AzTrials
AzTrials

MigrainePhase 3ATO ACUTENCT06241313

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

A Phase 3 study testing Atogepant in people with Migraine, run by AbbVie at 149 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,158 participants
Where
149 sitesin 15 countries
Study dates
25 Mar 2024to 11 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

149 sites in 15 countries.

149 sites in 15 countries

China35 sites

  • Baotou Central Hospital /ID# 258786

    Baotou, 014040

  • Beijing Friendship Hospital /ID# 258830

    Beijing, Beijing Municipality, 100032

  • Xuanwu Hospital Capital Medical University /ID# 258510

    Beijing, Beijing Municipality, 100053

  • Peking University Third Hospital /ID# 259573

    Beijing, Beijing Municipality, 100191

  • Chinese PLA General Hospital /ID# 257540

    Beijing, Beijing Municipality, 100853

  • The first affiliated hospital of bengbu medical college /ID# 258758

    Bengbu, Anhui, 233004

  • The First Hospital of Jilin University /ID# 259585

    Changchun, Jilin, 130021

  • The Second hospital of Jilin university /ID# 258556

    Changchun, Jilin, 130022

  • The Second Xiangya Hospital Of Central South University /ID# 260623

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital of Central South University /ID# 258787

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University /ID# 258664

    Chengdu, Sichuan, 610041

  • Fujian Medical University Union Hospital /ID# 259575

    Fuzhou, Fujian, 350001

  • Guangzhou First People's Hospital /ID# 258656

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638

    Guangzhou, Guangdong, 510260

  • The Affiliated Hospital of Guizhou Medical University /ID# 259536

    Guiyang, Guizhou, 550004

  • Hainan General Hospital /ID# 259548

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 258860

    Hangzhou, Zhejiang, 310009

  • Lanzhou University Second Hospital /ID# 259667

    Lanzhou, Gansu, 730030

  • The Second Affiliated Hospital of Nanjing Medical University /ID# 258648

    Nanjing, Jiangsu, 210011

  • Jiangxi Pingxiang Peoples Hospital /ID# 258652

    Pingxiang, Jiangxi, 337055

  • The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554

    Shanghai, 200080

  • General Hospital of Northern Theater Command /ID# 259556

    Shenyang, Liaoning, 110016

  • The University Of Hong Kong - Shenzhen Hospital /ID# 258462

    Shenzhen, Guangdong, 518053

  • Hebei General Hospital /ID# 258583

    Shijiazhuang, Hebei, 500051

  • The Second Affiliated Hospital of Soochow University /ID# 259551

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital of Soochow University /ID# 258783

    Suzhou, Jiangsu, 215031

  • Second Hospital of Shanxi Medical University /ID# 259669

    Taiyuan, Shanxi, 030001

  • Tianjin Medical University General Hospital /ID# 259513

    Tianjin, Tianjin Municipality, 300052

  • Tianjin People's Hospital /ID# 258625

    Tianjin, Tianjin Municipality, 300120

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 258939

    Wenzhou, Zhejiang, 325000

  • Shaanxi Provincial PeopleS Hospital /ID# 259529

    Xi'an, Shaanxi, 710054

  • The First Affiliated Hospital of Xiamen University /ID# 259576

    Xiamen, Fujian, 361003

  • Peking University First Hospital /ID# 258672

    Xicheng District, Beijing Municipality, 100034

  • Zhengzhou People's Hospital /ID# 258670

    Zhengzhou, Henan, 450012

  • Zhuzhou Central Hospital /ID# 260076

    Zhuzhou, Hunan, 412007

Other trials in China

Czechia11 sites

  • NeuroHK s.r.o. /ID# 257671

    Hradec Králové, 500 09

  • CCR Ostrava, s.r.o. /ID# 257743

    Ostrava, Ostrava-mesto, 702 00

  • Fakultni Nemocnice Ostrava /ID# 259023

    Ostrava, Ostrava-mesto, 708 52

  • Praglandia /ID# 257667

    Prague, Praha 5, 150 00

  • Clintrial s.r.o. /ID# 257663

    Prague, 100 00

  • DADO MEDICAL s.r.o. /ID# 257672

    Prague, 120 00

  • Axon Clinical, s.r.o. /ID# 259024

    Prague, 140 00

  • Fakultni Thomayerova nemocnice /ID# 259021

    Prague, 140 59

  • FORBELI s.r.o. /ID# 259019

    Prague, 160 00

  • INEP medical s.r.o. /ID# 257669

    Prague, 186 00

  • Vestra Clinics s.r.o. /ID# 259022

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Italy11 sites

  • ASL 1 Abruzzo - Ospedale SS. Filippo and Nicola /ID# 258590

    Avezzano, L Aquila, 67051

  • Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 261089

    Bologna, 40126

  • ASST degli Spedali Civili di Brescia /ID# 258594

    Brescia, 25123

  • ICOT Istituto Marco Pasquali /ID# 258621

    Latina, 04100

  • IRCCS Ospedale San Raffaele /ID# 258592

    Milan, Milano, 20132

  • Istituto Auxologico Italiano - Irccs /ID# 258623

    Milan, Milano, 20145

  • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 258589

    Pavia, 27100

  • Istituto Neurologico Mediterraneo Neuromed /ID# 258593

    Pozzilli, Isernia, 86077

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 258588

    Roma, 00128

  • Ospedale San Paolo - ASL2 /ID# 258622

    Savona, 17100

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258591

    Turin, Piedmont, 10126

Other trials in Italy

Japan11 sites

  • DOI Internal Medicine-Neurology Clinic /ID# 259009

    Hiroshima, 730-0031

  • Tokyo Dental College Ichikawa General Hospital /ID# 259570

    Ichikawa-shi, Chiba, 272-0824

  • Nagaseki Headache Clinic /ID# 259214

    Kai, Yamanashi, 400-0124

  • Ikeda Neurosurgical Clinic /ID# 259085

    Kasuga-shi, Fukuoka, 816-0824

  • Umenotsuji Clinic /ID# 258717

    Kochi, Kochi, 780-8011

  • Tatsuoka Neurology Clinic /ID# 258771

    Kyoto, 600-8811

  • Tominaga Clinic - Osaka /ID# 258553

    Osaka, Osaka, 556-0015

  • Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 262708

    Sapporo, Hokkaido, 003-0003

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862

    Sendai, Miyagi, 982-0014

  • Usuda Clinic Of Internal Medicine /ID# 260422

    Setagaya-ku, Tokyo, 156-0043

  • Tokyo Headache Clinic /ID# 258534

    Shibuya-ku, Tokyo, 151-0051

Other trials in Japan

United Kingdom11 sites

  • Re:Cognition Health Birmingham /ID# 258186

    Birmingham, B16 8LT

  • Re:Cognition Health Bristol /ID# 258187

    Bristol, BS32 4SY

  • St Pancras Clinical Research - Chester /ID# 277704

    Chester, Cheshire, CH2 1HX

  • Ashgate Medical Practice /ID# 258923

    Chesterfield, Derbyshire, S40 4AA

  • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 259384

    Glasgow, Lanarkshire, G51 4TF

  • Re:Cognition Health - Guildford /ID# 258188

    Guildford, GU2 7YD

  • St Pancras Clinical Research - London /ID# 258183

    London, Greater London, EC2Y 8EA

  • North Coast Medical Ltd - Newquay Health Centre /ID# 260019

    Newquay, Cornwall, TR7 1RU

  • The University of Nottingham Health Service /ID# 259380

    Nottingham, NG7 2QW

  • The Adam Practice /ID# 258190

    Poole, Dorset, BH15 4JQ

  • Primary Care Sheffield /ID# 259448

    Sheffield, S9 4EU

Other trials in United Kingdom

Germany10 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 258076

    Berlin, 10117

  • Universitaetsklinikum Duesseldorf /ID# 258078

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Essen /ID# 258023

    Essen, 45147

  • Kopfschmerzzentrum - Frankfurt /ID# 258019

    Frankfurt am Main, Hesse, 65929

  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 258008

    Kassel, 34131

  • Schmerzklinik Kiel /ID# 258005

    Kiel, Schleswig-Holstein, 24149

  • Ambenet Hausarztpraxis /ID# 258075

    Leipzig, Saxony, 04107

  • Neuropraxis Muenchen Sued /ID# 258077

    Unterhaching, Bavaria, 82008

  • Studienzentrum Nord-West /ID# 258024

    Westerstede, Lower Saxony, 26655

  • Velocity Clinical Research - Wiesbaden /ID# 258020

    Wiesbaden, Hesse, 65189

Other trials in Germany

Poland10 sites

  • Vitamed Galaj i Cichomski Sp.j. /ID# 258278

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Athleticomed Sp. z o.o /ID# 258253

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752

  • Silmedic Sp. z o.o. /ID# 258249

    Katowice, Silesian Voivodeship, 40-282

  • Linden Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa /ID# 258283

    Krakow, Lesser Poland Voivodeship, 30-105

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281

    Lublin, Lublin Voivodeship, 20-582

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Solumed Centrum Medyczne /ID# 258288

    Poznan, Greater Poland Voivodeship, 60-529

  • Clinical Research Center Medic-R /ID# 258268

    Poznan, Greater Poland Voivodeship, 60-848

  • Penta Hospitals Badania Kliniczne /ID# 258250

    Wroclaw, Lower Silesian Voivodeship, 54-429

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287

    Wroclaw, 52-210

Other trials in Poland

Belgium8 sites

  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 257585

    Bruges, West-Vlaanderen, 8000

  • Universitair Ziekenhuis Antwerpen /ID# 257582

    Edegem, Antwerpen, 2650

  • Jessa Ziekenhuis /ID# 257578

    Hasselt, Limburg, 3500

  • Universitair Ziekenhuis Brussel /ID# 257584

    Jette, Brussels Capital, 1090

  • AZ Groeninge /ID# 257586

    Kortrijk, 8500

  • CHR de la Citadelle /ID# 257587

    Liège, 4000

  • H.-Hartziekenhuis Lier /ID# 257577

    Lier, 2500

  • Cabinet Prive Dr Sava /ID# 257581

    Saint-Nicolas, Liege, 4420

Other trials in Belgium

Spain8 sites

  • Hospital Universitario Vall de Hebron /ID# 257652

    Barcelona, 08035

  • Hospital Universitario La Paz /ID# 257654

    Madrid, 28046

  • Clinica Universidad de Navarra - Pamplona /ID# 257656

    Pamplona, Navarre, 31008

  • Hospital Universitario Marques de Valdecilla /ID# 257658

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio /ID# 257657

    Seville, 41013

  • Hospital Universitario y Politecnico La Fe /ID# 257655

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid /ID# 257653

    Valladolid, 47003

  • Hospital Clinico Universitario Lozano Blesa /ID# 257661

    Zaragoza, 50009

Other trials in Spain

Hungary6 sites

  • Cortex Study Center /ID# 259032

    Budapest, 1026

  • Semmelweis Egyetem /ID# 258546

    Budapest, 1085

  • Semmelweis Egyetem /ID# 258800

    Budapest, 1085

  • UNO Medical Trials /ID# 259186

    Budapest, 1135

  • S-Medicon Kft /ID# 258547

    Budapest, 1138

  • Javorszky Odon Korhaz /ID# 258969

    Vác, Pest County, 2600

Other trials in Hungary

Portugal6 sites

  • Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987

    Almada, Setúbal District, 2805-267

  • Unidade Local de Saude do Alto Ave, EPE /ID# 257986

    Guimarães, Braga District, 4835-044

  • Hospital da Luz Lisboa /ID# 257983

    Lisbon, 1500-650

  • Unidade Local de Saude de Santa Maria /ID# 257989

    Lisbon, 1649-035

  • Unidade Local de Saude de Santo Antonio /ID# 258140

    Porto, 4099-003

  • Unidade Local de Saude da Arrabida, EPE /ID# 258139

    Setúbal, 2910-446

Other trials in Portugal

Slovakia6 sites

  • MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901

    Banská Bystrica, 974 04

  • Univerzitna nemocnica - Nemocnica svateho Michala a.s. /ID# 257909

    Bratislava, Bratislava Region, 811 08

  • Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961

    Bratislava, Bratislava Region, 811 09

  • University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947

    Bratislava, Bratislava Region, 831 01

  • Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315

    Liptovský Mikuláš, Žilina Region, 031 23

  • Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176

    Prešov, Presov, 080 01

Other trials in Slovakia

South Korea6 sites

  • Chonnam National University Hospital /ID# 259154

    Gwangju, Gwangju Gwang Yeogsi, 61469

  • Hallym University Dongtan Sacred Heart Hospital /ID# 257999

    Hwaseong, Gyeonggido, 18450

  • Nowon Eulji Medical Center, Eulji University /ID# 258000

    Seoul, Seoul Teugbyeolsi, 01830

  • Seoul National University Hospital /ID# 258002

    Seoul, Seoul Teugbyeolsi, 03080

  • Kangbuk Samsung Hospital /ID# 258001

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 257998

    Seoul, 03722

Other trials in South Korea

Sweden5 sites

  • Karolinska Universitetssjukhuset - Huddinge /ID# 258837

    Huddinge, Stockholm County, 141 57

  • CTC EbbePark Linkoping /ID# 261170

    Linköping, 582 13

  • Skaneuro Privatmottagning /ID# 258833

    Lund, Skåne County, 227 33

  • Neurology Clinic /ID# 258835

    Stockholm, Stockholm County, 114 33

  • Optimuskliniken /ID# 258834

    Upplands Vasby, Stockholm County, 194 61

Other trials in Sweden

Taiwan5 sites

  • Kuang-Tien General Hospital /ID# 258063

    Taichung, Taichung, 433

  • China Medical University Hospital /ID# 258417

    Taichung, 40447

  • Tri-Service General Hospital /ID# 258064

    Taipei, 11490

  • Taipei Veterans General Hospital /ID# 258062

    Taipei City, Taipei, 11217

  • Linkou Chang Gung Memorial Hospital /ID# 259171

    Taoyuan City, 333

Other trials in Taiwan

About this study

Official title: 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.

Read more

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.

Conditions
Migraine
Being tested
Atogepant, Placebo for Atogepant
Keywords
Migraine, Atogepant, ECLIPSE, Qulipta, Aquipta
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Also called Qulipta, Aquipta

    Oral Tablet

  • Placebo for AtogepantDrug

    Oral Tablet

Study groups in NCT06241313
Study groupRoleWhat they receive
Sequence 1Placebo comparatorParticipants will receive both atogepant and placebo to treat qualifying migraines.
Receives: Drug: Atogepant; Drug: Placebo for Atogepant
Sequence 2ExperimentalParticipants will receive both atogepant and placebo to treat qualifying migraines.
Receives: Drug: Atogepant; Drug: Placebo for Atogepant
Sequence 3ExperimentalParticipants will receive both atogepant and placebo to treat qualifying migraines.
Receives: Drug: Atogepant; Drug: Placebo for Atogepant
Sequence 4ExperimentalParticipants will receive both atogepant and placebo to treat qualifying migraines.
Receives: Drug: Atogepant; Drug: Placebo for Atogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 16 Weeks

Secondary outcomes (22)

  1. 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.

    Measured: Approximately 16 Weeks

  2. 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.

    Measured: Approximately 16 Weeks

  3. 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.

    Measured: Approximately 16 Weeks

  4. 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.

    Measured: Approximately 16 Weeks

  5. 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.

    Measured: Approximately 16 Weeks

  6. 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.

    Measured: Approximately 16 Weeks

  7. 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.

    Measured: Approximately 16 Weeks

  8. 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.

    Measured: Approximately 16 Weeks

  9. 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.

    Measured: Approximately 16 Weeks

  10. 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.

    Measured: Approximately 16 Weeks

  11. 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.

    Measured: Approximately 16 Weeks

  12. 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.

    Measured: Approximately 16 Weeks

  13. 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.

    Measured: Approximately 16 Weeks

  14. 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.

    Measured: Approximately 16 Weeks

  15. 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.

    Measured: Approximately 16 Weeks

  16. 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.

    Measured: Approximately 16 Weeks

  17. 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.

    Measured: Approximately 16 Weeks

  18. 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.

    Measured: Approximately 16 Weeks

  19. 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.

    Measured: Approximately 16 Weeks

  20. 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.

    Measured: Approximately 16 Weeks

  21. 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.

    Measured: Approximately 16 Weeks

  22. 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.

    Measured: Approximately 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start25 Mar 2024
  3. Primary completion7 Jul 2025
  4. Study completion11 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06241313
Sponsor's protocol ID
M24-305
Other IDs
2023-506029-12-00, 2023
Acronym
ATO ACUTE
Status last verified
Sep 2026
First submitted
28 Jan 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Iannone LF, Silvestro M, Munafo A, Romozzi M, Geppetti P, Russo A. The pharmacology of gepants in migraine: A scoping review on mechanisms, clinical applications, and combination strategies. Headache. 2026 Jul-Aug;66(7):1628-1643. doi: 10.1111/head.70114. Epub 2026 Jun 9.

    PubMed 42265882

  • 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.

    PubMed 41920093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant in people with Migraine, run by AbbVie at 149 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in China, Czechia, Italy, Japan, United Kingdom and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack (time frame: Approximately 16 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06241313, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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