingdom
Related Publications (1)
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.
PMID: 41920093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2024
First Posted
February 5, 2024
Study Start
March 25, 2024
Primary Completion
July 7, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
June 24, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.